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
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.
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