Clinical question: Is transcatheter aortic-valve replacement comparable to surgical valve replacement in high-operative-risk patients?
Background: In the randomized Placement of Aortic Transcatheter Valves (PARTNER) trial, patients who were not surgical candidates underwent transcatheter aortic-valve replacement, resulting in reduced symptoms and 20% improvement in one-year survival rates. Transcatheter valve replacement has not been compared to surgical replacement in high-operative-risk patients who remain candidates for surgical replacement.
Study design: Randomized controlled trial powered for noninferiority.
Setting: Twenty-five centers in the U.S., Canada, and Germany.
Synopsis: Six-hundred ninety-nine high-operative-risk patients with severe aortic stenosis were randomized to undergo transcatheter aortic-valve replacement or surgical replacement. In the intention-to-treat analysis, all-cause mortality rates were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P=0.07) and 24.2% vs. 26.8% at one year (P=0.44). Rates of major stroke were 3.8% in the transcatheter group compared with 2.1% in the surgical group at 30 days (P=0.20) and 5.1% vs. 2.4% at one year (P=0.07).
The transcatheter group had a significantly higher rate of major vascular complications, but had lower rates of major bleeding and new onset-atrial fibrillation. At one year, improvement in cardiac symptoms and the six-minute-walk distance were not significantly different in the two groups.
Bottom line: In high-operative-risk patients with severe aortic stenosis, transcatheter and surgical aortic-valve replacement had similar mortality at 30 days and one year, but there were a few significant differences in periprocedural risks.
Citation: Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364(23):2187-2198.
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