Department of Cardiovascular Surgery, German Heart Center, Munich, Germany.
JACC Cardiovasc Interv. 2013 May;6(5):443-51. doi: 10.1016/j.jcin.2013.01.136.
OBJECTIVES: This study sought to compare all-cause mortality in patients at intermediate surgical risk undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). BACKGROUND: Physicians are selecting "lower" surgical risk patients to undergo TAVI. No clinical data exist about the clinical outcomes of TAVI versus SAVR among intermediate-surgical-risk patients. METHODS: We prospectively enrolled symptomatic patients with severe aortic stenosis who underwent TAVI or SAVR. Propensity-score matched pairs of TAVI and SAVR patients with Society of Thoracic Surgeons (STS) scores between 3% and 8% made up the study population. Primary endpoint was all-cause mortality at 1 year. RESULTS: Between November 2006 and January 2010, 3,666 consecutive patients underwent either TAVI (n = 782) or SAVR (n = 2,884). Four hundred five TAVI patients were matched to 405 SAVR patients. Of matched TAVI patients, 99 (24%) patients had STS scores <3%, 255 (63%) had scores between 3% and 8%, and 51 (13%) had scores >8%. Among patients with STS scores between 3% and 8%, 20 (7.8%) versus 18 (7.1%) patients had died up to 30 days (hazard ratio: 1.12, 95% confidence interval: 0.58 to 2.15, p = 0.74) and 42 (16.5%) versus 43 (16.9%) patients had died up to 1 year (hazard ratio: 0.90, 95% confidence interval: 0.57 to 1.42, p = 0.64) after TAVI and SAVR, respectively. Effects of treatment on 1-year mortality were similar across all subgroups except for sex, with some evidence for a beneficial effect of TAVI in women but not in men (test for interaction p = 0.024). CONCLUSIONS: Cumulative all-cause mortality at 30 days and 1 year was similar among propensity-score matched TAVI and SAVR patients at intermediate surgical risk. (Surgical Replacement and Transcatheter Aortic Valve Implantation [SURTAVI]; NCT01586910).
目的:本研究旨在比较接受经导管主动脉瓣置换术(TAVI)或外科主动脉瓣置换术(SAVR)的中危手术风险患者的全因死亡率。
背景:医生正在选择“较低”手术风险的患者进行 TAVI。目前尚无关于中危手术风险患者 TAVI 与 SAVR 临床结局的临床数据。
方法:我们前瞻性地招募了接受 TAVI 或 SAVR 的有症状的严重主动脉瓣狭窄患者。使用 STS 评分在 3%至 8%之间的 TAVI 和 SAVR 患者的倾向评分匹配对构成了研究人群。主要终点是 1 年时的全因死亡率。
结果:2006 年 11 月至 2010 年 1 月期间,连续 3666 例患者接受了 TAVI(n=782)或 SAVR(n=2884)。405 例 TAVI 患者与 405 例 SAVR 患者匹配。在匹配的 TAVI 患者中,99 例(24%)患者的 STS 评分<3%,255 例(63%)患者的评分在 3%至 8%之间,51 例(13%)患者的评分>8%。在 STS 评分在 3%至 8%之间的患者中,30 天内死亡的患者分别有 20 例(7.8%)和 18 例(7.1%)(风险比:1.12,95%置信区间:0.58 至 2.15,p=0.74),1 年内死亡的患者分别有 42 例(16.5%)和 43 例(16.9%)(风险比:0.90,95%置信区间:0.57 至 1.42,p=0.64)。除性别外,TAVI 和 SAVR 治疗对 1 年死亡率的影响在所有亚组中均相似,而女性 TAVI 治疗有获益的证据,但男性则无(交互检验 p=0.024)。
结论:在中危手术风险的倾向评分匹配 TAVI 和 SAVR 患者中,30 天和 1 年的全因死亡率相似。(外科置换和经导管主动脉瓣置换术[SURTAVI];NCT01586910)。
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