Key result
ICD therapy for primary prevention significantly reduced the risk of death from any cause in men (HR 0.74; 95% CI 0.60-0.91) but not in women (HR 0.81; 95% CI 0.60-1.09).
Why the study?
Does implantable cardioverter defibrillator (ICD) therapy reduce death from any cause in men and women for primary prevention against sudden cardiac death?
Meta-Analysis
Does implantable cardioverter defibrillator (ICD) therapy reduce death from any cause in men and women for primary prevention against sudden cardiac death?
Primary prevention ICD therapy significantly reduces all-cause mortality in men but does not show a statistically significant survival benefit in women, highlighting a potential gender disparity in treatment efficacy.
Answers are grounded in this paper and cite their sources.
Supports primary prevention ICD use in men but not women; challenges sex-agnostic guideline recommendations.
BACKGROUND: Implantable cardioverter defibrillators (ICDs) are a life-saving therapy for many patients with cardiovascular disease at increased risk of fatal dysrhythmias. As men comprise the majority of the study population (67-92%) in clinical trials, the benefit to women is unknown. We performed a meta-analysis of primary prevention trials to evaluate the impact of ICDs in men and women on death from any cause. METHODS: Included trials met the following criteria: (i) randomized controlled trials versus standard of care, (ii) ICD used as primary prevention in a well-described protocol and (iii) data provided on risk of death from any cause for both male and female patients. RESULTS: Five clinical trials were included in this meta-analysis. The risk of death from any cause was significantly reduced by 26% in male patients who received ICD therapy compared to control, hazard ratio (HR) 0.74 (95% CI 0.60-0.91) but not amongst female patients, HR 0.81 (95% CI 0.60-1.09). As the COMPANION trial evaluated the combination of biventricular pacemaker with ICD therapy we conducted a separate analysis without the inclusion of this study. Male patients receiving ICD therapy demonstrated a similar 24% reduction in risk of death from any cause, HR 0.76 (95% CI 0.58-0.99) whilst female patients demonstrated a reduction of only 12%, HR 0.88 (95% CI 0.63-1.22). CONCLUSIONS: Unlike their male counterparts, females did not significantly benefit from ICD therapy and without concurrent biventricular pacing, appear only to achieve a nonsignificant 12% reduction in risk of death.
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Henyan et al. (2006) conducted a meta-analysis in cardiovascular disease at increased risk of fatal dysrhythmias. Implantable cardioverter defibrillators (ICDs) vs. standard of care was evaluated on death from any cause (HR 0.81, 95% CI 0.60-1.09). ICD therapy for primary prevention significantly reduced the risk of death from any cause in men (HR 0.74; 95% CI 0.60-0.91) but not in women (HR 0.81; 95% CI 0.60-1.09).
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