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Early P2Y12 Inhibitor Single Antiplatelet Therapy for High-Bleeding Risk Patients After Stenting ― PENDULUM Mono 24-Month Analysis

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 wit...

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Bibliographic Details
Published in:Circulation Journal 2022/08/25, Vol.86(9), pp.1352-1361
Main Authors: Nakagawa, Yoshihisa, Kadota, Kazushige, Nakao, Koichi, Shite, Junya, Yokoi, Hiroyoshi, Kozuma, Ken, Tanabe, Kengo, Akasaka, Takashi, Shinke, Toshiro, Ueno, Takafumi, Hirayama, Atsushi, Uemura, Shiro, Iijima, Raisuke, Harada, Atsushi, Kuroda, Takeshi, Takita, Atsushi, Murakami, Yoshitaka, Saito, Shigeru, Nakamura, Masato
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Language:English
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Summary: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.
ISSN:1346-9843
1347-4820
1347-4820
DOI:10.1253/circj.CJ-21-1004