Long-term bleeding events post-percutaneous coronary intervention in patients with malignancy with and without anticoagulant therapy

Yasuhiro Otsuka; Masanobu Ishii; So Ikebe; Tatsuya Tokai; Taishi Nakamura; Kenichi Tsujita; Naoyuki Akashi; Hideo Fujita; Yasuhiro Nakano; Tetsuya Matoba; Takahide Kohro; Yusuke Oba; Tomoyuki Kabutoya; Kazuomi Kario; Yasushi Imai; Arihiro Kiyosue; Yoshiko Mizuno; Kotaro Nochioka; Masaharu Nakayama; Takamasa Iwai; Yoshihiro Miyamoto; Hisahiko Sato; Ryozo Nagai; CLIDAS research group

doi:10.1007/s12928-025-01151-4

Long-term bleeding events post-percutaneous coronary intervention in patients with malignancy with and without anticoagulant therapy

Cardiovasc Interv Ther. 2025 Jun 9. doi: 10.1007/s12928-025-01151-4. Online ahead of print.

Authors

Yasuhiro Otsuka¹, Masanobu Ishii^{2

3}, So Ikebe¹, Tatsuya Tokai^{1

4}, Taishi Nakamura⁵, Kenichi Tsujita¹, Naoyuki Akashi⁶, Hideo Fujita⁶, Yasuhiro Nakano⁷, Tetsuya Matoba⁷, Takahide Kohro⁸, Yusuke Oba⁹, Tomoyuki Kabutoya⁹, Kazuomi Kario⁹, Yasushi Imai¹⁰, Arihiro Kiyosue¹¹, Yoshiko Mizuno^{11

12}, Kotaro Nochioka¹³, Masaharu Nakayama¹⁴, Takamasa Iwai¹⁵, Yoshihiro Miyamoto¹⁶, Hisahiko Sato¹⁷, Ryozo Nagai¹⁸; CLIDAS research group

Affiliations

¹ Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
² Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan. mishii4@kumamoto-u.ac.jp.
³ Department of Medical Information Science, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo Chuo-Ku, Kumamoto, 860-8556, Japan. mishii4@kumamoto-u.ac.jp.
⁴ Department of Cardiovascular Medicine, Miyazaki Prefectural Nobeoka Hospital, Miyazaki, Japan.
⁵ Department of Medical Information Science, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo Chuo-Ku, Kumamoto, 860-8556, Japan.
⁶ Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Saitama, Japan.
⁷ Department of Cardiovascular Medicine, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
⁸ Department of Clinical Informatics, Jichi Medical University School of Medicine, Tochigi, Japan.
⁹ Division of Cardiovascular Medicine, Jichi Medical University School of Medicine, Tochigi, Japan.
¹⁰ Division of Clinical Pharmacology, Department of Pharmacology, Jichi Medical University, Tochigi, Japan.
¹¹ Department of Cardiovascular Medicine, the University of Tokyo Hospital, Tokyo, Japan.
¹² Development Bank of Japan Inc., Tokyo, Japan.
¹³ Division of Cardiovascular Medicine, Tohoku University Hospital, Miyagi, Japan.
¹⁴ Department of Medical Informatics, Tohoku University Graduate School of Medicine, Miyagi, Japan.
¹⁵ Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.
¹⁶ Open Innovation Center, National Cerebral and Cardiovascular Center, Osaka, Japan.
¹⁷ Precision Inc., Tokyo, Japan.
¹⁸ Jichi Medical University School of Medicine, Tochigi, Japan.

PMID: 40489022
DOI: 10.1007/s12928-025-01151-4

Abstract

The prevalence of malignancies in patients undergoing percutaneous coronary intervention (PCI) is increasing with aging. Active malignancy is a significant contributor to high bleeding risk. For cancer patients requiring oral anticoagulant (OAC) therapy, the choice between direct oral anticoagulants (DOAC) and warfarin is critical. The aim of this study was to investigate long-term bleeding events in patients with malignancy undergoing PCI. The CLIDAS (Clinical Deep Data Accumulation System) multicenter database includes data from seven tertiary medical hospitals in Japan. This retrospective analysis included 6451 patients who underwent PCI between April 2013 and March 2019 and completed 3-year follow-up. The patients were divided into two groups; No malignancy (n = 5787) and Malignancy group (n = 664). Malignancy was defined by a history of cancer treatment. These groups were further subcategorized based on OAC therapy; (1) No malignancy without OAC (n = 5134), (2) No malignancy with DOAC (n = 261), (3) No malignancy with warfarin (n = 392), (4) Malignancy without OAC (n = 589), (5) Malignancy with DOAC (n = 38), and (6) Malignancy with warfarin (n = 37). The primary outcome was the incidence of bleeding events, defined according to the Global Use of Streptokinase and t-PA for Occluded Coronary Arteries classification of moderate and severe bleeding. The secondary outcomes were major adverse cardiac events (MACE) and net adverse clinical events (NACE). Multivariable Cox regression analysis showed that the malignancy with warfarin group had a significantly higher risk of bleeding events compared to the malignancy without OAC group (hazard ratio [HR], 3.64; 95% confidence interval [CI], 1.38-9.61, p value = 0.009). No significant differences were observed for MACE (HR, 1.39; 95% CI 0.59-3.25, p value = 0.454) or NACE (HR, 1.62; 95% CI, 0.80-3.29; p value = 0.184). Malignancy patients receiving warfarin were associated with a higher risk of bleeding events. DOACs may represent a preferable alternative to warfarin with regard to bleeding risk in patients with malignancy undergoing PCI.

Keywords: High bleeding risk; Malignancy; PCI.

Abstract

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