Gillian Jessurun (Treant Zorggroep, Scheper Hospital Emmen, The Netherlands) has enrolled the first patient in the investigator-initiated MASTER DAPT (Management of patients post bioresorbable polymer stent implantation with an abbreviated DAPT regimen) study, launching the global investigation.
Jessurun says, “Having the privilege of enrolling the study’s first patient reflects our team and Treant Zorggroep, Scheper Hospital’s commitment to research.”
The major new MASTER DAPT study is set to compare within current guidelines abbreviated versus prolonged dual anti-platelet therapy (DAPT), following implantation with Terumo’s Ultimaster DES, a drug-eluting bioresorbable polymer stent, in patients presenting with high bleeding-risk features. Patients (4300) will be randomly assigned to one of the treatment options in 130 hospitals across 34 countries in Europe, Asia, Australia and Latin America. The study primary end-points are non-inferiority for net adverse clinical events; superiority for bleeding; and non-inferiority for ischaemic endpoints of abbreviated versus prolonged DAPT, at one year.
Peter Smits, Head of Intervention Cardiology, Maasstad Hospital and study co-principal investigator says, “This new trial is an important step towards gathering robust evidence to define the safest DAPT regimen in this sizable proportion of patients treated in contemporary percutaneous coronary intervention practice. It is great that The Netherlands is the first of 34 countries worldwide to contribute to this important scientific work.”
Co-principal investigator Marco Valgimigli, prof of Cardiology and director of Clinical Research, Inselspital Universitätsspital Bern, Switzerland, says, “We have been working on this study for a long time, so it is a very rewarding moment to see it get underway with our first patient enrolled. We have an ambitious target but I am optimistic that with the support of many highly motivated centres and investigators across the globe we will get there.”
All patients in the study will have the Ultimaster stent implanted in the context of routine care.
Following a mandatory one month of DAPT treatment, patients will be randomised to either continue DAPT, or transition to APT monotherapy. The Ultimaster DES is designed to promote optimal vessel recovery and therefore hypothesised to facilitate a shortened DAPT regimen.
The study is sponsored by the European Cardiovascular Research Institute (ECRI, Rotterdam, The Netherlands) and supported with an unrestricted grant by Terumo Corporation.