Supraflex Cruz Outshines in Pioneering HBR Trial

SMT unveils COMPARE 60/80 HBR trial results in a leading cardiovascular journal, showcasing the Supraflex Cruz stent's excellent performance in high bleeding risk patients. In the first study of its kind, the stent demonstrated superior outcomes, including lower target lesion revascularization and stent thrombosis rates.

Sahajanand Medical Technologies (SMT) has announced impressive results from the COMPARE 60/80 HBR trial, now published in Circulation: Cardiovascular Interventions. The study highlighted the performance of SMT's biodegradable-polymer sirolimus-eluting Supraflex™ Cruz™ stent compared with the Ultimaster™ Tansei™ stent in patients classified as high bleeding risk (HBR), following abbreviated dual antiplatelet therapy (DAPT).

This landmark trial, the first to be conducted since the ARC HBR guidelines were released, enrolled 741 patients who were at high risk of both bleeding and ischemic events across 11 centers in the Netherlands. The findings indicated the noninferiority of the Supraflex Cruz stent, achieving a net adverse clinical event rate of 15.4% compared to 17.1% for the Ultimaster Tansei at 12 months, meeting the noninferiority criteria (P=0.02).

Study highlights included notable reductions in clinically driven target lesion revascularization and minimal stent thrombosis rates for the Supraflex Cruz. Dr. Krishna Sudhir, Chief Medical Officer at SMT, emphasized the stent's exceptional performance in high-risk patients, underlining its efficacy and safety. Principal Investigator Dr. Pieter C. Smits praised the stent's outcomes, highlighting its significance as dual antiplatelet therapy durations decrease post-PCI.

(With inputs from agencies.)