Steinberg Benjamin A, Simon DaJuanicia N, Thomas Laine, Ansell Jack, Fonarow Gregg C, Gersh Bernard J, Kowey Peter R, Mahaffey Kenneth W, Peterson Eric D, Piccini Jonathan P
Division of Cardiovascular Medicine, University of Utah Health Sciences Center, Salt Lake City, Utah; Department of Medicine, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.
Duke Clinical Research Institute, Durham, North Carolina.
Am J Cardiol. 2017 May 15;119(10):1590-1595. doi: 10.1016/j.amjcard.2017.02.015. Epub 2017 Mar 28.
Non-vitamin K antagonist oral anticoagulants (NOACs) are effective at preventing stroke in patients with atrial fibrillation (AF). However, little is known about the management of bleeding in contemporary, clinical use of NOACs. We aimed to assess the frequency, management, and outcomes of major bleeding in the setting of community use of NOACs. Using the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II registry, we analyzed rates of International Society on Thrombosis and Haemostasis major bleeding and subsequent outcomes in patients treated with NOACs versus warfarin. Outcomes of interest included acute and chronic bleeding management, recurrent bleeding, thromboembolic events, and death. In total, 344 patients with atrial fibrillation experienced major bleeding events over a median follow-up of 360 days follow-up: n = 273 on NOAC (3.3 per 100 patient-years) and n = 71 on warfarin (3.5 per 100 patient-years). Intracranial bleeding was uncommon but similar (0.34 per 100 patient-years for NOAC vs 0.44 for warfarin, p = 0.5), as was gastrointestinal bleeding (1.8 for NOAC vs 1.3 for warfarin, p = 0.1). Blood products and correction agents were less commonly used in NOAC patients with major bleeds compared with warfarin-treated patients (53% vs 76%, p = 0.0004 for blood products; 0% vs 1.5% for recombinant factor; p = 0.0499); no patients received pharmacologic hemostatic agents (aminocaproic acid, tranexamic acid, desmopressin, aprotinin). Within 30 days, 23 NOAC-treated patients (8.4%) died versus 5 (7.0%) on warfarin (p = 0.7). At follow-up, 126 NOAC-treated (46%) and 29 warfarin-treated patients (41%) were not receiving any anticoagulation. In conclusion, rates of major bleeding are similar in warfarin and NOAC-treated patients in clinical practice. However, NOAC-related bleeds require less blood product administration and rarely require factor replacement.
非维生素K拮抗剂口服抗凝药（NOACs）在预防心房颤动（AF）患者中风方面有效。然而，对于NOACs在当代临床应用中出血的管理知之甚少。我们旨在评估社区使用NOACs时严重出血的频率、管理及结局。利用房颤更好知情治疗结局登记库II登记数据，我们分析了接受NOACs治疗与华法林治疗患者的国际血栓与止血协会严重出血发生率及后续结局。感兴趣的结局包括急性和慢性出血管理、复发性出血、血栓栓塞事件及死亡。共有344例心房颤动患者在中位随访360天期间发生严重出血事件：接受NOACs治疗的有273例（每100患者年3.3例），接受华法林治疗的有71例（每100患者年3.5例）。颅内出血不常见但相似（NOACs为每100患者年0.34例，华法林为0.44例，p = 0.5），胃肠道出血情况也相似（NOACs为1.8例，华法林为1.3例，p = 0.1）。与接受华法林治疗的患者相比，发生严重出血的NOACs患者较少使用血液制品和纠正剂（血液制品：53%对76%，p = 0.0004；重组因子：0%对1.5%，p = 0.0499）；无患者接受药理止血剂（氨基己酸、氨甲环酸、去氨加压素抑肽酶）。30天内，接受NOACs治疗的23例患者（8.4%）死亡，接受华法林治疗的有5例（7.0%）死亡（p = 0.7）。随访时，126例接受NOACs治疗的患者（46%）和29例接受华法林治疗的患者（41%）未接受任何抗凝治疗。总之，在临床实践中，华法林治疗患者和NOACs治疗患者的严重出血发生率相似。然而，与NOACs相关的出血需要较少的血液制品输注，很少需要因子替代。
