MASTER DAPT Trial 2021

 In terms of net adverse clinical events, the MASTER DAPT trial found that shortened antiplatelet medication was not inferior to regular antiplatelet therapy.


Description:


The trial's purpose was to compare shortened antiplatelet therapy to standard antiplatelet therapy in patients who had percutaneous coronary intervention (PCI) using a biodegradable-polymer sirolimus-eluting stent.


Design of the Study: 


Participants with symptomatic coronary artery disease who had PCI during the previous 30-44 days were randomly assigned to one of two groups: shortened therapy (n = 2,295) or standard therapy (n = 2,284).


Among people who do not require oral anticoagulation:

Participants in the abbreviated therapy group promptly discontinued dual antiplatelet therapy (DAPT) and continued single antiplatelet therapy. Participants in the conventional therapy group received DAPT for 5 months before switching to mono antiplatelet medication.


Those with an indication for oral anticoagulation include:

Participants in the abbreviated therapy group promptly ceased DAPT and continued single antiplatelet therapy. Participants in the conventional therapy group received DAPT for two months before switching to mono antiplatelet medication.


The total number of enrollees; 4,579.

The duration of the follow-up: 12 months.

The average patient age:  76 years old.

31% of the population: female.

Diabetes affected 3% of the population.


Criteria for inclusion:


  • Coronary syndrome, acute or chronic
  • PCI using a biodegradable polymer sirolimus-eluting stent of more than one coronary stenosis (Ultimaster, Terumo).
  • There were no plans for further revascularization.
  • There was more than one criterion for high bleeding risk.


Criteria for exclusion:


  • Within the last 6 months, a non-Ultimaster stent was implanted.
  • Before the index surgery, a bioresorbable scaffold is implanted.
  • Treatment of stent thrombosis or in-stent restenosis.


In the shorter therapy group, the median duration of DAPT was 34 days.


In the standard therapy group, the median duration of DAPT was 193 days.



The primary outcomes are:


Net adverse clinical events (all-cause death, MI, stroke, or serious bleeding): 7.5% in the abbreviated therapy group vs. 7.7% in the regular therapy group (p 0.001 for noninferiority).


Major adverse cardiac or cerebral events (all-cause death, MI, or stroke) occurred at a rate of 6.1 percent in the abbreviated therapy group against 5.9 percent in the usual therapy group (p = 0.001 for noninferiority).


Major or clinically significant nonmajor bleeding: 6.5 percent in the reduced therapy group vs. 9.4 percent in the usual therapy group (p 0.001 for superiority).



Interpretation:


Abbreviated DAPT was non-inferior to standard DAPT in terms of net adverse clinical events and significant adverse cardiac or cerebral events in patients with acute or chronic coronary artery disease who received PCI during the last 30-44 days and were at elevated bleeding risk.


In terms of serious or clinically relevant nonmajor bleeding, abbreviated DAPT outperformed normal antiplatelet treatment.


These findings apply only to individuals who got a biodegradable polymer sirolimus-eluting stent.


The outcomes were the same for individuals who had an indication for oral anticoagulant treatment and those who did not.

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