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Master DAPT trial

06/06/2017 -  

​Video of PIs explaining the MASTER DAPT trial

 


MAnagement of high bleeding risk patients post bioresorbable polymer coated STEnt implantation with an abbReviated versus prolonged DAPT regimen – MASTER DAPT


The MASTER DAPT clinical trial is an Investigator-initiated, multi-center, randomized clinical trial investigating abbreviated versus prolonged DAPT following implantation with Ultimaster stent in patients at high bleeding risk.


3 primary endpoints:

  • Net adverse clinical endpoints (NACE) defined as a composite of all-cause death, myocardial infarction, stroke and bleeding events defined as BARC 3 or 5
  • Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke
  • Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events


Study design


DAPT studydesign.png


*DAPT duration is counted from the day of the last implanted stent; staging has to be pre-specified at the time of screening and cannot be planned later than 2 months after index PCI. †Patients receiving OAC can stop DAPT 2 months after confirmed randomisation.

ASA, acetylsalicylic acid; DAPT, dual antiplatelet therapy; MACCE, major adverse cardiac and cerebral events; MCB, major or clinically relevant non-major bleeding; MI, myocardial infarction; NACE, net adverse clinical endpoints; OAC, oral anticoagulant therapy; PCI, percutaneous coronary intervention; SAPT, single antiplatelet therapy. 

Terumo. Ultimaster Drug Eluting Stent Instructions for Use, version 0.1-2018; MASTER DAPT trial. Available at https://clinicaltrials.gov/ct2/show/NCT03023020?term=master+dapt&rank=1 (accessed April 2018).


MASTER DAPT clinical trial is the only randomized trial that truly focuses on HBR patients instead of comparing DES. 

Ultimaster DES family* was chosen as the MASTER DAPT study device thanks to its unique design with its exceptional safety, shown in the Global 40 000+ patients clinical program.


  • 85% of strut coverage at 1 month in DISCOVERY 1TO3 study1


DAPT strut coverage.png

Data shown are mean±SD. OCT, optical coherence tomography; SD, standard deviation..

  • 0,2% of Stent Thrombosis between 1 year and 5 year in CENTURY II randomized trial2

  • 1-month DAPT labelled3


References

* Ultimaster family consists of Ultimaster and Ultimaster Tansei Drug Eluting Stents. Ultimaster Tansei has all the key features of Ultimaster to support vascular repair with its innovative abluminal bioresorbable coating, additionally its deliverability is enhanced to facilitate the treatment of the most challenging cases.

1. Chevalier et al. Circ Cardiovasc Interv 2017;10:doi:10.1161/CIRCINTERVENTIONS.116.004801

2. Wijns W et al. Eurointervention 2018;14:343-351

3. Ultimaster IFU: Patients should be maintained on clinically adequate post-procedural antiplatelet therapy (Aspirin, Thienopyridine or other appropriate antiplatelet agents) according to the current guidelines. In case of need, dual antiplatelet therapy can be discontinued earlier, but not before 1 month.

MASTER DAPT clinical trial is sponsored by the European Cardiovascular Research Institute (ECRI, Rotterdam, the Netherlands) and supported by Terumo Corporation.