NEW HAVEN, Connecticut, USA, October 28, 2024 — SINOMED today announced that the five-year follow-up results of the PIONEER-III Global IDE trial for its flagship HT Supreme™ Drug-Eluting Stent System were presented at the 36th Transcatheter Cardiovascular Therapeutics (TCT) Conference by Professor Alexandra J. Lansky of Yale University School of Medicine. HT Supreme™ demonstrated numerically favorable outcomes versus contemporary drug-eluting stents including XIENCE and Promus across all key safety and efficacy endpoints at five years.
The PIONEER-III study is a prospective, randomized, controlled, global multi-center clinical trial conducted across 74 clinical centers in the United States, Europe, and Japan. A total of 1,632 patients were enrolled (1,629 actually randomized) with a 2:1 randomization between HT Supreme™ and control (XIENCE/Promus). The study was approved by both the U.S. FDA and Japan’s PMDA.
At five-year follow-up, HT Supreme™ demonstrated numerical advantages across all primary and secondary endpoints: Target Lesion Failure (TLF) 6.7% vs. 8.0% (P=0.39), Target Vessel Failure (TVF) 8.5% vs. 10.2% (P=0.28), Major Adverse Cardiac Events (MACE) 14.0% vs. 15.6% (P=0.36), and Stent Thrombosis (ST) 1.8% vs. 2.0% (P=0.78).
Although the differences did not reach statistical significance, HT Supreme™ demonstrated consistent numerical superiority throughout the 2-to-5-year follow-up period, suggesting sustained clinical benefit. These results reinforce the long-term safety and efficacy profile of the HT Supreme™ and provide robust clinical evidence to support ongoing regulatory filings in the United States, Japan, and Europe.
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 TCT
TCT (Transcatheter Cardiovascular Therapeutics) is the world’s premier educational forum for interventional cardiovascular medicine, bringing together leading interventional cardiologists, clinical researchers, and industry innovators to share real-world clinical experience and advance standards of care. Its annual scientific program serves as a curated, authoritative reference compiling late-breaking clinical trials, first-in-human studies, and pivotal evidence that shape daily practice and evidence-based decision-making in the field of transcatheter cardiovascular therapy.