April 2, 2016, American College of Cardiology -- Intermediate-risk patients with severe aortic stenosis who receive minimally invasive transcatheter aortic valve replacement, known as TAVR, have similar rates of death and disabling strokes after two years compared with those undergoing standard open heart surgical replacement, according to a study presented at the American College of Cardiology’s 65th Annual Scientific Session. Patients receiving TAVR also experienced shorter hospital stays and lower incidence of some major complications compared with those undergoing surgery.

Data from this non-inferiority trial—the first to evaluate TAVR in patients who are considered intermediate-risk—suggests TAVR is at least as safe and effective as surgery in these patients. Overall, the primary endpoint of all-cause death and disabling strokes was comparable at two years, 19.3 percent for TAVR and 21.1 percent for surgery. Among TAVR patients with transfemoral placement of the valve—the least invasive of two approaches in which the device is implanted through a small incision in the groin—the combined rate of death and disabling stroke was lower, 16.8 for TAVR compared with 20.4 percent for surgery (p-value=0.05).

“For the past five years, TAVR has been growing in use and acceptance largely based upon clinical evidence from multiple randomized controlled trials, but these have been limited to patients at the highest risk for surgery,” said Martin B. Leon, M.D., professor of medicine and director of the Center for Interventional Vascular Therapy at Columbia University Medical Center-New York Presbyterian Hospital and co-principal investigator of the PARTNER trials. “Here, we demonstrate outcomes related to death and stroke, which are equivalent in these patients and may be superior in the transfemoral group.”
To perform TAVR, a surgeon threads a replacement valve to the heart through a catheter placed in the groin or chest. TAVR is currently approved for patients with severe aortic stenosis—narrowing of the valve in the heart’s main artery—whose health profile makes them ineligible or high-risk candidates for open-heart valve replacement surgery.

In this randomized controlled PARTNER 2A trial, outcomes using the SAPIEN XT valve were compared with open-heart surgery valve replacement among 2,032 intermediate-risk patients treated between December 2011 and November 2013 at 57 sites, all but two in the U.S. Patients were randomly assigned; 1,011 to TAVR and 1,021 to surgery. Of those in the TAVR group, 76 percent underwent transfemoral placement, and the rest had transthoracic placement in which the new valve is thread through a cut in the chest wall.

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