Clinical outcomes and aortic valve hemodynamics were improved in patients at increased surgical risk who received transcatheter aortic valve replacement (TAVR) with a self-expanding prosthesis (CoreValve, Medtronic; Dublin, Ireland) compared with surgical aortic valve replacement (SAVR), according to 3-year results of the CoreValve US trial.
The findings were presented at the 2016 American College of Cardiology Scientific Sessions & Expo during the Featured Clinical Research I session and simultaneously published in the Journal of the American College of Cardiology.
In all, 797 patients with severe aortic stenosis deemed at increased risk for surgery by a multidisciplinary heart team were randomly assigned 1:1 to TAVR or SAVR.
Among patients who underwent an attempted procedure (n=750), G. Michael Deeb, MD, of the University of Michigan Medical Center, Ann Arbor, Michigan, and fellow researchers determined 3-year clinical and echocardiographic outcomes.
At 3 years, all-cause mortality or stroke was 37.3% in the TAVR arm and 46.7% in the surgery arm (P=.006). TAVR patients also demonstrated a lower rate of adverse clinical outcome components, including all stroke (12.6% vs 19.0%; P=.034) and major adverse cardiovascular or cerebrovascular events (40.2% vs 47.9%; P=.025). Additionally, there was a trend toward a lower all-cause mortality rate with TAVR (32.9% vs 39.1%; P=.068).
In other 3-year outcomes, aortic valve hemodynamics were improved with TAVR patients (mean aortic valve gradient:7.62 ± 3.57 mm Hg vs 11.4 ± 6.81 mm Hg; P<.001), whereas moderate or severe residual aortic regurgitation was higher in TAVR patients (6.8% vs 0%; P<.001).
No clinical evidence of valve thrombosis was reported in either group.
“The results of this analysis demonstrate the sustained 3-year clinical benefit of self-expanding TAVR over SAVR in patients with aortic stenosis at increased risk for surgery,” Dr Deeb and colleagues wrote in the study. “Coupled with reductions in all-cause mortality and stroke, self-expanding TAVR was also shown to have lower 3-year mean aortic valve gradients and larger effective orifice areas compared with SAVR, albeit with more total aortic regurgitation.”
These findings, the researchers concluded, support the use of self-expanding TAVR as the treatment of choice in patients at increased risk for surgery.
- Deeb GM. CoreValve: 3-year results from the CoreValve US pivotal high risk randomized trial comparing self-expanding transcatheter and surgical aortic valves. Presented at the 65th Annual Scientific Session and Expo of the American College of Cardiology. April 2-4, 2016; Chicago, IL.
- Deeb GM, Reardon MJ, Chetcuti S, et al; for the CoreValve US Clinical Investigators. Three-year outcomes in high-risk patients who underwent surgical or transcatheter aortic valve replacement. J Am Coll Cardiol. 2016;doi:10.1016/j.jacc.2016.03.506.