Survival of Patients Receiving a Primary Prevention Implantable Cardioverter-Defibrillator in Clinical Practice vs Clinical Trials

被引:80
作者
Al-Khatib, Sana M. [1 ,3 ]
Hellkamp, Anne [1 ]
Bardy, Gust H. [5 ]
Hammill, Stephen [6 ]
Hall, W. Jackson [7 ]
Mark, Daniel B. [1 ,3 ]
Anstrom, Kevin J. [1 ]
Curtis, Jeptha [8 ]
Al-Khalidi, Hussein [1 ]
Curtis, Lesley H. [1 ,2 ,4 ]
Heidenreich, Paul [9 ]
Peterson, Eric D. [1 ,3 ]
Sanders, Gillian [1 ]
Clapp-Channing, Nancy [1 ]
Lee, Kerry L. [1 ]
Moss, Arthur J. [7 ]
机构
[1] Duke Clin Res Inst, Durham, NC 27715 USA
[2] Duke Univ, Med Ctr, Dept Med, Ctr Clin & Genet Econ, Durham, NC 27710 USA
[3] Duke Univ, Med Ctr, Dept Med, Div Cardiol, Durham, NC 27710 USA
[4] Duke Univ, Med Ctr, Dept Med, Div Gen Internal Med, Durham, NC 27710 USA
[5] Univ Washington, Med Ctr, Seattle, WA 98195 USA
[6] Mayo Clin, Rochester, MN USA
[7] Univ Rochester, Rochester, NY USA
[8] Yale Univ, Sch Med, West Haven, CT 06516 USA
[9] Stanford Univ, Palo Alto Vet Hlth Care Syst, Palo Alto, CA 94304 USA
来源
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2013年 / 309卷 / 01期
基金
美国医疗保健研究与质量局; 美国国家卫生研究院;
关键词
MEDICARE BENEFICIARIES; HEART-FAILURE; GENERALIZABILITY; OUTCOMES; REGISTRY; DISEASE;
D O I
10.1001/jama.2012.157182
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
Importance Randomized clinical trials have shown that implantable cardioverter-defibrillator (ICD) therapy saves lives. Whether the survival of patients who received an ICD in primary prevention clinical trials differs from that of trial-eligible patients receiving a primary prevention ICD in clinical practice is unknown. Objective To determine whether trial-eligible patients who received a primary prevention ICD as documented in a large national registry have a survival rate that differs from the survival rate of similar patients who received an ICD in the 2 largest primary prevention clinical trials, MADIT-II (n = 742) and SCD-HeFT (n = 829). Design, Setting, and Patients Retrospective analysis of data for patients enrolled in the National Cardiovascular Data Registry ICD Registry between January 1, 2006, and December 31, 2007, meeting the MADIT-II criteria (2464 propensity score-matched patients) or the SCD-HeFT criteria (3352 propensity score-matched patients). Mortality data for the registry patients were collected through December 31, 2009. Main Outcome Measures Cox proportional hazards models were used to compare mortality from any cause. Results The median follow-up time in MADIT-II, SCD-HeFT, and the ICD Registry was 19.5, 46.1, and 35.2 months, respectively. Compared with patients enrolled in the clinical trials, patients in the ICD Registry were significantly older and had a higher burden of comorbidities. In the matched cohorts, there was no significant difference in survival between MADIT-II-like patients in the registry and MADIT-II patients randomized to receive an ICD (2-year mortality rates: 13.9% and 15.6%, respectively; adjusted ICD Registry vs trial hazard ratio, 1.06; 95% CI, 0.85-1.31; P = .62). Likewise, the survival among SCD-HeFT-like patients in the registry was not significantly different from survival among patients randomized to receive ICD therapy in SCD-HeFT (3-year mortality rates: 17.3% and 17.4%, respectively; adjusted registry vs trial hazard ratio, 1.16; 95% CI, 0.97-1.38; P = .11). Conclusions and Relevance There was no significant difference in survival between clinical trial patients randomized to receive an ICD and a similar group of clinical registry patients who received a primary prevention ICD. Our findings support the continued use of primary prevention ICDs in similar patients seen in clinical practice.
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收藏
页码:55 / 62
页数:8
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