SMART-CHOICE (3-year follow-up)
Trial question
Is P2Y12 inhibitor monotherapy after short-term dual antiplatelet therapy noninferior to long-term dual antiplatelet therapy after 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 who underwent PCI with drug-eluting stent.
Key exclusion criteria: hemodynamic instability or cardiogenic shock; active bleeding; hypersensitivity/contraindication to study medications; pregnancy; noncardiac comorbid conditions with life expectancy < 2 years.
Interventions
N=1495 P2Y12 inhibitor monotherapy (P2Y12 inhibitor monotherapy after 3 months of dual antiplatelet therapy).
N=1498 prolonged dual antiplatelet therapy (extended use of dual antiplatelet therapy up to 36 months).
Primary outcome
Major adverse cardiac and cerebrovascular events at 3 years
6.3%
6.1%
6.3 %
4.7 %
3.1 %
1.6 %
0.0 %
P2Y12 inhibitor
monotherapy
Prolonged dual antiplatelet
therapy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in major adverse cardiac and cerebrovascular events at 3 years (6.3% vs. 6.1%; HR 1.06, 95% CI 0.79 to 1.44).
Secondary outcomes
Significant decrease in bleeding (3.2% vs. 8.2%; HR 0.39, 95% CI 0.28 to 0.55).
Significant decrease in major bleeding (1.2% vs. 2.4%; HR 0.56, 95% CI 0.31 to 0.99).
No significant difference in cardiac death (2.2% vs. 2%; HR 1.12, 95% CI 0.68 to 1.89).
Conclusion
In patients who underwent PCI with drug-eluting stent, P2Y12 inhibitor monotherapy was noninferior to prolonged dual antiplatelet therapy with respect to major adverse cardiac and cerebrovascular events at 3 years.
Reference
Ki Hong Choi, Yong Hwan Park, Young Bin Song et al. Long-term Effects of P2Y12 Inhibitor Monotherapy After Percutaneous Coronary Intervention: 3-Year Follow-up of the SMART-CHOICE Randomized Clinical Trial. JAMA Cardiol. 2022 Nov 1;7(11):1100-1108.
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