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CoreValve transcatheter aortic valve decreased mortality, stroke in extreme-risk patients
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SAN FRANCISCO — The CoreValve self-expanding transcatheter aortic valve reduced all-cause mortality and major stroke in patients with severe aortic stenosis who were considered at extreme risk for mortality or serious morbidity with surgery, results from a late-breaking study presented at TCT 2013 suggest.
In the multicenter, prospective, controlled, nonrandomized CoreValve US Extreme Risk trial, researchers evaluated the safety and efficacy of the CoreValve (Medtronic) device in 487 patients with severe symptomatic aortic stenosis and adequate iliofemoral access. All patients were elderly (mean age, 83.1 years) and had a ≥50% predicted risk for operative mortality or serious, irreversible morbidity at 30 days. The primary “as-treated” analysis population included 471 patients who underwent attempted implantation.
Jeffrey J. Popma
The primary endpoint was all-cause mortality or major stroke at 12 months. Investigators used a meta-analysis of five contemporary balloon valvuloplasty trials and data from the 12-month PARTNER B trial to estimate the risk for all-cause mortality or major stroke in patients treated with standard therapy. This rate — 43% — served as the objective performance goal for the trial.
All-cause mortality or major stroke occurred in 25.5% of the cohort after 1 year, which was significantly lower than the objective performance goal (P<.0001). Specifically, all-cause mortality rate was 7.9% at 30 days and 24% at 1 year, with most deaths occurring due to CV issues. The incidence rate of major stroke was 2.4% at 30 days and 4.1% at 1 year.
Moderate paravalvular regurgitation was present in 11% of patients at 1 month and decreased to 4.1% at 1 year. Among patients with moderate regurgitation at 1 month who survived to 1 year, 80% experienced a reduction in regurgitation over time. Investigators observed no association between moderate or less severe regurgitation and late-term mortality, but 1-year mortality was extremely high among patients who had severe paravalvular regurgitation.
In a continued-access study of 830 additional patients conducted after completion of the trial, incidence of all-cause mortality or major stroke was 6% at 30 days and 16.1% at 6 months.
“The CoreValve Extreme Risk study achieved its primary endpoint in the reduction of all-cause mortality and major stroke compared to a rigorously defined objective performance goal,” researcher Jeffrey J. Popma, MD, director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston, said at a press conference. “We had low rates of major stroke at 1 month and 1 year, low rates of moderate and severe aortic regurgitation that improved over time. We did not find an association of moderate paravalvular regurgitation and late-term mortality, and we had even further improvement of clinical outcomes in our continued access study.”
For more information:
Popma JJ. Plenary session IV. Late breaking clinical trials I. Presented at: TCT 2013; Oct. 27-Nov. 1, 2013; San Francisco.
Disclosure: The trial was funded by Medtronic. Popma reports receiving research grants from Abbott, Abiomed, Boston Scientific, Cordis, Covidien, eV3 and Medtronic, and serving on medical advisory boards for Boston Scientific, Cordis and Covidien.