One-Month Dual Antiplatelet Therapy Followed by Aspirin Monotherapy After Drug-Eluting Stent Implantation - One-Month DAPT

Contribution To Literature:

The One-Month DAPT trial showed that 1 month of DAPT was noninferior to 6-12 months of DAPT at preventing adverse ischemic/bleeding events.

Description:

The goal of the trial was to evaluate 1-month dual antiplatelet therapy (DAPT) compared with 6-12 months of DAPT among patients undergoing percutaneous coronary intervention (PCI).

Study Design

  • Randomized
  • Parallel
  • Open-label
  • Stratified

Patients undergoing PCI for stable or unstable ischemic heart disease were randomized to 1-month of DAPT (n = 1,507) versus 6-12 months of DAPT (n = 1,513). In the 1-month DAPT group, patients received a polymer-free drug-coated stent (BioFreedom). In the 6- to 12-month DAPT group, patients received a contemporary drug-eluting stent (Biomatrix or Ultimaster).

  • Total number of enrollees: 3,020
  • Duration of follow-up: 12 months
  • Mean patient age: 67 years
  • Percentage female: 31%
  • Percentage with diabetes: 37%

Inclusion criteria:

  • Patients undergoing PCI for stable or unstable ischemic heart disease
  • ≥19 years of age

Exclusion criteria:

  • Acute myocardial infarction
  • Complex lesion; aorto-ostial, unprotected left main lesion, chronic total occlusion, bypass graft, thrombosis, or a heavily calcified or extremely tortuous lesion
  • Cardiogenic shock or previous cardiopulmonary resuscitation

Principal Findings:

The primary outcome, cardiac death, nonfatal myocardial infarction, target-vessel revascularization, stroke, or major bleeding at 12 months, occurred in 5.9% of the 1-month DAPT group compared with 6.5% of the 6- to 12-month DAPT group (p for noninferiority < 0.001; p for superiority = 0.48). One-month DAPT appeared preferential for stable PCI, while 6-12 months of DAPT appeared preferential for acute coronary syndromes (p for interaction = 0.013). Results were fundamentally the same with 1-month landmark analysis.

Secondary outcomes:

  • All-cause death: 0.9% of the 1-month DAPT group compared with 1.3% of the 6- to 12-month DAPT group
  • Stent thrombosis: 0.7% of the 1-month DAPT group compared with 0.8% of the 6- to 12-month DAPT group
  • Major bleeding: 1.7% of the 1-month DAPT group compared with 2.5% of the 6- to 12-month DAPT group

Interpretation:

Among patients undergoing PCI for stable or unstable coronary artery disease, 1 month of DAPT was noninferior to 6-12 months of DAPT. After the mandated period of DAPT, patients received aspirin monotherapy. One-month DAPT was noninferior to 6-12 months of DAPT at preventing adverse ischemic/bleeding events. There were numerically fewer bleeding events in the 1-month DAPT group. There was suggestion of benefit for 6-12 months of DAPT among those with unstable coronary artery disease.

References:

Hong SJ, Kim JS, Hong SJ, et al., on behalf of the One-Month DAPT Investigators. 1-Month Dual-Antiplatelet Therapy Followed by Aspirin Monotherapy After Polymer-Free Drug-Coated Stent Implantation: One-Month DAPT Trial. JACC Cardiovasc Interv 2021;14:1801-11.

Editorial Comment: Gargiulo G, Esposito G. Aspirin Monotherapy After BioFreedom Stent and 1-Month DAPT: Is Less More Even in Low-Risk Patients? JACC Cardiovasc Interv 2021;14:1812-4.

Presented by Dr. Myeong-Ki Hong at the American Heart Association Virtual Scientific Sessions, November 15, 2020.

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Prevention, Stable Ischemic Heart Disease, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and SIHD, Interventions and ACS, Interventions and Coronary Artery Disease, Chronic Angina, Vascular Medicine

Keywords: AHA20, AHA Annual Scientific Sessions, Acute Coronary Syndrome, Angina, Stable, Aspirin, Coronary Artery Disease, Drug-Eluting Stents, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Polymers, Secondary Prevention, Stroke, Thrombosis


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