Quality of anticoagulation control in preventing adverse events in patients with heart failure in sinus rhythm: Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction trial substudy.
Quality of anticoagulation control in preventing adverse events in patients with heart failure in sinus rhythm: Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction trial substudy.
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DOI：
10.1161/circheartfailure.114.001725
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发表时间：
2015-05
期刊：
影响因子：
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通讯作者：
WARCEF Investigators
中科院分区：
文献类型：
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作者：
Homma S;Thompson JL;Qian M;Ye S;Di Tullio MR;Lip GY;Mann DL;Sacco RL;Levin B;Pullicino PM;Freudenberger RS;Teerlink JR;Graham S;Mohr JP;Labovitz AJ;Buchsbaum R;Estol CJ;Lok DJ;Ponikowski P;Anker SD;WARCEF Investigators
本研究的目的是检查华法林治疗窦性心律心力衰竭患者的治疗范围内时间（TTR）和临床结局之间的关系。我们使用来自降低心脏射血分数试验（WARCEF）中华法林与阿司匹林的数据来评估TTR与WARCEF主要结局（缺血性卒中、脑出血或死亡）、单独死亡、单独缺血性卒中、单独大出血和净临床获益（主要结局和大出血合并）的关系。多变量考克斯模型用于检查事件风险如何随TTR变化，并比较高TTR、低TTR和阿司匹林患者，TTR作为时间依赖性协变量。2,217名患者被纳入分析，其中1,067名被随机分配到华法林组，1,150名被随机分配到阿司匹林组。中位（IQR）随访时间为3.6（2.0-5.0）年。平均（±SD）年龄为61±11.3岁，80%为男性。平均（±SD）TTR为57%（±28.5%）。TTR的增加与主要结局（校正后p<0.001）、死亡（校正后p=0.001）和净临床获益（校正后p<0.001）的减少显著相关。在其他两种结局中观察到类似的趋势，但未达到显著性（缺血性卒中校正后p=0.082，大出血校正后p=0.109）。在SR的HF患者中，增加TTR与更好的结局和改善的净临床获益相关。抗凝效果良好的患者可从抗凝剂的使用中获益。URL：http://www.clinicaltrials.gov。唯一标识符：NCT 00041938。
The aim of this study is to examine the relationship between time in therapeutic range (TTR) and clinical outcomes in heart failure (HF) patients in sinus rhythm (SR) treated with warfarin. We used data from the Warfarin vs. Aspirin in Reduced Cardiac Ejection Fraction Trial (WARCEF) to assess the relationship of TTR with the WARCEF primary outcome (ischemic stroke, intracerebral hemorrhage, or death); with death alone; ischemic stroke alone; major hemorrhage alone; and net clinical benefit (primary outcome and major hemorrhage combined). Multivariable Cox models were used to examine how the event risk changed with TTR and to compare the high TTR, low TTR, and aspirin patients, with TTR being treated as a time-dependent covariate. 2,217 patients were included in the analyses, among whom 1,067 were randomized to warfarin and 1,150 were randomized to aspirin. The median (IQR) follow-up duration was 3.6 (2.0–5.0) years. Mean (±SD) age was 61±11.3 years, with 80% being men. The mean (±SD) TTR was 57% (±28.5%). Increasing TTR was significantly associated with reduction in primary outcome (adjusted p<0.001), death alone (adjusted p=0.001), and improved net clinical benefit (adjusted p<0.001). A similar trend was observed for the other two outcomes but significance was not reached (adjusted p=0.082 for ischemic stroke, adjusted p=0.109 for major hemorrhage). In HF patients in SR, increasing TTR is associated with better outcome and improved net clinical benefit. Patients in whom good quality anticoagulation can be achieved may benefit from the use of anticoagulants. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00041938.