Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy.
Am J Cardiol. 2012 May 15;109(10):1487-93. doi: 10.1016/j.amjcard.2012.01.364. Epub 2012 Feb 21.
Comparisons of transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis remain sparse or limited by a short follow-up. We sought to evaluate early and midterm outcomes of consecutive patients (n = 618) undergoing successful TAVI (n = 218) or isolated SAVR (n = 400) at 2 centers. The primary end point was incidence of Valvular Academic Research Consortium-defined major adverse cerebrovascular and cardiac events (MACCEs) up to 1 year. Control of potential confounders was attempted with extensive statistical adjustment by covariates and/or propensity score. In-hospital MACCEs occurred in 73 patients (11.8%) and was more frequent in patients treated with SAVR compared to those treated with TAVI (7.8% vs 14.0%, p = 0.022). After addressing potential confounders using 3 methods of statistical adjustment, SAVR was consistently associated with a higher risk of MACCEs than TAVI, with estimates of relative risk ranging from 2.2 to 2.6 at 30 days, 2.3 to 2.5 at 6 months, and 2.0 to 2.2 at 12 months. This difference was driven by an adjusted increased risk of life-threatening bleeding at 6 and 12 months and stroke at 12 months with SAVR. Conversely, no differences in adjusted risk of death, stroke and myocardial infarction were noted between TAVI and SAVR at each time point. In conclusion, in a large observational registry with admitted potential for selection bias and residual confounding, TAVI was not associated with a higher risk of 1-year MACCEs compared to SAVR.
在严重主动脉瓣狭窄患者中,经导管主动脉瓣植入术(TAVI)与外科主动脉瓣置换术(SAVR)的比较仍然很少,或者受到随访时间短的限制。我们试图评估在 2 个中心连续接受成功 TAVI(n = 218)或单纯 SAVR(n = 400)的患者的早期和中期结果。主要终点是 1 年内 Valvular Academic Research Consortium 定义的主要不良心脑血管事件(MACCEs)的发生率。通过协变量和/或倾向评分的广泛统计调整来尝试控制潜在的混杂因素。住院期间发生的 MACCEs有 73 例(11.8%),接受 SAVR 治疗的患者比接受 TAVI 治疗的患者更常见(7.8%比 14.0%,p = 0.022)。在使用 3 种统计调整方法解决潜在混杂因素后,SAVR 始终与更高的 MACCEs 风险相关,30 天、6 个月和 12 个月的相对风险估计值分别为 2.2 至 2.6、2.3 至 2.5 和 2.0 至 2.2。这种差异是由于 SAVR 在 6 个月和 12 个月时致命性出血和 12 个月时卒中的风险增加导致的。相反,在每个时间点,TAVI 和 SAVR 之间在调整后的死亡、卒中和心肌梗死风险没有差异。总之,在一个存在选择偏倚和残余混杂的大型观察性注册研究中,与 SAVR 相比,TAVI 并不与 1 年 MACCEs 的更高风险相关。