5-Year SURTAVI Data Compare Outcomes for TAVR Versus Surgery in Intermediate-Risk Patients

November 5, 2021—New 5-year data from the SURTAVI trial found that there was no difference in all-cause mortality or stroke between patients at intermediate surgical risk who had transcatheter aortic valve replacement (TAVR) or surgery. Although there were initially more reinterventions after TAVR, the rates were similar after 2 years, and key clinical endpoints were also similar.

The SURTAVI data were presented in a late-breaking trials session at TCT 2021, the 33rd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held November 4-6 online and in Orlando, Florida.

As noted in the TCT press release, early randomized TAVR trials enrolled patients at high operative risk with reserved long-term prognosis. TAVR with balloon-expandable valves in intermediate-risk patients at 5 years was associated with higher rates of readmission and similar hemodynamics compared to surgery. Limited long-term data exist comparing surgery with self-expanding supra-annular TAVR.

In SURTAVI, which was funded by Medtronic, a total of 1,660 intermediate-risk patients (risk of operative mortality ≥ 3% to < 15%) underwent attempted implantation of a transcatheter aortic valve with Medtronic’s CoreValve platform (n = 864) or a surgical valve (n = 796) at 87 centers in Canada, Europe, and the United States.

Patients were stratified by investigational site and need for revascularization. Concomitant or staged percutaneous coronary intervention in the TAVR arm or coronary bypass graft in the surgical arm was performed as indicated.

TCT summarized the findings in the press release as follows:

• The primary endpoint of the composite of death or disabling stroke at 5 years were similar in both groups, with 31.3% for TAVR and 30.8% for surgery (hazard ratio [HR], 1.02; 95% CI, .085-1.22; P = .85).
• All-cause mortality had similar rates, and disabling stroke was 4.1% for TAVR compared to 5.8% for surgery (HR, 0.69; 95% CI, 0.43-1.10; P = .12).
• At 2 years, reinterventions were higher with TAVR compared to surgery (2.5% vs 0.5%; log-rank P = .002).
• At years 3 through 5, the reintervention rates were similar; at 5 years, the reintervention rate for TAVR was 1.0% versus 1.3% for surgery (log-rank P = .6).
• Core lab–assessed valve regurgitation showed that surgery patients had significantly less mild or greater than mild aortic regurgitation or paravalvular leak than TAVR at 1, 2, and 5-year follow-ups (all P < .001).
• Kansas City Cardiomyopathy Questionnaire summary scores were higher for TAVR patients at 1 year. However, scores were similar at each additional follow-up through 5 years.
• New York Heart Association Class was similar in both groups at each follow-up, and forward-flow hemodynamics were significantly better with TAVR.

“Longer-term outcomes data from the SURTAVI randomized trial comparing early generation TAVR to open heart surgery are similar and encouraging for TAVR in younger, healthier patients with aortic stenosis,” commented Nicolas M. Van Mieghem, MD, who is Professor of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center in Rotterdam, the Netherlands, in the TCT press release.