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日本庆应心血管注册研究:经皮冠状动脉介入治疗冠心病后胃肠道出血的发生率及危险因素比较。

Comparative incidence and risk factors for gastrointestinal bleeding following percutaneous coronary intervention for coronary artery disease: Insights from the Keio Cardiovascular Registry in Japan.

机构信息

Department of Cardiology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 1608582, Japan.

Department of Cardiology, Japanese Red Cross Ashikaga Hospital, Ashikaga, 284-1 Yobe-cho, Ashikaga, Tochigi 326-0843, Japan.

出版信息

Thromb Res. 2024 Nov;243:109150. doi: 10.1016/j.thromres.2024.109150. Epub 2024 Sep 12.

Abstract

BACKGROUND

In patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI), antiplatelet medication usage is crucial for preventing thrombotic events. However, it requires careful monitoring, especially because of the risk of life-threatening bleeding complications. In hemorrhagic complications, assessment of patient background and risk of gastrointestinal bleeding (GIB) remain limited for GIB that develops during long-term observation after hospital discharge. This study aimed to examine the incidence of GIB and patient characteristics in CAD post-PCI.

METHODS

All CAD patients undergoing PCI for urgent, emergent, or elective indications were enrolled in the Keio Interhospital Cardiovascular Studies (JCD-KiCS)-PCI registry (January 2009 and December 2017) and followed up to 2 years after PCI discharge. From the JCD-KiCS PCI registry, 8864 patients (median [interquartile range [IQR]] age: non-GIB: 69.0 y [16 y], upper GIB (UGI): 72.0 y [15.5 y], lower GIB (LGI): 73.0 y [IQR: 13 y]) were categorized based on the occurrence of hospitalization-requiring GIB. Patient characteristics and detailed information regarding these GIB events, including the location (upper vs lower GI) and bleeding severity, were analyzed.

RESULTS

Overall, 36 patients experienced UGI, while 85 patients experienced LGI. The rates of dual antiplatelet therapy (DAPT) and triple therapy were significantly different among the non-GIB (n = 8734), UGI (n = 36) and LGI (n = 85) groups (DAPT [aspirin + P2Y12 (clopidogrel/prasugrel/ticlopidine)]: 64 [76.2 %] in the LGI group vs 24 [68.6 %] in the UGI group vs 7330 [84.6 %] in the non-GIB group; triple therapy [aspirin + P2Y12 (clopidogrel/prasugrel/ticlopidine)] + oral anticoagulant (OAC) (warfarin/direct oral anticoagulant [DOAC]): 17 [20.2 %] in the LGI group vs 8 [22.9 %] in the UGI group vs 836 [9.6 %] in the non-GIB group; p < 0.001). In the LGI and UGI groups, aspirin and warfarin were used in 2 (2.4 %) and 2 (5.7 %) patients, respectively, but not in combination with DOAC. The 2-year post-PCI hospitalization incidence for GIB was 1.4 % (LGI, 1.0 %; UGI, 0.4 %). The most common causes were colonic diverticular hemorrhage (43.5 %) for LGI and duodenal ulcer (21.9 %) for UGI. No significant differences were found in the cumulative 2-year post-PCI risks between the LGI and UGI groups (log-rank p = 0.97). Most GIB events were Bleeding Academic Research Consortium 2-equivalent (hemoglobin decrease <3 g/dL). Notably, the use of OACs at PCI discharge, bleeding complications within 72 h, and preprocedural anemia were significantly correlated with an increased GIB risk.

CONCLUSIONS

The real-world incidence of LGI is two times higher than that of UGI in CAD patients undergoing PCI, and most events are mild. OAC use at PCI discharge is the strongest potential risk factor for GIB development.

摘要

背景

在接受经皮冠状动脉介入治疗(PCI)的冠心病(CAD)患者中,抗血小板药物的使用对于预防血栓事件至关重要。然而,这需要仔细监测,特别是因为有发生危及生命的出血并发症的风险。在出血并发症中,对于出院后长期观察期间发生的胃肠道出血(GIB),患者背景和胃肠道出血风险的评估仍然有限。本研究旨在检查 CAD 患者 PCI 后 GIB 的发生率和患者特征。

方法

所有因紧急、紧急或选择性指征而行 PCI 的 CAD 患者均被纳入 Keio 医院间心血管研究(JCD-KiCS)-PCI 注册研究(2009 年 1 月至 2017 年 12 月),并在 PCI 出院后随访 2 年。从 JCD-KiCS PCI 注册研究中,根据需要住院治疗的 GIB 发生情况,将 8864 例患者(中位数[四分位间距[IQR]]年龄:非 GIB:69.0 岁[16 岁],上 GIB(UGI):72.0 岁[15.5 岁],下 GIB(LGI):73.0 岁[IQR:13 岁])分为 3 组。分析了患者特征和这些 GIB 事件的详细信息,包括部位(上 GI 与下 GI)和出血严重程度。

结果

总体而言,36 例患者发生 UGI,85 例患者发生 LGI。非 GIB(n=8734)、UGI(n=36)和 LGI(n=85)组之间的双联抗血小板治疗(DAPT)和三联治疗的比例存在显著差异(DAPT [阿司匹林+P2Y12(氯吡格雷/普拉格雷/替卡格雷)]:LGI 组 36 例中 26 例[76.2%],UGI 组 24 例[68.6%],非 GIB 组 7330 例[84.6%];三联治疗[阿司匹林+P2Y12(氯吡格雷/普拉格雷/替卡格雷)]+口服抗凝剂(OAC)(华法林/直接口服抗凝剂[DOAC]):LGI 组 17 例[20.2%],UGI 组 8 例[22.9%],非 GIB 组 836 例[9.6%];p<0.001)。LGI 组和 UGI 组分别有 2 例(2.4%)和 2 例(5.7%)患者使用阿司匹林和华法林,但未联合使用 DOAC。GIB 的 2 年 PCI 后住院发生率为 1.4%(LGI 组 1.0%,UGI 组 0.4%)。最常见的原因是 LGI 组的结肠憩室出血(43.5%)和 UGI 组的十二指肠溃疡(21.9%)。LGI 组和 UGI 组的 2 年 PCI 后累积风险无显著差异(对数秩检验 p=0.97)。大多数 GIB 事件为 Bleeding Academic Research Consortium 2 等效(血红蛋白下降<3 g/dL)。值得注意的是,PCI 出院时使用 OAC、72 小时内出血并发症和术前贫血与 GIB 风险增加显著相关。

结论

在接受 PCI 的 CAD 患者中,LGI 的真实世界发生率是 UGI 的两倍,大多数事件为轻度。PCI 出院时使用 OAC 是 GIB 发展的最强潜在危险因素。

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