SURTAVI: TAVR Results Similar to Surgery at 5 Years

Results of the 5-year follow-up from SURTAVI, which were presented at TCT 2021, provide insight into the associations of TAVR with mortality and stroke compared to SAVR in patients with severe aortic stenosis considered to be at intermediate risk.

Data from the 5-year follow-up in the SURTAVI trial suggests there were no significant differences in mortality or stroke among intermediate-risk patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) or surgery.

Presented at TCT 2021, results of these study demonstrate TAVR patients experienced similar rates of the study’s primary composite endpoint and while there were initially more interventions were required with TAVR, investigators noted rates were similar after the 2-year follow-up.

“TAVR has revolutionized the treatment of aortic stenosis with more TAVR cases now performed than surgical aortic valve replacement for this disease. With this shift in treatment, longer-term, randomized data is increasingly important as we strive to better understand the lifetime management of these patients,” said Michael Reardon, MD, professor of cardiothoracic surgery and principal investigator in the SURTAVI trial, in a statement.

With the popularity of TAVR exploding over the past decade, SURTAVI is one of many trials designed to assess the safety and efficacy of TAVR against the traditional surgical approach in specific subgroups of patients. Specifically, SURTAVI was designed as a multinational, randomized, noninferiority clinical trial to compare the safety and efficacy of TAVR and surgery in patients with symptomatic, severe aortic stenosis at intermediate surgical risk.

Conducted across 87 centers in North America and Europe, the trial included 1660 patients, including 864 randomized to TAVR and 796 randomized to surgery. Investigators noted intermediate risk was defined as a risk of operative mortality of 3 to less than 15%. The primary end point of the trial was a composite of death from any cause or disabling stroke.

The 2-year results, which were published in the New England Journal of Medicine in 2017, demonstrated TAVR was noninferior to surgery for the study’s primary end point, with incidence rates of 12.6% and 14.0% among the TAVR and surgery arms, respectively. Results from the 2-year follow-up also suggested patients in the TAVR arm were more likely to require reintervention, with reintervention occurring among 2.5% and 0.5% of the TAVR and surgery arms, respectively (log-rank P=.002).

In the 5-year data presented at TCT 2021, results indicated rates of the primary composite end point were similar among both groups, with a primary outcome event occurring among 31.3% of the TAVR arm and 30.8% of the surgery arm (HR, 1.02 [95% CI, 0.85-1.22]; P=.85). When examining individual components of the composite end point, results suggested rates of all-cause mortality were 30.0% with TAVR and 28.7% with surgery and rates of disabling stroke were 4.1% for TAVR compared to 5.8% for surgery (HR 0.69 [95% CI, 0.43-1.10] P=.12).

When assessing rates of intervention from years 3-5, results indicated rates were similar between both arms, with a reintervention rate of 1.0% for TAVR and 1.3% for surgery at 5 years (log-rank P=.60). Further analysis revealed patients in the surgery arm of the trial experienced significantly less aortic regurgitation or paravalvular leak than TAVR at follow-ups occurring at years 1, 2, and 5 (all P <.001). Investigators noted forward-flow hemodynamics were significantly better among patients in the TAVR arm.

Additionally, KCCQ-OS scores were higher among the TAVR arm at 1-year, but scores were similar between the study arms at each additional follow-up through 5 years. Investigators also pointed out results indicated NYHA class was similar between both arms at each follow-up.

“These longer-term outcomes are remarkably similar after TAVR and surgery in patients with severe aortic stenosis at intermediate operative risk,” said Nicolas Van Mieghem, MD, PhD, professor of interventional cardiology, department of cardiology, Thoraxcenter, Erasmus University Medical Center in Rotterdam, The Netherlands, who presented the data at the meeting. “Additionally, results from this study are particularly impressive given the TAVR devices evaluated were first- and second-generation systems.”

This study, “5-Year Clinical and Echocardiographic Outcomes from the Randomized SURTAVI Trial,” was presented at TCT 2021.