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


Journal Article

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. TRIAL REGISTRATION: Identifier: NCT00000609.

Full Text

Duke Authors

Cited Authors

  • Al-Khatib, SM; Hellkamp, A; Bardy, GH; Hammill, S; Hall, WJ; Mark, DB; Anstrom, KJ; Curtis, J; Al-Khalidi, H; Curtis, LH; Heidenreich, P; Peterson, ED; Sanders, G; Clapp-Channing, N; Lee, KL; Moss, AJ

Published Date

  • January 2, 2013

Published In

Volume / Issue

  • 309 / 1

Start / End Page

  • 55 - 62

PubMed ID

  • 23280225

Pubmed Central ID

  • 23280225

Electronic International Standard Serial Number (EISSN)

  • 1538-3598

Digital Object Identifier (DOI)

  • 10.1001/jama.2012.157182


  • eng

Conference Location

  • United States