Background
Safety and efficacy of clopidogrel versus aspirin monotherapy beyond standard duration of DAPT after coronary stenting in patients with HBR and/or PCI complexity.
Methods
7,392 consecutive patients who received a standard duration of DAPT w/out clinical events for 12 months after PCI with DES were prospectively enrolled at Fuwai hospital. Patients who transitioned to antiplatelet monotherapy (aspirin or clopidogrel) were included in the present analysis. The primary endpoint was NACE, defined as a composite of MACCE (all-cause death, myocardial infarction, or stroke) or clinically relevant bleeding (BARC type 2, 3, or 5 bleeding), assessed from 12 to 36 months after PCI.
Results
Of 5,664 patients receiving antiplatelet monotherapy included (mean [SD] age, 58.5 [10.1] years; 4,295 male [75.8%]), 1,113 had HBR (19.7%), and 1,953 underwent complex PCI (34.5%). Compared with aspirin monotherapy (n=3,690), clopidogrel monotherapy (n=1,974) was associated with lower rates of NACE regardless of HBR and/or PCI complexity. For NACE, the HR was 0.62 (95% CI, 0.35–0.97; P=0.036) among patients with HBR and 0.64 (95% CI, 0.43–0.95; P=0.027) among patients without HBR (P for interaction=0.717). Similarly, the HR for NACE was 0.45 (95% CI, 0.25–0.82; P=0.010) among patients undergoing complex PCI and 0.70 (95% CI, 0.48–1.03; P=0.084) among those with noncomplex PCI (P for interaction=0.137). The HR by clopidogrel compared with aspirin was 0.60 (95% CI, 0.36-0.97) among the non-HBR and noncomplex PCI group, 0.71 (95% CI, 0.37-1.38) among the non-HBR and complex PCI group, 1.15 (95% CI, 0.60-2.22) among the HBR and noncomplex PCI group. Among patients with both HBR and complex PCI, clopidogrel monotherapy compared with aspirin monotherapy was associated with a marked reduction in NACE (HR, 0.08; 95% CI, 0.01–0.59; P=0.012), with a significant interaction effect (P for interaction=0.028).
Conclusions
In patients who experienced PCI and were event-free during 12 months of DAPT, clopidogrel monotherapy was associated with a reduction in NACE compared with aspirin monotherapy regardless of HBR and/or PCI complexity. The beneficial impact of clopidogrel monotherapy was more pronounced in the group with both HBR and complex PCI.