Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
St Antonius Hospital, Nieuwegein, the Netherlands.
JAMA Cardiol. 2019 Aug 1;4(8):810-814. doi: 10.1001/jamacardio.2019.1856.
Surgical aortic valve replacement (SAVR) has increased risk for patients with aortic stenosis (AS) and a history of coronary artery bypass graft (CABG) surgery. Transcatheter aortic valve replacement (TAVR) may be an alternative.
To compare TAVR with SAVR outcomes in patients at intermediate operative risk with prior CABG surgery.
DESIGN, SETTING, AND PARTICIPANTS: In this post hoc analysis of the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) noninferiority randomized clinical trial, patients with severe, symptomatic AS at intermediate operative risk were enrolled from 87 centers across the United States, Europe, and Canada from June 2012 to June 2016 and followed-up with up to July 2017. Those with a history of CABG surgery were considered for analysis. Data were analyzed from September to December 2017.
A total of 1746 patients were enrolled and randomized 1:1 to self-expanding TAVR or SAVR. An implant was attempted in 1660 patients, of whom 273 had prior CABG surgery, including 136 who underwent attempted TAVR and 137 who underwent attempted SAVR.
The primary outcome was all-cause mortality or disabling stroke at 1-year follow-up. Efficacy outcomes included quality of life, measured using the Kansas City Cardiomyopathy Questionnaire at 30 days, 6 months, and 1 year, and distance walked in 6 minutes, measured using the 6-minute walk test at 30 days and 1 year.
Of the 136 patients in the TAVR cohort, 111 (81.6%) were male, and the mean (SD) age was 76.9 (6.5) years; of the 137 in the SAVR cohort, 117 (85.4%) were male, and the mean (SD) age was 76.6 (6.5) years. The mean (SD) Society of Thoracic Surgeons Predicted Risk of Mortality score was 5.0% (1.6%) in the TAVR cohort and 5.2% (1.7%) in the SAVR cohort. All-cause mortality or disabling stroke at 1-year follow-up was 8.9% (95% CI, 5.2-15.2) in the TAVR cohort and 6.7% (95% CI, 3.5-12.8) in the SAVR cohort (log-rank P = .53). Compared with patients receiving SAVR, the mean (SD) Kansas City Cardiomyopathy Questionnaire summary score was significantly better among patients receiving TAVR at 30 days (81.4 [19.2] vs 69.7 [22.6]; P < .001); treatments were similar at 1 year (85.7 [14.6] vs 82.8 [18.4]; P = .19). Compared with patients in the SAVR cohort, those in the TAVR cohort showed greater mean (SD) improvement in distance walked at 1 year (48.3 [120.6] m vs 16.8 [88.7] m; P = .04).
Both TAVR and SAVR were safe for intermediate-risk patients with AS and prior CABG surgery. The transcatheter approach facilitated faster improvement in quality of life and better exercise capacity at 1-year follow-up.
ClinicalTrials.gov identifier: NCT01586910.
主动脉瓣置换术（SAVR）增加了有主动脉瓣狭窄（AS）病史和冠状动脉旁路移植术（CABG）病史的患者的风险。经导管主动脉瓣置换术（TAVR）可能是一种替代方法。
比较 TAVR 与 SAVR 治疗具有既往 CABG 手术史的中危患者的结果。
设计、地点和参与者：这是 SURTAVI 非劣效性随机临床试验的事后分析，从中性手术风险的美国、欧洲和加拿大的 87 个中心招募了有严重、有症状的 AS 且有中危手术史的患者，从 2012 年 6 月至 2016 年 6 月进行随访，随访至 2017 年 7 月。考虑对有 CABG 手术史的患者进行分析。数据分析于 2017 年 9 月至 12 月进行。
共纳入 1746 例患者，按 1:1 随机分为自膨式 TAVR 或 SAVR。对 1660 例患者进行了植入尝试，其中 273 例有 CABG 手术史，包括 136 例尝试 TAVR 和 137 例尝试 SAVR。
主要结果是 1 年随访时全因死亡率或致残性卒中。疗效结局包括生活质量，使用堪萨斯城心肌病问卷在 30 天、6 个月和 1 年进行评估，6 分钟步行试验在 30 天和 1 年评估 6 分钟步行距离。
在 TAVR 组的 136 例患者中，111 例（81.6%）为男性，平均（SD）年龄为 76.9（6.5）岁；在 SAVR 组的 137 例患者中，117 例（85.4%）为男性，平均（SD）年龄为 76.6（6.5）岁。TAVR 组的平均（SD）胸外科医生协会预测死亡率为 5.0%（1.6%），SAVR 组为 5.2%（1.7%）。TAVR 组 1 年随访时的全因死亡率或致残性卒中为 8.9%（95%CI，5.2-15.2），SAVR 组为 6.7%（95%CI，3.5-12.8）（对数秩 P=0.53）。与接受 SAVR 的患者相比，接受 TAVR 的患者在 30 天时的堪萨斯城心肌病问卷综合评分显著更高（81.4[19.2] vs 69.7[22.6]；P<0.001）；1 年时治疗效果相似（85.7[14.6] vs 82.8[18.4]；P=0.19）。与 SAVR 组患者相比，TAVR 组患者在 1 年时的 6 分钟步行距离有更大的平均（SD）改善（48.3[120.6]m 比 16.8[88.7]m；P=0.04）。
对于有 AS 和既往 CABG 病史的中危患者，TAVR 和 SAVR 均安全。经导管方法在 1 年随访时可更快地改善生活质量和更好的运动能力。
ClinicalTrials.gov 标识符：NCT01586910。
