Key result
Short-term DAPT followed by prasugrel single antiplatelet therapy resulted in a non-significant reduction in clinically relevant bleeding compared to conventional long-term DAPT in high bleeding risk patients after PCI (HR 0.77).
Why the study?
Following 1-year data showing better outcomes with short-term DAPT followed by prasugrel SAPT in Japanese HBR patients after PCI, this study evaluated 2-year results.
Does short-term DAPT followed by prasugrel single antiplatelet therapy reduce clinically relevant bleeding and ischemic events at 24 months compared to conventional DAPT in Japanese PCI patients with high bleeding risk?
Observational (n=3,380)
Yes
Does short-term DAPT followed by prasugrel single antiplatelet therapy reduce clinically relevant bleeding and ischemic events at 24 months compared to conventional DAPT in Japanese PCI patients with high bleeding risk?
Hazard Ratio: 0.77 (95% CI 0.57–1.04)
Absolute Event Rate: 5.8% vs 7.2%
p-value: p=0.086
In Japanese PCI patients with high bleeding risk, short-term DAPT followed by prasugrel monotherapy showed a non-significant trend toward lower clinically relevant bleeding and ischemic events at 24 months compared to conventional DAPT.
Non-significant bleeding reduction with short DAPT plus prasugrel monotherapy in high-bleeding-risk PCI; leaves open confirmation in randomized trials before practice change.
BACKGROUND: In PENDULUM mono, Japanese patients with high bleeding risk (HBR) received short-term dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) with prasugrel after percutaneous coronary intervention (PCI). One-year data from PENDULUM mono showed better outcomes with prasugrel monotherapy after short-term DAPT compared with matched patients in the PENDULUM registry with longer DAPT durations according to guidelines at that time. This study presents 2-year results. METHODS AND RESULTS: We compared 24-month data from PENDULUM mono (n=1,107; de-escalation strategy group) and the PENDULUM registry (n=2,273; conventional strategy group); both were multicenter, non-interventional, prospective registry studies, using the inverse probability of treatment weighting (IPTW) method. In the PENDULUM mono group, the cumulative incidence of clinically relevant bleeding (CRB) at 24 months post-PCI (primary endpoint) was 6.8%, and that of major adverse cardiac and cerebrovascular events (MACCE) was 8.9%. After IPTW adjustment, the cumulative incidence of CRB was 5.8% and 7.2% in PENDULUM mono and the PENDULUM registry, respectively (hazard ratio [HR] 0.77; 95% confidence interval [CI] 0.57-1.04; P=0.086), and that of MACCE was 8.0% and 9.5%, respectively (HR 0.77; 95% CI 0.59-1.01; P=0.061). CONCLUSIONS: Japanese PCI patients with HBR prescribed prasugrel SAPT after short-term DAPT had a lower ischemic event risk than those prescribed long-term DAPT, and this was particularly relevant for ischemic events after 1 year.
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Nakagawa et al. (2022) conducted an observational in High bleeding risk after percutaneous coronary intervention (n=3,380). Short-term DAPT followed by prasugrel single antiplatelet therapy vs. Conventional long-term DAPT was evaluated on Cumulative incidence of clinically relevant bleeding (CRB) at 24 months (HR 0.77, 95% CI 0.57-1.04, p=0.086). Short-term DAPT followed by prasugrel single antiplatelet therapy resulted in a non-significant reduction in clinically relevant bleeding compared to conventional long-term DAPT in high bleeding risk patients after PCI (HR 0.77).
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