March 30th, 2014
First TAVR Comparison Trial Favors Sapien XT Over CoreValve
Larry Husten, PHD
With two devices now approved for transcatheter aortic valve replacement (TAVR), the marketing battle has begun to win the hearts and minds of cardiologists. On Saturday at the ACC, Medtronic gained bragging rights showing the first mortality benefit for its CoreValve device. A similar improvement did not occur in the PARTNER trials with the Edwards Sapien device, but all the experts have warned against cross-trial comparisons. Now an actual randomized trial has emerged comparing the two platforms. The results favor the Sapien XT, but the size and scope of the trial mean that the discussion and debate will certainly continue.
CHOICE, presented at the American College of Cardiology meeting in Washington, DC, and published simultaneously in JAMA, was an investigator-initiated trial in which 241 patients with severe aortic stenosis were randomized to the Edwards Sapien XT or the Medtronic CoreValve at 5 centers in Germany. The primary endpoint was device success, defined as implantation of the device in the correct position with little or no regurgitation.
Device success was achieved in 95.9% of patients who received the balloon-expandable Sapien XT and in 77.5% of patients who received the self-expandable CoreValve (relative risk, 1.24; 95% CI, 1.12-1.37; P<0.001). The investigators attributed this difference to a significant reduction in more-than-mild aortic regurgitation (4.1% vs. 18.3%; RR, 0.23; 95% CI, 0.09-0.58; P<0 .001) and to a reduced need to implant more than 1 valve (0.8% vs. 5.8%; P=0.03) in the Sapien group.
There was no significant difference in cardiovascular mortality at 30 days, bleeding and vascular complications, or in a combined safety endpoint. But a new pacemaker was required less often in the Sapien group (17.3% vs. 37.6%; P=0.001). Improvement in symptoms and quality-of-life measures were more common in the Sapien group. The investigators speculated that the tighter seal of the balloon-expandable Sapien XT may account for some of the differences that emerged in the trial.
“This is a very dynamic field,” lead author Abdel-Wahab said. “We now have new valves coming out that will probably be even better, but we do not have enough data about them yet. These results can help to inform the design of future devices.”
In an accompanying editorial, E. Murat Tuzcu and Samir Kapadia take note of the advantages seen with the Sapien XT in the trial, including the primary endpoint of device success. They caution, however, that it “should not be interpreted as a surrogate for long-term outcomes such as death, stroke, and quality of life.”
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Regardless of the outcome of this trial, the biggest loser here are patients in the United States. The US remains the only country in the entire world where the first generation of Sapien Valve is being used. In every other country Sapien XT is used. Thus, although it is true that the Sapien Valve is FDA approved, the second generation of this valve (Sapien XT) which can be devivered through a smaller sheath and comes in a wider range of sizes, cannot be used commercially in the US. Why does the US lag behind the rest of the world in this area?
Ask the patients who received metal on metal hips or the St Jude ICD leads how they feel about the quick approval
No one is asking the FDA to be the quickest. However, when it comes to a new technologies do we really want them to be the slowest- which has been the case here. When these technologies offer mortality benefits being the slowest has consequences too. I for one would hope there would be a middle ground that could be found. We need to learn from our prior mistakes, not live in fear because of them .