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基线特征能否准确区分可能从植入式除颤器治疗中获益与不太可能获益的患者?在抗心律失常药物与植入式除颤器试验中对加拿大植入式除颤器研究的植入式心脏复律除颤疗效评分进行评估。

Do baseline characteristics accurately discriminate between patients likely versus unlikely to benefit from implantable defibrillator therapy? Evaluation of the Canadian implantable defibrillator study implantable cardioverter defibrillatory efficacy score in the antiarrhythmics versus implantable defibrillators trial.

作者信息

Exner D V, Sheldon R S, Pinski S L, Kron J, Hallstrom A

机构信息

University of Calgary, Calgary, Alberta, Canada.

出版信息

Am Heart J. 2001 Jan;141(1):99-104. doi: 10.1067/mhj.2001.111768.

Abstract

OBJECTIVE

Our purpose was to evaluate whether baseline characteristics predictive of implantable cardioverter defibrillator (ICD) efficacy in the Canadian Implantable Defibrillator Study (CIDS) are predictive in the Antiarrhythmics Versus Implantable Defibrillators (AVID) Trial.

BACKGROUND

ICD therapy is superior to antiarrhythmic drug use in patients with life-threatening arrhythmias. However, identification of subgroups most likely to benefit from ICD therapy may be useful. Data from CIDS suggest that 3 characteristics (age > or =70 years, ejection fraction [EF] < or =0.35, and New York Heart Association class >II) can be combined to reliably categorize patients as likely (> or =2 characteristics) versus unlikely to benefit (<2 characteristics) from ICD therapy.

METHODS

The utility of the CIDS categorization of ICD efficacy was assessed by Kaplan-Meier analysis and Cox hazards modeling. The accuracy of the CIDS score was formally tested by evaluating for interaction between categorization of benefit and treatment in a Cox model.

RESULTS

ICD therapy was associated with a significantly lower risk of death in the 320 patients categorized as likely to benefit (relative risk [RR] 0.57, 95% confidence interval [CI] 0.37-0.88, P =.01) and a trend toward a lower risk of death in the 689 patients categorized as unlikely to benefit (RR 0.70, 95% CI 0.48-1.03, P =.07). Categorization of benefit was imperfect, as evidenced by a lack of statistical interaction (P =.5). Although 32 of the 42 deaths prevented by ICD therapy in AVID were in patients categorized as likely to benefit, all 42 of these patients had EF values < or =0.35. Neither advanced age nor poorer functional class predicted ICD efficacy in AVID.

CONCLUSION

Of the 3 characteristics identified to predict ICD efficacy in CIDS, only depressed EF predicted ICD efficacy in AVID. Thus physicians faced with limited resources might elect to consider ICD therapy over antiarrhythmic drug use in patients with severely depressed EF values.

摘要

目的

我们旨在评估在加拿大植入式心脏除颤器研究(CIDS)中预测植入式心脏复律除颤器(ICD)疗效的基线特征在抗心律失常药物与植入式心脏除颤器(AVID)试验中是否具有预测性。

背景

在有危及生命心律失常的患者中,ICD治疗优于抗心律失常药物的使用。然而,识别最可能从ICD治疗中获益的亚组可能是有用的。CIDS的数据表明,3个特征(年龄≥70岁、射血分数[EF]≤0.35以及纽约心脏协会分级>II级)可合并用于可靠地将患者分类为从ICD治疗中可能获益(≥2个特征)或不太可能获益(<2个特征)。

方法

通过Kaplan-Meier分析和Cox风险模型评估CIDS对ICD疗效分类的效用。通过在Cox模型中评估获益分类与治疗之间的相互作用,正式检验CIDS评分的准确性。

结果

在分类为可能获益的320例患者中,ICD治疗与显著较低的死亡风险相关(相对风险[RR]0.57,95%置信区间[CI]0.37 - 0.88,P = 0.01),而在分类为不太可能获益的689例患者中,有死亡风险降低的趋势(RR 0.70,95% CI 0.48 - 1.03,P = 0.07)。获益分类并不完美,缺乏统计学相互作用证明了这一点(P = 0.5)。尽管在AVID试验中ICD治疗预防的42例死亡中有32例发生在分类为可能获益的患者中,但所有这42例患者的EF值均≤0.35。在AVID试验中,高龄和功能分级较差均不能预测ICD疗效。

结论

在CIDS中确定的预测ICD疗效的3个特征中,只有EF降低在AVID试验中能预测ICD疗效。因此,面对资源有限的医生可能会选择在EF值严重降低的患者中考虑使用ICD治疗而非抗心律失常药物治疗。

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