Wang Chun-Li, Huang Chien-Hao, Wu Victor Chien-Chia, Huang Ya-Chi, Wang Hsiang-Sheng, Kuo Chang-Fu, Chu Pao-Hsien, Wen Ming-Shien, Chen Ying-Jen, Huang Yu-Tung, Chang Shang-Hung
Cardiovascular Division, Department of Internal Medicine, Linkou Medical Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.
College of Medicine, Chang-Gung University, Taoyuan, Taiwan.
Front Cardiovasc Med. 2021 Dec 23;8:774072. doi: 10.3389/fcvm.2021.774072. eCollection 2021.
Patients with active peptic ulcer (PU) were excluded from direct oral anticoagulant (DOAC) trials for stroke prevention in patients with atrial fibrillation (AF). This study evaluated the safety and effectiveness of DOACs in AF patients with active, inactive and no peptic ulcer (PU). This study accessed electronic medical records from January 1, 2009 to May 31, 2019 at a multi-center healthcare provider in Taiwan and involved 2,955 AF patients who had undergone esophagogastroduodenoscopy ≤ 1 year before anticoagulation. Subjects were classified into 3 groups: active ( = 237), inactive ( = 828) and no-PU ( = 1,890) groups. We compared the risks of major bleeding, gastrointestinal bleeding, and ischemic stroke/systemic embolism (IS/SE) between DOACs and warfarin among the 3 groups. In the active PU group, there were no significant differences in the risks of major bleeding [hazard ratio (HR) = 0.65, 95% confidence interval (CI) 0.08-4.98, = 0.676], gastrointestinal bleeding (HR = 0.65, 95% CI 0.08-4.98, = 0.676) and IS/SE (HR = 2.58; 95% CI 0.53-12.70, = 0.243) between DOAC and warfarin (as the reference). In the inactive PU group, there were no significant differences in the risks of major bleeding (HR = 0.36, 95% CI 0.09-1.39, = 0.138), gastrointestinal bleeding (HR = 0.21, 95% CI 0.02-1.80, p = 0.153), and IS/SE (HR = 1.04, 95% CI 0.39-2.82, = 0.934) between DOAC and warfarin (as the reference). In the no-PU group, DOACs were associated with lower risk of major bleeding (HR = 0.26, 95% CI 0.12-0.53, < 0.001), gastrointestinal bleeding (HR = 0.25, 95% CI 0.01-0.59, = 0.002), and similar risk of IS/SE (HR = 0.92, 95% CI 0.55-1.54, = 0.757) compared to warfarin. DOACs were as effective as warfarin in preventing IS/SE irrespective of PU status and safer than warfarin in reducing major bleeding in the no-PU group. In patients with active or inactive PUs, DOAC and warfarin were not significantly different in their effects on major bleeding or gastrointestinal bleeding.
患有活动性消化性溃疡（PU）的患者被排除在房颤（AF）患者预防中风的直接口服抗凝剂（DOAC）试验之外。本研究评估了DOACs在患有活动性、非活动性和无消化性溃疡（PU）的房颤患者中的安全性和有效性。本研究获取了台湾一家多中心医疗服务机构2009年1月1日至2019年5月31日的电子病历，纳入了2955例在抗凝治疗前≤1年接受过食管胃十二指肠镜检查的房颤患者。受试者分为3组：活动性（=237）、非活动性（=828）和无PU（=1890）组。我们比较了DOACs与华法林在大出血、胃肠道出血以及缺血性中风/全身性栓塞（IS/SE）方面的风险。在活动性PU组中，DOAC与华法林（作为对照）相比，在大出血风险（风险比[HR]=0.65，95%置信区间[CI]0.08 - 4.98，P=0.676）、胃肠道出血（HR = 0.65，95% CI 0.08 - 4.98，P = 0.676）和IS/SE（HR = 2.58；95% CI 0.53 - 12.70，P = 0.243）方面无显著差异。在非活动性PU组中，DOAC与华法林（作为对照）相比，在大出血风险（HR = 0.36，95% CI 0.09 - 1.39，P = 0.138）、胃肠道出血（HR = 0.21，95% CI 0.02 - 1.80，P = 0.153）和IS/SE（HR = 1.04，95% CI 0.39 - 2.82，P = 0.934）方面无显著差异。在无PU组中，与华法林相比，DOACs与大出血风险较低（HR = 0.26，95% CI 0.12 - 0.53，P < 0.001）、胃肠道出血（HR = 0.25，95% CI 0.01 - 0.59，P = 0.002）相关，且IS/SE风险相似（HR = 0.92，95% CI 0.55 - 1.54，P = 0.757）。无论PU状态如何，DOACs在预防IS/SE方面与华法林同样有效，且在无PU组中在减少大出血方面比华法林更安全。在患有活动性或非活动性PU的患者中，DOAC与华法林在大出血或胃肠道出血方面的效果无显著差异。
