Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715, USA.
JAMA. 2013 Jan 2;309(1):55-62. doi: 10.1001/jama.2012.157182.
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.
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.
Cox proportional hazards models were used to compare mortality from any cause.
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).
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.
clinicaltrials.gov Identifier: NCT00000609.
随机临床试验表明，植入式心脏复律除颤器（ICD）治疗可挽救生命。在初级预防临床试验中接受 ICD 治疗的患者的生存率是否与在临床实践中接受初级预防 ICD 治疗的符合试验条件的患者的生存率不同，目前尚不清楚。
确定在大型全国注册中心记录中接受初级预防 ICD 治疗的符合试验条件的患者的生存率是否与在最大的两项初级预防临床试验，MADIT-II（n=742）和 SCD-HeFT（n=829）中接受 ICD 治疗的相似患者的生存率不同。
设计、设置和患者：对 2006 年 1 月 1 日至 2007 年 12 月 31 日期间登记在全国心血管数据注册 ICD 登记处的患者进行回顾性分析，符合 MADIT-II 标准（2464 名倾向评分匹配患者）或 SCD-HeFT 标准（3352 名倾向评分匹配患者）。登记处患者的死亡率数据收集至 2009 年 12 月 31 日。
使用 Cox 比例风险模型比较任何原因导致的死亡率。
MADIT-II、SCD-HeFT 和 ICD 登记处的中位随访时间分别为 19.5、46.1 和 35.2 个月。与临床试验中的患者相比，登记处的患者年龄较大，合并症负担较重。在匹配队列中，登记处与 MADIT-II 中接受 ICD 治疗的患者之间的生存率无显著差异（2 年死亡率：分别为 13.9%和 15.6%；调整后的 ICD 登记处与试验风险比，1.06；95%CI，0.85-1.31；P=0.62）。同样，登记处中与 SCD-HeFT 相似的患者的生存率与 SCD-HeFT 中随机接受 ICD 治疗的患者的生存率也无显著差异（3 年死亡率：分别为 17.3%和 17.4%；调整后的登记处与试验风险比，1.16；95%CI，0.97-1.38；P=0.11）。
在临床试验中随机接受 ICD 治疗的患者和在临床实践中接受初级预防 ICD 治疗的类似患者的生存率无显著差异。我们的研究结果支持在临床实践中对类似患者继续使用初级预防 ICD。
clinicaltrials.gov 标识符：NCT00000609。
