Enrolment completed for MASTER DAPT, a landmark trial investigating abbreviated DAPT post-implantation of Terumo's Ultimaster DES in high bleeding risk patients

LEUVEN, BELGIUM - November 27, 2019 - 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 randomized 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 Dr. Marco Valgimigli, Prof. of Cardiology and Director of Clinical Research, Inselspital Universitätsspital, Bern, Switzerland and Dr. Peter Smits, Head of Intervention Cardiology, Maasstad Hospital, Rotterdam, The Netherlands, said: "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^TM stent implantation."

MASTER DAPT compares abbreviated versus prolonged DAPT, following implantation with Terumo's Ultimaster^TM or Ultimaster^TM Tansei^TM 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 1 year.

"We thank all the investigators and patients who agreed to participate in this study, helping us meet this major milestone," the Principle Investigators said. "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^TM and Ultimaster^TM Tansei^TM 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 1 month.^*1 Robust safety data includes recently published results from the CENTURY II trial that showed a low stent thrombosis rate of 0,2% between 1 and 5 years.^*2

A shorter DAPT protocol will save substantial healthcare resources by reducing cost for DAPT, the number of hospitalizations for bleeding, and the number of working days lost.

About MASTER DAPT

MASTER DAPT study is sponsored by the European Cardiovascular Research Institute (ECRI, Rotterdam, The Netherlands) and supported with an unrestricted grant by Terumo Corporation. The study is managed by global CROs and data management group (CERC, Paris, France, Cardialysis, Rotterdam, The Netherlands, CV quest. Co. Ltd., Tokyo, Japan and CTU, Bern, Switzerland).

About Terumo Europe NV

Terumo Europe is a core player in the EMEA healthcare market. Terumo Europe produces, distributes, markets and sells a vast range of medical devices across the EMEA region. As a strong actor of Terumo Corporation, it conducts business locally while pursuing a unified EMEA strategy. The EMEA headquarters and production facilities are based in Leuven (Belgium). The European Distribution Center is based in Genk (Belgium). In addition, we have a production facility in Liverpool (UK) and sales and marketing offices across the EMEA region. Terumo EMEA employs approximately 1,300 Associates. www.terumo-europe.com

• *1

  B. Chevalier et al. Circ Cardiovasc Interv. 2017 Dec;10(12). pii: e004801. doi: 10.1161/ CIRCINTERVENTIONS.116.004801

• *2

  Wijns W. et al. EuroIntervention 2018;14:e343-51;5