08/12/2022 - LEUVEN, BELGIUM - Terumo Europe is proud to announce that the HAS (Haute Autorité de Santé) in France has acknowledged in an evidence-based assessment that for the Ultimaster™ and Ultimaster™ Tansei™ stents dual antiplatelet therapy (DAPT) can safely be stopped after 1 month for High Bleeding Risk patients. This conclusion is based on the strong and unmatched clinical data generated in the MASTER DAPT study and hence superiority of shortened DAPT regimen can only be attributable and linked to the Ultimaster™ stent.
The clinical data from the investigator-initiated MASTER DAPT (MAnagement of high bleeding risk patients post bioresorbable polymer coated STEnt implantation with an abbReviated versus prolonged DAPT regimen, NCT03023020)1 study demonstrates that one month of DAPT was non-inferior to treatment continuation (with DAPT) for at least 2 additional months for the occurrence of net and major adverse clinical events and reduced major or clinically relevant non-major bleeding. Randomization was stratified by oral anticoagulation (OAC) indication and the data also demonstrates that abbreviated antiplatelet therapy was associated with similar net and major adverse clinical events but with lower bleeding rates versus non-abbreviated antiplatelet therapy in high bleeding risk patients with or without OAC. These clinical data have been released last year at European Society of Cardiology (ESC) 2021 congress and have been simultaneously published in New England Journal of Medicine2 and in Circulation3.
"That's excellent news" says Prof. Jean-Philippe Collet (Interventional Cardiologist and Director of the Interventional Catheterization Laboratory at the Institut de Cardiologie of the Hôpital de la Pitié Salpêtrière_Sorbonne Université, Paris)," The haemorrhagic risk can be assessed by the ARC-HBR score, which is simple and pragmatic, but which takes on a very wide heterogeneity of risk, justifying a case-by-case assessment.
The duration of one month of dual therapy exists in the ESC 2021 NSTE-ACS recommendations and only concerns the very high risk of bleeding (2 major factors). Master DAPT, the only randomized study to have evaluated such a short duration of dual antiplatelet therapy, provides a real level of evidence on the high and very high bleeding risk. Based on this study, the HAS attributed the results solely to the stents in the study (Ultimaster™). The fact that this opinion concerns only one type of stent is not specified in the recommendations and is being evaluated in randomized studies with contemporary stents (Bioflow DAPT trial NCT04137510 and COMPARE 60/80 HBR trial NCT04500912).
The use of dual antiplatelet therapy for as short as one month should be done on a case-by-case basis, having carefully analyzed what determines the very high risk of bleeding, and should never be applied systematically".
This recognition of the value of Ultimaster™ stent in high-risk patients represents an important milestone for Terumo Interventional Systems, we are dedicated to improve patient care in everything we do.
Terumo Europe N.V. is a core player in the EMEA healthcare market by providing best-in-class quality medical products and services. We are a strong actor of the Terumo Group by contributing to innovation and sustainable growth. Terumo Europe produces, distributes, markets, and sells a vast range of medical devices in five main business units: Interventional Systems, Pharmaceutical Solutions, Medical Products, Cardiovascular Products and Diabetes Management. Terumo Europe EMEA headquarters and production facilities are located in Leuven (Belgium), production facility in Knowsley (UK), European Distribution Center in Genk (Belgium) and sales offices across EMEA.
Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.
Corporate Communication Dept., Terumo Corporation