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Retrospective Study
Copyright ©The Author(s) 2026. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Cardiol. Feb 26, 2026; 18(2): 114636
Published online Feb 26, 2026. doi: 10.4330/wjc.v18.i2.114636
Five-year mean follow-up of NeoHexa sirolimus eluting coronary stent: A retrospective evaluation of long-term safety and efficacy
Vijay K Trehan, Safal Safal, Siddhant Trehan, Sanjeev Kathuria, Preeti S Vani
Vijay K Trehan, Siddhant Trehan, Department of Cardiology, Maharaja Agrasen Hospital, Delhi 110026, India
Safal Safal, Sanjeev Kathuria, Department of Cardiology, MAMC and GB Pant Institute of Postgraduate Medical Education and Research, Delhi 110002, India
Preeti S Vani, Division of Medical, Sahajanand Laser Technology Ltd., Gandhinagar 382016, Gujarat, India
Co-first authors: Vijay K Trehan and Safal Safal.
Author contributions: Trehan VK and Safal S collected data and edited the manuscript, and they contributed equally to this manuscript as co-first authors; Trehan VK, Safal S, and Vani PS were involved in designing the study; Trehan VK, Safal S, Trehan S, Kathuria S, and Vani PS were involved in analyzing data; Trehan S, Kathuria S, and Vani PS prepared the manuscript. All authors have read and approved the final manuscript.
Supported by the Sahajanand Laser Technology Ltd.
Institutional review board statement: The study was reviewed and approved by an Independent Ethics Committee (approval No. F.1/IEC/MAMC/87/05/2021/No 89).
Informed consent statement: Patients were not required to give informed consent to the study because the analysis used anonymous clinical data that were obtained after each patient agreed to treatment by written consent.
Conflict-of-interest statement: Vani PS is employee of Sahajanand Laser Technology Limited. All other authors have nothing to disclose.
Data sharing statement: Detailed data may be accessed by contacting corresponding author.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Preeti S Vani, Division of Medical, Sahajanand Laser Technology Ltd., A-8, G.I.D.C, Electronic Estate, Sec-25, Gandhinagar 382016, Gujarat, India. clinical@sltl.com
Received: September 30, 2025
Revised: October 30, 2025
Accepted: December 15, 2025
Published online: February 26, 2026
Processing time: 132 Days and 14.2 Hours
Abstract
BACKGROUND

Patients suffering from coronary artery disease (CAD) are experiencing significantly improved outcomes in clinical practice through the use of drug-eluting stents. However, there is still a dearth of real-world long-term data, especially from different patient populations in India, whose clinical presentation is frequently different from trial patient populations. The purpose of this study was to retrospectively assess NeoHexa coronary stent’s long-term safety and effectiveness in all-comer patients, covering both ordinary and pandemic-era clinical settings, during an average follow-up duration of five years.

AIM

To investigate long-term safety and effectiveness of NeoHexa sirolimus-eluting stent (SES) in managing CAD among real-world all-comer patient population.

METHODS

740 individuals with CAD who had undergone percutaneous coronary intervention with NeoHexa SES minimum 2 years prior to the study were included in this single center retrospective, observational analysis. The data was extracted from medical records and patients were followed-up telephonically. The primary safety endpoint included cumulative major adverse cardiac event (MACE) at time of follow up (≥ 2 years after implantation). MACE was defined as a composite endpoint consisting of cardiac death, myocardial infarction, and target lesion revascularization (TLR). The primary efficacy endpoint involved sustained relief of angina or angina-equivalent symptoms at two years post- implantation, without the need for TLR. The secondary endpoints included individual components of MACE, all-cause mortality, target vessel revascularization and stent thrombosis.

RESULTS

At a mean follow-up period of 62.17 ± 9.86 months, 32 subjects (4.32%) experienced the key safety endpoint of MACE. This included 13 patients (1.76%) with TLR/target vessel revascularization and 19 patients (2.57%) with cardiac mortality. Additionally, non-cardiac mortality occurred in 35 cases (4.73%). In terms of effectiveness, 673 patients (90.95%) did not require revascularization and remained clinically stable in New York Heart Association functional class I-II.

CONCLUSION

The study suggests favourable long-term safety and efficacy of NeoHexa SES in a real-world setting with varied clinical presentations.

Keywords: Drug-eluting stents; Coronary artery disease; Percutaneous coronary intervention; NeoHexa sirolimus-eluting stent; Major adverse cardiac events; Target lesion revascularization; Target vessel revascularization; Cardiac mortality

Core Tip: This retrospective study provides valuable long-term real-world evidence on the safety and efficacy of the NeoHexa drug-eluting stent in an all-comer, real world patient population. Over an average follow-up of more than five years, the study observed low rates of major adverse cardiac events (4.32%), including minimal target lesion/target vessel revascularization. The findings highlight the stent’s durable performance, even in high-risk and complex patients across routine and pandemic-era clinical settings.