Preventive Cardiology and Preventive Medicine, Center for Cardiology, University Medical Center Mainz, Johannes Gutenberg-University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany.
Center for Thrombosis and Hemostasis, University Medical Center Mainz, Johannes Gutenberg-University Mainz, Mainz, Germany.
Clin Res Cardiol. 2018 Dec;107(12):1170-1179. doi: 10.1007/s00392-018-1293-4. Epub 2018 Jun 9.
Oral anticoagulation therapy in individuals with atrial fibrillation (AF) reduces the risk of thromboembolic events at cost of an increased bleeding risk. Whether anticoagulation-related outcomes differ between patients with paroxysmal and sustained AF receiving anticoagulation is controversially discussed.
In the present analysis of the prospective multi-center cohort study thrombEVAL, the incidence of anticoagulation-related adverse events was analyzed according to the AF phenotype. Information on outcome was centrally recorded over 3 years, validated via medical records and adjudicated by an independent review panel. Study monitoring was provided by an independent institution.
Overall, the sample comprised 1089 AF individuals, of whom n = 398 had paroxysmal AF and n = 691 experienced sustained AF. In Cox regression analysis with adjustment for potential confounders, sustained AF indicated an independently elevated risk of clinically relevant bleeding compared to paroxysmal AF [hazard ratio (HR) 1.40 (1.02; 1.93); P = 0.038]. For clinically relevant bleeding, a significant interaction of the pattern of AF type with concomitant heart failure (HF) was detected: HR 2.45 (1.51, 3.98) vs. HR 0.85 (0.55, 1.34); P = 0.003. In HF patients, sustained AF indicated also an elevated risk of major bleeding [HR 2.25 (1.26, 4.20); P = 0.006]. A simplified HAS-BLED score incorporating only information on age (> 65 years), bleeding history, and HF with sustained AF demonstrated better discriminative performance for clinically relevant bleeding than the original version: AUC: 0.583 vs. AUC: 0.642 (P = 0.004).
In HF patients receiving oral anticoagulation, sustained AF indicates a substantially elevated risk of bleeding.
https://clinicaltrials.gov , identifier: NCT01809015.
在房颤（AF）患者中进行口服抗凝治疗可降低血栓栓塞事件的风险，但代价是出血风险增加。接受抗凝治疗的阵发性和持续性 AF 患者的抗凝相关结局是否不同，这一问题存在争议。
在血栓栓塞风险评估（thrombEVAL）前瞻性多中心队列研究的本次分析中，根据 AF 表型分析抗凝相关不良事件的发生率。通过医疗记录和独立审查小组进行验证，并由独立机构提供研究监测，中心记录了 3 年的结局信息。
总体而言，该样本包括 1089 名 AF 患者，其中 n=398 名患者为阵发性 AF，n=691 名患者为持续性 AF。在调整潜在混杂因素的 Cox 回归分析中，持续性 AF 与阵发性 AF 相比，提示临床相关出血的风险独立增加[风险比（HR）1.40（1.02；1.93）；P=0.038]。对于临床相关出血，AF 类型模式与合并心力衰竭（HF）之间存在显著的交互作用：HR 2.45（1.51，3.98）与 HR 0.85（0.55，1.34）；P=0.003。在 HF 患者中，持续性 AF 也提示大出血的风险增加[HR 2.25（1.26，4.20）；P=0.006]。包含仅与年龄（>65 岁）、出血史和持续性 AF 合并 HF 相关信息的简化 HAS-BLED 评分，对于临床相关出血的鉴别性能优于原始版本：AUC：0.583 与 AUC：0.642（P=0.004）。
在接受口服抗凝治疗的 HF 患者中，持续性 AF 表明出血风险显著增加。
https://clinicaltrials.gov ，标识符：NCT01809015。
