Freudenberger Ronald S, Hellkamp Anne S, Halperin Jonathan L, Poole Jeanne, Anderson Jill, Johnson George, Mark Daniel B, Lee Kerry L, Bardy Gust H
Department of Medicine, Robert Wood Johnson Medical School, Suite 6100, 125 Paterson St, New Brunswick, NJ 08903, USA.
Circulation. 2007 May 22;115(20):2637-41. doi: 10.1161/CIRCULATIONAHA.106.661397. Epub 2007 May 7.
In patients with heart failure, rates of clinically apparent stroke range from 1.3% to 3.5% per year. Little is known about the incidence and risk factors in the absence of atrial fibrillation. In the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), 2521 patients with moderate heart failure were randomized to receive amiodarone, implanted cardioverter-defibrillators (ICDs), or placebo.
We determined the incidence of stroke or peripheral or pulmonary embolism in patients with no history of atrial fibrillation (n=2114), predictors of thromboembolism and the relationship to left ventricular ejection fraction. Median follow-up was 45.5 months. Kaplan-Meier estimates (95% CIs) for the incidence of thromboembolism by 4 years were 4.0% (3.0% to 4.9%), with 2.6% (1.1% to 4.1%) in patients randomized to amiodarone, 3.2% (1.8% to 4.7%) in patients randomized to ICD, and 6.0% (4.0% to 8.0%) in patients randomized to placebo (approximate rates of 0.7%, 0.8%, and 1.5% per year, respectively). By multivariable analysis, hypertension (P=0.021) and decreasing left ventricular ejection fraction (P=0.023) were significant predictors of thromboembolism; treatment with amiodarone or ICD treatment was a significant predictor of thromboembolism-free survival (P=0.014 for treatment effect; hazard ratio [95% CI] versus placebo, 0.57 [0.33 to 0.99] for ICD; 0.44 [0.24 to 0.80] for amiodarone). Inclusion of atrial fibrillation during follow-up in the multivariable model did not affect the significance of treatment assignment as a predictor of thromboembolism.
In the SCD-HeFT patient cohort, which reflects contemporary treatment of patients with moderately symptomatic systolic heart failure, patients experienced thromboembolism events at a rate of 1.7% per year without antiarrhythmic therapy. Those treated with amiodarone or ICDs had lower risk of thromboembolism than those given placebo. Hypertension at baseline and lower ejection fraction were independent predictors of risk.
在心力衰竭患者中，临床上明显的中风发生率为每年1.3%至3.5%。对于无房颤情况下的发病率和危险因素知之甚少。在心力衰竭心脏性猝死试验（SCD-HeFT）中，2521例中度心力衰竭患者被随机分配接受胺碘酮、植入式心脏复律除颤器（ICD）或安慰剂治疗。
我们确定了无房颤病史患者（n = 2114）的中风或外周或肺栓塞发生率、血栓栓塞的预测因素以及与左心室射血分数的关系。中位随访时间为45.5个月。4年时血栓栓塞发生率的Kaplan-Meier估计值（95%可信区间）为4.0%（3.0%至4.9%），随机接受胺碘酮治疗的患者为2.6%（1.1%至4.1%），随机接受ICD治疗的患者为3.2%（1.8%至4.7%），随机接受安慰剂治疗的患者为6.0%（4.0%至8.0%）（每年发生率分别约为0.7%、0.8%和1.5%）。通过多变量分析，高血压（P = 0.021）和左心室射血分数降低（P = 0.023）是血栓栓塞的显著预测因素；胺碘酮或ICD治疗是无血栓栓塞生存的显著预测因素（治疗效果P = 0.014；ICD与安慰剂相比的风险比[95%可信区间]为0.57[0.33至0.99]；胺碘酮为0.44[0.24至0.80]）。在多变量模型中纳入随访期间的房颤情况并不影响治疗分配作为血栓栓塞预测因素的显著性。
在反映中度症状性收缩性心力衰竭患者当代治疗情况的SCD-HeFT患者队列中，未经抗心律失常治疗的患者每年发生血栓栓塞事件的发生率为1.7%。接受胺碘酮或ICD治疗患者的血栓栓塞风险低于接受安慰剂治疗的患者。基线时的高血压和较低的射血分数是风险的独立预测因素。
