Transcatheter aortic valve implantation versus surgical aortic valve replacement for treatment of severe aortic stenosis: comparison of results from randomized controlled trials and real-world data

Abstract Objective: Results from randomized controlled trials (RCTs) and real-world study (RWS) appear to be discordant. We aimed to investigate whether data derived from RCTs and RWS evaluating long-term all-cause mortality of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) were in agreement. Methods: RCTs or RWS comparing TAVI and SAVR, reporting longterm (≥2-year follow-up) all-cause mortality, were identified. We also carried out subgroup analyses to access the effect in different subgroups. A pre-designated data extraction form including 5 domains and 26 items was used to explore the relationship between RCTs and RWS. Mortality and effect in different subgroups were evaluated using random-effects meta-analyses. Results: Five RCTs (5421 participants, TAVI: 2759, SAVR: 2662) and 33 RWS (20839 participants; TAVI: 6585, SAVR: 14254) were identified. Pooled RCT analysis showed no difference in all-cause mortality between TAVI and SAVR (HR=0.97, 95% CI: 0.88-1.07; P=0.55). In RWS, TAVI was associated with an increased risk of allcause mortality (HR=1.46, 95% CI: 1.26-1.69; P<0.001) compared to SAVR. Conclusion: These results highlight the inconsistencies between RCTs and RWS in assessing long-term all-cause mortality in the treatment of AS using TAVI or SAVR, which may be caused by interactions of clinical characteristics or study design. RCTs as well as RWS are both developing and improving; the advantages of one kind of design, measurement and evaluation can and should be thoughtfully referred to the other.

摘要 目的：随机对照试验（randomized controlled trials, RCTs）与真实世界研究（real-world study, RWS）的结果往往存在不一致性。本研究旨在探讨针对重度主动脉瓣狭窄（severe aortic stenosis, AS）患者，比较经导管主动脉瓣植入术（transcatheter aortic valve implantation, TAVI）与外科主动脉瓣置换术（surgical aortic valve replacement, SAVR）的两类研究在评估长期全因死亡率方面的结论是否一致。方法：本研究纳入所有比较TAVI与SAVR、报告长期（≥2年随访）全因死亡率的随机对照试验或真实世界研究。同时开展亚组分析，以评估不同亚组中的干预效应。我们采用预先设计的包含5个维度、26个条目的数据提取表单，探究两类研究之间的关联。采用随机效应荟萃分析评估不同亚组的死亡率及干预效应。结果：共纳入5项随机对照试验（共5421名受试者，TAVI组2759例，SAVR组2662例）及33项真实世界研究（共20839名受试者，TAVI组6585例，SAVR组14254例）。合并随机对照试验分析结果显示，TAVI与SAVR的全因死亡率无显著差异（风险比（hazard ratio, HR）=0.97，95%置信区间（confidence interval, CI）：0.88~1.07；P=0.55）。而在真实世界研究中，相较于SAVR，TAVI与全因死亡率风险升高相关（HR=1.46，95%CI：1.26~1.69；P<0.001）。结论：本研究结果表明，在采用TAVI或SAVR治疗主动脉瓣狭窄的长期全因死亡率评估中，随机对照试验与真实世界研究的结论存在不一致性，该差异可能由临床特征或研究设计的交互作用所致。随机对照试验与真实世界研究均处于不断发展完善的过程中，二者在研究设计、测量与评估环节的优势可且应当被审慎地相互借鉴。