| Survival of patients receiving a primary prevention implantable cardioverter-defibrillator in clinical practice vs clinical trials. | |
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MedLine Citation:
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PMID: 23280225 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Journal Article; Research Support, N.I.H., Extramural |
Journal Detail:
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Title: JAMA : the journal of the American Medical Association Volume: 309 ISSN: 1538-3598 ISO Abbreviation: JAMA Publication Date: 2013 Jan |
Date Detail:
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Created Date: 2013-01-02 Completed Date: 2013-01-03 Revised Date: 2013-05-20 |
Medline Journal Info:
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Nlm Unique ID: 7501160 Medline TA: JAMA Country: United States |
Other Details:
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Languages: eng Pagination: 55-62 Citation Subset: AIM; IM |
Affiliation:
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Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715, USA. alkha001@mc.duke.edu |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00000609 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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1R01-HL093071-01A1/HL/NHLBI NIH HHS; R01 HL093071/HL/NHLBI NIH HHS; UL1 TR000142/TR/NCATS NIH HHS |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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