New five-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 two years and key clinical endpoints were
also similar.

Findings were reported at TCT 2021, the 33rd annual
scientific symposium of the Cardiovascular Research Foundation (CRF). TCT is
the world’s premier educational meeting specialising in interventional
cardiovascular medicine.

Early randomised TAVR trials enrolled
patients at high operative risk with reserved long-term prognosis.

TAVR with balloon-expandable valves in
intermediate-risk patients at five years was associated with higher rates of
readmission and similar hemodynamics compared to surgery. Limited long-term
data exists comparing surgery with self-expanding supra-annular TAVR.

A total of 1660 intermediate-risk patients
(risk of operative mortality ≥3% to <15%) underwent attempted implant of a transcatheter aortic valve (n=864) or a surgical valve (n=796) at 87 centres in Canada, Europe and the United States. Patients were stratified by investigational site and need for revascularisation. Concomitant or staged PCI in the TAVR arm or coronary bypass graft in the surgical arm was performed as indicated.

The primary endpoint, consisting of the
composite of death or disabling stroke at five years, were similar in both
groups with 31.3% for TAVR and 30.8% for surgery (HR 1.02, 95% CI .085-1.22,
p=0.85). 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=0.12). At
two years, reinterventions were higher with TAVR (2.5% versus 0.5%, log-rank
p=0.002). However, at years three through five, the rates were similar. At five
years, the reintervention rate for TAVR was 1% compared to 1.3% compared with surgery
(log-rank p=0.60).

Core lab-assessed valve regurgitation
showed that surgery patients had significantly less ≥ mild aortic regurgitation
or paravalvular leak than TAVR at one, two and five-year follow-ups (all p < 0.001). Kansas City Cardiomyopathy Questionnaire summary scores were higher for TAVR patients at one year. However, the scores were similar at each additional follow up through five years. New York Heart Association Class was also similar between both groups at each follow up. In addition, 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,” said Nicolas M. Van Mieghem, MD, PhD, Professor of Interventional
Cardiology, Thoraxcentre, Erasmus University Medical Center (Rotterdam, the