Survival of patients receiving a primary prevention implantable cardioverter-defibrillator in clinical practice vs clinical trials

Sana M. Al-Khatib, Anne Hellkamp, Gust H. Bardy, Stephen Hammill, W. Jackson Hall, Daniel B. Mark, Kevin J. Anstrom, Jeptha Curtis, Hussein Al-Khalidi, Lesley H. Curtis, Paul Heidenreich, Eric D. Peterson, Gillian Sanders, Nancy Clapp-Channing, Kerry L. Lee, Arthur J. Moss

Research output: Contribution to journalArticlepeer-review

73 Scopus citations

Abstract

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 SCDHeFT (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. Trial Registration: clinicaltrials.gov Identifier: NCT00000609

Original languageEnglish (US)
Pages (from-to)55-62
Number of pages8
JournalJAMA - Journal of the American Medical Association
Volume309
Issue number1
DOIs
StatePublished - Jan 2 2013
Externally publishedYes

ASJC Scopus subject areas

  • Medicine(all)

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