LEUVEN, BELGIUM - August 30, 2021 - Terumo announced today the results from the largest multi-center randomized controlled study on the use of short duration of dual antiplatelet therapy (DAPT) in high bleeding risk patients following stenting procedures with Ultimaster™/Ultimaster™TanseiTM drug-eluting bioresorbable polymer stents (DES). The clinical data from this 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 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 new clinical data have been released at this years' European Society of Cardiology (ESC) 2021 congress and have been simultaneously published in New England Journal of Medicine2 and in Circulation3.
A total cohort of 4.579 patients have been randomized into this ambitious study. Patients joined the study from 140 hospitals across 30 countries in Europe, Japan, Asia, Australia and Latin America.
Patients were randomized at 1 month after PCI with implantation of Terumo's UltimasterTM or UltimasterTM TanseiTM DES to either abbreviated (n=2295) versus prolonged DAPT (n=2284). The patients represent an 'all-comer' population, presenting with high bleeding risk features. Randomization was stratified by concomitant OAC indication. At 335 days, complete follow up data were available for 4547 patients (99.3%). An independent clinical events committee blinded to treatment allocation adjudicated all suspected events.
- The three coprimary study endpoints at 335 days, in order of hierarchy, were met:
- ● Non-inferiority of abbreviated versus prolonged DAPT for net adverse clinical events (NACE: composite of all-cause death, myocardial infarction, stroke and bleeding events defined as BARC 3 or 5 bleeding events);
- ● Non-inferiority of abbreviated versus prolonged DAPT for major adverse cardiac and cerebral events (MACCE: composite of all-cause death, myocardial infarction and stroke);
- ● Superiority of abbreviated versus prolonged DAPT for major or clinically relevant non-major bleeding (MCB: composite of type 2, 3 and 5 BARC bleeding events).
Principal Investigator Prof Marco Valgimigli, Professor of Cardiology, deputy Chief of Cardiology and Director of Clinical Research, Istituto Cardiocentro Ticino, Lugano, Switzerland said, "MASTER DAPT has shown that 1-month DAPT followed by single antiplatelet therapy up to 1 year or 6 months after Ultimaster™ stent implantation preserves the ischemic risks while it mitigates the overall bleeding burden in patients who are at high risk for bleeding. This is a ground-breaking new information for clinicians who now know that reducing DAPT duration to 1 month is the new standard of care in this selected high bleeding risk population. These results carry high clinical relevance considering that patients with acute coronary syndrome or who underwent complex or multivessel PCI, including left main stenting were similarly included in our trial. Principal Investigator Dr Peter Smits, Head of Intervention Cardiology, Maasstad Hospital, Rotterdam, complemented: The OAC - non OAC subgroup analysis clearly shows that with the Ultimaster™ stent it is safe and beneficial to stop DAPT after 1 month both in the high bleeding risk populations with or without a clinical indication for oral anticoagulants. This is important additional information, as PCI patients with oral anticoagulants are at very high bleeding risk and little was known about the optimal DAPT duration in these patients".
The UltimasterTM and UltimasterTM TanseiTM DES have extensive real-world clinical data, having been studied in a population of over 50,000 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.4 Robust safety data includes published results from the CENTURY II trial that showed a low stent thrombosis rate of 0.2% between 1 and 5 years5 The efficacy and safety of the stent have been further confirmed by results from the e-ULTIMASTER registry, one of the largest real-world registries, including complex PCI patients.6
Toshi Osada, President of Terumo Corporation's Cardiac and Vascular Company commented, "It is great honor for us to support and be part of such a clinically valuable study. The MASTER DAPT study is a big step to improve high bleeding risk patients' prognosis. Going forward, we will continue to bring innovation to the field of interventional cardiology by delivering quality products and services, and by supporting to build clinical evidence for the future of healthcare".
The Principal Investigators concluded, "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."
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.
1. Frigoli E et al. Am Heart J 2019;209:97-105
2. M Valgimigli et al. NEJM 2021; DOI: 10.1056/NEJMoa2108749
3. P Smits et al. Circulation 2021; https://doi.org/10.1161/CIRCULATIONAHA.121.056680
4. B. Chevalier et al. Circ Cardiovasc Interv. 201710: e004801
5. Wijns W. et al. EuroIntervention 2018;14:e343-351
6. Mohamed MO et al. EuroIntervention 2020 ;16 : 603-612
About MASTER DAPT
MASTER DAPT study is sponsored by the European Cardiovascular Research Institute (ECRI, Rotterdam, The Netherlands) and supported with a restricted research grant by Terumo Europe. 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
Terumo Europe 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. www.terumo-europe.com
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.