Division of Gastroenterology and Hepatology, Creighton University School of Medicine, Omaha, Nebraska, USA.
Division of Gastroenterology and Hepatology, MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio, USA.
Gastrointest Endosc. 2023 Jun;97(6):1129-1136.e3. doi: 10.1016/j.gie.2023.01.043. Epub 2023 Jan 30.
GI bleeding after ERCP is a serious adverse event and most commonly occurs after endoscopic biliary and/or pancreatic sphincterotomy. Although the strength of available evidence for post-sphincterotomy GI bleeding risk is high for therapeutic warfarin and heparin, it remains unknown for antiplatelet agents like clopidogrel and prasugrel. We conducted a retrospective United States-based, propensity-matched cohort study to assess the risk of post-sphincterotomy bleeding in patients receiving anticoagulant (AC) and antiplatelet (APT) therapy.
We analyzed the U.S. Collaborative Network in the TriNetX platform through December 27, 2022, to include patients receiving APT and AC therapy who underwent ERCP within 7 days of hospitalization. One-to-one propensity score matching was performed. The primary outcome was the incidence of GI bleeding within 7 days of sphincterotomy. Secondary outcomes included need for blood transfusion, intensive care unit care, and all-cause mortality within 30 days of bleeding.
Overall, 2806 patients (1806 in the AC cohort and 1000 in the APT cohort) underwent ERCP with sphincterotomy. One-to-one propensity score matching was performed for age, body mass index ≥30 kg/m, gender, race, ethnicity, diabetes mellitus, nicotine dependence, presence and severity of chronic kidney disease, cirrhosis, and thrombocytopenia between the cohorts. Patients in both cohorts had an increased risk of post-sphincterotomy bleeding compared with matched control subjects (adjusted odds ratios of 3.6 [95% confidence interval, 2.58-5.06] and 2.2 [95% confidence interval, 1.43-3.56], respectively). Although heparin bridging therapy and concurrent use of aspirin did not further increase the risk of GI bleeding, resumption of AC within 24 hours' postprocedure did. Neither cohort of patients was at an increased risk for blood transfusion, intensive care unit care, or all-cause mortality.
Our database analysis shows that patients receiving AC and APT therapy are at a higher risk of post-sphincterotomy bleeding compared with matched control subjects. An appropriate drug cessation period or alternative biliary decompression modalities may be used in these patients.
ERCP 术后的胃肠道出血是一种严重的不良事件，最常发生在内镜下胆道和/或胰管括约肌切开术后。尽管有强有力的证据表明，在接受治疗性华法林和肝素治疗时，行括约肌切开术后胃肠道出血的风险较高，但对于氯吡格雷和普拉格雷等抗血小板药物，其风险仍然未知。我们进行了一项回顾性的基于美国的、倾向评分匹配队列研究，以评估接受抗凝（AC）和抗血小板（APT）治疗的患者在行 ERCP 术后发生括约肌切开术后出血的风险。
我们通过 TriNetX 平台上的美国协作网络分析，截至 2022 年 12 月 27 日，纳入在住院后 7 天内行 ERCP 并接受 APT 和 AC 治疗的患者。采用 1:1 倾向评分匹配。主要结局是括约肌切开术后 7 天内胃肠道出血的发生率。次要结局包括 30 天内需要输血、入住重症监护病房和全因死亡率。
总体而言，2806 例患者（AC 组 1806 例，APT 组 1000 例）行 ERCP 并行括约肌切开术。对两组患者的年龄、体重指数≥30kg/m2、性别、种族、民族、糖尿病、尼古丁依赖、慢性肾脏病的存在和严重程度、肝硬化和血小板减少症进行了 1:1 倾向评分匹配。与匹配对照组相比，两组患者行括约肌切开术后出血的风险均增加（调整后的优势比分别为 3.6[95%置信区间，2.58-5.06]和 2.2[95%置信区间，1.43-3.56]）。虽然肝素桥接治疗和同时使用阿司匹林并未进一步增加胃肠道出血的风险，但术后 24 小时内恢复 AC 治疗会增加风险。两个患者组在输血、入住重症监护病房或全因死亡率方面均无增加的风险。
我们的数据库分析表明，与匹配对照组相比，接受 AC 和 APT 治疗的患者行括约肌切开术后出血的风险更高。在这些患者中，可能需要适当的停药期或替代胆道减压方式。
