Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated vs. Standard DAPT Regimen - MASTER DAPT

Aug 29, 2022
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Terumo
Date Presented:
08/29/2022
Date Published:
05/17/2022
Date Updated:
08/29/2022
Original Posted Date:
08/28/2021
References

Contribution To Literature:

Highlighted text has been updated as of August 29, 2022.

The MASTER DAPT trial showed that among high bleeding risk individuals, abbreviated antiplatelet therapy was noninferior to standard antiplatelet therapy regarding net adverse clinical events.

Description:

The goal of the trial was to evaluate abbreviated antiplatelet therapy compared with standard antiplatelet therapy among high bleeding risk patients who underwent percutaneous coronary intervention (PCI) with a biodegradable-polymer sirolimus-eluting stent.

Study Design

  • Randomization
  • Parallel
  • Open-label
  • Stratification

Participants with symptomatic coronary artery disease who underwent PCI within the previous 30-44 days were randomized to an abbreviated therapy group (n = 2,295) versus a standard therapy group (n = 2,284).

Among those without an indication for oral anticoagulation:

In the abbreviated therapy group, participants immediately stopped dual antiplatelet therapy (DAPT) and continued single antiplatelet therapy. In the standard therapy group, participants continued DAPT for 5 months, then remained on single antiplatelet therapy.

Among those with an indication for oral anticoagulation:

In the abbreviated therapy group, participants immediately stopped DAPT and continued single antiplatelet therapy. In the standard therapy group, participants continued DAPT for 2 months, then remained on single antiplatelet therapy.

  • Total number of enrollees: 4,579
  • Duration of follow-up: 15 months
  • Mean patient age: 76 years
  • Percentage female: 31%
  • Percentage with diabetes: 33%

Inclusion criteria:

  • Acute or chronic coronary syndrome
  • PCI of ≥1 coronary stenosis with a biodegradable-polymer sirolimus-eluting stent (Ultimaster, Terumo)
  • No further revascularization was planned
  • ≥1 criterion for high bleeding risk

Exclusion criteria:

  • Implantation of a non-Ultimaster stent within the prior 6 months
  • Implantation of a bioresorbable scaffold before the index procedure
  • Treatment of in-stent restenosis or stent thrombosis

Other salient features/characteristics:

  • Stable angina: 40%
  • Silent ischemia: 11%
  • Non–ST-segment elevation myocardial infarction (NSTEMI): 26%
  • STEMI: 12%
  • Median duration of DAPT in the abbreviated therapy group: 34 days
  • Median duration of DAPT in the standard therapy group: 193 days

Principal Findings:

Primary outcomes:

  • Net adverse clinical events (all-cause mortality, MI, stroke, or major bleeding): 7.5% in the abbreviated therapy group compared with 7.7% in the standard therapy group (p < 0.001 for noninferiority)
  • Major adverse cardiac or cerebral events (all-cause mortality, MI, or stroke): 6.1% in the abbreviated therapy group compared with 5.9% in the standard therapy group (p = 0.001 for noninferiority)
  • Major or clinically relevant nonmajor bleeding: 6.5% in the abbreviated therapy group compared with 9.4% in the standard therapy group (p < 0.001 for superiority)

Secondary outcomes:

  • Net adverse clinical events for abbreviated vs. standard therapy among those with an indication for oral anticoagulation therapy: (relative risk [RR] 0.83)
  • Net adverse clinical events for abbreviated vs. standard therapy among those without an indication for oral anticoagulation therapy: (RR 1.01; p for interaction = 0.35)
  • Major adverse cardiac and cerebral events for abbreviated vs. standard therapy among those with an indication for oral anticoagulation therapy: (RR 0.88)
  • Major adverse cardiac and cerebral events for abbreviated vs. standard therapy among those without an indication for oral anticoagulation therapy: (RR 1.06; p for interaction = 0.45)
  • Major bleeding for abbreviated vs. standard therapy among those with an indication for oral anticoagulation therapy: (RR 0.83)
  • Major bleeding for abbreviated vs. standard therapy among those without an indication for oral anticoagulation therapy: (RR 0.55; p for interaction = 0.057)

Lesion complexity subanalysis (1,196 participants underwent complex PCI, while 3,383 underwent noncomplex PCI):

  • The association of net adverse clinical events (NACE) between abbreviated vs. standard DAPT with complex PCI (hazard ratio [HR] 1.03, 95% confidence interval [CI] 0.69-1.52) and with noncomplex PCI (HR 0.90, 95% CI 0.71-1.15; p for interaction = 0.60)
  • The association of major adverse cardiac or cerebral events (MACCE) between abbreviated vs. standard DAPT with complex PCI (HR 1.24, 95% CI 0.79-1.92) and with noncomplex PCI (HR 0.91, 95% CI 0.69-1.21; p for interaction = 0.26)

Outcomes at 15 months:

  • Net adverse clinical events (all-cause mortality, MI, stroke, or major bleeding): HR 0.92, 95% CI 0.76-1.12; p = 0.40 for abbreviated vs. standard therapy
  • Major adverse cardiac or cerebral events (all-cause mortality, MI, or stroke): HR 0.94, 95% CI 0.76-1.17; p = 0.58 for abbreviated vs. standard therapy
  • Major or clinically relevant nonmajor bleeding: HR 0.68, 95% CI 0.56-0.83; p = 0.001 for abbreviated vs. standard therapy

Interpretation:

Among patients with acute or chronic coronary artery disease who underwent PCI within the last 30-44 days and were at increased bleeding risk, abbreviated DAPT was noninferior to standard DAPT regarding net adverse clinical events and major adverse cardiac or cerebral events. Abbreviated DAPT was superior to standard antiplatelet therapy regarding major or clinically relevant nonmajor bleeding. These results are specific to patients who received a biodegradable-polymer sirolimus-eluting stent. The results were the same among those with and without an indication for oral anticoagulation therapy and also according to lesion complexity.

References:

Presented by Dr. Marco Valgimigli at the European Society of Cardiology Congress (ESC 2022), Barcelona, Spain, August 29, 2022.

Valgimigli M, Smits PC, Frigoli E, et al., on behalf of the MASTER DAPT Investigators. Duration of Antiplatelet Therapy After Complex Percutaneous Coronary Intervention in Patients at High Bleeding Risk: A MASTER DAPT Trial Sub-Analysis. Eur Heart J 2022;May 17:[Epub ahead of print].

Smits P, Frigoli E, Tijssen J, et al., on behalf of the MASTER DAPT Investigators. Abbreviated Antiplatelet Therapy in Patients at High Bleeding Risk With or Without Oral Anticoagulant Therapy After Coronary Stenting: An Open-Label, Randomized, Controlled Trial. Circulation 2021;144:1196-1211.

Valgimigli M, Frigoli E, Heg D, et al., on behalf of the MASTER DAPT Investigators. Dual Antiplatelet Therapy After PCI in Patients at High Bleeding Risk. N Engl J Med 2021;385:1643-55.

Editorial: Ohman EM. The Evolving Post-PCI Antithrombotic Therapies. N Engl J Med 2021;385:1712-4.

Presented by Dr. Marco Valgimigli at the European Society of Cardiology Virtual Congress, August 27, 2021.

Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Invasive Cardiovascular Angiography and Intervention, Prevention, Stable Ischemic Heart Disease, Atherosclerotic Disease (CAD/PAD), Anticoagulation Management and ACS, Interventions and ACS, Interventions and Coronary Artery Disease, Chronic Angina

Keywords: ESC Congress, ESC21, ESC22, Acute Coronary Syndrome, Anticoagulants, Coronary Artery Disease, Coronary Restenosis, Drug-Eluting Stents, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Primary Prevention, Risk, Sirolimus, Stents, Stroke, Thrombosis


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