Concept Medical enrols first patients in STARS DAPT trial

Concept Medical Inc, a global developer of drug-delivery technologies for cardiovascular interventions, has announced the successful enrolment of the first patients in the STARS DAPT randomised clinical trial, marking a key milestone in the evaluation of its polymer-free drug-eluting stent, Abluminus np, in patients with ST-segment elevation myocardial infarction (STEMI).

The first four patients were enrolled at the University Hospital of Zurich, Switzerland, by Professor Barbara Stähli and her team, formally initiating the international investigator-led study. The trial will examine different antiplatelet strategies in acute coronary syndrome (ACS) patients undergoing primary percutaneous coronary intervention (PCI).

STARS DAPT (ST-Segment Elevation Myocardial Infarction treated with a Polymer-Free Sirolimus-based Nanocarrier Eluting Stent and a P2Y12 inhibitor-based Single Antiplatelet Strategy after a Short Dual Antiplatelet Therapy versus conventional Dual Antiplatelet Therapy) is a prospective, multicentre, international, open-label, randomized controlled pilot study. The trial plans to enrol 350 all-comer STEMI patients treated with the Abluminus np stent.

The study compares a P2Y12 inhibitor–based single antiplatelet therapy (SAPT) following a short duration of dual antiplatelet therapy (DAPT) with the conventional six- or twelve-month DAPT regimen. The co-primary endpoints at 12 months include major adverse cardiac and cerebrovascular events and major bleeding complications.

The randomized controlled trial is led by Principal Investigator PD Dr. Juan F. Iglesias of Geneva University Hospitals and the University of Geneva, Switzerland.

“Patients with acute STEMI represent a particularly challenging population due to their simultaneously high risks of ischemic events and bleeding complications,” said Dr. Iglesias. “Recent advances in polymer-free DES technology may enable novel antiplatelet strategies that reduce bleeding risk while maintaining ischemic protection. STARS DAPT is the first randomized trial designed to assess whether a P2Y12 inhibitor–based single antiplatelet strategy after a very short course of DAPT is non-inferior to the current standard of care.”