Key result
Prasugrel single antiplatelet therapy resulted in a non-significant reduction in BARC 2, 3, or 5 bleeding from 1 to 12 months after PCI compared to dual antiplatelet therapy (HR 0.69).
Why the study?
Outcomes with prasugrel single antiplatelet therapy versus dual antiplatelet therapy in Japanese percutaneous coronary intervention patients with high bleeding risk were unknown.
Does prasugrel single antiplatelet therapy reduce bleeding compared to dual antiplatelet therapy in Japanese percutaneous coronary intervention patients with high bleeding risk?
Cohort (n=3,708)
Yes
Does prasugrel single antiplatelet therapy reduce bleeding compared to dual antiplatelet therapy in Japanese percutaneous coronary intervention patients with high bleeding risk?
Hazard Ratio: 0.69 (95% CI 0.45–1.06)
Absolute Event Rate: 2.8% vs 4.1%
p-value: p=0.090
In Japanese PCI patients with high bleeding risk, prasugrel single antiplatelet therapy showed a trend toward reduced bleeding without increasing ischemic events compared to standard dual antiplatelet therapy.
Registry data suggest prasugrel SAPT may lower bleeding in Japanese HBR PCI patients; leaves open randomized confirmation of net benefit.
BACKGROUND: Outcomes with prasugrel single antiplatelet therapy (SAPT) vs. dual antiplatelet therapy (DAPT) in Japanese percutaneous coronary intervention (PCI) patients with high bleeding risk (HBR) are currently unknown. METHODS AND RESULTS: Data from 1,173 SAPT and 2,535 DAPT patients from the PENDULUM mono and PENDULUM registry studies (respective median DAPT durations: 108 vs. 312 days) were compared. The adjusted cumulative incidence of Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding from 1 to 12 months after PCI (primary endpoint) was 2.8% (95% confidence interval [CI], 1.9-4.2) and 4.1% (95% CI, 3.3-5.1), respectively (hazard ratio [HR], 0.69; 95% CI, 0.45-1.06; P=0.090). The adjusted cumulative incidences of BARC 2, 3, or 5 bleeding from 0 to 12 months after PCI (secondary endpoint) were 3.8% (95% CI, 2.7-5.3) and 5.6% (95% CI, 4.7-6.7), respectively (HR, 0.68; 95% CI, 0.47-0.98; P=0.039). There was no significant difference in major adverse cardiac and cerebrovascular events (MACCE) from 1 to 12 months after PCI (HR, 0.93; 95% CI, 0.63-1.37; P=0.696) and at 12 months after PCI (HR, 0.85; 95% CI, 0.61-1.19; P=0.348) between the groups. CONCLUSIONS: Prasugrel SAPT may reduce BARC 2, 3, or 5 bleeding, without increasing MACCE, in Japanese patients with HBR.
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Nakamura et al. (2021) conducted a cohort in High bleeding risk in patients undergoing percutaneous coronary intervention (n=3,708). Prasugrel single antiplatelet therapy vs. Dual antiplatelet therapy was evaluated on Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding from 1 to 12 months after PCI (HR 0.69, 95% CI 0.45-1.06, p=0.090). Prasugrel single antiplatelet therapy resulted in a non-significant reduction in BARC 2, 3, or 5 bleeding from 1 to 12 months after PCI compared to dual antiplatelet therapy (HR 0.69).
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