At EuroPCR (17–20 May, Paris, France), a new global study that involves 4,300 patients from 34 countries was announced. The study, according to a press release, is set to shed light into the use of short duration dual antiplatelet therapy (DAPT) in patients following stenting procedures, with a particular focus on those with a high bleeding risk. The investigator-initiated MASTER DAPT (Management of patients post bioresorbable polymer stent implantation with an abbreviated DAPT regimen) study will be supported by an unrestricted grant from Terumo.
Co-principal Investigator Marco Valgimigli (Inselspital Universitätsspital Bern, Switzerland) says that there is growing interest in abbreviated DAPT regimens but added that sufficiently powered randomised trials are necessary to show how such regimens compared with current guideline-recommended DAPT durations. “This new trial is an important step towards gathering robust evidence to support a short DAPT regimen in higher risk patients. We currently have very little data to inform the optimal duration of DAPT in patients with a high bleeding risk,” he comments.
MASTER DAPT is the first global DAPT study and involves 130 hospitals across 34 countries in Europe, Asia, Australia, Africa and South America. Patients on oral anticoagulant therapy, one of the least studied but growing populations in contemporary percutaneous coronary intervention (PCI) practice, are also included in the study. It is anticipated that 4,300 patients will participate in the study.
Fellow co-principal Investigator Peter Smits (Maasstad Hospital, Rotterdam, The Netherlands) says that previous studies had tended to exclude patients who had experienced previous bleeding or who were older than 75. “The high bleeding risk population represents a sizable proportion of patients with coronary artery disease undergoing stent procedures. We need the data to help us determine the most appropriate course of DAPT. At the moment, it is a clinical challenge to know the best time to transition our patients to antiplatelet monotherapy,” he adds.
All patients in the study will have received the Ultimaster stent in the context of routine clinical care. A press release reports that the Ultimaster drug-eluting stent is designed to promote optimal vessel recovery and, therefore, is hypothesised to facilitate a shortened DAPT regimen. It adds that this hypothesis has been confirmed in the recently completed DISCOVERY 1TO3 clinical trial, which proved an excellent strut coverage of nearly 90% as early as one month, paving the way to the safe initiation of the abbreviated DAPT study.
Post-stent implantation, patients will be randomised to receive either guideline-recommended standard DAPT treatment or transitioned to antiplatelet monotherapy, following one month of post-procedure DAPT treatment for all patients.
The study endpoints for the abbreviated DAPT regimen compared with standard therapy are non-inferiority for net adverse clinical events; superiority for bleeding at 1 year; and non-inferiority for ischaemic endpoints.
Patient enrolment for MASTER DAPT is scheduled to begin in November 2016.