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Self-expanding TAVR system superior to surgery in high-risk patients at 2 years
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SAN DIEGO — Transcatheter aortic valve replacement with a self-expanding valve was associated with superior outcomes compared with surgical aortic valve replacement at 2 years in patients at high risk for surgery, according to data from the U.S. CoreValve High Risk Study presented at the American College of Cardiology Scientific Sessions.
“This is going to change the future of TAVR, and where TAVR sits vis-à-vis surgery,” Michael J. Reardon, MD, FACC, told Cardiology Today.
TAVR with the self-expanding transcatheter valve (CoreValve, Medtronic) was compared with surgical AVR in patients with severe aortic stenosis at increased surgical risk as determined by a heart team.
Michael J. Reardon
At 2 years, for the endpoint of all-cause mortality, TAVR was superior to surgery, as 22.2% of patients assigned to TAVR died vs. 28.6% of patients assigned to surgery (∆ = 6.5; log-rank P = .04).
Reardon, professor of cardiothoracic surgery and Allison Family Distinguished Chair of Cardiovascular Research at the Houston Methodist DeBakey Heart and Vascular Center, told Cardiology Today that the 2-year results curb any doubt as to whether the 1-year mortality results reported a year ago were actually superior in favor of the self-expanding TAVR system.
“Where we stand at 2 years says a lot about the potential for TAVR and its place in this increased-risk surgical population,” he said. “Not only did we see sustained, durable survival, but we actually saw a widening of these curves, which to me is a tremendously thought-provoking observation. We had never seen any trial that had shown superiority of TAVR over surgery head-to-head and, in fact, to my knowledge, there were no trials anywhere ever showing superiority of any interventional device over surgery.”
Reardon and colleagues also reported that the TAVR group was less likely to experience any stroke at 2 years than the surgery group (10.9% vs. 16.6%; ∆ = 5.7; log-rank P = .05), as well as less likely to experience all-cause mortality or major stroke at 2 years (24.2% vs. 32.5%; ∆ = 8.3; log-rank P = .01). Major strokes were lower in the TAVR group, but not by a statistically significant margin (log-rank P = .25) because of low numbers, he said.
“This is the first time in a head-to-head trial where we have ever seen superior stroke results for TAVR over [surgical] AVR,” he told Cardiology Today. “Now we’re worried about surgery being worse. What my older patients worry about is being alive without a stroke.”
In other results, hemodynamic indicators were better in the TAVR group compared with the surgery group at all time points, without any structural valve failure, he said. At 2 years, the TAVR group had an aortic valve area of 1.87 cm2 vs. 1.51 cm2 for the surgery group, and had an aortic valve mean gradient of 8.5 mm Hg, compared with 12.1 mm Hg for the surgery group.
“In a lot of areas, this is better than something we’ve used for 60 years,” Reardon said during an interview. “The guidelines say TAVR is a reasonable alternative in high-risk patients. I would say that these data would argue that for the self-expanding CoreValve, it is the preferable treatment in patients at increased risk for surgery. We probably need to revise the guidelines.”
Reardon said factors that might explain the widening curves favoring the self-expanding TAVR system include superior hemodynamics; low rates of paravalvular leak; 80% of paravalvular leaks resolving within 1 year; and more transfusions, atrial fibrillation and acute kidney injuries, all of which impact mortality, associated with surgery. – by Erik Swain
Reference:
Reardon MJ, et al. Late-Breaking Clinical Trials III. Presented at: American College of Cardiology Scientific Sessions; March 14-16, 2015; San Diego.
Disclosure: The study was funded by Medtronic. Reardon reports serving on an advisory panel for Medtronic and as an investigator for trials funded by Boston Scientific and Medtronic, but does not receive direct compensation for any of those duties.
Perspective
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Stephen Ramee, MD, MS, FACC, FSCAI, FAHA
The biggest takeaway from this study was the impressive survival data and complication data, all in favor of TAVR vs. surgery in a high-risk patient cohort. That’s compelling for TAVR. This is not yet published or peer-reviewed, so we will probably have to wait to see any impact on the guidelines. But if the data are as the investigators have presented it, I think both intermediate-risk and high-risk are going to be TAVR indications. It’s hard to compare the self-expandable and balloon-expandable valves against each other; we are going to need a randomized trial between the two.
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