PARTNER: TAVR Results Appear Durable at 2 Years

March 26th, 2012

PARTNER: TAVR Results Appear Durable at 2 Years

Larry Husten, PHD

Two-year results of the influential PARTNER trial provide continued support for the growing acceptance of transcatheter aortic valve replacement (TAVR) in clinical practice. Previously, results of PARTNER at 1 year had demonstrated similar mortality in high-risk patients with aortic stenosis who underwent TAVR or surgery. Now, the 2-year results have been presented at the American College of Cardiology and published simultaneously in the New England Journal of Medicine.

Two-year mortality:

ITT analysis: 33.9% in the TAVR group and 35.0% in the AVR group (HR 0.90, CI 0.71-1.15, p=0.41)
As-treated analysis: 33.9% and 32.7% (HR 0.98, CI 0.76-1.25, p=0.85)

Stroke at 2 years:

ITT: 7.7% and 4.9% (HR 1.22, CI 0.67-2.23, p=0.52)

All-cause mortality or stroke at 2 years:

ITT: 37.1% and 36.4% (HR 0.93, CI 0.73-1.18, p=0.55)

The PARTNER investigators reported that the valve gradients and areas were similar between TAVR and AVR at 2 years and that they had found no evidence of structural valve deterioration. However, periprocedural aortic regurgitation was a highly significant predictor of late mortality (p<0.001).

“We’re most concerned about valve durability, which you have to look at over five to 10 years, but any longer-term information is useful because trends tend to hold true over time,” said Susheel Kodali, who presented the results, in an ACC press release. “We have no evidence that the initial good results in improved valve performance have deteriorated during the follow-up to this time point. TAVR appears to be as durable as AVR.

“During this follow-up, we observed that significant leakiness around the valve was associated with higher subsequent mortality in TAVR patients, but it’s important to note that overall mortality between the two groups is the same,” he said. “Now we have a target – we know what to fix in the future. TAVR is already comparable to results for AVR in the most experienced surgeons’ hands. If we can reduce these leaks, there’s a good chance we can reduce mortality with TAVR even more.”

The PARTNER investigators concluded that the study “supports the use of TAVR as an alternative to surgery in selected high-risk patients with aortic stenosis.”

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March 26th, 2012