PIONEER IV Clinical Trial Interim Results Published in European Heart Journal

TIANJIN, China, February 15, 2026 — SINOMED today announced that the interim results of the PIONEER IV post-market clinical study of its HT Supreme™ Drug-Eluting Stent System have been published in the European Heart Journal, the official journal of the European Society of Cardiology (ESC). The publication provides pivotal clinical evidence that supported the subsequent EU approval of a one-month DAPT regimen for HT Supreme™ in all-comer patients.

PIONEER IV is a post-market, all-comer clinical study conducted by SINOMED in Europe. The interim results published in the European Heart Journal provided the key clinical evidence base for the EU regulatory approval of an expanded DAPT regimen indication for HT Supreme™.

The PIONEER IV study addressed an important clinical question in modern interventional cardiology: whether a shortened DAPT duration can be safely applied to all-comer patient populations (both Acute Coronary Syndrome and Chronic Coronary Syndrome) following healing-targeted stent implantation. The study’s findings support the “healing window” theory underlying the HT Supreme™ design.

Combined with the earlier PIONEER-III Global IDE five-year results (presented at TCT 2024), the PIONEER IV evidence base provides comprehensive support for HT Supreme™’s clinical positioning as a healing-targeted stent enabling safe DAPT de-escalation—a key differentiator in the global drug-eluting stent market.

 

About SINOMED

SINOMED is a global medical device company engaged in research, development, production, and commercialization of interventional devices. We are focused on developing first-in-class technologies to target unmet clinical needs in the interventional treatment of coronary, neurovascular and structural heart disease. Our mission is to bring the benefits of medical innovation to more patients worldwide, improving both the longevity and quality of their lives.

 

About European Heart Journal

European Heart Journal (EHJ) is the premier global peer-reviewed journal for cardiovascular medicine, publishing cutting-edge clinical research, state-of-the-art reviews, and expert consensus documents that define modern cardiovascular practice. Bringing together leading cardiologists, clinical researchers, and cardiovascular innovators, the journal serves as the flagship scientific publication of the European Society of Cardiology (ESC). Each annual volume serves as a curated, authoritative compilation of landmark trials, practice-changing guidelines, and emerging evidence that shape daily practice and evidence-based decision-making in the cardiovascular field.

For full article access, please visit: https://academic.oup.com/eurheartj

2026-10-20T17:39:48+08:00