Cardiac Surgery Department, University Hospital of Zurich, Zurich, Switzerland; Postgraduate Program in Health Sciences: Cardiology and Cardiovascular Sciences, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
Cardiac Surgery Department, University Hospital of Zurich, Zurich, Switzerland; Fundación Interhospitalaria para la Investigación Cardiovascular, Madrid, Spain.
Am J Cardiol. 2021 Jun 15;149:64-71. doi: 10.1016/j.amjcard.2021.03.022. Epub 2021 Mar 20.
Considering that there is a lack of evidence and guideline-based recommendations on the best preoperative oral anticoagulation management (OAC) for transcatheter aortic valve implantation (TAVI), this cohort study aimed to evaluate bleeding, access site complications, and early safety in patients undergoing TAVI on continued OAC therapy vs no-OAC therapy. Three-hundred forty-four patients submitted to a TAVI procedure (66.3% no-OAC vs 33.7% OAC) were consecutively enrolled. Primary endpoint was defined as in-hospital VARC-2 life-threatening or disabling bleeding. Secondary endpoints were in-hospital VARC-2 major vascular complications and VARC-2 early safety at 30 days. Propensity score matching analysis was performed to reduce potential distribution bias, resulting in 2 well-balanced groups (92 patients in each arm). In the overall cohort, mean age, median EuroScore II, and STS-score were 78.7±7.6 years, 2.9% (1.7-5.9), and 2.3% (1.6-3.6), respectively. Despite being older (78 ± 8 vs 80 ± 6, p = 0.004) and having higher STS score (2.1 vs 2.6, p = 0.001), patients on OAC had similar incidence of in-hospital VARC-2 life-threatening or disabling bleeding (1.3% vs. 0.9%, p = 0.711), major vascular complications (4.8% vs 5.2%, p = 0.888), and VARC-2 early safety at 30 days (10.1% vs 12.1%, p = 0.575). No significant differences in the main outcomes were observed when propensity score matching was applied. In conclusion, the management of patients on OAC submitted to a TAVI procedure is challenging and requires balancing the risk of bleeding with the risk of thromboembolic events. The present study suggests that continued OAC was not associated with increased in-hospital VARC-2 life-threatening or disabling bleeding, major vascular complications, and VARC-2 early safety at 30 days.
考虑到经导管主动脉瓣植入术(TAVI)前最佳口服抗凝管理(OAC)缺乏证据和基于指南的建议,本队列研究旨在评估继续 OAC 治疗与非 OAC 治疗的患者在 TAVI 中出血、入路部位并发症和早期安全性。344 例患者接受 TAVI 手术(66.3%非 OAC 与 33.7%OAC)连续入组。主要终点定义为院内 VARC-2 危及生命或致残性出血。次要终点为院内 VARC-2 主要血管并发症和 VARC-2 术后 30 天早期安全性。进行倾向评分匹配分析以减少潜在分布偏差,结果形成 2 个平衡良好的组(每组 92 例)。在总体队列中,平均年龄、中位数欧洲心脏手术风险评估 II (EuroScore II)和 STS 评分分别为 78.7±7.6 岁、2.9%(1.7-5.9)和 2.3%(1.6-3.6)。尽管 OAC 组年龄更大(78±8 岁 vs 80±6 岁,p=0.004)且 STS 评分更高(2.1 vs 2.6,p=0.001),但两组院内 VARC-2 危及生命或致残性出血发生率相似(1.3% vs. 0.9%,p=0.711)、主要血管并发症(4.8% vs 5.2%,p=0.888)和 VARC-2 术后 30 天早期安全性(10.1% vs 12.1%,p=0.575)。应用倾向评分匹配后,主要结局无显著差异。总之,OAC 管理的患者接受 TAVI 手术具有挑战性,需要平衡出血风险与血栓栓塞事件风险。本研究表明,继续 OAC 治疗与院内 VARC-2 危及生命或致残性出血、主要血管并发症和术后 30 天 VARC-2 早期安全性增加无关。