P2Y12 inhibitor monotherapy after 3 months of DAPT noninferior to 12 months of DAPT after PCI: JAMA
South Korea: P2Y12 inhibitor monotherapy after 3-month dual antiplatelet therapy (DAPT) is not inferior to 12-month DAPT in patients with coronary artery disease undergoing PCI with the latest generation of drug-eluting stents, findings from SHARE Randomized Clinical Trial have shown. The findings were published online in JAMA Network Open on March 7, 2024.
The randomized clinical trial of 1387 patients in South Korea revealed the net adverse clinical events (NACEs) rate to be 1.7% for the P2Y12 inhibitor monotherapy group and 2.6% for the DAPT group. The 1-sided confidence limit of this difference was within the noninferiority margin of 3.0%.
P2Y12 inhibitor monotherapy after DAPT (a P2Y12 inhibitor plus aspirin) for a brief duration has recently emerged as an attractive alternative for patients undergoing percutaneous coronary intervention (PCI) with a drug-eluting stent. Pil-Ki Min, Yonsei University College of Medicine, Seoul, Republic of Korea, and colleagues aimed to investigate whether P2Y12 inhibitor monotherapy following three months of DAPT was noninferior to 12 months of DAPT following PCI with a drug-eluting stent.
For this purpose, the researchers conducted the SHARE open-label, noninferiority randomized clinical trial from 2017 to 2020. Final 1-year clinical follow-up completed in 2022. The study was a multicenter trial conducted at 20 hospitals in South Korea. It enrolled patients who underwent successful PCI with bioabsorbable polymer everolimus-eluting stents.
The participants were randomly assigned to receive P2Y12 inhibitor monotherapy after 3 months of DAPT (n = 694) or 12 months of DAPT (n = 693).
The primary outcome was a net adverse clinical event, a composite of major bleeding and major adverse cardiac and cerebrovascular events (myocardial infarction, cardiac death, stroke, stent thrombosis, or ischemia-driven target lesion revascularization) between 3 and 12 months after the index PCI. The major secondary outcomes were MACCEs and major bleeding. The noninferiority margin was 3.0%.
The researchers reported the following findings:
- Of the total 1452 eligible patients, 65 patients were excluded before the 3-month follow-up, and 1387 patients (mean age, 63.0 years; 76.1% men) were assigned to P2Y12 inhibitor monotherapy (n = 694) or DAPT (n = 693).
- Between 3 and 12 months of follow-up, the primary outcome (using Kaplan-Meier estimates) occurred in 1.7% of patients in the P2Y12 inhibitor monotherapy group and 2.6% of patients in the DAPT group.
- For the major secondary outcomes (using Kaplan-Meier estimates), major adverse cardiac and cerebrovascular events occurred in 1.5% of patients in the P2Y12 inhibitor monotherapy group and 2.0% of patients in the DAPT group.
- Major bleeding occurred in 1 patient in the P2Y12 inhibitor monotherapy group and five patients in the DAPT group.
"These findings suggest that early discontinuation of aspirin and P2Y12 monotherapy was not inferior to 12 months of DAPT," the researchers wrote.
"Further research is required to analyze the impact of this strategy on individual outcomes, including bleeding events," they concluded.
Reference:
Min P, Kang TS, Cho Y, et al. P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy After Deployment of a Drug-Eluting Stent: The SHARE Randomized Clinical Trial. JAMA Netw Open. 2024;7(3):e240877. doi:10.1001/jamanetworkopen.2024.0877
