MASTER DAPT - Study design


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

An Investigator-initiated, multi-center, randomized clinical trial in HBR patients after PCI with Ultimaster bioresorbable polymer coated sirolimus-eluting stent implantation.

Randomization is performed at a randomization visit at one month that occurs between 30 and 44 days after index PCI. Patients are randomized to abbreviated or prolonged dual antiplatelet regimen. Randomization is stratified per site, by history of acute myocardial infarction (≤12 months prior to randomization), and planned use of OAC.

Patients are treated according to the randomized regimen until 11 months after randomization. Clinical follow-up is performed 2, 5, 11 and 14 months after randomization.

This study has 3 primary endpoints:
1) 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
2) Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke
3) Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events

The main analyses evaluate the occurrence of the primary endpoints between randomization and 11 months thereafter. In secondary analyses, the occurrence of primary endpoints between randomization and 15 months after index PCI is evaluated.