Heart Research Follow-up Program, Box 653, University of Rochester Medical Center, Rochester, NY 14642, USA.
Circulation. 2010 Sep 28;122(13):1265-71. doi: 10.1161/CIRCULATIONAHA.110.940148. Epub 2010 Sep 13.
The Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II) showed a significant 31 reduction in the risk of death with primary implantable cardioverter-defibrillator (ICD) therapy during a median follow-up of 1.5 years. However, currently there are no data on the long-term efficacy of primary defibrillator therapy.
MADIT-II enrolled 1232 patients with ischemic left ventricular dysfunction who were randomized to ICD and non-ICD medical therapy and were followed up through November 2001. For the present long-term study, we acquired posttrial mortality data through March 2009 for all study participants (median follow-up, 7.6 years). Multivariate Cox proportional hazards regression modeling was performed to calculate the hazard ratio for ICD versus non-ICD therapy during long-term follow-up. At 8 years of follow-up, the cumulative probability of all-cause mortality was 49 among patients treated with an ICD compared with 62 among non-ICD patients (P<0.001). Multivariate analysis demonstrated that ICD therapy was associated with a significant long-term survival benefit (hazard ratio for 0- through 8-year mortality=0.66 [95 confidence interval, 0.56 to 0.78]; P<0.001). Treatment with an ICD was shown to be associated with a significant reduction in the risk of death during the early phase of the extended follow-up period (0 through 4 years: hazard ratio=0.61 [95 confidence interval, 0.50 to 0.76]; P<0.001) and with continued life-saving benefit during the late phase of follow-up (5 through 8 years: hazard ratio=0.74 [95 confidence interval, 0.57 to 0.96]; P=0.02).
Our findings demonstrate a sustained 8-year survival benefit with primary ICD therapy in the MADIT-II population.
多中心自动除颤器植入试验 II 期（MADIT-II）显示，在中位随访 1.5 年期间，原发性植入式心脏复律除颤器（ICD）治疗可使死亡率显著降低 31%。然而，目前尚无关于原发性除颤器治疗的长期疗效的数据。
MADIT-II 纳入了 1232 例缺血性左心室功能障碍患者，他们被随机分为 ICD 和非 ICD 药物治疗组，并在 2001 年 11 月前进行随访。为了进行本次长期研究，我们通过 2009 年 3 月获得了所有研究参与者的试验后死亡率数据（中位随访时间为 7.6 年）。采用多变量 Cox 比例风险回归模型计算长期随访期间 ICD 与非 ICD 治疗的风险比。在 8 年的随访中，ICD 治疗组患者的全因死亡率累积概率为 49%，而非 ICD 治疗组患者的全因死亡率累积概率为 62%（P<0.001）。多变量分析表明，ICD 治疗与显著的长期生存获益相关（0 至 8 年死亡率的风险比=0.66[95%置信区间，0.56 至 0.78]；P<0.001）。ICD 治疗与扩展随访早期死亡风险显著降低相关（0 至 4 年：风险比=0.61[95%置信区间，0.50 至 0.76]；P<0.001），并在随访后期持续具有救生获益（5 至 8 年：风险比=0.74[95%置信区间，0.57 至 0.96]；P=0.02）。
我们的研究结果表明，在 MADIT-II 人群中，原发性 ICD 治疗可带来持续 8 年的生存获益。
