Major study investigating abbreviated DAPT post- Ultimaster DES in high bleeding risk patients reaches half-way mark

Published
Wednesday, January 9, 2019

Significant milestone achieved for global study likely to change DAPT guidelines

Leuven Belgium, 2018, January, 9th – December marked a significant milestone for a landmark study into the use of short duration dual anti-platelet therapy (DAPT) in HBR patients following stenting procedures, with patient recruitment reaching the half-way point.

The ambitious investigator-initiated MASTER DAPT (MAnagement of patients post bioresorbable polymer STEnt implantation with an abbreviated DAPT regimen) study, just randomised patient number 2.150 – half-way towards the target of 4.300. Patients join the study from more than 120 hospitals across 32 countries in Europe, Japan, Asia, Australia and Latin America.

The study compares abbreviated versus prolonged DAPT, following implantation with UltimasterTM or UltimasterTM TanseiTM drug-eluting bioresorbable polymer stents, in ‘all-comer’ patients, presenting with high bleeding risk features. 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 1 year.

Co-Principal Investigator Dr Marco Valgimigli, Prof of Cardiology and Director of Clinical Research, Inselspital Universitätsspital Bern, Switzerland, said: ”The study has the potential to influence future guidelines regarding DAPT duration following PCI. MASTER DAPT is gathering robust evidence to support a short DAPT regimen in higher risk patients. We currently have very little data to inform the optimal duration of DAPT in this patient group, so the study’s outcome is keenly awaited.

MASTER DAPT differs from other studies because it compares different DAPT regiments rather than different stents,” Prof Valgimigli continued. “The reality is, patients with high bleeding risk features represent a sizable proportion of patients with coronary artery disease undergoing stent procedures, so it’s critical we capture data in this population and understand how best to treat them.

The UltimasterTM DES has extensive real-world clinical data, having been studied in a population of over 40,000 patients. Both UltimasterTM and the recently launched UltimasterTM TanseiTM 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 of nearly 90% 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

Commenting on patient recruitment reaching the half-way mark, Co-Principal Investigator Dr Peter Smits, Head of Intervention Cardiology, Maasstad Hospital, Rotterdam, The Netherlands, praised the participating clinicians. “It’s fantastic to see colleagues across the globe contributing to this important study,” he said. “With each patient enrolled we move a step closer towards defining the safest DAPT regimen for this sizable proportion of PCI patients. This is a pragmatic trial that has high potential to change current clinical practice and re-shape the DAPT guidelines.

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

Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers with over US$5 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 interventional procedures, cardiovascular surgery, and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use and also supplies drug delivery/injection devices to pharmaceutical firms. 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.

About Terumo Europe NV

Terumo Europe, founded in 1971, 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 four main business units: Hospital and Laboratory Systems, Global Pharmaceutical Solutions, Interventional Systems and Cardio Vascular Products. Terumo Europe EMEA headquarters and production facilities are located in Haasrode (Belgium), production facility in Knowsley (UK) and sales units across EMEA. Please visit www.terumo-europe.com for more information.

References

  1. Smits P. Presented at EuroPCR 2015
  2. Wijns W. et al. EuroIntervention2018;14:e343-51;5