CHICAGO – The “groundbreaking” results from the PARTNER 2 trial of transcatheter aortic valve replacement in patients at intermediate risk for death or complications from surgical replacement of a stenotic aortic valve provide substantially increased certainty that the transcatheter approach is at least as good as surgical valve replacement, commented Dr. Roxana Mehran in a video interview at the annual meeting of the American College of Cardiology.
In addition to providing important new data on the equivalence of surgical and transcatheter aortic valve replacement (TAVR) in a new target population--intermediate-risk patients, the findings from the randomized, multicenter PARTNER trial, which enrolled 2,032 patients, may also lead to expansion of the Food and Drug Administration labeling of the balloon-expandable TAVR device used in the study, the Sapien XT, to intermediate-risk patients. This expanded indication may also apply to the newer, smaller and more advanced iteration of this device, the Sapien 3, which has largely replaced the XT in U.S. practice, Dr. Mehran suggested.
Although the results came from the XT TAVR system, “these results have big relevance” to current U.S. practice said Dr. Mehran, professor and director of interventional cardiovascular research at Mount Sinai Hospital in New York.
The primary outcome of the Placement of Aortic Transcatheter Valves (PARTNER) 2 trial showed that all-cause mortality or disabling stroke after 2 years follow-up occurred in 21.2% (695) of the surgery patients and 19.3% (775) of the TAVR patients, meeting the prespecified noninferiority endpoint, with a P value of .001. Full results from the study were published online concurrent with their presentation at the meeting (New Engl J Med 2016;doi:10.1056/NEJMoa1514616).
Dr. Mehran has received consultant fees and honoraria from Abbott Vascular, AstraZeneca, and Bayer.
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