CoreValve Outperformed by Sapien XT in First Randomised Study

A new study, presented at ACC 2014 and published in the Journal of the American Medical Association, points to significantly better procedural outcomes for Edwards Lifesciences’ Sapien XT when compared with Medtronic’s CoreValve.

Background

If I was a sales specialist for Edwards Lifesciences today I’d be touting this newly published work pretty hard. After all, it’s the first time the two main transcatheter aortic valve replacement protagonists have faced off in a randomised study.

Authored by an independent German group, the five centre CHOICE study prospectively evaluated 241 patients, randomised into two groups and assessed for procedural success, 30 day follow up and complications. Importantly the investigators had considered factors such as experience curve in their study design, so operators were matched in their previous usage of the two devices.

Aside from a greater number of patients in the Sapien group suffering stroke (7 vs 3) the balloon-expandable offering seemed to outperform Medtronic’s self-expanding nitinol framed CoreValve in most other respects. The balloon device demonstrated less paravalvular leakage, leading to its overall assessment of procedural success being 95.9% compared with CoreValve’s 77.5%. Reinforcing this, CoreValve procedures needed a second valve on 5.8% of occasions, compared with only 0.8% in the Sapien XT group.

There’s little doubt that physicians will require more than this one study to help them decide which valve works best for them, but it does point to the possibility that a balloon-expandable device, with its theoretical advantage in terms of radial expansive strength, may present advantages in certain key regards over a self-expanding frame-based method.

The authors themselves conclude that the findings of the CHOICE trial may have important clinical implications when there exists an accumulating body of evidence linking more-than-mild aortic regurgitation and consequently device failure with a worse clinical outcome after TAVR. They point out that at short-term follow-up, improvement of heart failure symptoms was more frequently observed with the balloon-expandable valve (although minor stroke rates were numerically higher). They conclude that “long-term follow-up of the CHOICE population should be awaited to determine whether differences in device success will translate into a clinically relevant overall benefit for the balloon-expandable valve”.

 

See the full JAMA paper here.

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