Monotherapy With Prasugrel After Dual-Antiplatelet Therapy for Japanese Percutaneous Coronary Intervention Patients With High Bleeding Risk　- A Prospective Cohort Study (PENDULUM mono Study).

Abstract

BACKGROUND:

The risks of bleeding and cardiovascular events in high bleeding risk (HBR) Japanese patients undergoing percutaneous coronary intervention (PCI) while receiving single-antiplatelet therapy (SAPT) remains unknown. We aimed to evaluate the frequency of bleeding and cardiovascular events associated with prasugrel monotherapy after short-term dual-antiplatelet therapy (DAPT) in Japanese HBR patients after PCI.Methods and Results:The PENDULUM mono study was a multicenter, non-interventional, prospective registry (n=1,173). The primary endpoint was the cumulative incidence of clinically relevant bleeding (CRB; Bleeding Academic Research Consortium types 2, 3, and 5) from 1 to 12 months after PCI. Secondary endpoints included major adverse cardiac and cerebrovascular events (MACCE). The proportion of patients who received prasugrel monotherapy at 12 months after PCI was 79.7%, and no cases of stent thrombosis were observed among these patients. The cumulative incidence of CRB was 3.2% from 1 to 12 months after PCI; that of MACCE was 3.8%. Severe anemia, chronic kidney disease, oral anticoagulant use at discharge, and heart failure were significantly associated with CRB.

CONCLUSIONS:

Among HBR patients undergoing PCI who were not suitable for concomitant aspirin and were scheduled for prasugrel monotherapy, most patients were on prasugrel monotherapy after DAPT. Cumulative incidences of CRB and MACCE after periprocedural period were 3.2% and 3.8%, respectively, and no cases of stent thrombosis were reported. SAPT might be a suitable alternative to DAPT.

• Authors: Masato Nakamura, Yoshihiro Morino, Tsunekazu Kakuta, Yoshiki Hata, Itaru Takamisawa, Kengo Tanabe, Hitoshi Anzai, Akihiko Takahashi, Kazushige Kadota, Hiroshi Suzuki, Tetsuzo Wakatsuki, Hideki Okayama, Jun Yamashita, Takashi Akasaka, Hiroyoshi Yokoi, Takuo Nakagami, Yoshiharu Higuchi, Junichi Yamaguchi, Takumi Kimura, Atsushi Harada, Takeshi Kuroda, Atsushi Takita, Raisuke Iijima, Yoshitaka Murakami, Shigeru Saito
• Journal: Circulation journal : official journal of the Japanese Circulation Society (Circ J) Vol. 85 Issue 1 Pg. 27-36 (12 25 2020) ISSN: 1347-4820 [Electronic] Japan
• PMID: 33162490 (Publication Type: Journal Article, Multicenter Study)

Chemical References

• Platelet Aggregation Inhibitors
• Prasugrel Hydrochloride

Topics

• Hemorrhage (chemically induced, epidemiology)
• Humans
• Japan (epidemiology)
• Percutaneous Coronary Intervention
• Platelet Aggregation Inhibitors (therapeutic use)
• Prasugrel Hydrochloride (therapeutic use)
• Prospective Studies
• Thrombosis
• Treatment Outcome