April 3rd, 2011

PARTNER A: TAVI Noninferior to Surgery, but Stroke Might Be a Problem

Here are the main results of the much anticipated PARTNER A trial comparing transcatheter aortic valve implantation (TAVI) versus surgery for aortic valve replacement (AVR). They were presented this morning in New Orleans at the ACC.

Some 699 high-risk older patients with severe aortic stenosis were randomized to either TAVI or AVR.  The primary endpoint, all-cause mortality at 1 year, was 24.2% in the TAVI group and 26.8%  in the AVR group (HR 0.93, CI 0.71-1.22, p=0.62), thereby meeting the prespecified margin for noninferiority. Thirty-day mortality was 3.4% and 6.5%, respectively (p=0.07).

The rate of major stroke at 1 year was 5.1% for TAVI versus 2.4% for AVR (p=0.07). For all strokes, the difference achieved statistical significance: 8.3% versus 4.3% (p=0.04). There were no significant differences at either 30 days or 1 year in cardiac mortality, rehospitalization, MI, or acute renal injury requiring renal replacement therapy.

Major vascular complications occurred more frequently with TAVI, both at 30 days (11% versus 3.2%, p<0.01) and at 1 year (11.3% versus 3.5%, p<0.01). Major bleeding, on the other hand, occurred more often with AVR, both at 30 days (9.3% versus 19.5%, p<0.01) and at 1 year (14.7% versus 25.7%, p<0.01).

New AF occurred more frequently in the surgery group: 12.1% versus 17.1% at 1 year (p=0.07).

The rate of all-cause mortality or stroke was 26.5% for TAVI versus 28% for AVR (p=0.70).

The authors conclude: “Both [TAVI] and AVR were associated with important but different peri-procedural hazards: Major strokes at 30 days and one year and major vascular complications were more frequent with [TAVI.] Major bleeding and new onset atrial fibrillation were more frequent with AVR. [TAVI] and AVR are both acceptable therapies in these high-risk patients; differing peri-procedural hazards may impact case-based decision-making.”

View Rick Lange’s Interventional Cardiology blog on the PARTNER A trial here, and for more of our ACC.11 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Roundup.

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