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
Processing time: 140 Days and 18.4 Hours
ARTICLE HIGHLIGHTS
Research background

Biodegradable polymer drug-eluting stents have been shown to reduce restenosis rates and have low rates of stent thrombosis. Thus, this post-marketing surveillance assessing outcomes after 1 year of treatment shows the real implications of biodegradable drug eluting stents.

Research motivation

Proving the real-life reduced restenosis rates of biodegradable stents was the motivation behind this study. Key problems were the rates of major adverse cardiac events (MACEs) myocardial infarction, and target lesion revascularization. Solving this would increase patient survival rate.

Research objectives

The main objective was to identify the rate of MACE during the follow-up period at 1 mo, 6 mo, and 1 year after the procedure completion.

Research methods

This was a retrospective analysis of a single-centre cohort of patients who had received NeoHexa stents as part of routine treatment for CAD.

Research results

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.

Research conclusions

Relatively low rates of MACE and stent thrombosis in this study support the safety and performance of NeoHexa stents, suggesting that it is an effective alternative for treatment of de novo lesions.

Research perspectives

Our results must be further substantiated in well-designed studies with longer follow-up duration.