Retrospective Study
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Cardiol. Aug 26, 2019; 11(8): 200-208
Published online Aug 26, 2019. doi: 10.4330/wjc.v11.i8.200
One-year outcomes of a NeoHexa sirolimus-eluting coronary stent system with a biodegradable polymer in all-comers coronary artery disease patients: Results from NeoRegistry in India
Rajagopal Jambunathan, Dinesh Basavanna, Preeti Vani, Malte Neuss, Prashant Janbandhu
Rajagopal Jambunathan, Dinesh Basavanna, Cauvery Heart and Multispecialty Hospital, Mysore, Karnataka 570011, India
Dinesh Basavanna, Department of Cardiology Mysore Medical College and Research Institute, Mysore, Karnataka 570001, India
Preeti Vani, Malte Neuss, Prashant Janbandhu, Medical Division, Sahajanand Laser Technology Ltd., Gandhinagar, Gujarat 382027, India
Malte Neuss, Manemed Research and Development, Roeckumstr, Bonn 53123, Germany
Author contributions: Jambunathan R, Basavanna D, Vani P, Neuss M and Janbandhu P were equally involved in designing the report, collecting and analysis of patient’s clinical data, and preparing the manuscript.
Supported by the Sahajanand Laser Technology Ltd,India.
Institutional review board statement: This study was approved by the Ethics Committee of Mysore Medical College and Research Institute (EC REG: ECR/134/Inst/KA/2013/RR-16).
Informed consent statement: As per IEC, in case of prospective studies, there is a need to take informed consent from subjects. However, in our case (a retrospective trial) permission should be taken from the Head of Institution.
Conflict-of-interest statement: Mr. Prashant, Dr. Malte, and Ms. Preeti are employees of Sahajanand Laser Technology Ltd. India. All other authors have nothing to disclose.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Prashant Janbandhu, MSc, Medical Division, Sahajanand Laser Technology Ltd., Gandhinagar, Gujarat 382027, India. clinical@sltl.com
Telephone: +91-72-27039377Fax: +91-79-23287470
Received: April 4, 2019
Peer-review started: April 4, 2019
First decision: June 7, 2019
Revised: June 18, 2019
Accepted: July 17, 2019
Article in press: July 17,2019
Published online: August 26, 2019
Abstract
BACKGROUND

Biodegradable polymer drug-eluting stents (BP-DES) have shown to reduce restenosis rates and have low rates of stent thrombosis. The present postmarketing surveillance assessed 1-year clinical outcomes of patients who had received NeoHexa DES in real practice.

AIM

To investigate 1-year clinical outcomes of Neohexa DES in real practice.

METHODS

Data obtained from a single-center cohort of patients who had received NeoHexa stents as part of routine treatment of coronary artery disease (CAD) were retrospectively investigated. The primary study endpoint was the rate of major adverse cardiac events (MACEs) defined as the composite of death, myocardial infarction (MI), and target lesion revascularization (TLR) during the follow-up at 1 mo, 6 mo, and 1 year after the index procedure.

RESULTS

A total of 129 patients with 172 lesions were enrolled. The most common comorbid conditions were hypertension (49.61%) and diabetes mellitus (39.53%). Procedural success was achieved in all patients, and no in-hospital MACE was reported. The incidence of composite MACE at 30 d, 6 mo, and 1 year was 0.78%, 3.94%, and 4.87%, respectively. The rate of possible and probable late stent thrombosis was 0.78%. The cumulative incidences of death, MI, and TLR at 1 year were 2.44%, 0.81%, and 1.63%, respectively.

CONCLUSION

The relatively low rates of MACE and stent thrombosis in this study support safety and performance of NeoHexa stents, suggesting it to be an effective alternative to other contemporary stents for the treatment of de novo lesions in native coronary arteries.

Keywords: Sirolimus, Drug-eluting stent, Myocardial infarction, Thrombosis, Coronary artery disease

Core tip: Reports have indicated the use of stents in patients with coronary artery disease has reduced the rates of restenosis. Biodegradable polymer drug eluting stents, have shown to reduce restenosis rates and lower the stent thrombosis rate. Our study assessed 1-year, single-center cohort for clinical outcomes of patients who had received NeoHexa sirolimus drug-eluting stents in real practice. It showed relatively low rates of major adverse cardiac event and stent thrombosis supporting safety and performance of NeoHexa stent and supporting its use as an effective alternative to other existing stents.