Quick Take: Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention: The SMART-CHOICE Randomized Clinical Trial

The current standard therapy following percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is dual antiplatelet therapy (DAPT) with aspirin plus a P2Y12 inhibitor, followed by aspirin (ASA) monotherapy. P2Y12 inhibitor monotherapy has recently been suggested as an alternative to DAPT, with studies showing reduced risk of subsequent ischemic events compared to ASA in those with cardiovascular disease or undergoing PCI, and lower bleeding risk with comparable thrombotic risks compared to DAPT in those with strokes or transient ischemic attacks. The Smart Angioplasty Research Team: Comparison Between P2Y12 Antagonist Monotherapy vs. Dual Antiplatelet Therapy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents (SMART-CHOICE) open-label, non-inferiority randomized trial aimed to compare P2Y12 inhibitor monotherapy to DAPT in patients receiving PCI with DES. As part of this study, 2993 patients undergoing PCI with DES from 33 Korean hospitals were randomized to receive either DAPT with ASA plus a P2Y12 inhibitor for 3 months followed by monotherapy with a P2Y12 inhibitor alone or DAPT for 12 months. The primary outcome was major adverse cardiac and cerebrovascular events (MACE) (composite of all-cause mortality, myocardial infarction and stroke) at 12 months following PCI, while secondary outcomes included individual components of the composite primary outcome and bleeding endpoints. A non-inferiority margin of 1.8% was established. With follow-up for the primary endpoint complete for 97.1% of patients receiving P2Y12 monotherapy and 97.5% of those receiving DAPT, MACE occurred in 2.9% of the former and 2.5% of the latter groups (estimated difference 0.4%, 1-sided 95% CI -∞% to 1.3%, p=0.007 for noninferiority). Bleeding occurred in 2.0% of the P2Y12 monotherapy group, and 3.4% of the DAPT group (estimated difference 0.58%, 1-sided 95% CI 0.36% to 0.92%). No significant differences were observed between groups in terms of all-cause mortality (HR 1.18, 95% CI 0.63 to 2.21, p=0.61), myocardial infarction (HR 0.66, 95% CI 0.31 to 1.40, p=0.28) and stroke (HR 2.23, 95% CI 0.78 to 6.43, p=0.14) as individual endpoints. Study findings suggest that P2Y12 monotherapy after 3 months of DAPT is non-inferior to prolonged DAPT in patients undergoing PCI intervention with regards to MACE, and is associated with a lower rate of clinically significant bleeding.

Click to read the study in JAMA

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