(HealthDay News) — For patients with severe aortic stenosis at intermediate surgical risk, transcatheter aortic-valve replacement (TAVR) is noninferior to surgery, according to a study published online March 17 in the New England Journal of Medicine. The research was published to coincide with the annual meeting of the American College of Cardiology, held from March 17 to 19 in Washington, D.C.
Michael J. Reardon, M.D., from Methodist DeBakey Heart and Vascular Center in Houston, and colleagues randomized 1,746 intermediate-risk patients with severe, symptomatic aortic stenosis to TAVR or surgical aortic-valve replacement.
The researchers found that the estimated incidence of the primary end point (a composite of death from any cause or disabling stroke at 24 months) was 12.6 and 14.0 percent in the TAVR and surgery groups, respectively (95 percent credible interval [Bayesian analysis] for difference, −5.2 to 2.3 percent; posterior probability of noninferiority, >0.999). Higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements were seen for surgery, while TAVR correlated with increased rates of residual aortic regurgitation and need for pacemaker implantation. Lower mean gradients and lower aortic-valve areas were seen for TAVR versus surgery. At 24 months there was no structural valve deterioration in either group.
“TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a unique set of adverse events associated with each procedure,” the authors write.
The study was funded by Medtronic.