November 27, 2019
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 UltimasterTM stent implantation."
MASTER DAPT compares abbreviated versus prolonged DAPT, following implantation with Terumo's UltimasterTM or UltimasterTM TanseiTM 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 UltimasterTM and UltimasterTM TanseiTM 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.
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).
Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers, with approximately US$6 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures and distributes world-class medical devices, including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician-office use. Terumo contributes to society by providing valued products and services to the healthcare market, and by responding to the needs of healthcare providers and the people they serve. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.
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
B. Chevalier et al. Circ Cardiovasc Interv. 2017 Dec;10(12). pii: e004801. doi: 10.1161/ CIRCINTERVENTIONS.116.004801
Wijns W. et al. EuroIntervention 2018;14:e343-51;5
Corporate Communication Dept., Terumo Corporation
(Notice) Among the information that Terumo discloses, the forward-looking statements including financial projections are based upon our assumptions using information available to us at the time and are not intended to be guarantees of future events or performance. Accordingly, it should be noted that actual results may differ from those forecasts on projections due to various factors. Factors affecting to actual results include, but are not limited to, changes in economic conditions surrounding Terumo, fluctuations of foreign exchange rates, and state of competition. The market share information in this press release is partly derived from our own independent research.