Long-Term Effects of P2Y12 Inhibitor Monotherapy After PCI
- P2Y12 inhibitor monotherapy was comparable with prolonged DAPT in the 3-year risk of ischemic events after PCI with a second-generation DES.
- The 3-year rates of major bleeding and overall bleeding were significantly lower in the P2Y12 inhibitor monotherapy group than in the prolonged DAPT group.
- Long-term maintenance of P2Y12 inhibitor monotherapy after initial DAPT may be a reasonable antiplatelet strategy after PCI.
What is the long-term safety and efficacy of P2Y12 inhibitor monotherapy following 3 months of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI)?
The investigators conducted an open-label, noninferiority, randomized clinical trial, SMART-CHOICE (The Smart Angioplasty Research Team: Comparison Between P2Y12 Antagonist Monotherapy and Dual Antiplatelet Therapy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents), enrolling patients who underwent PCI with drug-eluting stent (DES) at 33 hospitals in Korea from March 2014–July 2017. Clinical follow-up was extended to 3 years and completed in August 2020. Patients were randomly assigned to either P2Y12 inhibitor monotherapy after 3 months of DAPT or DAPT for 12 months or longer. The primary endpoint was major adverse cardiac and cerebrovascular events (a composite of all-cause death, myocardial infarction, or stroke) at 3 years. The secondary endpoints included the components of the primary endpoint, bleeding (defined as Bleeding Academic Research Consortium [BARC] types 2-5), and major bleeding (BARC types 3-5).
In total, 2,993 patients were randomly assigned to receive P2Y12 inhibitor monotherapy after 3 months of DAPT (1,495 patients [50%]; mean [SD] age, 64.6 [10.7] years; 1,087 [72.7%] male) or prolonged DAPT (1,498 patients [50%]; mean [SD] age, 64.6 [10.7] years; 1,111 [74.2%] male) after PCI. At 3 years, the primary endpoint occurred in 87 individuals (6.3%) in the P2Y12 inhibitor monotherapy group and 83 (6.1%) in the prolonged DAPT group (hazard ratio [HR], 1.06 [95% CI, 0.79-1.44]; p = 0.69). P2Y12 inhibitor monotherapy significantly reduced the risk of bleeding (BARC types 2-5: 112 [3.2%] vs. 44 [8.2%]; HR, 0.39 [95% CI, 0.28-0.55]; p < 0.001) and major bleeding (BARC types 3-5; 17 [1.2%] vs. 31 [2.4%]; HR, 0.56 [95% CI, 0.31-0.99]; p = 0.048), compared with prolonged DAPT. The landmark analyses between 3 months and 3 years and per-protocol analyses showed consistent results.
The authors concluded that among patients who underwent PCI and completed 3-month DAPT, P2Y12 inhibitor monotherapy was associated with a lower risk of clinically relevant major bleeding than prolonged DAPT.
This extended 3-year follow-up of patients from the SMART-CHOICE trial that randomized patients undergoing PCI to P2Y12 inhibitor monotherapy after DAPT for 3 months or prolonged DAPT, reports that P2Y12 inhibitor monotherapy was comparable with prolonged DAPT in the 3-year risk of ischemic events after PCI with a second-generation DES. Furthermore, the 3-year rates of major bleeding and overall bleeding were significantly lower in the P2Y12 inhibitor monotherapy group than in the prolonged DAPT group. Of note, those differences were present between 3 months and 3 years in the post hoc 3-month landmark analysis. These and other available data suggest that long-term maintenance of P2Y12 inhibitor monotherapy may be a reasonable antiplatelet strategy after PCI and supports the updated 2021 American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions guideline for coronary artery revascularization, which recommends a shorter course of DAPT followed by P2Y12 monotherapy as a Class IIa indication.
Keywords: Angioplasty, Drug-Eluting Stents, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Risk, Secondary Prevention, Stroke
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