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Lee J, Park HS, Lee J, Choi KD, Kang DY, Ahn JM, Kim W, Lee JY, Lim YH, Kang SH, Kwon SU, Park H, Choi EK, Hong SJ, Kim BK, Jin ES, Jeong JO, Nam CW, Lee WS, Kim SM, Park KH, Her SH, Shin ES, Choi YJ, Yang TH, Kim SH, Suh JW, Park HC, Yoon YH, Yoon MH, Park SJ, Park DW, PROTECT-HBR Trial. Potassium-competitive acid blocker vs proton-pump inhibitor in patients receiving antithrombotic therapy who are at high risk for gastrointestinal bleeding: Rationale and design of the randomized PROTECT- HBR trial. Am Heart J 2025; 287:50-60. [PMID: 40188976 DOI: 10.1016/j.ahj.2025.04.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/18/2025] [Revised: 03/31/2025] [Accepted: 04/01/2025] [Indexed: 05/02/2025]
Abstract
BACKGROUND Concomitant use of proton pump inhibitor (PPI) is recommended in patients receiving chronic antithrombotic therapy who are at high risk of gastrointestinal (GI) bleeding. However, long-term safety and efficacy of chronic PPI use have been concerned. Potassium-competitive acid blocker (P-CAB) is a novel class of acid suppressants, providing more acid stability, rapid onset of action, less variability with CYP2C19 polymorphisms, and longer duration of action than PPI. DESIGN The PROTECT-HBR trial is a multicenter, randomized, double-blind, double-dummy, parallel-group clinical trial. Approximately 3320 patients with known cardiac or vascular disease receiving antithrombotic drugs (either antiplatelet or anticoagulant agents) and who are at high risk of GI bleeding will be randomized to P-CAB (tegoprazan 50mg once daily) or PPI (rabeprazole 20mg once daily) for up to 12 months. The primary endpoint is a composite outcome of upper GI clinical events, including overt or occult GI bleeding, symptomatic gastroduodenal ulcers or erosions, obstruction, or perforation, at 12 months. Secondary endpoints also included cardiovascular events and safety outcomes. RESULTS As of December 2024, approximately 1460 patients were enrolled from 32 participating sites in South Korea. The complete enrollment is anticipated at the mid- or late-term of 2025, and the primary results will be available by 2027. CONCLUSION PROTECT-HBR is a large-scale, multicenter, clinical trial, which will provide a pivotal comparison of the efficacy and safety of novel P-CAB, tegoprazan with those of PPI, rabeprazole in patients with documented cardiac or vascular disease receiving chronic antithrombotic drugs and at high risk of GI bleeding. CLINICAL TRIAL REGISTRATION Potassium-Competitive Acid Blocker versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High GastroIntestinal Bleeding Risk Receiving Antithrombotic Therapy (PROTECT-HBR): NCT04416581.
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Affiliation(s)
- Jinho Lee
- Division of Cardiology, Kyung Hee Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea
| | - Han-Su Park
- Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
| | - Junghoon Lee
- Department of Cardiology, Eunpyeong St. Mary's Hospital, Seoul, South Korea
| | - Kee Don Choi
- Division of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
| | - Do-Yoon Kang
- Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
| | - Jung-Min Ahn
- Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
| | - Weon Kim
- Division of Cardiology, Kyung Hee Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea
| | - Jong-Young Lee
- Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea
| | - Young-Hyo Lim
- Division of Cardiology, Department of Internal Medicine, College of Medicine, Hanyang University, Seoul, South Korea
| | - Se Hun Kang
- Department of Cardiology, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, South Korea
| | - Sung Uk Kwon
- Department of Cardiology, Ilsan-Paik Hospital, Inje University College of Medicine, Goyang, South Korea
| | - Hanbit Park
- Division of Cardiology, Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, South Korea
| | - Eue-Keun Choi
- Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea
| | - Soon Jun Hong
- Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Korea University College of Medicine, Seoul, South Korea
| | - Byeong-Keuk Kim
- Division of Cardiology, Severance Cardiovascular Hospital. Yonsei University College of Medicine, Seoul
| | - Eun-Sun Jin
- Department of Cardiology, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, South Korea
| | - Jin-Ok Jeong
- Division of Cardiology, Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, South Korea
| | - Chang-Wook Nam
- Division of Cardiology, Department of Internal Medicine, Cardiovascular Center, Keimyung University Dongsan Hospital, Keimyung University College of Medicine, Daegu, South Korea
| | - Wang Soo Lee
- Division of Cardiology, Department of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, South Korea
| | - Sang Min Kim
- Regional Cardiovascular Center, Division of Cardiology, Chungbuk National University Hospital, Cheongju, South Korea
| | - Kyoung-Ha Park
- Division of Cardiovascular Disease, Hallym University Medical Center, Anyang, South Korea
| | - Sung-Ho Her
- Department of Cardiology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, South Korea
| | - Eun-Seok Shin
- Division of Cardiology, Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea
| | - Young Jin Choi
- Department of Cardiology, Sejong General Hospital, Bucheon, South Korea
| | - Tae-Hyun Yang
- Department of Cardiology, Busan Paik Hospital, University of Inje College of Medicine, Busan, South Korea
| | - Sang-Hyun Kim
- Division of Cardiology, Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, South Korea
| | - Jung-Won Suh
- Department of Cardiology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea
| | - Hwan-Cheol Park
- Division of Cardiology, Department of Internal Medicine, Hanyang University Guri Hospital, Guri, South Korea
| | - Yong-Hoon Yoon
- Department of Cardiology, Chungnam National University Sejong Hospital, Chungnam National University School of Medicine, Sejong, South Korea
| | - Myeong-Ho Yoon
- Department of Cardiology, Ajou University School of Medicine, Suwon, South Korea
| | - Seung-Jung Park
- Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
| | - Duk-Woo Park
- Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
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Branzoli S, Marini M, Catanzariti D, Pravadelli C, Pannone L, D'Onghia G, Fantinel M, Guarracini F, Franceschini G, Zadro M, Baroni G, Casagrande S, Ottaviani D, Turco R, Nicolussi Paolaz S, Annicchiarico L, Corsini F, Rordorf R, Krishnadath K, Ravelli F, de Asmundis C, La Meir M. Patients with Gastrointestinal Bleeding and Atrial Fibrillation: Potential Ideal Target for Epicardial Appendage Occlusion. J Cardiovasc Dev Dis 2025; 12:173. [PMID: 40422944 DOI: 10.3390/jcdd12050173] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/07/2025] [Revised: 04/15/2025] [Accepted: 04/22/2025] [Indexed: 05/28/2025] Open
Abstract
BACKGROUND Gastrointestinal bleeding in patients with atrial fibrillation is an indication for left appendage occlusion. All endovascular devices mandate antithrombotic therapies: rebleeding risk remains an issue. To date, there are no reports on gastrointestinal rebleeding and stroke prevention by left appendage occlusion without any antithrombotic therapy in this category of patients. METHODS A total of 129 patients (male 85, mean age 76.6 ± 7.1, CHA2DS2Vasc 3.8 ± 1.5, HASBLED 3.3 ± 1.0; upper GI bleeding 10%, lower GI bleeding 86%, obscure occult 4.6%, on NOACS full dose 77.5%, NOACs reduced dose 13.1%, on anti-vitamin K 9.3%) with atrial fibrillation and history of repetitive gastrointestinal bleeding from ten centers underwent standalone thoracoscopic epicardial appendage closure without antithrombotic therapy for the entire follow up. RESULTS The observed bleeding rate was 0.91 events per year, equivalent to a relative risk of RR = 0.17 (p = 0.02) and a relative risk reduction (RRR) of 83%. The observed relative risk of stroke was 0.91 events per year, with a relative risk of RR = 0.19 (p = 0.03) and a relative risk reduction (RRR) of 81%. CONCLUSION Standalone epicardial appendage occlusion without antithrombotic therapy in patients with repetitive gastrointestinal bleeding is safe and promising when rebleeding and stroke risk reduction need to be optimized.
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Affiliation(s)
- Stefano Branzoli
- Cardiac Surgery Unit, Santa Chiara Hospital, Largo Medaglie d'Oro, 38122 Trento, Italy
- Cardiac Surgery Department, Universitair Ziekenhuis, Av du Laerbeek 101, 1090 Brussel, Belgium
| | - Massimiliano Marini
- Department of Cardiology, Santa Chiara Hospital, Largo Medaglie d'Oro, 38122 Trento, Italy
- Heart Rhythm Management Center, Universitair Ziekenhuis, Av du Laerbeek 101, 1090 Brussel, Belgium
| | - Domenico Catanzariti
- Department of Cardiology, Santa Maria del Carmine Hospital, Corso Verona 4, 38068 Rovereto, Italy
| | - Cecilia Pravadelli
- Department of Gastroenterology, Santa Chiara Hospital, Largo Medaglie d'Oro, 38122 Trento, Italy
| | - Luigi Pannone
- Heart Rhythm Management Center, Universitair Ziekenhuis, Av du Laerbeek 101, 1090 Brussel, Belgium
| | - Giovanni D'Onghia
- Department of Cardiology, Santa Chiara Hospital, Largo Medaglie d'Oro, 38122 Trento, Italy
| | - Mauro Fantinel
- Department of Cardiology, Santa Maria Hospital, Via Bagnols sur Ceze, 32032 Feltre, Italy
| | - Fabrizio Guarracini
- Department of Cardiology, Niguarda Hospital, Piazza Ospedale Maggiore, 20162 Milano, Italy
| | - Gaia Franceschini
- Department of Gastroenterology, Santa Chiara Hospital, Largo Medaglie d'Oro, 38122 Trento, Italy
| | - Mirco Zadro
- Cardiology Department, San Bassiano Hospital, Via Lotti, 36061 Bassano, Italy
| | - Giulia Baroni
- Cardiology Department, San Bassiano Hospital, Via Lotti, 36061 Bassano, Italy
| | - Silvia Casagrande
- Neurology Unit, Santa Maria del Carmine Hospital, Corso Verona, 38068 Rovereto, Italy
| | - Donatella Ottaviani
- Neurology Unit, Santa Maria del Carmine Hospital, Corso Verona, 38068 Rovereto, Italy
| | - Renato Turco
- Geriatrics Department, Santa Chiara Hospital, Largo Medaglie d'Oro, 38122 Trento, Italy
| | - Serena Nicolussi Paolaz
- Geriatrics Department, Santa Maria del Carmine Hospital, Corso Verona, 38068 Rovereto, Italy
| | | | - Francesco Corsini
- Neurosurgery Unit, Santa Chiara Hospital, Largo Medaglie d'Oro, 38122 Trento, Italy
| | - Roberto Rordorf
- Department of Cardiology, IRCCS San Matteo, Via Golgi, 27100 Pavia, Italy
| | - Kausilia Krishnadath
- Gastroneterology Department, Universitair Ziekenhuis Antwerpen, 2650 Antwerp, Belgium
| | - Flavia Ravelli
- Laboratory of Biophysic and Translation Cardiology, Department of Cellular Computational and Integrative Biology (CIBIO), Centre for Medical Sciences (CISMed), University of Trento, 38123 Trento, Italy
| | - Carlo de Asmundis
- Heart Rhythm Management Center, Universitair Ziekenhuis, Av du Laerbeek 101, 1090 Brussel, Belgium
| | - Mark La Meir
- Cardiac Surgery Unit, Santa Chiara Hospital, Largo Medaglie d'Oro, 38122 Trento, Italy
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Butt N, Usmani MT, Mehak N, Mughal S, Qazi-Arisar FA, Mohiuddin G, Khan G. Risk factors and outcomes of peptic ulcer bleed in a Pakistani population: A single-center observational study. World J Gastrointest Pharmacol Ther 2024; 15:92305. [PMID: 38846968 PMCID: PMC11151881 DOI: 10.4292/wjgpt.v15.i3.92305] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/22/2024] [Revised: 04/24/2024] [Accepted: 05/20/2024] [Indexed: 05/27/2024] Open
Abstract
BACKGROUND Peptic ulcer disease (PUD) remains a significant healthcare burden, contributing to morbidity and mortality worldwide. Despite advancements in therapies, its prevalence persists, particularly in regions with widespread nonsteroidal anti-inflammatory drugs (NSAIDs) use and Helicobacter pylori infection. AIM To comprehensively analyse the risk factors and outcomes of PUD-related upper gastrointestinal (GI) bleeding in Pakistani population. METHODS This retrospective cohort study included 142 patients with peptic ulcer bleeding who underwent upper GI endoscopy from January to December 2022. Data on demographics, symptoms, length of stay, mortality, re-bleed, and Forrest classification was collected. RESULTS The mean age of patients was 53 years, and the majority was men (68.3%). Hematemesis (82.4%) and epigastric pain (75.4%) were the most common presenting symptoms. Most patients (73.2%) were discharged within five days. The mortality rates at one week and one month were 10.6% and 14.8%, respectively. Re-bleed within 24 h and seven days occurred in 14.1% and 18.3% of patients, respectively. Most ulcers were Forrest class (FC) III (72.5%). Antiplatelet use was associated with higher mortality at 7 and 30 d, while alternative medications were linked to higher 24-hour re-bleed rates. NSAID use was associated with more FC III ulcers. Re-bleed at 24 h and 7 d was strongly associated with one-week or one-month mortality. CONCLUSION Antiplatelet use and rebleeding increase the risk of early mortality in PUD-related upper GI bleeding, while alternative medicines are associated with early rebleeding.
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Affiliation(s)
- Nazish Butt
- Department of Gastroenterology, Jinnah Postgraduate Medical Centre, Karachi 75505, Sindh, Pakistan
| | - Muhammad Tayyab Usmani
- National Institute of Liver & GI Diseases, Dow University of Health Sciences, Karachi 75330, Sindh, Pakistan
| | - Nimrah Mehak
- Department of Gastroenterology, Jinnah Postgraduate Medical Centre, Karachi 75505, Sindh, Pakistan
| | - Saba Mughal
- School of Public Health, Dow University of Health Sciences, Karachi 75330, Sindh, Pakistan
| | - Fakhar Ali Qazi-Arisar
- National Institute of Liver & GI Diseases, Dow University of Health Sciences, Karachi 75330, Sindh, Pakistan
| | - Ghulam Mohiuddin
- Department of Gastroenterology, Jinnah Postgraduate Medical Centre, Karachi 75505, Sindh, Pakistan
| | - Gulzar Khan
- Department of Gastroenterology, Jinnah Postgraduate Medical Centre, Karachi 75505, Sindh, Pakistan
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Hao W, Liu A, Zhu H, Yu X, Chen G, Xu J. Risk factors and management of gastrointestinal bleeding in patients with or without antiplatelet and anticoagulation therapy: a multicenter real-world prospective study. BMC Gastroenterol 2024; 24:155. [PMID: 38714955 PMCID: PMC11077848 DOI: 10.1186/s12876-024-03238-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/05/2023] [Accepted: 04/23/2024] [Indexed: 05/12/2024] Open
Abstract
BACKGROUND Antiplatelet and anticoagulation drugs complicate acute gastrointestinal bleeding (GIB) patients. Limited data about the risk factors and patient management has been presented. This study explored the association between previous antiplatelet or anticoagulant drug usage and clinical outcomes in GIB patients to improve awareness further and optimize treatment. METHODS We conducted a multicenter, non-interventional, real-world prospective study in 106 hospitals in 23 provinces in China. GIB patients confirmed in the emergency department were included and were grouped according to previous drug histories. Univariate analysis, multivariate logistic regression, and multivariate stratification models were performed separately to investigate the associations. RESULTS A total of 2299 patients (57.23 ± 17.21 years old, 68.3% male) were included, of whom 20.1% and 2.9% received antiplatelet and anticoagulation therapy, respectively. The all-cause 28-day mortality rates in patients without antiplatelet or anticoagulants, patients undergoing antiplatelet treatment, and patients with anticoagulation therapy were 2.8%, 4.6%, and 10.5%, respectively. After adjusting for confounding factors, both antiplatelet [odd ratio (OR), 2.92; 95% confidence interval (CI), 1.48-5.76; p = 0.002] and anticoagulation therapy (OR, 8.87; 95% CI, 3.02-26.02; p < 0.001) were associated with higher 28-day mortality. In the subgroup analysis, blood transfusion, especially red blood cell transfusion, in patients undergoing antiplatelet and anticoagulation therapy was associated with a decreased death risk. CONCLUSION We confirmed an association between concurrent antiplatelet or anticoagulation therapy in GIB patients and elevated 28-day mortality. Blood transfusions could improve poor outcomes in such patients.
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Affiliation(s)
- Wenlin Hao
- Emergency Department, The State Key Laboratory for Complex, Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, 100730, China
| | - Anlei Liu
- Emergency Department, The State Key Laboratory for Complex, Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, 100730, China
| | - Huadong Zhu
- Emergency Department, The State Key Laboratory for Complex, Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, 100730, China
| | - Xuezhong Yu
- Emergency Department, The State Key Laboratory for Complex, Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, 100730, China
| | - Gang Chen
- Nephrology Department, The State Key Laboratory for Complex, Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, 100730, China.
| | - Jun Xu
- Emergency Department, The State Key Laboratory for Complex, Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, 100730, China.
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Rasmussen SL, Torp-Pedersen C, Gotschalck KA, Thorlacius-Ussing O. The effect of antithrombotic treatment on the fecal immunochemical test for colorectal cancer screening: a nationwide cross-sectional study. Endoscopy 2023; 55:444-455. [PMID: 36702131 DOI: 10.1055/a-1992-5598] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/28/2023]
Abstract
BACKGROUND : Screening for colorectal cancer (CRC) using the fecal immunochemical test (FIT) has been widely adopted. The use of antithrombotic treatment is increasing in the Western world. This study aimed to assess the effects of antithrombotic treatment on the FIT-based Danish national screening program for CRC. METHODS : This was a cross-sectional study of all individuals returning a FIT from 2014 until 2016. The effect of antithrombotic treatment on FIT positivity and the positive predictive value (PPV) were assessed using proportions and multivariable Poisson regression. RESULTS : Of 884 036 invited individuals, we identified 551 570 participants. A positive FIT was observed in 9052 of 77 007 individuals (11.8 %) receiving antithrombotic treatment compared with 28 387 of 474 587 individuals (6.0 %) receiving no treatment. The adjusted relative risk (RR) for a positive FIT was 1.59 (95 %CI 1.56-1.63) for any treatment. Nonvitamin K oral anticoagulants (NOACs) were associated with the largest increase in FIT positivity (adjusted RR 2.40, 95 %CI 2.48-2.54). The proportion of CRC detected at colonoscopy was slightly lower among patients on antithrombotic treatment (6.0 %, 95 %CI 5.5 %-6.6 %) than among treatment-naïve patients (6.4 %, 95 %CI 6.1 %-6.7 %). The PPV for CRC or high risk adenomas was decreased nearly twofold in patients treated with NOAC (adjusted RR 0.58, 95 %CI 0.51-0.66]). CONCLUSION : Antithrombotic treatment was associated with a decreased PPV in FIT-based CRC screening.
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Affiliation(s)
- Simon Ladefoged Rasmussen
- Department of Gastrointestinal Surgery, Aalborg University Hospital, Aalborg, Denmark.,Clinical Cancer Research Center, Aalborg University Hospital, Aalborg, Denmark.,Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
| | - Christian Torp-Pedersen
- Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.,Department of Clinical Investigation and Cardiology, Nordsjaellands Hospital Hillerød, Denmark
| | | | - Ole Thorlacius-Ussing
- Department of Gastrointestinal Surgery, Aalborg University Hospital, Aalborg, Denmark.,Clinical Cancer Research Center, Aalborg University Hospital, Aalborg, Denmark.,Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
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Magnetically-controlled Capsule Endoscopy for Assessment of Antiplatelet Therapy-induced Gastrointestinal Injury. J Am Coll Cardiol 2021; 79:116-128. [PMID: 34752902 DOI: 10.1016/j.jacc.2021.10.028] [Citation(s) in RCA: 44] [Impact Index Per Article: 11.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/07/2021] [Revised: 10/05/2021] [Accepted: 10/15/2021] [Indexed: 11/22/2022]
Abstract
BACKGROUND Gastrointestinal bleeding is the most frequent major complication of antiplatelet therapy. In patients at low bleeding risk, however, clinically overt gastrointestinal bleeding is relatively uncommon. OBJECTIVE We sought to assess the effects of different antiplatelet regimens on gastrointestinal mucosal injury using a novel magnetically-controlled capsule endoscopy system in patients at low bleeding risk. METHODS Patients (n=505) undergoing percutaneous coronary intervention in whom capsule endoscopy demonstrated no ulcerations or bleeding (although erosions were permitted) after 6 months of dual antiplatelet therapy (DAPT) were randomly assigned to aspirin plus placebo (n=168), clopidogrel plus placebo (n=169), or aspirin plus clopidogrel (n=168) for an additional 6 months. The primary endpoint was the incidence of gastrointestinal mucosal injury (erosions, ulceration, or bleeding) at 6-month or 12-month capsule endoscopy. RESULTS Gastrointestinal mucosal injury through 12 months was less with single antiplatelet therapy (SAPT) compared with DAPT (94.3% vs. 99.2%, P=0.02). Aspirin and clopidogrel monotherapy had similar effects. Among 68 patients without any gastrointestinal injury at randomization (including no erosions), SAPT compared with DAPT caused less gastrointestinal injury (68.1% vs. 95.2%, P=0.006), including fewer new ulcers (8.5% vs. 38.1%, P=0.009). Clinical gastrointestinal bleeding between 6 and 12 months was less with SAPT compared with DAPT (0.6% vs. 5.4%, P=0.001). CONCLUSIONS Despite being at low risk of bleeding, nearly all patients receiving antiplatelet therapy developed gastrointestinal injury, although overt bleeding was infrequent. DAPT for 6 months followed by SAPT with aspirin or clopidogrel between 6 and 12 months resulted in less gastrointestinal mucosal injury and clinical bleeding compared with DAPT through 12 months.
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Predicting major bleeding among hospitalized patients using oral anticoagulants for atrial fibrillation after discharge. PLoS One 2021; 16:e0246691. [PMID: 33657116 PMCID: PMC7928472 DOI: 10.1371/journal.pone.0246691] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/04/2020] [Accepted: 01/23/2021] [Indexed: 11/19/2022] Open
Abstract
Aim Real-world predictors of major bleeding (MB) have been well-studied among warfarin users, but not among all direct oral anticoagulant (DOAC) users diagnosed with atrial fibrillation (AF). Thus, our goal was to build a predictive model of MB for new users of all oral anticoagulants (OAC) with AF. Methods We identified patients hospitalized for any cause and discharged alive in the community from 2011 to 2017 with a primary or secondary diagnosis of AF in Quebec’s RAMQ and Med-Echo administrative databases. Cohort entry occurred at the first OAC claim. Patients were categorized according to OAC type. Outcomes were incident MB, gastrointestinal bleeding (GIB), non-GI extracranial bleeding (NGIB) and intracranial bleeding within 1 year of follow-up. Covariates included age, sex, co-morbidities (within 3 years before cohort entry) and medication use (within 2 weeks before cohort entry). We used logistic-LASSO and adaptive logistic-LASSO regressions to identify MB predictors among OAC users. Discrimination and calibration were assessed for each model and a global model was selected. Subgroup analyses were performed for MB subtypes and OAC types. Results Our cohort consisted of 14,741 warfarin, 3,722 dabigatran, 6,722 rivaroxaban and 11,196 apixaban users aged 70–86 years old. The important MB predictors were age, prior MB and liver disease with ORs ranging from 1.37–1.64. The final model had a c-statistic of 0.63 (95% CI 0.60–0.65) with adequate calibration. The GIB and NGIB models had similar c-statistics of 0.65 (95% CI 0.63–0.66) and 0.67 (95% CI 0.64–0.70), respectively. Conclusions MB and MB subtype predictors were similar among DOAC and warfarin users. The predictors selected by our models and their discriminative potential are concordant with published data. Thus, these models can be useful tools for future pharmacoepidemiologic studies involving older oral anticoagulant users with AF.
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Arai J, Kato J, Toda N, Kurokawa K, Shibata C, Kurosaki S, Funato K, Kondo M, Takagi K, Kojima K, Ohki T, Seki M, Tagawa K. Risk factors of poor prognosis and impairment of activities of daily living in patients with hemorrhagic gastroduodenal ulcers. BMC Gastroenterol 2021; 21:16. [PMID: 33407172 PMCID: PMC7789673 DOI: 10.1186/s12876-020-01580-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/28/2020] [Accepted: 12/13/2020] [Indexed: 11/10/2022] Open
Abstract
Background Impairment of activities of daily living (ADL) due to hemorrhagic gastroduodenal ulcers (HGU) has rarely been evaluated. We analyzed the risk factors of poor prognosis, including mortality and impairment of ADL, in patients with HGU. Methods In total, 582 patients diagnosed with HGU were retrospectively analyzed. Admission to a care facility or the need for home adaptations during hospitalization were defined as ADL decline. The clinical factors were evaluated: endoscopic features, need for interventional endoscopic procedures, comorbidities, symptoms, and medications. The risk factors of outcomes were examined with multivariate analysis. Results Advanced age (> 75 years) was a significant predictor of poor prognosis, including impairment of ADL. Additional significant risk factors were renal disease (odds ratio [OR] 3.43; 95% confidence interval [CI] 1.44–8.14) for overall mortality, proton pump inhibitor (PPIs) usage prior to hemorrhage (OR 5.80; 95% CI 2.08–16.2), and heart disease (OR 3.05; 95% CI 1.11–8.43) for the impairment of ADL. Analysis of elderly (> 75 years) subjects alone also revealed that use of PPIs prior to hemorrhage was a significant predictor for the impairment of ADL (OR 8.24; 95% CI 2.36–28.7). Conclusion In addition to advanced age, the presence of comorbidities was a risk of poor outcomes in patients with HGU. PPI use prior to hemorrhage was a significant risk factor for the impairment of ADL, both in overall HGU patients and in elderly patients alone. These findings suggest that the current strategy for PPI use needs reconsideration.
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Affiliation(s)
- Junya Arai
- Department of Gastroenterology, Mitsui Memorial Hospital, 1 Kanda-Izumi-cho, Chiyoda-ku, Tokyo, 101-8643, Japan
| | - Jun Kato
- Department of Gastroenterology, Mitsui Memorial Hospital, 1 Kanda-Izumi-cho, Chiyoda-ku, Tokyo, 101-8643, Japan
| | - Nobuo Toda
- Department of Gastroenterology, Mitsui Memorial Hospital, 1 Kanda-Izumi-cho, Chiyoda-ku, Tokyo, 101-8643, Japan.
| | - Ken Kurokawa
- Department of Gastroenterology, Mitsui Memorial Hospital, 1 Kanda-Izumi-cho, Chiyoda-ku, Tokyo, 101-8643, Japan
| | - Chikako Shibata
- Department of Gastroenterology, Mitsui Memorial Hospital, 1 Kanda-Izumi-cho, Chiyoda-ku, Tokyo, 101-8643, Japan
| | - Shigeyuki Kurosaki
- Department of Gastroenterology, Mitsui Memorial Hospital, 1 Kanda-Izumi-cho, Chiyoda-ku, Tokyo, 101-8643, Japan
| | - Kazuyoshi Funato
- Department of Gastroenterology, Mitsui Memorial Hospital, 1 Kanda-Izumi-cho, Chiyoda-ku, Tokyo, 101-8643, Japan
| | - Mayuko Kondo
- Department of Gastroenterology, Mitsui Memorial Hospital, 1 Kanda-Izumi-cho, Chiyoda-ku, Tokyo, 101-8643, Japan
| | - Kaoru Takagi
- Department of Gastroenterology, Mitsui Memorial Hospital, 1 Kanda-Izumi-cho, Chiyoda-ku, Tokyo, 101-8643, Japan
| | - Kentaro Kojima
- Department of Gastroenterology, Mitsui Memorial Hospital, 1 Kanda-Izumi-cho, Chiyoda-ku, Tokyo, 101-8643, Japan
| | - Takamasa Ohki
- Department of Gastroenterology, Mitsui Memorial Hospital, 1 Kanda-Izumi-cho, Chiyoda-ku, Tokyo, 101-8643, Japan
| | - Michiharu Seki
- Department of Gastroenterology, Mitsui Memorial Hospital, 1 Kanda-Izumi-cho, Chiyoda-ku, Tokyo, 101-8643, Japan
| | - Kazumi Tagawa
- Department of Gastroenterology, Mitsui Memorial Hospital, 1 Kanda-Izumi-cho, Chiyoda-ku, Tokyo, 101-8643, Japan
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Chang TY, Chan YH, Chiang CE, Lin YJ, Chang SL, Lo LW, Hu YF, Tuan TC, Liao JN, Chung FP, Chen TJ, Lip GY, Chen SA, Chao TF. Risks and outcomes of gastrointestinal malignancies in anticoagulated atrial fibrillation patients experiencing gastrointestinal bleeding: A nationwide cohort study. Heart Rhythm 2020; 17:1745-1751. [DOI: 10.1016/j.hrthm.2020.05.026] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/09/2020] [Revised: 05/05/2020] [Accepted: 05/14/2020] [Indexed: 01/16/2023]
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Bang CS, Joo MK, Kim BW, Kim JS, Park CH, Ahn JY, Lee JH, Lee BE, Yang HJ, Cho YK, Park JM, Kim BJ, Jung HK, Korean College of Helicobacter and Upper Gastrointestinal Research. The Role of Acid Suppressants in the Prevention of Anticoagulant-Related Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis. Gut Liver 2020; 14:57-66. [PMID: 30974930 PMCID: PMC6974330 DOI: 10.5009/gnl19009] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/04/2019] [Revised: 02/01/2019] [Accepted: 02/13/2019] [Indexed: 12/11/2022] Open
Abstract
Background/Aims: Although acid suppressants are widely used for the prevention or treatment of drug-induced upper gastrointestinal bleeding (GIB), evidence regarding the prevention of anticoagulant-related GIB is scarce. The aim of this study was to evaluate the protective effect of acid suppressants against anticoagulant-related GIB. Methods: A systematic review was conducted of studies that evaluated the protective effect of acid suppressants against anticoagulant-related GIB found in PubMed, the Cochrane library, Embase, and KoreaMed from the date of database inception to April 2018. Random effect model meta-analyses with sensitivity analyses were conducted. The methodological quality of each included publication was evaluated using the Risk of Bias Assessment Tool for Nonrandomized Studies. Publication bias was assessed. Results: In total, six nested case-control or cohort studies were identified and analyzed. Proton-pump inhibitors (PPI) had a protective effect against upper GIB in patients on dicumarinics (risk ratio [RR], 0.56; 95% confidence interval [CI], 0.38 to 0.83; I2, 0%); however, the histamine-2 receptor antagonist did not have the same effect (RR, 0.97; 95% CI, 0.52 to 1.81; I2, 0%). Acid suppressants did not have a protective effect against GIB in patients on dabigatran (hazard ratio, 0.78; 95% CI, 0.44 to 1.37; I2, 81.8%). Conclusions: The protective effect of PPIs against dicumarinics-related upper GIB was clear, while there was no evidence supporting the protective effect of acid suppressants against dabigatran-related GIB. However, in the absence of randomized trials demonstrating a lack of bias, solid conclusions cannot be drawn.
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Affiliation(s)
- Chang Seok Bang
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon,
Korea
| | - Moon Kyung Joo
- Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul,
Korea
| | - Byung-Wook Kim
- Department of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul,
Korea
| | - Joon Sung Kim
- Department of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul,
Korea
| | - Chan Hyuk Park
- Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri,
Korea
| | - Ji Yong Ahn
- Division of Gastroenterology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul,
Korea
| | - Jeong Hoon Lee
- Division of Gastroenterology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul,
Korea
| | - Bong Eun Lee
- Department of Internal Medicine, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan,
Korea
| | - Hyo-Joon Yang
- Division of Gastroenterology, Department of Internal Medicine and Gastrointestinal Cancer Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul,
Korea
| | - Yu Kyung Cho
- Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul,
Korea
| | - Jae Myung Park
- Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul,
Korea
| | - Beom Jin Kim
- Department of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul,
Korea
| | - Hye-Kyung Jung
- Department of Internal Medicine, Ewha Medical Research Institute, Ewha Womans University School of Medicine, Seoul,
Korea
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11
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Mangiafico S, Pigò F, Bertani H, Caruso A, Grande G, Sgamato C, Manta R, Conigliaro R. Over-the-scope clip vs epinephrine with clip for first-line hemostasis in non-variceal upper gastrointestinal bleeding: a propensity score match analysis. Endosc Int Open 2020; 8:E50-E58. [PMID: 31921984 PMCID: PMC6949178 DOI: 10.1055/a-1005-6401] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/05/2019] [Accepted: 07/29/2019] [Indexed: 02/07/2023] Open
Abstract
Background and study aims The over-the-scope clip (OTSC) is a novel tool used to improve the maintenance of hemostasis for non-variceal upper gastrointestinal bleeding (NVUGIB); however, studies on the comparison with "conventional" techniques are lacking. In this study, we aimed to compare first-line endoscopic hemostasis achieved using conventional techniques with that achieved using OTSC placement for NVUGIB. Patients and methods From January 2007 to March 2018, 793 consecutive patients underwent upper endoscopy with the hemostasis procedure. Among them, 327 patients were eligible for inclusion (112 patients had OTSC placement and 215 underwent conventional hemostasis). After propensity score matching and adjustment for confounding factors, 84 patients were stratified into the "conventional" group and 84 into the OTSC group. Patient characteristics and outcomes (rebleeding rate, mortality rate within 30 days, and adverse events) were compared between the two groups. Results In the unmatched cohort, hemostasis with OTSC was more frequent in cases of duodenal ulcers with Forrest Ia to IIa and in patients with a higher Rockall score compared with the "conventional group". In the matched cohort, 93 % of the patients in the "conventional group" underwent hemostasis with epinephrine + through-the-scope clip. Rebleeding events were significantly less frequent in the OTSC group (8 % vs 20 %, 95 %CI 3 - 16 vs 12 - 30; P = 0.02); however, the mortality rate in the two groups was not significantly different (6 % vs 2 %, 95 %CI 1 - 8 vs 2 - 13; P = 0.4). Conclusions OTSC is a safe and effective tool for achieving hemostasis, and we recommend its use as the first-line therapy for lesions with a high risk of rebleeding and in patients with a high risk Rockall score.
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Affiliation(s)
- Santi Mangiafico
- Azienda Ospedaliero-Universitaria di Modena Ospedale Civile di Baggiovara, Gastroenterology and Digestive Endoscopy Unit, Modena, Italy
| | - Flavia Pigò
- Azienda Ospedaliero-Universitaria di Modena Ospedale Civile di Baggiovara, Gastroenterology and Digestive Endoscopy Unit, Modena, Italy
| | - Helga Bertani
- Azienda Ospedaliero-Universitaria di Modena Ospedale Civile di Baggiovara, Gastroenterology and Digestive Endoscopy Unit, Modena, Italy
| | - Angelo Caruso
- Azienda Ospedaliero-Universitaria di Modena Ospedale Civile di Baggiovara, Gastroenterology and Digestive Endoscopy Unit, Modena, Italy
| | - Giuseppe Grande
- Azienda Ospedaliero-Universitaria di Modena Ospedale Civile di Baggiovara, Gastroenterology and Digestive Endoscopy Unit, Modena, Italy
| | - Costantino Sgamato
- University of Naples Federico II, Department of Clinical Medicine and Surgery, Gastroenterology Unit, Naples, Italy
| | - Raffaele Manta
- Azienda Ospedaliera di Perugia, Gastroenterology and Digestive Endoscopy Unit, Perugia, Italy
| | - Rita Conigliaro
- Azienda Ospedaliero-Universitaria di Modena Ospedale Civile di Baggiovara, Gastroenterology and Digestive Endoscopy Unit, Modena, Italy
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Abstract
Gastrointestinal bleeding (GIB) is a common complication that occurs after stroke, and GIB may negatively affect patient prognosis. In this study, we aimed to examine:(1) the risk factors of GIB in acute cerebral infarction patients;(2) association between GIB and 1-year mortality in patients with acute cerebral infarction.Patients with acute cerebral infarction were divided into 2 groups based on the occurrence of GIB during acute stroke stage. Patient characteristics, clinical presentation, stroke risk factors, comorbidities, laboratory data, medication, and outcomes were investigated to analyze the associations between the variables and the probability of having GIB. In addition, patients in the study were matched individually by age, gender. A 1:1 matched case-control method and conditional logistic regression models for single and multiple factors were used to assess the risk factors of GIB in acute cerebral infarction patients.Clinical data of patients with acute cerebral infarction were reviewed and analyzed during the years 2015 and 2016. Finally, 1662 patients with acute cerebral infarction were included in this study, of whom 139 (8.5%) patients had GIB at admission. Multivariate logistic regression analysis revealed that the independent risk factors for GIB in patients with acute cerebral infarction were advanced age (OR = 1.030, P = .009), low Glasgow Coma Scale (GSC) score (OR = 0.850, P = .014), infection (OR = 4.693, P < .001), high NIHSS score (OR = 1.114, P = .001), and posterior circulation infarction (OR = 4.981, P = .010). The case-control study ultimately included 136 case-control pairs. Stepwise conditional regression analyses revealed that the independent risk factors for GIB in patients with acute cerebral infarction were low Glasgow Coma Scale (GSC) score (RR = 0.645, P = .011), infection (RR = 15.326, P = .001), and posterior circulation infarction (RR = 6.129, P = .045). The group with GIB had a higher rate of mortality and disability level (mRS grade ≥ 4) than the group without GIB (P < .001) within 1 year after stroke. In addition, independent risk factors of death within 1 year after stroke in patients were GIB (OR = 6.096, P < .001), infection (OR = 4.493, P < .001), mRS grade ≥ 4 (OR = 4.129, P < .001), and coronary heart disease (OR = 3.718, P = .001).GIB is a common complication after ischemic stroke. These identified factors may help clinicians identify risks of GIB before it develops. GIB is associated with increased risk of 1-year mortality and poor functional outcome in acute cerebral infarction patients.
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Welden CV, Truss W, McGwin G, Weber F, Peter S. Clinical Predictors for Repeat Hospitalizations in Left Ventricular Assist Device (LVAD) Patients With Gastrointestinal Bleeding. Gastroenterology Res 2018; 11:100-105. [PMID: 29707076 PMCID: PMC5916633 DOI: 10.14740/gr972w] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/02/2018] [Accepted: 03/01/2018] [Indexed: 02/07/2023] Open
Abstract
Background Patients implanted with left ventricular assist devices (LVAD) carry an increased risk of gastrointestinal bleeding (GIB), estimated at 25% in most studies. Significant efforts are employed in localizing and stopping the source of bleeding, but the rates of repeat hospitalization for GIB remain surprisingly high. Given the increasing incidence of LVAD-dependent end-stage heart failure and the excessive costs associated with repetitive endoscopic investigations, risk factors associated with re-bleeding need to be determined. The aim of our study was to investigate clinical predictors associated with repeat hospitalizations for GIB in patients implanted with a LVAD. Methods We conducted a retrospective cohort using the prospectively assembled ventricular assist device database at the University of Alabama at Birmingham. We identified all end-stage heart failure patients who were implanted with a continuous-flow (CF) LVAD between Jan 1, 2009 and Dec 31, 2013. We excluded pulsatile devices, biventricular assist devices (BiVADs), right ventricular assist devices (RVADs), and patients under 19 years of age. Results There were 102 patients implanted with a CF-LVAD within the specified time period. With an average follow-up of 127 weeks, 32 (31.4%) patients developed GIB requiring 79 separate hospitalizations. Average time from LVAD implantation to first bleed was 343 days. The re-bleeding rate requiring readmission was 56.3% in those admitted with GIB, with eight (25%) of the patients necessitating multiple readmissions. The average hospital stay for a primary diagnosis of GIB was 9.45 days. Totally, 68 (86%) patients required endoscopic evaluation during their hospitalization, with 35 (44%) necessitating multiple procedures during the same admission. The average time to first endoscopy was 2.5 days with a median of 2 days. Patients receiving early endoscopy (< 48 h from admission) were 57% less likely to require future readmission for GIB compared to patients undergoing late endoscopy (> 48 h) (OR: 0.43, CI: 0.19 - 0.9). Other factors associated with repeat admissions for GIB included indication for LVAD (bridge to transplant had OR: 0.07, CI: 0.02 - 0.27), male gender (OR: 10.4, CI: 1.8 - 59), length of initial hospital stay (OR: 0.83, CI: 0.71 - 0.97), and INR on admission (OR: 3.6, CI: 1.46 - 8.8). Although not statistically significant, patients undergoing subsequent endoscopies during a single admission were 84% less likely to develop re-bleeding in the future (OR: 0.158, CI: 0.025 - 1.02). Conclusions GIB in LVAD patients is a significant problem with high rates of readmission despite extensive endoscopic investigations and anticoagulant adjustments. Our experience revealed that early endoscopy, longer initial hospital stay, and better INR control were all associated with decreased rates of readmission for GIB in this population. These modifiable factors should be emphasized and addressed in the future to reduce the burdens associated with repeated hospitalizations.
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Affiliation(s)
| | - Wiley Truss
- Univeristy of Alabama at Birmingham, Birmingham, Al 35203, USA
| | - Gerald McGwin
- Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Al 35294, USA
| | - Frederick Weber
- Department of Gastroenterology and Hepatology, University of Alabama at Birmingham, Birmingham, Al 35233, USA
| | - Shajan Peter
- Department of Gastroenterology and Hepatology, University of Alabama at Birmingham, Birmingham, Al 35233, USA
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Dignass A, Farrag K, Stein J. Limitations of Serum Ferritin in Diagnosing Iron Deficiency in Inflammatory Conditions. Int J Chronic Dis 2018; 2018:9394060. [PMID: 29744352 PMCID: PMC5878890 DOI: 10.1155/2018/9394060] [Citation(s) in RCA: 118] [Impact Index Per Article: 16.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/03/2017] [Revised: 01/09/2018] [Accepted: 02/06/2018] [Indexed: 12/16/2022] Open
Abstract
Patients with inflammatory conditions such as inflammatory bowel disease (IBD), chronic heart failure (CHF), and chronic kidney disease (CKD) have high rates of iron deficiency with adverse clinical consequences. Under normal circumstances, serum ferritin levels are a sensitive marker for iron status but ferritin is an acute-phase reactant that becomes elevated in response to inflammation, complicating the diagnosis. Proinflammatory cytokines also trigger an increase in hepcidin, which restricts uptake of dietary iron and promotes sequestration of iron by ferritin within storage sites. Patients with inflammatory conditions may thus have restricted availability of iron for erythropoiesis and other cell functions due to increased hepcidin expression, despite normal or high levels of serum ferritin. The standard threshold for iron deficiency (<30 μg/L) therefore does not apply and transferrin saturation (TSAT), a marker of iron availability, should also be assessed. A serum ferritin threshold of <100 μg/L or TSAT < 20% can be considered diagnostic for iron deficiency in CHF, CKD, and IBD. If serum ferritin is 100-300 μg/L, TSAT < 20% is required to confirm iron deficiency. Routine surveillance of serum ferritin and TSAT in these at-risk groups is advisable so that iron deficiency can be detected and managed.
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Affiliation(s)
- Axel Dignass
- Department of Medicine 1, Agaplesion Markus Hospital, Goethe University, 60431 Frankfurt am Main, Germany
- Interdisciplinary Crohn Colitis Center Rhein-Main, 60594 Frankfurt am Main, Germany
| | - Karima Farrag
- Interdisciplinary Crohn Colitis Center Rhein-Main, 60594 Frankfurt am Main, Germany
- Department of Gastroenterology and Clinical Nutrition, DGD Clinics Sachsenhausen, 60594 Frankfurt am Main, Germany
| | - Jürgen Stein
- Interdisciplinary Crohn Colitis Center Rhein-Main, 60594 Frankfurt am Main, Germany
- Department of Gastroenterology and Clinical Nutrition, DGD Clinics Sachsenhausen, 60594 Frankfurt am Main, Germany
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Kawasaki K, Nakamura S, Kurahara K, Nagasue T, Yanai S, Harada A, Yaita H, Fuchigami T, Matsumoto T. Continuing use of antithrombotic medications for patients with bleeding gastroduodenal ulcer requiring endoscopic hemostasis: a case-control study. Scand J Gastroenterol 2017; 52:948-953. [PMID: 28532190 DOI: 10.1080/00365521.2017.1328989] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
OBJECTIVE The aim of this study was to compare clinical characteristics and outcomes of bleeding gastroduodenal ulcer between patients taking antithrombotic medications and those not taking antithrombotic medications. METHODS We performed a case-control study of 346 patients with endoscopically verified bleeding gastroduodenal ulcer, which included 173 cases taking antithrombotic medications throughout peri-bleeding period and 173 age- and sex-matched controls not taking antithrombotic medications. RESULTS The cases showed less frequent Helicobacter pylori (H. pylori) infections (45.1% versus 60.7%, p = .005), more frequent duodenal location (31.8% versus 19.1%, p = .009), and more frequent rebleeding (13.9% versus 5.8%, p = .02) than the controls. Multivariate analysis revealed that duodenal location (odds ratio [OR] 3.01, 95% confidence interval [CI] 1.37-6.65) and use of antithrombotic medications (OR 2.47, 95% CI 1.13-5.77) were independent factors for rebleeding. However, there were no differences in clinical outcomes, including final successful endoscopic hemostasis, need for surgical intervention, and mortality between cases and controls. Thromboembolic events did not occur in any cases and controls during the periendoscopic period. CONCLUSIONS Low prevalence of H. pylori infection, frequent duodenal location, and high rebleeding rate are characteristics of patients with bleeding gastroduodenal ulcer under antithrombotic medications. Continuation of antithrombotic medications can be accepted for bleeding gastroduodenal ulcer.
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Affiliation(s)
- Keisuke Kawasaki
- a Division of Gastroenterology, Department of Internal Medicine , Iwate Medical University , Morioka , Japan.,b Division of Gastroenterology , Matsuyama Red Cross Hospital , Matsuyama , Japan
| | - Shotaro Nakamura
- a Division of Gastroenterology, Department of Internal Medicine , Iwate Medical University , Morioka , Japan
| | - Koichi Kurahara
- b Division of Gastroenterology , Matsuyama Red Cross Hospital , Matsuyama , Japan
| | - Tomohiro Nagasue
- b Division of Gastroenterology , Matsuyama Red Cross Hospital , Matsuyama , Japan
| | - Shunichi Yanai
- a Division of Gastroenterology, Department of Internal Medicine , Iwate Medical University , Morioka , Japan
| | - Akira Harada
- b Division of Gastroenterology , Matsuyama Red Cross Hospital , Matsuyama , Japan
| | - Hiroki Yaita
- b Division of Gastroenterology , Matsuyama Red Cross Hospital , Matsuyama , Japan
| | - Tadahiko Fuchigami
- b Division of Gastroenterology , Matsuyama Red Cross Hospital , Matsuyama , Japan
| | - Takayuki Matsumoto
- a Division of Gastroenterology, Department of Internal Medicine , Iwate Medical University , Morioka , Japan
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Pasin F, Testa S, Capone P, Iiritano E, Grassia R. Gastrointestinal bleeding during Direct Oral AntiCoagulants-anticoagulant therapy. Is there nothing so bad that is not good for something? Eur J Intern Med 2017; 39:e25-e26. [PMID: 28242185 DOI: 10.1016/j.ejim.2017.02.020] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/07/2017] [Revised: 02/14/2017] [Accepted: 02/20/2017] [Indexed: 10/20/2022]
Affiliation(s)
| | - Sophie Testa
- Haemostasis and Thrombosis Center, ASST Cremona, Italy
| | - Pietro Capone
- Digestive Endoscopy and Gastroenterology Unit, ASST Cremona, Italy
| | - Elena Iiritano
- Digestive Endoscopy and Gastroenterology Unit, ASST Cremona, Italy
| | - Roberto Grassia
- Digestive Endoscopy and Gastroenterology Unit, ASST Cremona, Italy
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Risk of gastrointestinal bleeding with direct oral anticoagulants: a systematic review and network meta-analysis. Lancet Gastroenterol Hepatol 2017; 2:85-93. [DOI: 10.1016/s2468-1253(16)30162-5] [Citation(s) in RCA: 31] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/25/2016] [Revised: 10/10/2016] [Accepted: 10/12/2016] [Indexed: 12/31/2022]
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Souk KM, Tamim HM, Abu Daya HA, Rockey DC, Barada KA. Aspirin use for primary prophylaxis: Adverse outcomes in non-variceal upper gastrointestinal bleeding. World J Gastrointest Surg 2016; 8:501-507. [PMID: 27462392 PMCID: PMC4942750 DOI: 10.4240/wjgs.v8.i7.501] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/03/2016] [Revised: 04/21/2016] [Accepted: 05/10/2016] [Indexed: 02/06/2023] Open
Abstract
AIM To compare outcomes of patients with non-variceal upper gastrointestinal bleeding (NVUGIB) taking aspirin for primary prophylaxis to those not taking it. METHODS Patients not known to have any vascular disease (coronary artery or cerebrovascular disease) who were admitted to the American University of Beirut Medical Center between 1993 and 2010 with NVUGIB were included. The frequencies of in-hospital mortality, re-bleeding, severe bleeding, need for surgery or embolization, and of a composite outcome defined as the occurrence of any of the 4 bleeding related adverse outcomes were compared between patients receiving aspirin and those on no antithrombotics. We also compared frequency of in hospital complications and length of hospital stay between the two groups. RESULTS Of 357 eligible patients, 94 were on aspirin and 263 patients were on no antithrombotics (control group). Patients in the aspirin group were older, the mean age was 58 years in controls and 67 years in the aspirin group (P < 0.001). Patients in the aspirin group had significantly more co-morbidities, including diabetes mellitus and hypertension [25 (27%) vs 31 (112%) and 44 (47%) vs 74 (28%) respectively, (P = 0.001)], as well as dyslipidemia [21 (22%) vs 16 (6%), P < 0.0001). Smoking was more frequent in the aspirin group [34 (41%) vs 60 (27%), P = 0.02)]. The frequencies of endoscopic therapy and surgery were similar in both groups. Patients who were on aspirin had lower in-hospital mortality rates (2.1% vs 13.7%, P = 0.002), shorter hospital stay (4.9 d vs 7 d, P = 0.01), and fewer composite outcomes (10.6% vs 24%, P = 0.01). The frequencies of in-hospital complications and re-bleeding were similar in the two groups. CONCLUSION Patients who present with NVUGIB while receiving aspirin for primary prophylaxis had fewer adverse outcomes. Thus aspirin may have a protective effect beyond its cardiovascular benefits.
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Is Endoscopic Therapy Safe for Upper Gastrointestinal Bleeding in Anticoagulated Patients With Supratherapeutic International Normalized Ratios? Am J Ther 2016; 23:e995-e1003. [DOI: 10.1097/mjt.0000000000000002] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
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Teles Sampaio E, Maia L, Salgueiro P, Marcos-Pinto R, Dinis-Ribeiro M, Pedroto I. Antiplatelet agents and/or anticoagulants are not associated with worse outcome following nonvariceal upper gastrointestinal bleeding. REVISTA ESPANOLA DE ENFERMEDADES DIGESTIVAS 2016; 108:703-708. [DOI: 10.17235/reed.2016.4424/2016] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
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Lauffenburger JC, Rhoney DH, Farley JF, Gehi AK, Fang G. Predictors of gastrointestinal bleeding among patients with atrial fibrillation after initiating dabigatran therapy. Pharmacotherapy 2015; 35:560-8. [PMID: 26044889 DOI: 10.1002/phar.1597] [Citation(s) in RCA: 31] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Abstract
STUDY OBJECTIVES To identify demographic and clinical risk factors associated with gastrointestinal (GI) bleeding among a large cohort of patients with atrial fibrillation (AF) who initiated dabigatran therapy for stroke prevention, and to describe patterns of subsequent anticoagulant use after occurrence of the GI bleeding event. DESIGN Retrospective cohort study. DATA SOURCES Large, nationwide United States commercial insurance database. PATIENTS A total of 21,033 patients with nonvalvular AF who initiated dabigatran between October 19, 2010, and December 31, 2012. MEASUREMENTS AND MAIN RESULTS We used multivariate Cox regression analysis to estimate the effect of baseline demographic and clinical characteristics on the probability of a GI bleeding event. Patterns of anticoagulation use after GI bleeding were also examined descriptively. Of the 21,033 patients receiving dabigatran, 446 (2.1%) experienced a GI bleed during follow-up. GI bleeding rates differed across many baseline characteristics. Male sex was associated with a lower risk (adjusted hazard ratio [aHR] 0.78, 95% confidence interval [CI] 0.64-0.95) of GI bleeding. Compared with patients younger than 55 years, those aged 55-64, 65-74, and 75 years or older yielded aHRs of 1.54 (95% CI 0.89-2.68), 2.72 (95% CI 1.59-4.65), and 4.52 (95% CI 2.68-7.64), respectively. Renal impairment (aHR 1.67, 95% CI 1.24-2.25), heart failure (aHR 1.25, 95% CI 1.01-1.56), alcohol abuse (aHR 2.57, 95%CI 1.52-4.35), previous Helicobacter pylori infection (aHR 4.75, 95% CI 1.93-11.68), antiplatelet therapy (aHR 1.49, 95% CI 1.19-1.88), and digoxin use (aHR 1.49, 95% CI 1.19-1.88) were also associated with an increased GI bleeding risk. Of the 446 patients who experienced a GI bleed, 193 (43.3%) restarted an anticoagulant, with most (65.8%) filling prescriptions for dabigatran; the mean time was 50.4 days until restarting any subsequent anticoagulant. CONCLUSION The risk of GI bleeding in patients receiving dabigatran is highly associated with increased age and cardiovascular, renal, and other comorbidities, even after adjusting for other factors. Fewer than 50% of patients restarted an anticoagulant after experiencing a GI bleed. Clinicians should continue to monitor for these risk factors or consider whether alternative therapies may be appropriate.
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Affiliation(s)
- Julie C Lauffenburger
- Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
| | - Denise H Rhoney
- Division of Practice Advancement and Clinical Education, UNC Eshelman School of Pharmacy, Chapel Hill, North Carolina
| | - Joel F Farley
- Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
| | - Anil K Gehi
- Department of Cardiology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
| | - Gang Fang
- Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
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Effect of esomeprazole on gastroduodenal erosions in patients at increased gastrointestinal risk treated with low-dose acetylsalicylic acid: A post-hoc analysis of the OBERON trial. Int J Cardiol 2015; 182:500-2. [DOI: 10.1016/j.ijcard.2014.12.140] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/11/2014] [Accepted: 12/29/2014] [Indexed: 11/19/2022]
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Peptic ulcer diseases: genetics, mechanism, and therapies. BIOMED RESEARCH INTERNATIONAL 2014; 2014:898349. [PMID: 25610875 PMCID: PMC4290999 DOI: 10.1155/2014/898349] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 09/22/2014] [Accepted: 09/22/2014] [Indexed: 01/10/2023]
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Clemens A, Strack A, Noack H, Konstantinides S, Brueckmann M, Lip GYH. Anticoagulant-related gastrointestinal bleeding--could this facilitate early detection of benign or malignant gastrointestinal lesions? Ann Med 2014; 46:672-8. [PMID: 25174259 DOI: 10.3109/07853890.2014.952327] [Citation(s) in RCA: 41] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/22/2023] Open
Abstract
INTRODUCTION The higher incidence of gastrointestinal (GI) bleeding with the non-vitamin K oral anticoagulants (NOACs) may be related to pre-existing malignancies; diagnostic measures triggered by these bleedings could lead to early detection of these malignancies. METHODS We retrieved the preferred terms on GI bleeding and GI cancer reported as adverse events (AEs) from phase III studies in patients with atrial fibrillation for each NOAC on ClinicalTrials.gov . We also analyzed the RE-LY trial database. RESULTS From ClinicalTrials.gov , AE-GI bleeding incidence was: dabigatran 110 mg b.i.d. (D110: 1.42% versus 1.37%), dabigatran 150 mg b.i.d. (D150: 1.93% versus 1.37%), rivaroxaban (3.52% versus 2.68%), and apixaban (1.93% versus 1.59%), compared with warfarin, respectively. The incidence of AE-GI cancer was similar between the NOACs (D110 [0.79%], D150 [0.61%], rivaroxaban [0.83%], and apixaban [0.69%]), but numerically higher compared with warfarin (0.37%; 0.73%; 0.57%, respectively). In the RE-LY database, the same pattern was seen for dabigatran, with an association between GI bleeding and GI cancer diagnosis. CONCLUSION Anticoagulant-related GI bleeding may represent the unmasking of pre-existing malignancies leading to increased detection of GI cancer. This may be especially in the first month of treatment and could explain the numerically higher numbers of GI malignancies observed with NOACs.
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Affiliation(s)
- Andreas Clemens
- Center for Thrombosis and Hemostasis, University Medical Center , Mainz , Germany
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25
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Sánchez-Capilla AD, De La Torre-Rubio P, Redondo-Cerezo E. New insights to occult gastrointestinal bleeding: From pathophysiology to therapeutics. World J Gastrointest Pathophysiol 2014; 5:271-283. [PMID: 25133028 PMCID: PMC4133525 DOI: 10.4291/wjgp.v5.i3.271] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/11/2014] [Revised: 06/01/2014] [Accepted: 06/18/2014] [Indexed: 02/06/2023] Open
Abstract
Obscure gastrointestinal bleeding is still a clinical challenge for gastroenterologists. The recent development of novel technologies for the diagnosis and treatment of different bleeding causes has allowed a better management of patients, but it also determines the need of a deeper comprehension of pathophysiology and the analysis of local expertise in order to develop a rational management algorithm. Obscure gastrointestinal bleeding can be divided in occult, when a positive occult blood fecal test is the main manifestation, and overt, when external sings of bleeding are visible. In this paper we are going to focus on overt gastrointestinal bleeding, describing the physiopathology of the most usual causes, analyzing the diagnostic procedures available, from the most classical to the novel ones, and establishing a standard algorithm which can be adapted depending on the local expertise or availability. Finally, we will review the main therapeutic options for this complex and not so uncommon clinical problem.
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26
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Diagnosis, treatment, and outcome in patients with bleeding peptic ulcers and Helicobacter pylori infections. BIOMED RESEARCH INTERNATIONAL 2014; 2014:658108. [PMID: 25101293 PMCID: PMC4101224 DOI: 10.1155/2014/658108] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 04/15/2014] [Accepted: 06/10/2014] [Indexed: 12/13/2022]
Abstract
Upper gastrointestinal (UGI) bleeding is the most frequently encountered complication of peptic ulcer disease. Helicobacter pylori (Hp) infection and nonsteroidal anti-inflammatory drug (NSAID) administration are two independent risk factors for UGI bleeding. Therefore, testing for and diagnosing Hp infection are essential for every patient with UGI hemorrhage. The presence of the infection is usually underestimated in cases of bleeding peptic ulcers. A rapid urease test (RUT), with or without histology, is usually the first test performed during endoscopy. If the initial diagnostic test is negative, a delayed 13C-urea breath test (UBT) or serology should be performed. Once an infection is diagnosed, antibiotic treatment is advocated. Sufficient evidence supports the concept that Hp infection eradication can heal the ulcer and reduce the likelihood of rebleeding. With increased awareness of the effects of Hp infection, the etiologies of bleeding peptic ulcers have shifted to NSAID use, old age, and disease comorbidity.
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Abu Daya H, Eloubeidi M, Tamim H, Halawi H, Malli AH, Rockey DC, Barada K. Opposing effects of aspirin and anticoagulants on morbidity and mortality in patients with upper gastrointestinal bleeding. J Dig Dis 2014; 15:283-292. [PMID: 24593260 DOI: 10.1111/1751-2980.12140] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
OBJECTIVE We aimed to determine the effect of antithrombotics on in-hospital mortality and morbidity in patients with peptic ulcer disease-related upper gastrointestinal bleeding (PUD-related UGIB). METHODS The study cohort was retrospectively selected from a tertiary center database of patients with PUD-related UGIB, defined as bleeding due to gastric or duodenal ulcers, or erosive duodenitis, gastritis or esophagitis. Outcomes were compared among patient groups based on their antithrombotic medications before admission. Patients on no antithrombotics served as controls. The composite adverse outcomes, in-hospital mortality, rebleeding and/or need for surgery were measured. Severe bleeding and in-hospital complications were also recorded. RESULTS Of 398 patients with PUD-related UGIB, 44.5% were on aspirin or anticoagulants only. The composite adverse outcome was most common in patients taking anticoagulants only (40.5%), intermediate in controls (23.1%) and least in those taking aspirin only (12.1%). On multivariate analysis, patients taking aspirin alone had a significantly lower risk of adverse outcome events (odds ratio [OR] 0.4, 95% CI 0.2-0.8) and a shorter length of hospital stay (regression coefficient = -3.4, 95% CI [-6.6, -0.6]). In contrast, taking anticoagulants was associated with a greater risk of adverse outcome events (OR 2.3, 95% CI 1.0-5.3), severe bleeding (OR 2.6, 95% CI 1.2-5.8) and in-hospital complications (OR 2.9, 95% CI 1.3-6.6). CONCLUSIONS Patients with PUB-related UGIB while taking aspirin had fewer adverse outcomes compared with those taking anticoagulants. Aspirin may have beneficial effects in this population.
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Affiliation(s)
- Hussein Abu Daya
- Department of Internal Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA; Division of Gastroenterology and Hepatology, American University of Beirut Medical Center, Beirut, Lebanon
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28
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LaMori J, Gross HJ, DiBonaventura M, Bookhart BK, Schein J. Prior myocardial infarction and presence of upper gastrointestinal conditions among patients with venous thromboembolism: prevalence, associated comorbidities and burden. J Clin Pharm Ther 2014; 39:253-8. [PMID: 24494931 DOI: 10.1111/jcpt.12133] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/07/2013] [Accepted: 12/16/2013] [Indexed: 11/28/2022]
Abstract
WHAT IS KNOWN AND OBJECTIVES Venous thromboembolism (VTE), comprising deep vein thrombosis (DVT) and pulmonary embolism (PE), is a serious, life-threatening condition that often complicates treatment of individuals who are already ill and increases in risk with age. The comorbidity burden of VTE can complicate treatment; therefore, treatment should be influenced by the presence of comorbidities (Kearon 2012). The prevalence of common conditions in the VTE population is, therefore, an important subject of research. Prevalence of two common comorbid burdens, prior myocardial infarction (MI) and upper gastrointestinal (GI) conditions, was studied among survey respondents who reported DVT or PE. METHODS Responses to the 2010 wave of the National Health and Wellness Survey (NHWS), a self-administered, internet-based questionnaire from a nationwide, demographically representative sample of adults, were evaluated. RESULTS AND DISCUSSION Among the 814 participants reporting a history of VTE, 9·7% (n = 60) of the DVT subpopulation and 13·2% (n = 39) of the PE subpopulation also reported prior MI. In respondents with prior MI, cardiovascular, urological, and pain comorbidities were each reported as additional comorbidities by at least two thirds of respondents in both the PE and DVT subpopulations, with cardiovascular and urological conditions reported significantly (P < 0·05) more often than among respondents with no prior MI. Among the respondents reporting VTE, 48·9% (n = 302) of the subpopulation reporting DVT and 52·2% (n = 154) of those reporting PE also reported upper GI comorbidities. Cardiovascular and pain conditions in the respondents reporting upper GI comorbidities were each reported by more than three quarters of VTE patients in both the DVT and PE subpopulations and were significantly more common (P < 0·05) than among their counterparts without upper GI comorbidities. WHAT IS NEW AND CONCLUSION The results of the NHWS indicate that VTE patients who have either of two common comorbid burdens, prior MI and concomitant upper GI conditions, also showed high levels of additional, concurrent comorbidities and generally poor health status. Clinicians must be aware of the total comorbidity profile of their patients who have experienced VTE in order to best manage them and prescribe appropriate therapy.
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Affiliation(s)
- J LaMori
- Janssen Scientific Affairs, LLC, Raritan, NJ, USA
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29
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Konturek P, Hess T. [Gastrointestinal bleeding under treatment with new oral anticoagulants]. MMW Fortschr Med 2014; 156:50-52. [PMID: 24934056 DOI: 10.1007/s15006-014-2599-4] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/03/2023]
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Solakoglu T, Koseoglu H, Atalay R, Sari SO, Yurekli OT, Akin E, Bolat AD, Buyukasik S, Ersoy O. Impact of anti-aggregant, anti-coagulant and non-steroidal anti-inflammatory drugs on hospital outcomes in patients with peptic ulcer bleeding. Saudi J Gastroenterol 2014; 20:113-9. [PMID: 24705149 PMCID: PMC3987151 DOI: 10.4103/1319-3767.129476] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/27/2023] Open
Abstract
BACKGROUND/AIMS There are a limited number of studies including the impact of antiplatelet drugs use on hospital outcomes for nonvariceal upper gastrointestinal bleeding. The aim of this study was to determine the effect of anti-aggregant, anti-coagulant and non-steroidal anti-inflammatory drugs upon hospital outcomes in patients with peptic ulcer bleeding. MATERIALS AND METHODS The patients under treatment with antiaggregant, anticoagulant or non-steroidal anti-inflammatory drugs were categorized as exposed group (n = 118) and the patients who were not taking any of these drugs were categorized as non-exposed group (n = 81). We analyzed the data of drug intake, comorbid disease, blood transfusion, duration of hospital stay, Blatchford/total Rockall score and diagnosis of patients. RESULTS In total, 199 patients were included. Of these 59.3% (exposed group) were taking drugs. The patients in exposed group were significantly older than those in non-exposed group (62.9 ± 17.3 years; 55.5 ± 19.3 years, P = 0.005, respectively). Mean number of red blood cell units transfused (2.21 ± 1.51; 2.05 ± 1.87, P = 0.5), duration of hospital stay (3.46 ± 2.80 days; 3.20 ± 2.30 days, P = 0.532) and gastric ulcer rate (33% vs 23.4%, P = 0.172) were higher in exposed group than in non-exposed group but the differences were not statistically significant. Total Rockall and Blatchford scores of the patients were significantly higher in exposed group than in non-exposed group (3.46 ± 1.72 vs 2.94 ± 1.87, P = 0.045; 10.29 ± 3.15 vs 9.31 ± 3.40, P = 0.038). CONCLUSION Our study has shown that anticoagulants, antiaggregants and nonsteroidal anti-inflammatory drugs do not effect duration of hospital stay, red blood cell transfusion requirement and rebleeding for peptic ulcer bleeding.
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Affiliation(s)
- Tevfik Solakoglu
- Department of Gastroenterology, Ankara Ataturk Education and Research Hospital, Bilkent, Ankara, Turkey,Address for correspondence: Dr. Tevfik Solakoglu, Ankara Ataturk Education and Research Hospital, Department of Gastroenterology, Bilkent, Ankara 06800, Turkey. E-mail:
| | - Huseyin Koseoglu
- Department of Gastroenterology, Yildirim Beyazit University, Faculty of Medicine, Ankara, Turkey
| | - Roni Atalay
- Department of Gastroenterology, Ankara Ataturk Education and Research Hospital, Bilkent, Ankara, Turkey
| | - Sevil O. Sari
- Department of Gastroenterology, Ankara Ataturk Education and Research Hospital, Bilkent, Ankara, Turkey
| | - Oyku T. Yurekli
- Department of Gastroenterology, Ankara Ataturk Education and Research Hospital, Bilkent, Ankara, Turkey
| | - Ebru Akin
- Department of Gastroenterology, Ankara Ataturk Education and Research Hospital, Bilkent, Ankara, Turkey
| | - Aylin D. Bolat
- Department of Gastroenterology, Ankara Ataturk Education and Research Hospital, Bilkent, Ankara, Turkey
| | - Semnur Buyukasik
- Department of Gastroenterology, Ankara Ataturk Education and Research Hospital, Bilkent, Ankara, Turkey
| | - Osman Ersoy
- Department of Gastroenterology, Yildirim Beyazit University, Faculty of Medicine, Ankara, Turkey
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Mahan CE, Spyropoulos AC, Fisher MD, Fields LE, Mills RM, Stephenson JJ, Fu AC, Klaskala W. Antithrombotic medication use and bleeding risk in medically ill patients after hospitalization. Clin Appl Thromb Hemost 2013; 19:504-12. [PMID: 23324537 DOI: 10.1177/1076029612470967] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/22/2022] Open
Abstract
BACKGROUND Hospitalized medically ill patients receiving antithrombotic medications experience increased risk of bleeding. We examined antithrombotic use, bleeding rates, and associated risk factors at 30 days post discharge. METHODS This retrospective database analysis included nonsurgical patients aged ≥40 years hospitalized for ≥2 days during 2005 to 2009. Previously cited, validated International Classification of Diseases, Ninth Revision, Clinical Modification codes for major bleeding were used to define clinically relevant bleeding. RESULTS Of the 327,578 patients, 9.1% received antithrombotic medications, of which 3.7% were anticoagulants. Rates of major and minor bleeding were 1.8% and 7.1%, respectively. Preindex gastroduodenal ulcer, thromboembolic stroke, blood dyscrasias, liver disease, and rehospitalization were the strongest predictors of major bleeding. Other risk factors included increasing age, male gender, and hospital stay of ≥3 days. CONCLUSIONS Careful consideration of these demonstrated bleed-associated comorbidities before initiating anticoagulation or combining antithrombotic medications in medically ill patients may improve strategies for prevention of postdischarge thromboembolism.
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Affiliation(s)
- Charles E Mahan
- 1Department of Outcomes Research, New Mexico Heart Institute, Albuquerque, NM, USA
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Evaluation of GI bleeding after implantation of left ventricular assist device. Gastrointest Endosc 2012; 75:973-9. [PMID: 22341716 PMCID: PMC3835739 DOI: 10.1016/j.gie.2011.12.014] [Citation(s) in RCA: 84] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/07/2011] [Accepted: 12/07/2011] [Indexed: 02/08/2023]
Abstract
BACKGROUND Left ventricular assist devices (LVADs) have revolutionized the management of end-stage heart failure (ESHF). However, unexpectedly high rates of GI bleeding (GIB) have been described, and etiology and outcome remain unclear. OBJECTIVE To determine the prevalence, etiology, and outcome of GIB in LVAD recipients. DESIGN Retrospective case series. SETTING Tertiary care academic university hospital. PATIENTS 154 ESHF patients (55.4 years, 122 men/32 women) with LVADs implanted over a 10-year period. MAIN OUTCOME MEASUREMENTS Overt or occult GIB prompting endoscopic evaluation ≥ 7 days after LVAD implantation. RESULTS Over a mean of 0.9 ± 0.1 years of follow-up, 29 patients (19%) experienced 44 GIB episodes. Patients with GIB were older and received anticoagulation therapy before devices were implanted (P ≤ .02 for each). GIB was overt (n = 31) rather than occult (n = 13), and most patients presented with melena (n = 22, 50%); hemodynamic instability was observed in 13.6%. Each bleeding episode required 2.1 ± 0.1 diagnostic or therapeutic procedures, and a source was localized in 71%. Upper endoscopy provided the highest diagnostic yield; peptic bleeding (n = 14) and vascular malformations (n = 8) dominated the findings. Endoscopy was safe and well tolerated. Overall mortality was 35%, none directly from GIB. LIMITATION Retrospective design. CONCLUSIONS Rates of GIB with LVADs are higher than that seen in other patient populations, including those receiving anticoagulation and antiplatelet therapy. GIB episodes are mostly overt and predominantly from the upper GI tract. Endoscopy is safe in the LVAD population.
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Chen CM, Hsu HC, Chuang YW, Chang CH, Lin CH, Hong CZ. Study on factors affecting the occurrence of upper gastrointestinal bleeding in elderly acute stroke patients undergoing rehabilitation. J Nutr Health Aging 2011; 15:632-6. [PMID: 21968857 DOI: 10.1007/s12603-011-0052-2] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
Abstract
OBJECTIVE To investigate factors affecting upper gastrointestinal bleeding (UGIB) in elderly first-time acute stroke patients undergoing rehabilitation. PARTICIPANTS AND SETTING Three hundred and thirty-one elderly first-time acute stroke patients (age ≥65 years) transferred to our rehabilitative ward from July 2002 to June 2009 were included in the study. DESIGN We divided patients into UGIB and non-UGIB groups. Demographic data and possible precipitating factors were analyzed. RESULTS Sixty-eight (20.5%) patients experienced UGIB. The patients with UGIB were of older age (75.4 vs. 72.92 years, P = 0.003), had a longer rehabilitative ward stay (26.32 vs. 21 days, P = 0.002), more frequently had stroke-induced consciousness impairment (60.3 vs. 38%, P = 0.001), had a higher incidence of bilateral brain lesion (7.4 vs. 1.9%, P = 0.034), and more frequently used anticoagulants (17.6 vs. 9.1%, P = 0.044) than patients in the non-UGIB group. In multivariate logistic regression analysis, stroke-induced impaired consciousness (odds ratio: 2.806, 95% CI = 1.588-4.957, P = 0.000) was the most important risk factor for UGIB. CONCLUSIONS UGIB may prolong a patient's length of stay in a rehabilitative ward. These identified factors may help clinicians identify risks of UGIB before it develops.
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Affiliation(s)
- C-M Chen
- Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital, Chiayi, No.6, W. Sec., Jiapu Rd., Puzih City, Chiayi County 613, Taiwan, ROC
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Oswanski MF, Shaik I, Nazzal M, Calkins K, Stombaugh H, Lowe S. Activated Recombinant Factor VIIa and Uncontrolled Gastrointestinal Bleeding. Am Surg 2011. [DOI: 10.1177/000313481107700401] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Affiliation(s)
- Michael F. Oswanski
- Trauma Services The Toledo Hospital & Toledo Children's Hospital Toledo, Ohio
| | - Imtiazuddin Shaik
- College of Medicine University of Toledo Medical Center Toledo, Ohio
| | - Mustafa Nazzal
- College of Medicine University of Toledo Medical Center Toledo, Ohio
| | | | - Heather Stombaugh
- Trauma Services The Toledo Hospital & Toledo Children's Hospital Toledo, Ohio
| | - Steve Lowe
- College of Medicine Northeastern Ohio Universities Colleges of Medicine and Pharmacy Rootstown, Ohio
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Stern DR, Kazam J, Edwards P, Maybaum S, Bello RA, D'Alessandro DA, Goldstein DJ. Increased incidence of gastrointestinal bleeding following implantation of the HeartMate II LVAD. J Card Surg 2010; 25:352-6. [PMID: 20331479 DOI: 10.1111/j.1540-8191.2010.01025.x] [Citation(s) in RCA: 161] [Impact Index Per Article: 10.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
BACKGROUND The HeartMate II (HMII) Left Ventricular Assist System (Thoratec Corporation, Pleasanton, CA, USA), an axial continuous-flow left ventricular assist device (LVAD), has been approved for use in bridge-to-transplant patients and is under investigation for destination therapy. To avoid device-related thromboembolic complications, antiplatelet, and anticoagulation therapy are routinely administered. A worrisome frequency of gastrointestinal (GI) bleeding events has been observed. METHODS A retrospective review of all 33 patients undergoing long-term LVAD implantation between June 1, 2006 and July 31, 2008 at our institution for any indication was conducted. Anticoagulation consisted of heparin (intravenous or subcutaneous) followed by transition to Coumadin therapy to a target INR of two to three. Antiplatelet therapy consisted of low-dose aspirin and dipyridamole. RESULTS Twenty patients received the HMII and 13 patients received other devices. Eight (40%) HMII recipients suffered at least one episode of GI bleeding while no GI bleeding occurred in recipients of other devices (p = 0.012). Of 17 total bleeding episodes, no definitive source could be identified in 11 instances (65%). CONCLUSIONS Although definitive source identification remains elusive, we believe that the majority of bleeding arises in the small bowel, possibly due to angiodysplasias, similar to the pathophysiology encountered in patients with aortic stenosis and GI bleeding. As we move toward wider use of the HMII and other axial continuous-flow devices in both bridge-to-transplant patients and for destination therapy, more studies will be necessary to understand the mechanisms of this obscure GI bleeding and develop treatment strategies to minimize its development.
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Affiliation(s)
- David R Stern
- Department of Cardiothoracic Surgery, Montefiore/Einstein Heart Center, Albert Einstein College of Medicine, New York, New York, USA
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Gadelha T, Bisbe J, Toril J, Alcalá Pedrajas JN, Monreal M. Major bleeding events in stable outpatients with coronary, cerebrovascular or peripheral artery disease: findings from the FRENA registry. J Thromb Haemost 2009; 7:1414-6. [PMID: 19566549 DOI: 10.1111/j.1538-7836.2009.03487.x] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 08/31/2023]
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