Jambunathan R, Basavanna D, Vani P, Neuss M, Janbandhu P. 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. World J Cardiol 2019; 11(8): 200-208 [PMID: 31523398 DOI: 10.4330/wjc.v11.i8.200]
Corresponding Author of This Article
Prashant Janbandhu, MSc, Medical Division, Sahajanand Laser Technology Ltd., Gandhinagar, Gujarat 382027, India. clinical@sltl.com
Research Domain of This Article
Cardiac & Cardiovascular Systems
Article-Type of This Article
Retrospective Study
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Jambunathan R, Basavanna D, Vani P, Neuss M, Janbandhu P. 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. World J Cardiol 2019; 11(8): 200-208 [PMID: 31523398 DOI: 10.4330/wjc.v11.i8.200]
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, 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.
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.
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.
