Semco Robert S, Bergmark Regan W, Murphy Sabina A, Cange Abby L, Unverdorben Martin, Chen Cathy Z L, Ruff Christian T, Antman Elliott M, Giugliano Robert P, Bergmark Brian A
Center for Surgery and Public Health Brigham and Women's Hospital Boston MA USA.
Division of Otolaryngology-Head and Neck Surgery, Department of Surgery Brigham and Women's Hospital and Dana Farber Cancer Institute Boston MA USA.
J Am Heart Assoc. 2025 Jan 21;14(2):e031434. doi: 10.1161/JAHA.123.031434. Epub 2025 Jan 10.
Epistaxis is common with antithrombotic therapy and is often troublesome to patients, yet its frequency, severity, and outcomes are poorly characterized.
Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) randomized 21 105 patients with atrial fibrillation and CHADS2 risk score ≥2 to higher-dose edoxaban regimen (60 mg daily, dose-reduced to 30 mg), lower-dose edoxaban regimen (30 mg, dose reduced to 15 mg, daily), or warfarin. Bleeds were adjudicated using International Society on Thrombosis and Haemostasis criteria. Patients with intracranial hemorrhage during follow-up were excluded; those with >1 bleeding event were categorized according to their most severe event. The safety cohort with interval censoring during drug interruption was analyzed. Proportions were compared using Pearson's chi-square test and treatment arms were compared using a Cox proportional hazards model. Among 5247 patients with a bleeding event, 1008 (19.2%) had epistaxis and 4239 (80.8%) had nonepistaxis bleeding. Epistaxis events were less severe than nonepistaxis bleeds (International Society on Thrombosis and Haemostasis major: 3.2% versus 20.7%; clinically relevant nonmajor: 64.7% versus 60.1%; minor: 32.1% versus 19.2%; <0.001). Permanent drug discontinuation was similar following epistaxis versus nonepistaxis bleeding in patients with major (59.4% versus 53.6%; =0.52) or clinically relevant nonmajor (32.5% versus 33.3%; =0.70) bleeding but was significantly higher in patients with minor epistaxis versus other minor bleeds (33.3% versus 23.9%; =0.001). Compared with warfarin, higher-dose edoxaban regimen had similar risk of epistaxis (hazard ratio [HR], 1.09 [95% CI, 0.95-1.26]), whereas lower-dose edoxaban regimen conferred reduced risk (HR, 0.73 [95% CI, 0.62-0.86]).
Epistaxis was frequent, and despite being overall less severe than nonepistaxis bleeding, was associated with similar rates of anticoagulant discontinuation. Compared with warfarin, lower-dose edoxaban regimen reduced the risk of epistaxis by 27% whereas higher-dose edoxaban regimen had no effect.
URL: https://clinicaltrials.gov; Unique Identifier: NCT00781391.
鼻出血在抗栓治疗中很常见，且常常给患者带来困扰，但其发生频率、严重程度及后果目前仍缺乏充分描述。
房颤患者中有效抗凝治疗——新一代Xa因子在心肌梗死溶栓治疗48研究（ENGAGE AF-TIMI 48）将21105例CHADS2风险评分≥2的房颤患者随机分为高剂量依度沙班治疗方案（每日60mg，剂量可减至30mg）、低剂量依度沙班治疗方案（每日30mg，剂量可减至15mg）或华法林治疗组。出血事件依据国际血栓与止血学会标准进行判定。随访期间发生颅内出血的患者被排除；有>1次出血事件的患者根据其最严重的事件进行分类。对药物中断期间进行间隔删失的安全队列进行分析。比例比较采用Pearson卡方检验，治疗组比较采用Cox比例风险模型。在5247例发生出血事件的患者中，1008例（19.2%）发生鼻出血，4239例（80.8%）发生非鼻出血性出血。鼻出血事件的严重程度低于非鼻出血性出血（国际血栓与止血学会定义的大出血：3.2%对20.7%；临床相关非大出血：64.7%对60.1%；小出血：32.1%对19.2%；P<0.001）。大出血（59.4%对53.6%；P=0.52）或临床相关非大出血（32.5%对33.3%；P=0.70）的患者中，鼻出血后与非鼻出血性出血后永久停药情况相似，但小鼻出血患者与其他小出血患者相比，永久停药率显著更高（33.3%对23.9%；P=0.001）。与华法林相比，高剂量依度沙班治疗方案发生鼻出血的风险相似（风险比[HR]，1.09[95%CI，0.95 - 1.26]），而低剂量依度沙班治疗方案可降低风险（HR，0.73[95%CI，0.62 - 0.86]）。
鼻出血很常见，尽管总体严重程度低于非鼻出血性出血，但抗凝药物停药率相似。与华法林相比，低剂量依度沙班治疗方案可使鼻出血风险降低27%，而高剂量依度沙班治疗方案无此作用。
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