Abstract：
BACKGROUND: There is a paucity of data comparing vitamin K antagonists (VKAs) to direct oral anticoagulants (DOACs) at the time of cardiac implantable electronic device (CIED) surgery. Furthermore, the best management of DOACs (interruption vs continuation) is yet to be determined.
OBJECTIVE: This study aimed to compare the incidence of device-related bleeds and thrombotic events based on anticoagulant type (DOAC vs VKA) and regimen (interrupted vs uninterrupted).
METHODS: This was an observational multicenter study. We included patients on chronic oral anticoagulation undergoing CIED surgery. Patients were matched using propensity scoring.
RESULTS: We included 1,975 patients (age 73.8 ± 12.4 years). Among 1,326 patients on DOAC, this was interrupted presurgery in 78.2% (n = 1,039) and continued in 21.8% (n = 287). There were 649 patients on continued VKA. The matched population included 861 patients. The rate of any major bleeding was higher with continued DOAC (5.2%) compared to interrupted DOAC (1.7%) and continued VKA (2.1%) (P = 0.03). The rate of perioperative thromboembolism was 1.4% with interrupted DOAC, whereas no thromboembolic events occurred with DOAC or VKA continuation (P = 0.04). The use of dual antiplatelet therapy, DOAC continuation, and male sex were independent predictors of major bleeding on a multivariable analysis.
CONCLUSIONS: In this large real-world cohort, a continued DOAC strategy was associated with a higher bleeding risk compared to DOAC interruption or VKA continuation in patients undergoing CIED surgery. However, DOAC interruption was associated with increased thromboembolic risk. Concomitant dual antiplatelet therapy should be avoided whenever clinically possible. A bespoke approach is necessary, with a strategy of minimal DOAC interruption likely to represent the best compromise.
OBJECTIVE: This study aimed to compare the incidence of device-related bleeds and thrombotic events based on anticoagulant type (DOAC vs VKA) and regimen (interrupted vs uninterrupted).
METHODS: This was an observational multicenter study. We included patients on chronic oral anticoagulation undergoing CIED surgery. Patients were matched using propensity scoring.
RESULTS: We included 1,975 patients (age 73.8 ± 12.4 years). Among 1,326 patients on DOAC, this was interrupted presurgery in 78.2% (n = 1,039) and continued in 21.8% (n = 287). There were 649 patients on continued VKA. The matched population included 861 patients. The rate of any major bleeding was higher with continued DOAC (5.2%) compared to interrupted DOAC (1.7%) and continued VKA (2.1%) (P = 0.03). The rate of perioperative thromboembolism was 1.4% with interrupted DOAC, whereas no thromboembolic events occurred with DOAC or VKA continuation (P = 0.04). The use of dual antiplatelet therapy, DOAC continuation, and male sex were independent predictors of major bleeding on a multivariable analysis.
CONCLUSIONS: In this large real-world cohort, a continued DOAC strategy was associated with a higher bleeding risk compared to DOAC interruption or VKA continuation in patients undergoing CIED surgery. However, DOAC interruption was associated with increased thromboembolic risk. Concomitant dual antiplatelet therapy should be avoided whenever clinically possible. A bespoke approach is necessary, with a strategy of minimal DOAC interruption likely to represent the best compromise.
摘要：
背景：在心脏可植入电子设备（CIED）手术时，缺乏将维生素K拮抗剂（VKAs）与直接口服抗凝剂（DOAC）进行比较的数据。此外，DOAC的最佳管理(中断与延续)尚未确定。
目的：本研究旨在根据抗凝剂类型（DOAC与VKA）和治疗方案（中断与不间断）比较器械相关出血和血栓事件的发生率。
方法：这是一项观察性的多中心研究。我们纳入了接受慢性口服抗凝治疗的患者，这些患者正在接受CIED手术。使用倾向评分对患者进行匹配。
结果：我们纳入了1,975名患者（年龄73.8±12.4岁）。在DOAC的1,326名患者中，78.2%(n=1039)的产前中断，21.8%(n=287)的中断继续。有649名患者继续进行VKA。匹配人群包括861名患者。与中断DOAC（1.7％）和持续VKA（2.1％）相比，持续DOAC（5.2％）的任何大出血率更高（P=0.03）。中断DOAC的围手术期血栓栓塞率为1.4%,而在DOAC或VKA继续治疗时没有发生血栓栓塞事件(P=0.04).使用双重抗血小板治疗，DOAC延续，在多变量分析中,男性是大出血的独立预测因子.
结论：在这个庞大的现实世界中，在进行CIED手术的患者中,与DOAC中断或VKA延续相比,延续DOAC策略与更高的出血风险相关.然而,DOAC中断与血栓栓塞风险增加相关。临床上尽可能避免同时使用双重抗血小板治疗。定制的方法是必要的，最小DOAC中断的策略可能代表最好的妥协。
目的：本研究旨在根据抗凝剂类型（DOAC与VKA）和治疗方案（中断与不间断）比较器械相关出血和血栓事件的发生率。
方法：这是一项观察性的多中心研究。我们纳入了接受慢性口服抗凝治疗的患者，这些患者正在接受CIED手术。使用倾向评分对患者进行匹配。
结果：我们纳入了1,975名患者（年龄73.8±12.4岁）。在DOAC的1,326名患者中，78.2%(n=1039)的产前中断，21.8%(n=287)的中断继续。有649名患者继续进行VKA。匹配人群包括861名患者。与中断DOAC（1.7％）和持续VKA（2.1％）相比，持续DOAC（5.2％）的任何大出血率更高（P=0.03）。中断DOAC的围手术期血栓栓塞率为1.4%,而在DOAC或VKA继续治疗时没有发生血栓栓塞事件(P=0.04).使用双重抗血小板治疗，DOAC延续，在多变量分析中,男性是大出血的独立预测因子.
结论：在这个庞大的现实世界中，在进行CIED手术的患者中,与DOAC中断或VKA延续相比,延续DOAC策略与更高的出血风险相关.然而,DOAC中断与血栓栓塞风险增加相关。临床上尽可能避免同时使用双重抗血小板治疗。定制的方法是必要的，最小DOAC中断的策略可能代表最好的妥协。
