Tomonari M Shimoda, Yoshihisa Miyamoto, Shinichi Fukuhara, Hiroki A Ueyama, Yosuke Sakurai, Yujiro Yokoyama, Michel Pompeu Sá, Azeem Latib, Roger J Laham, Kaveh Hosseini, Tsuyoshi Kaneko, Toshiki Kuno
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引用次数: 0
摘要
背景:对于低危主动脉狭窄(AS)患者进行经导管(TAVR)和手术(SAVR)主动脉瓣置换术的选择,长期数据是必要的。鉴于最近的随机对照试验(RCTs)和现有试验的中期结果,有必要对当前文献进行重新评估。方法系统地筛选比较低危AS患者TAVR和SAVR的随机对照试验。利用已发表的Kaplan-Meier曲线重构的事件时间数据进行meta分析。我们感兴趣的结果是中期死亡率。采用分层Cox模型计算风险比(hr)。对比例风险假设进行检验,并据此进行里程碑分析和限制平均生存时间(RMST)分析。结果7项随机对照试验包括5,740例患者(TAVR: 2,927;SAVR: 2,813)。5年时,TAVR与全因死亡率降低相关(HR 0.83;95% ci 0.70-1.00)。具有里程碑意义的分析显示,第一年的生存获益显著(HR 0.75;95% CI 0.61-0.93),但此后没有。5年的RMST分析使TAVR优势1.01个月(p=0.011)。结论:在低风险AS患者中,TAVR具有早期生存优势。然而,目前还不确定这种短期效益是否会转化为长期优势。长期的数据是必要的,以充分告知临床实践。
Transcatheter versus Surgical Aortic Valve Replacement in Low-Risk Patients: Updated Meta-Analysis.
Background Long-term data are essential for selection between transcatheter (TAVR) and surgical (SAVR) aortic valve replacement in low-risk aortic stenosis (AS) patients. Given the recent randomized controlled trials (RCTs) and mid-term outcomes from existing trials, a reappraisal of the current literature is necessary. Methods We systematically identified RCTs comparing TAVR and SAVR in low risk AS patients. A meta-analysis was performed using the reconstructed time-to-event data from published Kaplan-Meier curves. The outcome of interest was mid-term mortality. A stratified Cox model was used to calculate hazard ratios (HRs). Proportional hazard assumptions were tested, with landmark analysis and restricted mean survival time (RMST) analysis conducted accordingly. Results Seven RCTs including 5,740 patients (TAVR: 2,927; SAVR: 2,813) were included. At 5 years, TAVR was associated with reduced all-cause mortality (HR 0.83; 95% CI 0.70-1.00). Landmark analysis showed a significant survival benefit in the first year (HR 0.75; 95% CI 0.61-0.93), but not thereafter. The RMST analysis at 5 years favored TAVR by 1.01 months (p=0.011). Conclusions In low risk AS patients, TAVR demonstrated an early survival advantage. However, it remains uncertain whether this short-term benefit translates to long-term advantages. Long-term data are necessary to fully inform clinical practice.
期刊介绍:
Published 24 times a year, The American Journal of Cardiology® is an independent journal designed for cardiovascular disease specialists and internists with a subspecialty in cardiology throughout the world. AJC is an independent, scientific, peer-reviewed journal of original articles that focus on the practical, clinical approach to the diagnosis and treatment of cardiovascular disease. AJC has one of the fastest acceptance to publication times in Cardiology. Features report on systemic hypertension, methodology, drugs, pacing, arrhythmia, preventive cardiology, congestive heart failure, valvular heart disease, congenital heart disease, and cardiomyopathy. Also included are editorials, readers'' comments, and symposia.