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.
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).
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.
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.
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).
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).
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。
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。
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。
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）。
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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