Concept Medical has announced enrolment of the first patients in the STARS DAPT randomised controlled trial, evaluating its polymer-free sirolimus drug-eluting stent (DES) technology for the treatment of ST-segment elevation myocardial infarction (STEMI).
The first four patients were enrolled by Barbara Stähli and her team at the University Hospital of Zurich in Zurich, Switzerland, marking the beginning of the trial which will assess the different strategies to manage acute coronary syndrome (ACS) patients with antiplatelet regimen.
STARS DAPT is an investigator-initiated, prospective, multicentre, international, open-label, randomised controlled pilot study. The trial will enrol 350 all-comer subjects with STEMI undergoing primary percutaneous coronary intervention (PCI) with the Abluminus np (Concept Medical).
STARS DAPT aims to study the difference between a P2Y12 receptor inhibitor-based single antiplatelet therapy (SAPT) regimen after a short period of dual antiplatelet therapy (DAPT) versus conventional six or 12 months of DAPT. The co-primary endpoints at 12 months are major adverse cardiac and cerebrovascular events and major bleeding complications.
The trial is led by principal investigator Juan F Iglesias (Geneva University Hospitals and University of Geneva, Switzerland).
Newer generation polymer-free DES like the Abluminus np with thin struts, fusion and abluminal coating of Sirolimus aids in natural vascular healing of the arteries, faster re-endothelialisation and mitigating chronic inflammation which permits the possibility of potentially shortening the DAPT requirement, Concept Medical says in a press release. Abluminus np has been studied in single-arm Indian registries with promising safety and efficacy leading up to STARS DAPT being the first randomised evaluation, the press release adds.
“Patients with acute STEMI represent a particularly challenging population, characterised by a dual risk profile: a high risk of ischaemic events driven by a heightened prothrombotic and proinflammatory state, and an increased risk of bleeding complications associated with the use of potent antithrombotic therapies during management,” comments Iglesias on the initiation of the trial. “Achieving an optimal balance between preventing acute thrombotic events and minimising major bleeding remains a persistent challenge and an important unmet need in routine clinical practice. Recent advances in polymer-free DES technology may facilitate the adoption of novel antiplatelet strategies aimed at reducing bleeding risk while preserving ischemic protection after primary PCI. STARS DAPT is the first RCT designed to evaluate the non-inferiority of a P2Y12 inhibitor–based SAPT strategy following a very short course of DAPT, compared with the current standard of care of 12-month DAPT, with respect to both major ischemic and bleeding outcomes at one year after primary PCI using the Abluminus np DES.
“The results of the STARS DAPT trial are expected to provide important insights into the optimal antiplatelet regimen after primary PCI and have the potential to meaningfully improve STEMI care.”
Manish Doshi, founder & managing director of Concept Medical Group, said: “The initiation of patient enrolment in the STARS DAPT trial marks an important milestone for Abluminus np. While contemporary drug-eluting stents have achieved excellent outcomes, challenges such as polymer-related inflammation, late catch-up, and the need for prolonged dual antiplatelet therapy persist. Abluminus np was designed as a polymer-free, sub-micron sirolimus delivery platform to enable more uniform drug distribution across the diseased vessel, extending beyond the stent struts to the stent edges and adjacent vessel segments.
“The STARS DAPT trial is designed to evaluate whether this approach can support safe and effective reduction in DAPT duration, particularly for patients at increased bleeding risk.”
