Document Detail


Survival of patients receiving a primary prevention implantable cardioverter-defibrillator in clinical practice vs clinical trials.
MedLine Citation:
PMID:  23280225     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  JAMA : the journal of the American Medical Association     Volume:  309     ISSN:  1538-3598     ISO Abbreviation:  JAMA     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-01-02     Completed Date:  2013-01-03     Revised Date:  2014-05-01    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  55-62     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00000609
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MeSH Terms
Descriptor/Qualifier:
Age Factors
Aged
Cause of Death
Comorbidity
Death, Sudden, Cardiac / prevention & control
Defibrillators, Implantable / statistics & numerical data*
Eligibility Determination
Female
Heart Failure / mortality*,  therapy*
Humans
Male
Middle Aged
Primary Prevention
Propensity Score
Randomized Controlled Trials as Topic
Registries / statistics & numerical data
Retrospective Studies
Survival Analysis
Grant Support
ID/Acronym/Agency:
1R01-HL093071-01A1/HL/NHLBI NIH HHS; R01 HL093071/HL/NHLBI NIH HHS
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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