P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy After Deployment of a Drug-Eluting Stent: The SHARE Randomized Clinical Trial

P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy After Deployment of a Drug-Eluting Stent: The SHARE Randomized Clinical Trial JAMA Netw Open. 2024 Mar 4;7(3):e240877  Abstract Importance: P2Y12 inhibitor monotherapy after dual antiplatelet therapy (DAPT; a P2Y12 inhibitor plus aspirin) for a brief duration has recently emerged as an attractive alternative for patients undergoing percutaneous coronary intervention with a drug-eluting stent.  Objective: To investigate whether P2Y12 inhibitor monotherapy after 3 months of DAPT was noninferior to 12 months of DAPT following percutaneous coronary intervention with a drug-eluting stent.  Design, setting, and participants: The Short-Term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-Eluting Stent (SHARE) open-label, noninferiority randomized clinical trial was conducted from December 15, 2017, to December 14, 2020. Final 1-year clinical follow-up was completed in January 2022. This study was a multicenter trial that was conducted at 20 hospitals in South Korea. Patients who underwent successful percutaneous coronary intervention with bioabsorbable polymer everolimus-eluting stents were enrolled.  Interventions: Patients were randomly assigned to receive P2Y12 inhibitor monotherapy after 3 months of DAPT (n = 694) or 12 months of Dual Antiplatelet Therapy (n = 693).  Main outcomes and measures: The primary outcome was a net adverse clinical event, a composite of major bleeding and major adverse cardiac and cerebrovascular events (cardiac death, myocardial infarction, stent thrombosis, stroke, or ischemia-driven target lesion revascularization) between 3 and 12 months after the index percutaneous coronary intervention. The major secondary outcomes were major adverse cardiac and cerebrovascular events and major bleeding. The noninferiority margin was 3.0%.  Results: Of the total 1452 eligible patients, 65 patients were excluded before the 3-month follow-up, and 1387 patients were assigned to P2Y12 inhibitor monotherapy or Dual Antiplatelet Therapy Between 3 and 12 months of follow-up, the primary outcome occurred in 9 patients in the P2Y12 inhibitor monotherapy group and in 16 patients in the Dual Antiplatelet Therapy group  .The major secondary outcomes major adverse cardiac and cerebrovascular events occurred in 8 patients  in the P2Y12 inhibitor monotherapy group and in 12 patients  in the Dual Antiplatelet Therapy group . Major bleeding occurred in 1 patient in the P2Y12 inhibitor monotherapy group and in 5 patients in the Dual Antiplatelet Therapy group  Conclusions and relevance: In patients with coronary artery disease undergoing percutaneous coronary intervention with the latest generation of drug-eluting stents, P2Y12 inhibitor monotherapy after 3-month Dual Antiplatelet Therapy was not inferior to 12-month Dual Antiplatelet Therapy for net adverse clinical events. Considering the study population and lower-than-expected event rates, further research is required in other populations. Disclaimer: Lupin makes no representation or warranty of any kind, expressed or implied, regarding the accuracy, adequacy, validity, reliability, availability, or completeness of any scientific information shared by the HCP on the ­­­STAR UPDATE podcast. You should not allow the contents of this to substitute for your own medical judgment, which you should exercise in evaluating the information on this website.