PARTNER A Results Published in NEJM

June 5th, 2011

PARTNER A Results Published in NEJM

Larry Husten, PHD

Following its initial presentation at the ACC meeting in March, the results of PARTNER A have now been published online in the New England Journal of Medicine, in conjunction with a presentation at the Transcatheter Valve Therapies meeting in Vancouver. As reported previously, 699 high-risk older patients with severe aortic stenosis were randomized to either transcatheter aortic valve implantation (TAVI) or surgery for aortic valve replacement (AVR). Death at one year, the primary endpoint of the study, was 24.2% in the TAVI group and 26.8% in the AVR group (p=0.44), a reduction of 2.6% in favor of TAVI ,which met the predefined margin for noninferiority. The PARTNER investigators also reported:

Major stroke at 30 days: 3.8% for TAVI vs. 2.1% for AVR (p=0.20)
Major stroke at 1 year: 5.1% vs. 2.4% (p=0.07)
Major vascular complications at 30 days: 11% vs. 3.2% (p<0.001)

Compared with TAVI patients, AVR patients had more episodes of major bleeding (9.3% vs. 19.5%, p<0.001) and new-onset AF (8.6% vs. 16%, p=0.006). At 30 days, more TAVI patients than AVR patients had an improvement in symptoms, but this difference was no longer significant at 1 year.

The authors concluded that TAVI “is an alternative to surgical replacement in a well-chosen, high-risk subgroup of patients with aortic stenosis. In the absence of long-term follow-up data, recommendations to individual patients must balance the appeal of avoiding the known risks of open-heart surgery against the less invasive transcatheter approach, which has different and less well understood risks, particularly with respect to stroke.”

In an accompanying editorial, Hartzell Schaff considers the implications of the increased risk of stroke observed in the trial. He writes that it is “not surprising that neurologic complications occur” with TAVI because “calcific atherosclerotic emboli are common during catheter and device manipulation of a stenotic aortic valve.” He says that “continued surveillance of patients… will be critically important to determine the durability of the transcatheter prosthesis and to assess the risk of late thromboembolic events.”

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June 5th, 2011