CHOICE: Self-Expandable vs. Balloon Expandable Prostheses in Transfemoral TAVR Patients
Among patients with high-risk aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), the use of a balloon-expandable valve resulted in a greater rate of device success than use of a self-expandable valve, according to results from the CHOICE trial released Sunday as part of ACC.14.
The trial, the results of which were simultaneously published in the Journal of the American Medical Association, looked at 241 high-risk patients with severe aortic stenosis and an anatomy suitable for the transfemoral TAVR procedure that were randomly assigned to either receive a balloon-expandable valve or a self-expandable valve.
Results found that device success occurred in 116 of 121 patients (95.9 percent) in the balloon-expandable valve group compared to 93 of 120 patients (77.5 percent) in the self-expandable valve group (relative risk [RR], 1.24, 95%CI, 1.12-1.37, P < .001). According to study investigators, the difference was attributed to a significantly lower frequency of residual more-than-mild aortic regurgitation (4.1%vs 18.3%; RR, 0.23; 95%CI, 0.09-0.58; P < .001) and the less frequent need for implanting more than 1 valve (0.8%vs 5.8%, P = .03) in the balloon-expandable valve group.
Additional results showed cardiovascular mortality at 30 days at 4.1 percent in the balloon-expandable valve group and 4.3 percent in the self-expandable valve group (RR, 0.97; 95% CI, 0.29-3.25; P = .99). Additionally, bleeding and vascular complications were not significantly different between the two groups, and placement of a new permanent pacemaker was less frequent in the balloon-expandable valve group (17.3 percent vs 37.6 percent, respectively).
"We know in general that the transcatheter approach works and that patients benefit from it," said Mohamed Abdel-Wahab, MD, head of the cardiac catheterization laboratory at Segeberger Kliniken, Bad Segeberg, Germany, and senior author of the study. "But we have two main types of valves available for this procedure, and until now, there was no conclusive data about their relative effectiveness. This study is important because it’s the first randomized comparison of these two technologies."
In a JAMA editorial, E. Murat Tuzcu, MD, and Samir R. Kapadia, MD, write that the CHOICE trial partially fills the important need for a head-to-head comparison in a multicenter, randomized clinical trial. However, they note that "continued efforts at understanding the risks and benefits of TAVR particularly in relation to patient characteristics and long-term outcomes are imperative for continued progress and refinement of these revolutionary devices." They suggest that additional trials like CHOICE are needed to provide the "quality of evidence necessary to ensure optimal use and optimal patient outcomes from TAVR."
< Back to Listings