Department of Internal Medicine II, Cardiology, University of Ulm, Ulm, Germany.
Department of Internal Medicine II, Cardiology, University of Ulm, Ulm, Germany.
JACC Cardiovasc Interv. 2017 Jan 9;10(1):66-74. doi: 10.1016/j.jcin.2016.10.023.
The aims of this study were to assess the impact of atrial fibrillation (AF) on outcome in transfemoral aortic valve replacement (TAVR) and to evaluate the safety and efficacy of apixaban compared with a vitamin K antagonist (VKA) in patients with AF after TAVR.
Non-VKA oral anticoagulant agents have not been systematically used in patients with AF after TAVR.
Of the 617 patients enrolled, 55.9% (n = 345) were in sinus rhythm and 44.1% (n = 272) in AF. Clinical follow-up was performed after 30 days and 12 months.
The early safety endpoint at 30 days was significantly more frequent in patients with AF compared with those in sinus rhythm (23.2% vs. 11.0%; p < 0.01). During 12-month follow-up, the secondary endpoint of all-cause mortality and stroke was significantly higher in patients with AF (20.6% vs. 9.7%; p = 0.02), driven by a significantly higher rate of all-cause mortality (19.1% vs. 7.8%; p = 0.01). Among patients with AF, 141 (51.8%) were treated with apixaban and 131 (48.2%) with a VKA. There was a significantly lower rate of the early safety endpoint in patients with AF treated with apixaban compared with patients treated with a VKA (13.5% vs. 30.5%; p < 0.01), with a numerically lower stroke rate (2.1% vs. 5.3%; p = 0.17) at 30 days and 12 months (1.2% vs. 2.0%; p = 0.73) of follow-up.
In patients undergoing TAVR, AF was associated with a significantly higher rate of all-cause mortality throughout 12 months follow-up. The early safety endpoint in patients with AF on apixaban was significantly less frequent compared with patients receiving a VKA.
本研究旨在评估房颤（AF）对经股主动脉瓣置换术（TAVR）患者预后的影响，并评估在 TAVR 后 AF 患者中使用阿哌沙班与维生素 K 拮抗剂（VKA）相比的安全性和疗效。
非 VKA 口服抗凝剂尚未在 TAVR 后 AF 患者中系统使用。
在纳入的 617 例患者中，55.9%（n=345）处于窦性心律，44.1%（n=272）处于 AF。在 30 天和 12 个月时进行临床随访。
AF 患者的早期安全性终点在 30 天内明显高于窦性心律患者（23.2%比 11.0%；p<0.01）。在 12 个月的随访期间，AF 患者的全因死亡率和卒中的次要终点明显更高（20.6%比 9.7%；p=0.02），这主要归因于全因死亡率的显著升高（19.1%比 7.8%；p=0.01）。在 AF 患者中，141 例（51.8%）接受了阿哌沙班治疗，131 例（48.2%）接受了 VKA 治疗。与 VKA 治疗组相比，AF 患者接受阿哌沙班治疗的早期安全性终点发生率显著降低（13.5%比 30.5%；p<0.01），30 天和 12 个月（1.2%比 2.0%；p=0.73）的卒中发生率也更低。
在接受 TAVR 的患者中，AF 与 12 个月随访期间全因死亡率显著升高相关。在接受阿哌沙班治疗的 AF 患者中，早期安全性终点发生率明显低于接受 VKA 治疗的患者。
