Essebag Vidal, Healey Jeff S, Ayala-Paredes Felix, Kalfon Eli, Coutu Benoit, Nery Pablo, Verma Atul, Sapp John, Philippon Francois, Sandhu Roopinder K, Coyle Doug, Eikelboom John, Wells George, Birnie David H
McGill University Health Centre, Montreal, Quebec, Canada; Hôpital Sacré-Coeur de Montréal, Montreal, Quebec, Canada.
Population Health Research Institute, Hamilton, Ontario, Canada.
Am Heart J. 2016 Mar;173:102-7. doi: 10.1016/j.ahj.2015.12.007. Epub 2015 Dec 19.
Patients who require perioperative anticoagulation during cardiac implantable electronic device surgery are at increased risk for bleeding complications. The BRUISE CONTROL trial demonstrated that continuing warfarin was safer than heparin bridging, reducing the incidence of clinically significant pocket hematoma. Novel oral anticoagulants are being increasingly prescribed in place of warfarin. The best perioperative management of these new anticoagulants is unknown.
METHODS/DESIGN: A randomized controlled trial to investigate whether a strategy of continued vs interrupted novel oral anticoagulant (dabigatran, rivaroxaban, or apixaban) at the time of device surgery, in patients with moderate to high risk of arterial thromboembolic events, reduces the incidence of clinically significant hematoma (defined as a hematoma requiring reoperation and/or resulting in prolongation of hospitalization, and/or requiring interruption of anticoagulation). The secondary outcomes include components of the primary outcome, composite of all other major perioperative bleeding events, thromboembolic events, all-cause mortality, cost-effectiveness, patient quality of life, perioperative pain, and satisfaction. Planned analyses include descriptive statistics of all baseline variables. For the primary outcome, interrupted vs continued novel oral anticoagulant arms will be compared using the χ(2) test. If any clinically significant differences are identified, a logistic regression analysis will be conducted. Quality of life will be assessed using EuroQol-5D, and perioperative pain using a visual analog scale.
BRUISE CONTROL-2 is a randomized trial evaluating the best strategy to manage novel oral anticoagulants at the time of device surgery. We hypothesize that device surgery can be performed safely without interruption of these medications.
在心脏植入式电子设备手术期间需要围手术期抗凝的患者发生出血并发症的风险增加。BRUISE CONTROL试验表明，继续使用华法林比肝素桥接更安全，可降低具有临床意义的囊袋血肿的发生率。新型口服抗凝剂正越来越多地被用于替代华法林。这些新型抗凝剂的最佳围手术期管理尚不清楚。
方法/设计：一项随机对照试验，旨在调查在动脉血栓栓塞事件中、高风险患者进行设备手术时，继续或中断新型口服抗凝剂（达比加群、利伐沙班或阿哌沙班）的策略是否能降低具有临床意义的血肿（定义为需要再次手术和/或导致住院时间延长和/或需要中断抗凝的血肿）的发生率。次要结局包括主要结局的组成部分、所有其他主要围手术期出血事件的综合、血栓栓塞事件、全因死亡率、成本效益、患者生活质量、围手术期疼痛和满意度。计划分析包括所有基线变量的描述性统计。对于主要结局，将使用χ(2)检验比较中断与继续使用新型口服抗凝剂的组。如果发现任何具有临床意义的差异，将进行逻辑回归分析。生活质量将使用欧洲五维健康量表进行评估，围手术期疼痛将使用视觉模拟量表进行评估。
BRUISE CONTROL-2是一项随机试验，评估在设备手术时管理新型口服抗凝剂的最佳策略。我们假设在不中断这些药物的情况下可以安全地进行设备手术。
