Absolute risk reduction in total mortality with implantable cardioverter defibrillators: analysis of primary and secondary prevention trial data to aid risk/benefit analysis

被引:34
作者
Betts, Timothy R. [1 ]
Sadarmin, Praveen P. [1 ]
Tomlinson, David R. [1 ]
Rajappan, Kim [1 ]
Wong, Kelvin C. K. [1 ]
de Bono, Joseph P. [1 ]
Bashir, Yaver [1 ]
机构
[1] Oxford Univ Hosp NHS Trust, John Radcliffe Hosp, Oxford Heart Ctr, Oxford OX3 9DU, England
来源
EUROPACE | 2013年 / 15卷 / 06期
关键词
Absolute risk reduction; Relative risk reduction; Number needed to treat; Implantable cardioverter defibrillator; Primary prevention trials; Secondary prevention trials; Patient consent; SUDDEN CARDIAC DEATH; LEFT-VENTRICULAR DYSFUNCTION; NONISCHEMIC DILATED CARDIOMYOPATHY; ANTIARRHYTHMIC-DRUG THERAPY; MYOCARDIAL-INFARCTION; HEART-FAILURE; MADIT-II; CARDLOVERTER-DEFIBRILLATORS; COST-EFFECTIVENESS; IMPROVED SURVIVAL;
D O I
10.1093/europace/eus427
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Absolute risk reduction (ARR) and number needed to treat (NNT) are considered by many to be the most appropriate figures to use for the informed consent process, yet the results of published implantable cardioverter defibrillators (ICD) trials are frequently presented as relative risk reduction or odds ratio. The period over which risk reduction is calculated also varies between trials, making comparison difficult. Published ICD trials used to formulate national and international guidelines were examined for 1, 2, and 3 year total mortality in ICD and medically treated patients. The number of patients enrolled and at risk at these time points were also sought. Where the raw data were not included in the original text, estimates were taken from published KaplanMeier graphs. Eight primary prevention (PP) trials, three secondary prevention (SP) trials, and one SP meta-analyses were included. For PP, ARR at 3-year follow-up ranged from 0 (no benefit) to 24.6 (NNT 4). For SP, ARR at 3-year follow up ranged from 3.7 (NNT 27) to 11.3 (NNT 9). Absolute risk reduction increased with follow-up in PP trials, whereas there was considerable variation in SP trials. Overall, very few trial patients received 3-year follow-up, giving wide confidence intervals (CIs). Absolute risk reduction from ICD trials varies significantly depending upon trial entry criteria, subgroup characteristics, and duration of follow-up. The relatively small number of patients followed for 2 or more years leads to wide CIs. Despite these limitations, the standardized ARR and NNT data presented may give a more individualized estimate of risk/benefit that could potentially aid an informed consent process.
引用
收藏
页码:813 / 819
页数:7
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