ADVANCE, a study of 1,015 patients who underwent transcatheter aortic valve implantation (TAVI) using Medtronic’s CoreValve system, continued to show clinical benefits at one year. The results were presented May 21 at EuroPCR 2013 in Paris.
ADVANCE is monitoring outcomes of “real-world” TAVI patients with severe aortic stenosis who are high to extremely high risk, according to Stephen Brecker, MD, of St. George’s Hospital in London, who presented the findings. The international trial includes 44 facilities that have performed at least 40 TAVI procedures with a heart team.
Randomized controlled clinical trials such as the PARTNER series, which evaluated Edwards Lifesciences’ Sapien valve in patients with severe aortic stenosis who were either at high risk or inoperable, or a pivotal trial that is studying CoreValve as a treatment in the U.S., by design impose inclusion and exclusion criteria for selecting patients.
“This means you have to screen 20, 30, 40—up to 100 patients—to get one eligible for the trial,” Brecker said in an interview with Cardiovascular Business. “The criticism is, how applicable are the results to the real world? This registry basically recruits consecutive patients who were being treated.”
Entry criteria included consent and approval of the participating center’s heart team. The centers represented 12 countries from Western Europe, Asia and South America. Enrollment ran from March 2010 to July 2011, with a planned five-year follow-up.
Thirty-day results showed major adverse cardiac and cerebrovascular events (MACCE) occurred in 8.3 percent of patients and the stroke rate was 3 percent. At one year, the rates of MACCE and stroke were 21.2 percent and 4.5 percent, respectively. All-cause mortality was 17.9 percent and cardiovascular mortality 11.7 percent.
Survival rates varied by EuroScore, with patients scoring 1-10 having the highest rate (88.9 percent) compared with 83.5 percent for scores between 10-20 and 76.4 percent for scores greater than 20. New York Heart Association (NYHA) grades improved as expected, Brecker said. At baseline, 12 percent of patients were ranked NYHA grade IV and 3 percent class I; at one year, 1 percent were grade IV and 43 percent were grade I.
Aortic regurgitation, assessed by echocardiograph, ranged from none to moderate, with no severe cases. While the percentage of assessments showing no aortic regurgitation increased from 20 percent at discharge to 29 percent at one year, the number of patients assessed dropped from 873 at discharge to 609 at one year. Moderate regurgitation rates changed from 16 percent to 13 percent.
“We don’t think there is a significant improvement in aortic regurgitation,” Brecker said, noting data in other studies suggest aortic regurgitation may get worse over time. “What the [ADVANCE] data refute is that it is getting any worse.”
Other studies have found an association between paravalvular leak at follow-up and increased morbidity and mortality. In ADVANCE, paravalvular leak followed patterns similar to aortic regurgitation, with 12 percent of patients having moderate paravalvular leak at one year.
The researchers described both the rates for aortic regurgitation and paravalvular leak as low. They noted that survival rates for patients with mild or no aortic regurgitation were equally high, at 86.8 percent and 85.5 percent. The survival rate for those with moderate to severe aortic regurgitation was 78.8 percent.
In a separate cost-utility analysis based on ADVANCE, Brecker presented data that showed TAVI using the CoreValve system was cost effective, with an average cost per quality-adjusted life-year gained of £11,265 ($16,965) for the entire patient population and £13,778 ($20,750) for patients with a EuroSCORE of 20 or more.
Medtronic sponsored the ADVANCE study. The CoreValve system received CE mark in 2007 and is limited to investigational use in the U.S.