A significant milestone has been reached for a landmark study into the use of short duration dual anti-platelet therapy (DAPT) in high-bleeding-risk (HBR) patients following stenting procedures, with patient recruitment just completed.
A total cohort of approximately 4,500 patients have been randomised into the ambitious investigator-initiated MASTER DAPT “MAnagement of high bleeding risk patients post bioresorbable polymer coated STEnt implantation with an abbReviated versus prolonged DAPT regimen” study. Patients joined the study from 140 hospitals across 30 countries in Europe, Japan, Asia, Australia and Latin America.
Co-principal investigators Marco Valgimigli (Inselspital Universitätsspital, Bern, Switzerland) and Peter Smits, (Maasstad Hospital, Rotterdam, The Netherlands) say: “We are extremely thrilled to have completed recruitment of this large-scale global trial, which we believe will shape the future of secondary prevention antithrombotic medications in high bleeding risk patients treated with Ultimaster stent implantation.“
MASTER DAPT compares abbreviated versus prolonged DAPT, following implantation with Terumo’s Ultimaster or Ultimaster Tansei drug-eluting bioresorbable polymer stents, in ‘all-comer’ patients, presenting with HBR features. The study primary end-points are non-inferiority for net adverse clinical events; non-inferiority for ischaemic endpoints; and superiority for bleeding of abbreviated versus prolonged DAPT, at one year.
“We thank all the investigators and patients who agreed to participate in this study, helping us meet this major milestone,” the principle investigators comment. “MASTER DAPT is a truly global effort with hundreds of dedicated stakeholders sharing a vision of advancing care for a large and vulnerable patient population that has been too frequently excluded from major trials.”
The Ultimaster and Ultimaster Tansei DES have extensive real-world clinical data, having been studied in a population of over 40,000 patients. Both DES are designed to promote optimal vessel healing and therefore hypothesised to facilitate a shortened DAPT regimen. This hypothesis was confirmed in the DISCOVERY 1TO3 clinical trial that proved an excellent strut coverage as early as one month. Robust safety data includes recently published results from the CENTURY II trial that showed a low stent thrombosis rate of 0,2% between one and five years.
A shorter DAPT protocol will save substantial healthcare resources by reducing cost for DAPT, the number of hospitalisations for bleeding, and the number of working days lost.