Otsuka Yasuhiro, Ishii Masanobu, Ikebe So, Tokai Tatsuya, Nakamura Taishi, Tsujita Kenichi, Akashi Naoyuki, Fujita Hideo, Nakano Yasuhiro, Matoba Tetsuya, Kohro Takahide, Oba Yusuke, Kabutoya Tomoyuki, Kario Kazuomi, Imai Yasushi, Kiyosue Arihiro, Mizuno Yoshiko, Nochioka Kotaro, Nakayama Masaharu, Iwai Takamasa, Miyamoto Yoshihiro, Sato Hisahiko, Nagai Ryozo
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
Department of Medical Information Science, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo Chuo-Ku, Kumamoto, 860-8556, Japan.
Cardiovasc Interv Ther. 2025 Jun 9. doi: 10.1007/s12928-025-01151-4.
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.
接受经皮冠状动脉介入治疗（PCI）的患者中恶性肿瘤的患病率随着年龄增长而增加。活动性恶性肿瘤是导致高出血风险的重要因素。对于需要口服抗凝剂（OAC）治疗的癌症患者，直接口服抗凝剂（DOAC）和华法林之间的选择至关重要。本研究的目的是调查接受PCI的恶性肿瘤患者的长期出血事件。CLIDAS（临床深度数据积累系统）多中心数据库包含来自日本七家三级医疗机构的数据。这项回顾性分析纳入了2013年4月至2019年3月期间接受PCI并完成3年随访的6451例患者。患者分为两组：无恶性肿瘤组（n = 5787）和恶性肿瘤组（n = 664）。恶性肿瘤由癌症治疗史定义。这些组根据OAC治疗进一步细分：（1）无OAC的无恶性肿瘤组（n = 5134），（2）使用DOAC的无恶性肿瘤组（n = 261），（3）使用华法林的无恶性肿瘤组（n = 392），（4）无OAC的恶性肿瘤组（n = 589），（5）使用DOAC的恶性肿瘤组（n = 38），以及（6）使用华法林的恶性肿瘤组（n = 37）。主要结局是出血事件的发生率，根据全球应用链激酶和t-PA治疗闭塞冠状动脉的中度和重度出血分类进行定义。次要结局是主要不良心脏事件（MACE）和净不良临床事件（NACE）。多变量Cox回归分析显示，与无OAC的恶性肿瘤组相比，使用华法林的恶性肿瘤组出血事件风险显著更高（风险比[HR]，3.64；95%置信区间[CI]，1.38 - 9.61，p值 = 0.009）。MACE（HR，1.39；95% CI 0.59 - 3.25，p值 = 0.454）或NACE（HR，1.62；95% CI，0.80 - 3.29；p值 = 0.184）未观察到显著差异。接受华法林治疗的恶性肿瘤患者出血事件风险更高。对于接受PCI的恶性肿瘤患者，就出血风险而言，DOACs可能是华法林的更优替代选择。
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