Comparison of Outcomes After Transcatheter vs Surgical Aortic Valve Replacement Among Patients at Intermediate Operative Risk With a History of Coronary Artery Bypass Graft Surgery: A Post Hoc Analysis of the SURTAVI Randomized Clinical Trial

Abstract

Importance: 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.

Objective: 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.

Interventions: 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.

Main outcomes and measures: 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.

Results: 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).

Conclusions and relevance: 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.

Trial registration: ClinicalTrials.gov identifier: NCT01586910.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Reardon serves on an advisory board for Medtronic. Dr Heijmen serves as a consultant for Medtronic and Terumo Aortic. Dr Van Mieghem has received research grants from Boston Scientific, Medtronic, Edwards Lifesciences, and Abbott Vascular and serves on the advisory boards of Ancora Heart and PulseCath BV. Dr Williams serves as a consultant for Edwards Lifesciences and Medtronic, has received speaker fees from Abbott Laboratories, and has received research grants from Medtronic. Dr Yakubov has received research grants from Medtronic and Boston Scientific, serves on advisory boards for Medtronic and Boston Scientific, and is a principal investigator, steering committee member, and screening committee member for the CoreValve clinical trials. Dr Watson serves on the speakers’ bureau and is a proctor for Boston Scientific, Edwards Lifesciences, Medtronic, and LivaNova. Dr Kleiman has received fees for providing educational services from Medtronic. Dr Chawla has served as a proctor for Medtronic. Dr Petrossian has received research support from Medtronic. Dr Kappetein is an employee and shareholder of Medtronic. Dr Li is an employee and shareholder of Medtronic. Dr Popma has received grants from Medtronic, Boston Scientific, Edwards Lifesciences, Abbott Vascular, and Direct Flow Medical; personal fees from Boston Scientific and Edwards Lifesciences; and serves on the medical advisory board of Boston Scientific and Cordis. No other disclosures were reported.

Figures

Figure.. Exercise Capacity and Quality-of-Life Outcomes at 1 Year

A, The mean difference in meters walked at 30 days and 1 year relative to baseline in patients receiving transcatheter aortic valve replacement (TAVR; 112 patients at 30 days and 103 at 1 year) and surgical aortic valve replacement (SAVR; 103 patients at 30 days and 90 at 1 year). B, Mean Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score for patients receiving TAVR and SAVR. Data were available at baseline, 30 days, 6 months, and 1 year for 135, 133, 121, and 116 patients receiving TAVR, respectively, and for 133, 123, 120, and 106 patients receiving SAVR. The difference between groups was significant at 30 days. aP < .001. bP = .04.