Skip to main content
Journal cover image

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

Publication ,  Journal Article
Al-Khatib, SM; Hellkamp, A; Bardy, GH; Hammill, S; Hall, WJ; Mark, DB; Anstrom, KJ; Curtis, J; Al-Khalidi, H; Curtis, LH; Heidenreich, P ...
Published in: JAMA
January 2, 2013

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: clinicaltrials.gov Identifier: NCT00000609.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

January 2, 2013

Volume

309

Issue

1

Start / End Page

55 / 62

Location

United States

Related Subject Headings

  • Survival Analysis
  • Retrospective Studies
  • Registries
  • Randomized Controlled Trials as Topic
  • Propensity Score
  • Primary Prevention
  • Middle Aged
  • Male
  • Humans
  • Heart Failure
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Al-Khatib, S. M., Hellkamp, A., Bardy, G. H., Hammill, S., Hall, W. J., Mark, D. B., … Moss, A. J. (2013). Survival of patients receiving a primary prevention implantable cardioverter-defibrillator in clinical practice vs clinical trials. JAMA, 309(1), 55–62. https://doi.org/10.1001/jama.2012.157182
Al-Khatib, Sana M., Anne Hellkamp, Gust H. Bardy, Stephen Hammill, W Jackson Hall, Daniel B. Mark, Kevin J. Anstrom, et al. “Survival of patients receiving a primary prevention implantable cardioverter-defibrillator in clinical practice vs clinical trials.JAMA 309, no. 1 (January 2, 2013): 55–62. https://doi.org/10.1001/jama.2012.157182.
Al-Khatib SM, Hellkamp A, Bardy GH, Hammill S, Hall WJ, Mark DB, et al. Survival of patients receiving a primary prevention implantable cardioverter-defibrillator in clinical practice vs clinical trials. JAMA. 2013 Jan 2;309(1):55–62.
Al-Khatib, Sana M., et al. “Survival of patients receiving a primary prevention implantable cardioverter-defibrillator in clinical practice vs clinical trials.JAMA, vol. 309, no. 1, Jan. 2013, pp. 55–62. Pubmed, doi:10.1001/jama.2012.157182.
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. Survival of patients receiving a primary prevention implantable cardioverter-defibrillator in clinical practice vs clinical trials. JAMA. 2013 Jan 2;309(1):55–62.
Journal cover image

Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

January 2, 2013

Volume

309

Issue

1

Start / End Page

55 / 62

Location

United States

Related Subject Headings

  • Survival Analysis
  • Retrospective Studies
  • Registries
  • Randomized Controlled Trials as Topic
  • Propensity Score
  • Primary Prevention
  • Middle Aged
  • Male
  • Humans
  • Heart Failure