Copyright
©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Cardiol. Oct 26, 2018; 10(10): 165-186
Published online Oct 26, 2018. doi: 10.4330/wjc.v10.i10.165
Published online Oct 26, 2018. doi: 10.4330/wjc.v10.i10.165
Undiscovered pathology of transient scaffolding t1remains a driver of failures in clinical trials
Alexander N Kharlamov, Department of Interventional Cardiovascular Biomedicine, De Haar Research Foundation, Amsterdam 1069CD, The Netherlands.
Alexander N Kharlamov, Research Division, Transfiguration Clinic, Yekaterinburg 620078, Russia
Author contributions: Kharlamov AN was the only author who comprehensively contributed to the analysis and writing.
Conflict-of-interest statement: The author does not have any conflict of interest to report.
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/
Correspondence to: Alexander N Kharlamov, MD, Academic Research, Doctor, Lecturer, Department of Interventional Cardiovascular Biomedicine, De Haar Research Foundation, Keurenplein 41, Box G9950, 1069CD Amsterdam, The Netherlands. akharlamov@dhrfpro.com
Telephone: +31-87-7842273
Received: March 27, 2018
Peer-review started: March 28, 2018
First decision: May 2, 2018
Revised: May 21, 2018
Accepted: August 26, 2018
Article in press: August 27, 2018
Published online: October 26, 2018
Peer-review started: March 28, 2018
First decision: May 2, 2018
Revised: May 21, 2018
Accepted: August 26, 2018
Article in press: August 27, 2018
Published online: October 26, 2018
Core Tip
Core tip: The high rates of target lesion failure and device thrombosis in randomized controlled trials caused confusion in the international interventional community with a decline of the technology in routine practice. The provided statistical analysis confirms the underpowered design of some clinical studies and meta-analyses of bioresorbable scaffolds. The misunderstanding of the pathobiology of the transient scaffolding drives the failures of the clinical trials. More bench studies of the vascular response are required to verify the leading mechanism of the device failure. Several next-generation scaffolds including multifunctional electronic scaffold grant cardiology with a huge promise to make this technology great again.