Clinical predictors and timing of New York Heart Association class improvement with cardiac resynchronization therapy in patients with advanced chronic heart failure: Results from the Multicenter InSync Randomized Clinical Evaluation (MIRACLE) and Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE-ICD) trials
Clinical predictors and timing of New York Heart Association class improvement with cardiac resynchronization therapy in patients with advanced chronic heart failure: Results from the Multicenter InSync Randomized Clinical Evaluation (MIRACLE) and Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE-ICD) trials
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DOI：
10.1016/j.ahj.2005.06.024
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发表时间：
2006-04-01
影响因子：
4.8
通讯作者：
Johnson, KM
中科院分区：
文献类型：
--
作者：
Pires, LA;Abraham, WT;Johnson, KM
根据目前的患者选择标准，相当一部分接受心脏起搏治疗（CRT）的患者对治疗无反应。本分析的目的是确定预测因素和描述晚期心力衰竭患者对CRT的反应时间。方法在MIRACLE和MIRACLE-ICD试验中，患者随机接受CRT，旨在评估CRT与标准药物治疗相比对晚期心力衰竭患者的益处，左心室射血分数< 0.35，QRS = >= 130毫秒，纳入本分析。从基线到6个月随访，纽约心脏协会（NYHA）分级改善≥ 1纽约的患者被视为应答者，NYHA分级无变化或恶化或死亡的患者被归类为无应答者。结果在MIRACLE和MIRACLE-ICD试验中，分别有143例（64%）和190例（61%）患者对治疗有反应，143例中有81例（57%）和190例（53%）患者早期有反应。在两项试验中，几个不同的因素预测了CRT反应和时间，敏感性高（89-90%），但由于特异性低（31%-49%），预测准确性中等（66%-75%）。只有超过一半的人在第一个月内做出了回应。几个因素预测CRT反应和时间，但鉴于其适度的预测准确性，可比的两项研究，额外的方法来选择候选人最有可能受益于CRT是必要的。
Background Based on current patient selection criteria, a significant proportion of recipients of cardiac resynchronization therapy (CRT) do not respond to treatment. The purpose of this analysis is to identify predictors and characterize the timing of response to CRT in patients with advanced heart failure.Methods Patients randomized to receive CRT in the MIRACLE and MIRACLE-ICD trials, designed to assess the benefit of CRT compared with standard medical therapy in patients with advanced heart failure, left ventricular ejection fraction < 0.35, and QRS = >= 130 milliseconds, were included for this analysis. Patients with an improvement of >= 1 New York Heart Association (NYHA) class from baseline to the 6-month follow-up were considered responders and those who had no change or worse NYHA class or died were classified as nonresponders. Responders were subdivided into early (within 1-3 months) and late (6 months).Results One hundred forty-three (64%) of 224 and 190 (61%) of 313 patients in the MIRACLE and MIRACLE-ICD trials, respectively, responded to therapy, with 81 (57%) of 143 and 100 (53%) of 190 responding early. Several but differing factors predicted CRT response and timing in the two trials with a high sensitivity (89-90%) but, owing to a low specificity (31%-49%), a modest predictive accuracy (66%-75%).Conclusions Based on improvement of >= 1 NYHA class, less than two thirds of patients enrolled in the MIRACLE or MIRACLE-ICD trials responded to CRT, with just more than half responding within the first month. Several factors predicted CRT response and timing, but given their modest predictive accuracy, comparable for both studies, additional methods for selecting candidates most likely to benefit from CRT are needed.