CHOICE: High device success rate with Sapien XT transcatheter valve

Issue: May 2014

WASHINGTON — Use of the Sapien XT transcatheter valve in patients with high-risk aortic stenosis undergoing transcatheter aortic valve replacement was associated with a greater rate of device success compared with the CoreValve, according to data from the first head-to-head comparison between the valves.

Perspective from Howard Bauchner, MD

Device success was reported in 95.9% of patients who received Edwards Lifesciences’ Sapien XT balloon-expandable transcatheter aortic valve vs. 77.5% of those who received Medtronic’s self-expandable CoreValve (RR=1.24; 95% CI, 1.12-1.37). Researchers attributed this difference to a significantly reduced frequency of residual more-than-mild aortic regurgitation (4.1% vs. 18.3%; RR=0.23; 95% CI, 0.09-0.58) and fewer patients in the balloon-expandable valve group requiring implantation of more than one valve (0.8% vs. 5.8%; P=.03), according to the study.

The combined safety endpoint of all-cause mortality, major stroke and other major complications at 30 days occurred in 18.2% of the balloon-expandable valve group vs. 23.1% of the self-expandable valve group (RR=0.79; 95% CI, 0.48-1.3). Similar rates of CV-related mortality were observed in the two groups: 4.1% with the balloon-expandable valve vs. 4.3% with the self-expandable valve (RR=0.97; 95% CI, 0.29-3.25). Both valves were associated with similar rates of bleeding and vascular complications.

Additionally, patients assigned the balloon-expandable valve required placement of a new permanent pacemaker less frequently than those assigned the self-expandable valve (17.3% vs. 37.6%; P=.001).

Results were similar regardless of age, sex, CAD status, ejection fraction and other evaluated subgroups. At 30 days post-discharge, significantly more patients in the self-expandable valve group were readmitted for HF (4.3% vs. 0%; P=.02), and quality of life was higher in the balloon-expandable valve group according to the EuroQol visual analog scale (mean, 71 vs. 65.9; P=.02).

The CHOICE trial included 241 patients with severe aortic stenosis with anatomy suitable for transfemoral TAVR. Patients were randomly assigned to the Sapien XT valve (n=121) or CoreValve (n=120) between March 2012 and December 2013 at five centers in Germany. Device success, the primary endpoint, included vascular access, correct placement, deployment and retrieval of the device, performance as intended without moderate or severe aortic regurgitation, and the implantation of only a single valve.

"Among patients with high-risk aortic stenosis undergoing transfemoral TAVR, the use of a balloon-expandable valve compared to a self-expandable one resulted in a greater rate of device success. Thirty-day improvement of HF symptoms was more frequently observed in the balloon-expandable valve, while minor stroke rates were numerically higher.

Mohamed Abdel-Wahab

“However, long-term outcome of the CHOICE population should be awaited to determine whether these differences will translate into a clinically-relevant overall benefit for the balloon-expandable valve,” Mohamed Abdel-Wahab, MD, head of the cardiac catheterization laboratory at Segeberger Kliniken, Bad Segeberg, Germany, said here.

In a related editorial published in JAMA, E. Murat Tuzcu, MD, and Samir R. Kapadia, MD, both from the Heart and Vascular Institute at Cleveland Clinic, wrote that additional trials similar to CHOICE are needed to provide additional evidence for the optimal use and outcomes from TAVR. “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 wrote. – by Adam Taliercio

For more information:

Abdel-Wahab M. Joint American College of Cardiology/Journal of the American Medical Association Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Sessions ; March 29-31, 2014; Washington, D.C.

Abdel-Wahab M. JAMA. 2014;doi:10.1001/jama.2014.3316.

Tuzcu EM. JAMA. 2014;doi:10.1001/jama.2014.3317.

Disclosure: See the study for a list of relevant financial disclosures.

Perspective

Howard Bauchner, MD

The CHOICE trial results are provocative. Short-term follow-up is the key issue, so I think the real question is: What do the results look like at 6 months and 1 year, and does it really appear as though one of the TAVR devices is better than the other?

These are preliminary results. I do think, though, that this may lead to an era where you can personalize or individualize the selection of a device for a particular patient, and this study suggested that may be important to do as we go forward. Also, the device that was trialed in this study is already evolving to the next generation. So that makes it difficult, as the device has evolved so quickly, to know if the results from the current trial will be helpful in 2 years because the devices may change over a 2-year period.

At 1 month, one device looks superior in a particular area: this composite outcome, particularly with regurgitation, which is a very important marker of long-term issues. But there was a signal around stroke that goes in the other direction, in terms of favoring a particular device, and that's why I think it is too early to speculate what the follow-up will look like at 6 months to 1 year.

Howard Bauchner, MD

Editor-in-Chief, JAMA

Disclosures: Bauchner reports no relevant financial disclosures.