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SURTAVI subanalysis: TAVR confers better outcomes at 1 year compared with surgical AVR

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WASHINGTON — Patients assigned transcatheter aortic valve replacement had fewer events at 1 year compared with those assigned surgical AVR, including disabling stroke, all-cause mortality, HF hospitalization, aortic valve hospitalization and atrial fibrillation, according to a subanalysis of the SURTAVI trial presented at Cardiovascular Research Technologies.

In addition, patients assigned TAVR underwent more permanent pacemaker implantations vs. those assigned surgical AVR, according to the presentation.

“Advancements in catheter design technology may help drive greater success for intermediate-risk patients with severe, symptomatic aortic stenosis,” Steven J. Yakubov, MD, FACC, FSCAI, John H. McConnell Chair of Advanced Structural Heart Disease, system chief of OhioHealth Structural Heart Disease and medical director of OhioHealth Research Institute at Riverside Methodist Hospital in Columbus, said during the presentation.

As Cardiology Today’s Intervention previously reported, a final analysis of 24-month results from the SURTAVI trial confirmed interim findings that TAVR with a self-expanding bioprosthesis (CoreValve or Evolut R, Medtronic) had similar outcomes vs. surgical AVR in patients at intermediate risk for surgery.

“The advantages of the Evolut R device are that it has an improved delivery profile,” Yakubov said. “It has an extended skirt to decrease [paravalvular leak], and it has enhanced radial force to enhance annular sealing.”

In the SURTAVI trial, 863 patients were assigned TAVR and 794 patients were assigned surgical AVR. In a continued access study, which was intimated after the original trial was fully enrolled, 274 patients underwent TAVR with the Evolut R device. Patients in both studies had severe aortic stenosis and a NYHA functional class II or greater.

Patients who were enrolled between May 2014 and June 2016 and those in the continued access study were defined as having intermediate risk if they had a predicted risk between 3% and 15% based on the Society of Thoracic Surgeons Predicted Risk of Mortality score and overall clinical status including disability, frailty and comorbidity factors.

Patients in both studies underwent stroke assessment by a trained neurologist or a stroke specialist at baseline, discharge, 30 days, 6, 12, 18 and 24 months.

The main purpose of this study was to compare outcomes at 1 year in patients with intermediate risk who underwent TAVR with those who underwent surgical AVR. Propensity score match analysis was performed in 197 patients who underwent TAVR (mean age, 79 years; 41% men; mean STS Predicted Risk of Mortality score = 4%) and 197 patients who underwent surgical AVR (mean age, 79 years; 41% men; mean STS Predicted Risk of Mortality score = 3.9%).

At 1 year, the rate of all-cause mortality or disability stroke was higher in the surgical AVR group (8.2%; 95% CI, 5.1-13.1) compared with the TAVR group (4.1%; 95% CI, 1.8-9.3; P for log-rank = .08). This was also seen for all-cause mortality alone in patients assigned TAVR vs. those assigned surgical AVR at 30 days (0% vs. 2.6%; 95% CI, 1.1-6) and 1 year (3.6% vs. 5.7%; P for log-rank = .31).

Patients assigned TAVR had lower rates of disabling stroke at 1 year (1%; 95% CI, 0.2-5.6) compared with those assigned surgical AVR (3.1%; 95% CI, 1.3-6.9; P for log-rank = .15).

Rates of aortic valve hospitalization were lower in the TAVR group vs. the surgical AVR group at 30 days (1.5% vs. 3.6%; P = .19) and 1 year (4.6% vs. 6.8%; P = .33). This was also seen in rates of AF at 30 days (13.7% vs. 35.8%; P < .01) and 1 year (18.3% vs. 37.4%; P < .01).

The incidence of permanent pacemaker implantation was higher in patients assigned TAVR compared with those assigned surgical AVR at 30 days (13.2% vs. 6.2%; P = .01) and 1 year (15.3% vs. 7.8%; P = .02).

Out to 1 year, the TAVR group had better valve performance vs. the surgical AVR group (P < .01).

Researchers also compared data from the randomized SURTAVI trial with the propensity score matched analysis.

“If we overlay the SURTAVI results, we get similar appearing Kaplan-Meier curves for the surgical arm,” Yakubov said. “We have improved numerical performance in the TAVR arm with this new valve.” – by Darlene Dobkowski

Reference:

Yakubov SJ, et al. Late Breaking Trials: Session II. Presented at: Cardiovascular Research Technologies; March 2-5, 2019; Washington, D.C.

Disclosure: Yakubov reports he is on the medical advisory board for Abbott Vascular, Boston Scientific and Medtronic; a steering committee member/proctor for Medtronic; on the advisory board with equity interest for BioStar Ventures, and consults for Foldax and SentreHeart.