ACC 2016: In some patients, TAVR is non-inferior to surgical aortic-valve replacement

by Bruce Sylvester: In intermediate-risk patients with symptomatic severe aortic stenosis, transcatheter aortic-valve replacement (TAVR) is similar to surgical aortic-valve replacement with respect to death or disabling stroke.

Researchers reported findings from the Placement of Aortic Transcatheter Valves (PARTNER) 2 trial on April 2, 2016 at the American College of Cardiology 2016 annual meeting. The findings were published simultaneously in the NEJM/New England Journal of Medicine.

“The significantly lower rates of acute kidney injury and atrial fibrillation and shorter hospital stay reported in the TAVR group than in the surgery group are very important findings and reinforce the fact that TAVR is less invasive than conventional surgery,” Neil Moat, MBBS, MS, leading specialist in mitral valve repair and consultant at  Royal Brompton Hospital in London, wrote in an accompanying NEJM editorial.

The investigators enrolled and randomized 2,032 intermediate-risk patients with severe aortic stenosis to receive TAVR or surgical replacement.

The primary end point was death from any cause or disabling stroke at 2 years.

Prior to randomization, subjects were placed into one of two cohorts based upon clinical data and imaging findings; 76.3% of the subjects went into the transfemoral-access cohort and 23.7% went into the transthoracic-access cohort.

Martin Leon, MD, Director of the Center for Interventional Vascular Therapy Columbia University Medical Center / New York-Presbyterian Hospital in New York, and his team reported that, at 2 years, the rate of death from any cause or disabling stroke was similar for the TAVR group and the surgery group (P=0.001 for non-inferiority). Event rates were 19.3% in the TAVR group and 21.1% in the surgery group, a non-significant difference (P=0.25).

Among the transfemoral-access subjects, TAVR was associated with a significantly lower rate of death or disabling stroke than surgery (P=0.05). In the transthoracic-access cohort, outcomes were similar for both groups.

TAVR was associated with larger aortic-valve areas than surgery. It also led lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation. Surgery led to fewer major vascular complications and less paravalvular aortic regurgitation.

“In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke,” the authors concluded.