CoreValve US Pivotal: at 3 Years, the Self-Expanding Valve Maintains Its Advantage vs. Surgery

At 3 year follow up, the CoreValve US Pivotal study on high risk elderly patients, the self-expanding valve showed a lasting benefit vs. surgery.

These findings could suggest that the self-expanding valve should be considered the preferred treatment in patients with symptomatic severe aortic stenosis at increased risk for surgery.

The study included 797 patients (mean age 83.2 years). At 1 year, the self-expanding valve showed a benefit in terms of all-cause mortality, compared to surgery (14.2% vs 19.1%; p=0.04). At two years, there was an even bigger difference infavor of the CoreValve (22.2% vs 28.6%; p=0.04) that was consistent across subgroups.

At 3 years, clinical outcomes were available for 92% of the surviving population in each group. Compared to surgery, the CoreValve maintained a numerical difference in favor, thoughnot a significant one.

TAVI also showed improved rates of stroke and combined events.

On the other hand, those undergoing TAVI had three times more vascular complications vs. those undergoing surgery, and double the chance of requiring a pacemaker.

Those undergoing surgery showed more bleeding and acute kidney failure.