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WASHINGTON -- Transcatheter aortic valve implantation (TAVI) with the CoreValve device improved survival compared with surgery in the high-risk pivotal trial cohort.
versus 19.1% with surgical valve replacement, meeting criteria both for noninferiority and superiority (P<0.001 and P=0.04), , of Mount Sinai Medical Center in New York City, reported here at the American College of Cardiology meeting.
The trial didn't meet its secondary endpoint for a reduction in the composite of major adverse cardiovascular and cerebrovascular events at 30 days or discharge with TAVI (8.2% versus 10.9%, P=0.10 for superiority).
But major adverse cardiovascular and cerebrovascular events at 1 year were reduced compared with surgery in an exploratory analysis (20.4% versus 27.3%, P=0.03).
Stroke rates were similar between groups at 30 days and 1 year (P=0.46 and P=0.10, respectively) in the trial, reported simultaneously online in the New England Journal of Medicine.
Positive results from the "extreme-risk" cohort of the trial -- symptomatic severe aortic stenosis patients ineligible for surgery compared against historical, medically-treated patients -- led to swift approval of the CoreValve device in that patient population earlier this year without even an FDA advisory panel meeting.
The findings could put Medtronic's CoreValve in competition with the Edwards Sapien valve, which is approved for both inoperable and high surgical-risk patients.
, of St. Joseph's Hospital Heart and Vascular Institute in Atlanta, predicted that would be the case, calling CoreValve "in good shape" for approval in the high-risk but operable group.
"I think all of us, including the surgeons, are going to applaud the ability to do this percutaneously if these valves hold up in the long term," he told 鶹ý. "The next shoe to drop will be what is the 5- and 10-year durability."
The CoreValve U.S. Pivotal Trial high-risk cohort included 795 patients with severe aortic stenosis and New York Heart Association (NYHA) class II or higher symptoms whom two cardiac surgeons and one interventional cardiologist agreed had at least a 15% risk of dying within 30 days if treated surgically.
Those projected to have 50% or higher risk of death or irreversible complications within 30 days after surgery were considered part of the extreme-risk cohort.
The high rate of new pacemaker implantation had been a concern in that highest-risk group, and again came in above what has been reported with other TAVI devices in the high-risk group.
Permanent pacemakers were needed by 22% of CoreValve patients by 1 year compared with 11% in the surgical group (P<0.001).
However, moderate-to-severe paravalvular leak appeared to be less of a problem than with other TAVI devices (6% at 1 year versus reported rates of 7% to 16%), although still more common than with surgery.
"These outcomes may be attributable to the use of CT assessment of aortic annular diameter for valve-size selection before enrollment, higher placement of the valve within the aortic annulus, and sustained expansion of the nitinol frame," Adams's group wrote.
Other risks significantly associated with TAVI in the high-risk cohort compared with surgery were major vascular complications (5.9% versus 1.7% at 30 days and 6.2% versus 2.0% at 1 year) and cardiac perforation (1.3% versus none).
However, surgery was significantly riskier for major and life-threatening or disabling bleeding, acute kidney injury, cardiogenic shock, and new onset or worsening atrial fibrillation.
The CoreValve device came out noninferior to surgical valve replacement for valve stenosis, functional status, and quality of life.
Results were similar by intent-to-treat analysis and across patient subgroups in the high-risk cohort.
Disclosures
The trial was funded by Medtronic.
Adams disclosed financial relationships with Medtronic.
Primary Source
New England Journal of Medicine
Adams DH, et al "Transcatheter aortic-valve replacement with a self-expanding prosthesis" N Engl J Med 2014; DOI: 10.1056/NEJMoa1400590.