Key result
Survival of patients receiving a primary prevention ICD in clinical practice did not differ significantly from trial patients in MADIT-II (HR 1.06, P=0.62) or SCD-HeFT (HR 1.16, P=0.11).
Why the study?
Does the survival of trial-eligible patients receiving a primary prevention ICD in clinical practice differ from that of similar patients receiving an ICD in clinical trials?
Population
Patients meeting MADIT-II criteria or SCD-HeFT criteria from the National Cardiovascular Data Registry ICD…
Comparison
Primary prevention implantable… vs Primary prevention implantable…
Design
Cohort
Follow-up
Median 19.5 months, 46.1 months, and 35.2 months
Authors
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Supports real-world ICD efficacy in older, comorbid patients; leaves open optimal selection criteria pending prospective confirmation.
Cohort (n=7,387)
Yes
Does the survival of trial-eligible patients receiving a primary prevention ICD in clinical practice differ from that of similar patients receiving an ICD in clinical trials?
Hazard Ratio: 1.06 (95% CI 0.85–1.31)
Absolute Event Rate: 13.9% vs 15.6%
p-value: p=.62
Survival rates of patients receiving primary prevention ICDs in real-world clinical practice are comparable to those observed in the landmark MADIT-II and SCD-HeFT clinical trials, supporting their continued use.
Al‐Khatib et al. (2013) conducted a cohort in Primary prevention implantable cardioverter-defibrillator (ICD) indication (n=7,387). Primary prevention ICD in clinical practice vs. Primary prevention ICD in clinical trials was evaluated on Mortality from any cause (HR 1.06, 95% CI 0.85-1.31, p=.62). Survival of patients receiving a primary prevention ICD in clinical practice did not differ significantly from trial patients in MADIT-II (HR 1.06, P=0.62) or SCD-HeFT (HR 1.16, P=0.11).
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