Self-expanding TAVR system shows 3-year positive outcomes in high-risk patients

CHICAGO — At 3 years, a self-expanding transcatheter aortic valve replacement system was associated with more positive outcomes than surgery in high-risk patients, according to data presented at the American College of Cardiology Scientific Session.

Researchers had previously reported at 1 year and 2 years that in this cohort of 750 patients (mean age, 83 years; 53% men) with severe aortic stenosis at high risk for surgery, the TAVR system (CoreValve, Medtronic) was superior to surgical AVR in mortality. They presented 3-year findings here and published them in the Journal of the American College of Cardiology.

At 3 years, mortality rates remained lower in the TAVR group compared with the surgery group, but the difference was no longer statistically significant (32.9% vs. 39.1%; P = .068), G. Michael Deeb, MD, and colleagues reported.

However, the endpoint of all-cause mortality or stroke at 3 years was significantly lower in the TAVR group (37.3% vs. 46.7%; P = .006), as were the 3-year endpoints of stroke (12.6% vs, 19%; P = .034) and MACCE (40.2% vs. 47.9%; P = .025), according to the researchers.

Deeb, from University of Michigan Medical Center, Ann Arbor, and colleagues also found that at 3 years, aortic valve hemodynamics were more favorable in the TAVR group (mean aortic valve gradient: TAVR group, 7.62 mm Hg; surgery group, 11.4 mm Hg; P < .001), though moderate or severe aortic regurgitation was higher in the TAVR group (6.8% vs. 0%; P < .001).

They reported that there were no cases of valve thrombosis in either group.

Michael J. Reardon

In an interview with Cardiology Today’s Intervention, investigator Michael J. Reardon, MD, from the Houston Methodist DeBakey Heart & Vascular Center, said that long-term outcomes are important because “by the time you pass 1 year, any influence of the invasiveness of the [surgical] procedure should be long gone, and your survival after that should really depend on how well the device relieves aortic stenosis. [TAVR] is still far apart at 3 years but has lost superiority. That is not a surprise because of lower numbers, but we still have a delta that is in favor of TAVR.

“What this tells me is that TAVR valves continue to do a really good job of relieving aortic stenosis, and gives me real hope that this is going to have a good long-term effect,” Reardon concluded. – by Erik Swain

References:

Deeb GM, et al. Featured Clinical Research I. Presented at: American College of Cardiology Scientific Session; April 2-4, 2016; Chicago.

Deeb GM, et al. J Am Coll Cardiol. 2016;doi:10.1016/j.jacc/2016.03.506.

Disclosures : Deeb reports serving on an advisory board and as a proctor for Medtronic, serving as a consultant and research investigator for Edwards Lifesciences, serving as consultant and a proctor for Terumo and serving as a research investigator for Gore Medical. Reardon reports that his institution receives compensation from Medtronic for his service on an advisory board. Please see the full study for a list of the other researchers’ relevant financial disclosures.