SHARE
Trial question
Is P2Y12 inhibitor monotherapy noninferior to dual antiplatelet therapy in patients with coronary artery disease undergoing PCI with a drug-eluting stent?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
24.0% female
76.0% male
N = 1387
1387 patients (332 female, 1055 male).
Inclusion criteria: patients who underwent successful PCI with bioabsorbable polymer everolimus-eluting stents.
Key exclusion criteria: hemodynamic instability or cardiogenic shock; increased risk of bleeding, anemia, or thrombocytopenia; need for oral anticoagulation therapy; noncardiac comorbid conditions with a life expectancy of < 1 year; history of ICH; and coronary stent implantation within 12 months before the index procedure.
Interventions
N=694 P2Y12 inhibitor monotherapy (aspirin plus a P2Y12 inhibitor for 3 months followed by P2Y12 inhibitor monotherapy for 9 months).
N=693 dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor for 12 months).
Primary outcome
Rate of net adverse clinical event between 3 and 12 months
1.7%
2.6%
2.6 %
2.0 %
1.3 %
0.7 %
0.0 %
P2Y12 inhibitor
monotherapy
Dual antiplatelet
therapy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in the rate of net adverse clinical event between 3 and 12 months (1.7% vs. 2.6%; ARD -0.93, 95% CI -2.64 to 0.77).
Secondary outcomes
No significant difference in major adverse cardiac and cerebrovascular event (1.5% vs. 2%; ARD -0.49, 95% CI -2.07 to 1.09).
No significant difference in major bleeding (0.2% vs. 0.8%; ARD -0.6, 95% CI -1.33 to 0.12).
No significant difference in any revascularization (3.7% vs. 4.3%; ARD -0.56, 95% CI -2.99 to 1.87).
Conclusion
In patients who underwent successful PCI with bioabsorbable polymer everolimus-eluting stents, P2Y12 inhibitor monotherapy was noninferior to dual antiplatelet therapy with respect to the rate of net adverse clinical event between 3 and 12 months.
Reference
Pil-Ki Min, Tae Soo Kang, Yun-Hyeong Cho 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 Mar 4;7(3):e240877.
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