P2Y12 Inhibitor Monotherapy vs. Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention - SMART-CHOICE

Contribution To Literature:

Short-duration DAPT (3 months) followed by P2Y12 inhibitor monotherapy is noninferior to longer-duration DAPT (12 months) among unselected patients undergoing PCI with a DES.

Description:

The goal of the trial was to compare the safety and efficacy of short-duration dual antiplatelet therapy (DAPT) (3 months) compared with longer duration DAPT (12 months) among patients undergoing percutaneous coronary intervention (PCI).


Study Design

Eligible patients were randomized in a 1:1 fashion to either DAPT for 3 months (n = 1,495) or 12 months (n = 1,498). In the former group, after 3 months, aspirin was discontinued and P2Y12 inhibitor monotherapy was continued. Stratification was performed by type of drug-eluting stent (DES) used (Cobalt-chromium everolimus-eluting stent [EES] vs. platinum-chromium EES vs. biodegradable polymer sirolimus-eluting stent).

  • Total number of enrollees: 2,993
  • Duration of follow-up: 12 months
  • Mean patient age: 65 years
  • Percentage female: 27%

Inclusion criteria:

  • Patients undergoing PCI with DES

Exclusion criteria:

  • Active bleeding
  • DES implantation within 12 months
  • Life expectancy <2 years
  • Patients with known hypersensitivity or contraindication to study medication

Other salient features/characteristics:

  • Previous myocardial infarction (MI): 4%, previous revascularization: 11%
  • Acute coronary intervention (ACS) presentation: 58%
  • PCI location: left main trunk: 2%, left anterior descending artery: 62%, left main circumflex artery: 26%, right coronary artery 35%
  • Calcified lesion: 15%, bifurcation lesion: 13%, thrombotic lesion: 7.5%
  • Number of stents per patient: 1.5, stent length: 38 mm
  • Use of intravascular imaging: 26%
  • Approximately 9% still on aspirin in the short-duration arm at 12 months

Principal Findings:

The primary outcome, major adverse cardiac and cerebrovascular events (MACCE) (all-cause death, MI, or stroke) at 12 months, for 3 months vs. 12 months of DAPT, was 2.9% vs. 2.5%, p for noninferiority = 0.007; p for superiority = 0.46.

  • All-cause death: 1.4% vs. 1.2%, p = 0.61
  • MI: 0.8% vs. 1.2%, p = 0.28

Secondary outcomes for 3 months vs. 12 months of DAPT:

  • Stent thrombosis: 0.2% vs. 0.1%, p = 0.65
  • Bleeding Academic Research Consortium (BARC) 2-5: 2.0% vs. 3.4%, p = 0.02

Interpretation:

The results of this trial indicate that short-duration DAPT (3 months) is noninferior to longer-duration DAPT (12 months) among unselected patients undergoing PCI with a DES. In the arm receiving short-duration DAPT, P2Y12 inhibitor monotherapy was continued between 3 and 12 months, rather than aspirin monotherapy. Bleeding was lower with this strategy. These are interesting findings and help advance our understanding of the optimal duration and type of antiplatelet agent post-PCI. However, there were some important limitations. Nearly 10% of patients in the short-duration DAPT arm were still on aspirin at 12 months. Also, the effect may be different among patients with ACS in whom a longer duration of DAPT is needed versus among patients with stable ischemic heart disease in whom 6 months of DAPT is sufficient. In this trial, the interaction by ACS was negative, but it was likely not powered for this comparison.

References:

Presented by Dr. Joo-Yong Hahn at the American College of Cardiology Annual Scientific Session (ACC 2019), New Orleans, LA, March 18, 2019.

Clinical Topics: Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Interventions and ACS, Interventions and Coronary Artery Disease

Keywords: ACC19, ACC Annual Scientific Session, Acute Coronary Syndrome, Aspirin, Chromium, Cobalt, Coronary Artery Disease, Drug-Eluting Stents, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Platinum, Polymers, Stroke, Thrombosis, Vascular Diseases


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