March 21, 2014Journal of the American College of Cardiology
Transcatheter Aortic Valve Replacement Using a Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis at Extreme Risk for Surgery
Jeffrey J. PopmaDavid AdamsMichael J. ReardonSteven J. YakubovNeal S. KleimanDavid HeimansohnJames HermillerG. Chad HughesJ. Kevin HarrisonJoseph S. CoselliJosé Gutiérrez DíezAli KafiTheodore SchreiberThomas G. GleasonJohn V. ConteMaurice BuchbinderG. Michael DeebBlasé A. CarabelloPatrick W. SerruysSharla ChenowethJae K. Oh
Key result
Self-expanding TAVR achieves ~40% lower mortality or major stroke versus the objective performance goal.
- P<0.0001
- n=506
Why the study?
Untreated severe aortic stenosis has a poor prognosis, and TAVR with a self-expanding bioprosthesis is a potentially effective therapy requiring evaluation in patients at extreme surgical risk.
Does TAVR with a self-expanding bioprosthesis reduce the composite of all-cause mortality or major stroke in patients with symptomatic severe aortic stenosis at extreme risk for surgery compared to an objective performance goal?
Key Points
- This investigation aims to assess the safety and efficacy of CoreValve TAVR for severe aortic stenosis in patients facing extreme surgical risks.
- Conducted a prospective, multicenter, nonrandomized examination across 41 sites in the U.S.
- Evaluated patients with symptomatic severe aortic stenosis and high prohibitive surgical risks.
- Primary endpoint assessed was the composite of all-cause mortality or major stroke at 12 months.
- All-cause mortality or major stroke at 12 months occurred in 26.0% of treated patients, significantly lower than the OPG of 43.0% (p < 0.0001).
- 30-day events included all-cause mortality at 8.4% and major stroke at 2.3%.
- Moderate or severe paravalvular aortic regurgitation decreased from 10.7% at discharge to 4.2% at 12 months (p = 0.004).
Structured PICO
Does TAVR with a self-expanding bioprosthesis reduce the composite of all-cause mortality or major stroke in patients with symptomatic severe aortic stenosis at extreme risk for surgery compared to an objective performance goal?
P
Population
506 patients with symptomatic severe aortic stenosis at prohibitive risk for surgery, followed for 12 months.
I
Intervention
Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis
C
Comparator
Pre-specified objective performance goal (OPG)
O
Outcome
Composite of all-cause mortality or major stroke at 12 monthscomposite
Main Result
Absolute Event Rate: 26% vs 43%
p-value: p=< 0.0001
TAVR with a self-expanding bioprosthesis is safe and effective, significantly reducing the composite of all-cause mortality or major stroke at 12 months compared to a pre-specified objective performance goal in patients with severe aortic stenosis at extreme surgical risk.
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The low rates of stroke and valve leakage with the CoreValve System — two of the most concerning complications of valve replacement because they increase the risk of death and have a dramatic impact on quality of life — set a new standard for transcatheter valves.”
“The COREVALVE EXTREME RISK study achieved its primary endpoint of a reduction in all cause mortality or major stroke at one year compared to a rigorously defined OPG.”
“For the 20 to 25 percent of extreme risk patients who are not eligible for transfemoral TAVR due to vascular anatomy, this study confirms that TAVR can be successful in these patients as well. These results demonstrate a non-iliofemoral approach is a viable option for patients with severe aortic stenosis who are not candidates for surgery or transcatheter valve replacement through traditional peripheral access.”
Implication
Supports TAVR consideration in extreme-risk severe AS; leaves open randomized confirmation versus alternatives.
Abstract
OBJECTIVES: This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery. BACKGROUND: Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy. METHODS: We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG). RESULTS: A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis). CONCLUSIONS: TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).
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Cite This Study
Popma et al. (2014) studied Symptomatic severe aortic stenosis (n=506). Self-expanding transcatheter aortic valve replacement (CoreValve THV) vs. Pre-specified objective performance goal (OPG) was evaluated on Composite of all-cause mortality or major stroke at 12 months (p=< 0.0001). Self-expanding TAVR resulted in a 26.0% rate of all-cause mortality or major stroke at 12 months, significantly lower than the 43.0% objective performance goal (p < 0.0001).