CardioExchange Archive

Patients with aortic stenosis who are not candidates for aortic valve replacement surgery can benefit from transcatheter aortic-valve implantation (TAVI), according to results of the PARTNER (Placement of AoRTic TraNscathetER Valves) trial published in the New England Journal of Medicine. (The trial will also be presented at the TCT conference on Thursday.) Martin Leon and colleagues randomized 358 patients with aortic stenosis who were judged ineligible for aortic replacement by a surgeon to receive TAVI or standard therapy.

At 1 year, the mortality rate (the primary endpoint) was 30.7% in the TAVI group versus 50.7% in the control group, a highly significant difference (HR, 0.55; CI, 0.40-0.74; p<0.001). The coprimary endpoint, a composite of death from any cause or repeat hospitalization, occurred in 42.5% of the TAVI group versus 71.6% of the control group (HR, 0.46; CI, 0.35-0.59; p<0.001). Stroke or TIA, however, occurred in 10.6% of the TAVI group versus 4.5% of controls (p=0.04). Major vascular complications occurred in 16.8% of the TAVI group versus 2.2% of controls.

As expected, TAVI was associated with more early hazards: At 30 days there were more deaths and strokes in the TAVI group, although these differences did not reach statistical significance. Increases in bleeding and vascular complications, however, were highly significant both at 30 days and at 1year. Balloon aortic valvuloplasty was performed in nearly two-thirds of patients in the control group in the first 30 days and in an additional 20% of controls after 30 days.

The authors conclude:

On the basis of a rate of death from any cause at 1 year that was 20 percentage points lower with TAVI than with standard therapy, balloon-expandable TAVI should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery (like the patients enrolled in this study). These results cannot be extrapolated to other patients with aortic stenosis.

This first installment of the PARTNER trial is called Cohort B. The second installment, Cohort A, which is comparing TAVI to surgical valve replacement in high-risk patients, is expected to report its findings next year.