Institute of Cardiology, Catholic University of the Sacred Heart, Rome, Italy.
Heart Rhythm. 2010 Jul;7(7):876-82. doi: 10.1016/j.hrthm.2010.03.042. Epub 2010 Apr 7.
Women are underrepresented in primary prevention implantable cardioverter-defibrillator (ICD) trials, and data on the benefit of ICD therapy in this subgroup are controversial.
The purpose of this study was to better evaluate the benefit of prophylactic ICD in women by performing a meta-analysis of primary prevention ICD trials that assessed gender differences on the end-points of total mortality, appropriate ICD intervention, and survival benefit of ICD compared with placebo.
PubMed, CENTRAL, and other databases were searched in October 2009. Studies were included only if they examined gender differences in the specified end-points, providing the hazard ratio (HR) obtained in multiple Cox regression analyses, and adjusted for all confounding variables.
We retrieved five studies (MADIT-II, MUSTT, SCD-HeFT, DEFINITE, COMPANION) that enrolled 7,229 patients (22% women) with dilated cardiomyopathy (74% ischemic). Compared to men, women had no significant difference in overall mortality (HR 0.96, 95% confidence interval [CI] 0.67-1.39, P = .84) but experienced significantly less appropriate ICD interventions (HR 0.63, 95% CI 0.49-0.82, P < or =.001). The benefit of ICD on mortality was significantly higher in men (HR 0.67, 95% CI 0.58-0.78, P <.001) but did not reach statistical significance in women (HR 0.78, 95% CI 0.57-1.05, P = .1).
Women enrolled in primary prevention ICD trials have the same mortality compared to men while experiencing significantly less appropriate ICD interventions, thus suggesting a smaller impact of sudden cardiac death on overall mortality in women with dilated cardiomyopathy. These findings may explain the smaller ICD survival benefit among women.
女性在植入式心脏复律除颤器（ICD）一级预防试验中的代表性不足，关于该亚组中 ICD 治疗益处的数据存在争议。
本研究旨在通过对评估终点为总死亡率、合适的 ICD 干预以及与安慰剂相比 ICD 生存获益的 ICD 一级预防试验进行荟萃分析，更好地评估女性预防性 ICD 的益处，这些试验评估了性别差异。
2009 年 10 月，检索了 PubMed、CENTRAL 和其他数据库。仅纳入研究，如果研究考察了指定终点的性别差异，提供了在多 Cox 回归分析中获得的危险比（HR），并根据所有混杂变量进行了调整。
我们检索到五项研究（MADIT-II、MUSTT、SCD-HeFT、DEFINITE、COMPANION），共纳入 7229 例扩张型心肌病患者（22%为女性）（74%为缺血性）。与男性相比，女性的总死亡率无显著差异（HR 0.96，95%置信区间[CI]0.67-1.39，P=0.84），但合适的 ICD 干预显著减少（HR 0.63，95%CI0.49-0.82，P<0.001）。男性的 ICD 死亡率获益显著高于女性（HR 0.67，95%CI0.58-0.78，P<0.001），但在女性中未达到统计学意义（HR 0.78，95%CI0.57-1.05，P=0.1）。
与男性相比，纳入 ICD 一级预防试验的女性的死亡率相同，但经历的合适 ICD 干预明显减少，这表明女性扩张型心肌病患者的心脏性猝死对总体死亡率的影响较小。这些发现可能解释了女性 ICD 生存获益较小的原因。
