Seeger Julia, Bothner Carlo, Dahme Tillman, Gonska Birgid, Scharnbeck Dominik, Markovic Sinisa, Rottbauer Wolfgang, Wöhrle Jochen
Department of Internal Medicine II, Cardiology, University of Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
Clin Res Cardiol. 2016 Mar;105(3):225-9. doi: 10.1007/s00392-015-0910-8. Epub 2015 Aug 30.
The randomized PROTECT AF trial demonstrated non-inferiority of left atrial appendage (LAA) closure to oral anticoagulation with warfarin. Current guidelines give a class IIb recommendation for LAA closure. We evaluated the efficacy and safety of LAA closure in a consecutive series of non-valvular atrial fibrillation patients with contraindications to long-term oral anticoagulation or at high bleeding risk.
101 consecutive non-valvular atrial fibrillation patients (age 74.7 ± 7.5 years) at high risk for stroke (CHA2DS2-VASc Score 4.4 ± 1.6) and high bleeding risk (HAS-BLED Score 4.2 ± 1.3) received LAA closure with either the Watchman closure device (n = 38) or the Amplatzer cardiac plug (n = 63). Dual antiplatelet therapy with aspirin and clopidogrel was recommended for 3-6 months after device implantation, followed by long-term antiplatelet therapy with aspirin. No anticoagulation was given after device implantation. Mean follow-up was 400 days. One patient (1 %) experienced a transient ischemic attack, and two patients (2 %) suffered from ischemic stroke. While on recommended antiplatelet therapy, bleeding occurred in 12/101 patients (12 %). Bleeding was significantly reduced with 3 compared with 6 months dual antiplatelet therapy (3.0 vs. 16.2 %, p < 0.05) while ischemic or thrombotic events were similar.
Left atrial appendage closure in patients with non-valvular atrial fibrillation and high risk for stroke and bleeding events effectively prevented stroke and reduced cerebral ischemic events compared to expected stroke rate according to CHA2DS2-VASc Score. Dual antiplatelet therapy for 3 months reduced the rate of bleeding events compared to 6 months therapy with no increase of thrombotic events.
随机对照的PROTECT AF试验表明，左心耳（LAA）封堵术不劣于华法林口服抗凝治疗。当前指南对LAA封堵术给出了IIb类推荐。我们评估了一系列有长期口服抗凝治疗禁忌证或高出血风险的非瓣膜性房颤患者中LAA封堵术的疗效和安全性。
101例连续的非瓣膜性房颤患者（年龄74.7±7.5岁），具有高卒中风险（CHA2DS2-VASc评分4.4±1.6）和高出血风险（HAS-BLED评分4.2±1.3），接受了LAA封堵术，其中使用Watchman封堵器的有38例，使用Amplatzer心脏封堵器的有63例。推荐在装置植入后3至6个月进行阿司匹林和氯吡格雷双联抗血小板治疗，之后长期使用阿司匹林进行抗血小板治疗。装置植入后未给予抗凝治疗。平均随访400天。1例患者（1%）发生短暂性脑缺血发作，2例患者（2%）发生缺血性卒中。在接受推荐的抗血小板治疗期间，12/101例患者（12%）发生出血。与6个月双联抗血小板治疗相比，3个月治疗时出血明显减少（3.0%对16.2%，p<0.05），而缺血或血栓事件相似。
与根据CHA2DS2-VASc评分预期的卒中发生率相比，非瓣膜性房颤且有卒中及出血事件高风险患者的左心耳封堵术有效预防了卒中并减少了脑缺血事件。与6个月治疗相比，3个月双联抗血小板治疗降低了出血事件发生率，且未增加血栓事件。
