SMART-CHOICE (1-year follow-up)
Trial question
Is P2Y12 inhibitor monotherapy noninferior to dual antiplatelet therapy in patients undergoing PCI?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
27.0% female
73.0% male
N = 2993
2993 patients (795 female, 2198 male).
Inclusion criteria: patients undergoing PCI with drug-eluting stents.
Key exclusion criteria: known hypersensitivity or contraindication to aspirin; clopidogrel; prasugrel; ticagrelor; everolimus or sirolimus.
Interventions
N=1495 P2Y12 inhibitor monotherapy (aspirin plus a P2Y12 inhibitor for 3 months and thereafter a P2Y12 inhibitor alone).
N=1498 dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor for at least 12 months).
Primary outcome
Major adverse cardiac and cerebrovascular events at 12 months
2.9%
2.5%
2.9 %
2.2 %
1.4 %
0.7 %
0.0 %
P2Y12 inhibitor
monotherapy
Dual antiplatelet
therapy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in major adverse cardiac and cerebrovascular events at 12 months (2.9% vs. 2.5%; AD 0.4%, 95% CI -Infinity to 1.3).
Secondary outcomes
No significant difference in all-cause mortality (1.4% vs. 1.2%; HR 1.18, 95% CI 0.63 to 2.21).
No significant difference in MI (0.8% vs. 1.2%; HR 0.66, 95% CI 0.31 to 1.4).
No significant difference in stroke (0.8% vs. 0.3%; HR 2.23, 95% CI 0.78 to 6.43).
Safety outcomes
No significant difference in major bleeding.
Significant difference in bleeding (2.0% vs. 3.4%).
Conclusion
In patients undergoing PCI with drug-eluting stents, P2Y12 inhibitor monotherapy was noninferior to dual antiplatelet therapy with respect to major adverse cardiac and cerebrovascular events at 12 months.
Reference
Joo-Yong Hahn, Young Bin Song, Ju-Hyeon Oh et al. Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention: The SMART-CHOICE Randomized Clinical Trial. JAMA. 2019 Jun 25;321(24):2428-2437.
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