BACKGROUND: For patients with severe aortic stenosis (AS) and coronary artery disease (CAD), the completely percutaneous approach to aortic valve replacement and revascularization has not been compared to the standard surgical approach.
METHODS: The prospective SURTAVI trial enrolled intermediate-risk patients with severe AS from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score >22 was an exclusion criterion. Patients were stratified according to need for revascularization and then randomized to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in the TAVR group underwent percutaneous coronary intervention (PCI), while those in the SAVR group had coronary artery bypass grafting (CABG). The primary endpoint was the rate of all-cause mortality or disabling stroke at two years.
RESULTS: Of 1,660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization. They had a higher STS risk score for mortality (4.8±1.7% vs 4.4±1.5%; p<0.01) and were more likely to be male (65.1% vs 54.2%; p<0.01) than the 1,328 patients not assigned to revascularization. After randomization to treatment, there were 169 TAVR and PCI patients, 163 SAVR and CABG patients, 695 TAVR patients, and 633 SAVR patients. No significant difference in the rate of the primary endpoint was found between TAVR and PCI and SAVR and CABG (16.0%; 95% CI 11.1 - 22.9 vs. 14.0%; 95% CI 9.2 - 21.1; p=0.62), or between TAVR and SAVR (11.9%; 95% CI 9.5 - 14.7 vs. 12.3%; 95% CI 9.8 - 15.4; p=0.76).
CONCLUSIONS: For patients at intermediate surgical risk with severe AS and non-complex CAD (SYNTAX score ≤ 22), a complete percutaneous approach of TAVR and PCI is a reasonable alternative to SAVR and CABG.
CLINICAL TRIAL REGISTRATION: URL: www.clinicaltrials.gov Unique Identifier: NCT01586910.