Division of Cardiology, Medical University of South Carolina, Charleston, South Carolina.
Health Economics and Epidemiology, ICON/Oxford Outcomes, Oxford, United Kingdom.
JACC Heart Fail. 2015 Sep;3(9):691-700. doi: 10.1016/j.jchf.2015.05.005. Epub 2015 Aug 12.
This study sought to assess the lifelong extrapolated patient outcomes with cardiac resynchronization therapy (CRT) in mild heart failure (HF), beyond the follow-up of randomized clinical trials (RCTs).
RCTs have demonstrated short-term survival and HF hospitalization benefits of CRT in mild HF. We used data from the 5-year follow-up of the REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) study to extrapolate survival and HF hospitalizations. We compared CRT-ON versus CRT-OFF and CRT defibrillators (CRT-D) versus CRT pacemakers (CRT-P).
Multivariate regression models were used to estimate treatment-specific all-cause mortality, disease progression, and HF-related hospitalization rates. Rank-preserving structural failure time (RPSFT) models were used to adjust for protocol-mandated crossover in the survival analysis.
CRT-ON was predicted to increase survival by 22.8% (CRT-ON 52.5% vs. CRT-OFF 29.7%; hazard ratio [HR]: 0.45; p = 0.21), leading to an expected survival of 9.76 years (CRT-ON) versus 7.5 years (CRT-OFF). CRT-D showed a significant improvement in survival compared with CRT-P (HR: 0.47; 95% confidence interval [CI]: 0.25 to 0.88; p = 0.02) and were predicted to offer 2.77 additional life-years. New York Heart Association (NYHA) functional class II patients had a 30.6% higher HF hospitalization risk than class I (I vs. II incident rate ratio [IRR]: 0.69; 95% CI: 0.57 to 0.85; p < 0.001) and 3 times lower rate compared with class III (III vs.
2.98; 95% CI: 2.29 to 3.87; p < 0.001).
RPSFT estimates yielded results demonstrating clinically important long-term benefit of CRT in mild HF. CRT was predicted to reduce mortality, with CRT-D prolonging life more than CRT-P. NYHA functional class I/II patients were shown to have a significantly reduced risk of HF hospitalization compared with class III, leading to CRT reducing HF hospitalization rates.
本研究旨在评估心脏再同步治疗（CRT）在轻度心力衰竭（HF）患者中的终生预测患者结局，超越随机临床试验（RCT）的随访。
RCT 已经证明了 CRT 在轻度 HF 中的短期生存率和 HF 住院获益。我们使用了 REVERSE（左心室收缩功能障碍的再同步逆转重构）研究 5 年随访的数据来推断生存率和 HF 住院率。我们比较了 CRT-ON 与 CRT-OFF 和 CRT 除颤器（CRT-D）与 CRT 起搏器（CRT-P）。
使用多变量回归模型估计特定于治疗的全因死亡率、疾病进展和 HF 相关住院率。使用保留等级结构失效时间（RPSFT）模型调整生存分析中协议规定的交叉。
CRT-ON 预计可使生存率提高 22.8%（CRT-ON 为 52.5%，而 CRT-OFF 为 29.7%；风险比[HR]：0.45；p = 0.21），预期生存率为 9.76 年（CRT-ON）与 7.5 年（CRT-OFF）。与 CRT-P 相比，CRT-D 显示出生存率的显著改善（HR：0.47；95%置信区间[CI]：0.25 至 0.88；p = 0.02），预计可额外延长 2.77 年寿命。纽约心脏协会（NYHA）心功能 II 级患者的 HF 住院风险比 I 级患者高 30.6%（I 级 vs. II 级发生率比[IRR]：0.69；95%CI：0.57 至 0.85；p < 0.001），比 III 级患者低 3 倍（III 级 vs. II 级 IRR：2.98；95%CI：2.29 至 3.87；p < 0.001）。
RPSFT 估计结果表明，CRT 在轻度 HF 中具有重要的长期临床获益。CRT 预计可降低死亡率，而 CRT-D 比 CRT-P 更能延长寿命。与 III 级患者相比，NYHA 心功能 I/II 级患者的 HF 住院风险显著降低，导致 CRT 降低 HF 住院率。
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