Department of Interventional Cardiology, Erasmus University Medical Centre, Rotterdam, the Netherlands.
Department of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
JACC Cardiovasc Interv. 2020 Feb 10;13(3):323-331. doi: 10.1016/j.jcin.2019.10.043.
The aim of this study was to report the 2-year results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial and confirm the interim Bayesian analysis.
Transcatheter aortic valve replacement (TAVR) with a self-expanding valve was noninferior to surgery in patients with severe aortic stenosis and intermediate operative risk using Bayesian statistical methods. Novel Bayesian designs have been used to shorten the time to primary endpoint analysis in randomized clinical trials, although the predictive value of Bayesian analysis compared with frequentist approaches remains debated.
The SURTAVI trial randomized 1,660 patients. An interim analysis was performed 1 year after the 1,400th patient was treated to estimate the primary 2-year endpoint of all-cause mortality or disabling strokes for all patients.
The Kaplan-Meier rate for the complete 2-year primary endpoint was 12.7% in the TAVR group and 12.6% in the surgery group (0.0% difference; 95% confidence interval: -3.4% to 3.5%), compared with 12.6% with TAVR and 14.0% with surgery (-1.4% difference; Bayesian credible interval: -5.2% to 2.3%) in the interim Bayesian analysis. A comparison of individual clinical, hemodynamic, and quality-of-life endpoints using Bayesian and frequentist methods found no significant differences.
The complete analysis of all patients with aortic stenosis at intermediate risk for surgery in the SURTAVI trial confirmed the noninferiority, with respect to the frequency of all-cause mortality or disabling stroke, of TAVR to surgery, as determined in the interim Bayesian analysis. Follow-up will extend out to 10 years.
本研究旨在报告 SURTAVI（外科置换与经导管主动脉瓣植入术）试验的 2 年结果，并确认中期贝叶斯分析。
使用贝叶斯统计方法，对于中危手术主动脉瓣狭窄患者，经导管主动脉瓣置换（TAVR）与手术相比非劣效。新型贝叶斯设计已被用于缩短随机临床试验主要终点分析的时间，但贝叶斯分析与频率方法相比的预测价值仍存在争议。
SURTAVI 试验共纳入 1660 例患者。在第 1400 例患者治疗后 1 年进行中期分析，以估计所有患者的主要 2 年全因死亡率或致残性卒中终点。
TAVR 组和手术组的完整 2 年主要终点的 Kaplan-Meier 率分别为 12.7%和 12.6%（差异为 0.0%；95%置信区间：-3.4%至 3.5%），而中期贝叶斯分析中 TAVR 组和手术组分别为 12.6%和 14.0%（差异为-1.4%；贝叶斯可信区间：-5.2%至 2.3%）。使用贝叶斯和频率方法比较个体临床、血流动力学和生活质量终点，未发现显著差异。
在 SURTAVI 试验中，对于中危手术的主动脉瓣狭窄患者的所有患者进行完整分析，确认了 TAVR 与手术相比在全因死亡率或致残性卒中频率方面的非劣效性，这与中期贝叶斯分析一致。随访将延长至 10 年。
