TAVR system with repositionable valve safe, effective vs. self-expanding valve

A transcatheter aortic valve replacement system with a repositionable valve was similar in safety and superior in efficacy to a self-expanding system, according to findings from the REPRISE III trial presented at EuroPCR.

The data from the REPRISE III trial will be used to support approval for the repositionable valve system (Lotus, Boston Scientific) in the United States, presenter Ted E. Feldman, MD, director of the cardiac catheterization laboratory at Evanston Hospital, NorthShore University HealthSystem, Illinois, and Cardiology Today’s Intervention Editorial Board member, said in an interview.

“We anticipated seeing how this valve compared to a commercially approved TAVR platform in the United States and, of course, globally,” he said. “With this trial, we have the first direct head-to-head large-scale comparison of contemporary TAVR devices.”

Ted E. Feldman

Feldman and colleagues randomly assigned 912 patients with severe aortic stenosis at extreme or high operative risk on a 2:1 basis to the repositionable valve or the self-expanding valve (CoreValve, Medtronic).

The primary safety outcome was a composite of all-cause death, stroke, major vascular complications, life-threatening or major bleeding and stage 2/3 acute kidney injury at 30 days. The primary effectiveness outcome was a composite of all-cause death, disabling stroke and moderate or greater paravalvular leak as assessed by a core lab at 1 year.

At 30 days, the repositionable valve was noninferior to the self-expanding valve for the primary safety outcome (Lotus, 20.3%; CoreValve, 17.2%; P for noninferiority = .003), but the repositionable valve was associated with a higher rate of pacemaker implantation (35.5% vs. 19.6%; P < .001).

At 1 year, the repositionable valve was superior to the self-expanding valve for the primary effectiveness outcome (16.7% vs. 29%; P < .001), and was also linked to lower rates of disabling stroke (3.6% vs. 7.3%; P = .02), moderate or greater paravalvular leak (2% vs. 11.1%; P < .001), repeat procedures (0.2% vs. 2%; P = .007), transcatheter aortic valve-in-transcatheter aortic valve implantation (0% vs. 3%; P < .001) and valve malposition (0% vs. 2.6%; P < .001). The self-expanding valve was superior for valve thrombosis at 1 year (1.5% vs. 0%; P = .03). There was a trend favoring the repositionable valve in all-cause mortality or disabling stroke at 1 year (13.2% vs. 17.9%; P = .06).

“We demonstrated that there’s another TAVR platform that has some clear benefits for patients, including the virtual elimination of moderate or severe paravalvular leak as a limitation,” Feldman told Cardiology Today’s Intervention. “We hope these strengths are going to be available in clinical practice.

Other benefits of the repositionable valve include ability to function early in the deployment process “so that the need for rapid pacing or the presence of hemodynamic compromise during deployment is rare,” Feldman said. “This makes the procedure easier for both the physician and patient. Also, the fact that the valve can be completely retrieved from its final locked position if need be, or repositioned, is unique. The trial [also found] the absence of the need for a second valve during the index procedure, which is an infrequent but important problem with some of the other devices.”

The high rate of pacemaker implantation associated with the repositionable valve is being addressed by “using implant techniques aimed at keeping the valve system from interacting with the left ventricular outflow tract,” Feldman told Cardiology Today’s Intervention. “The earliest results we have with the next-generation deployment system … showed a rate of hospital discharges with new pacemakers under 20%. This is an important part of the development of the technology, and we hope this will ultimately be the platform that’s initially approved in the United States.”

After the data were presented, Medtronic issued the following statement:

“While the REPRISE III data reinforce [TAVR] therapy in this [high-risk/extreme-risk] patient population, it is difficult to draw firm conclusions from this study as it was conducted with first-generation technology and reported some results inconsistent with contemporary findings. It should also be noted that the difference in disabling stroke is inconsistent with published data from the CoreValve and Evolut R pivotal trials: As the [principal investigator] in the study stated from the podium, the stroke outcome was `probably a chance finding.’ Further, latest generation Evolut PRO has shown no moderate/severe [paravalvular leak] (0%), low rates of disabling stroke (1.7%) and low pacemaker rate (10%) at 30 days as presented at [the American College of Cardiology Scientific Session]. Given all the limitations and unknowns surrounding this study right now, we trust that the physician community will further evaluate the study findings when this is published in a peer-review journal and make their own determination of the study’s clinical relevance.” – by Erik Swain

Reference:

Feldman TE, et al. Late-breaking trials and trial updates. Presented at: EuroPCR; May 16-19, 2017; Paris.

Disclosure: Feldman reports consulting for and receiving institutional research grants from Abbott, Boston Scientific and Edwards Lifesciences.