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Transcatheter Aortic-Valve Replacement With a Self-Expanding Prosthesis
Study Questions:
What is the safety and efficacy of transcatheter aortic valve replacement (TAVR), using a self-expanding transcatheter aortic valve bioprosthesis, with surgical aortic valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery?
Methods:
The CoreValve High-Risk (A Randomized Comparison of Self-Expanding Transcatheter and Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis Deemed High-Risk for Surgery) study enrolled 795 patients with severe aortic stenosis who were at increased surgical risk, as determined by the heart team at each study center using the Society of Thoracic Surgeons Predictor Risk of Mortality estimate, and consideration of other key risk factors. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgical aortic valve replacement (surgical group). The primary endpoint was the rate of death from any cause at 1 year.
Results:
A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%, p < 0.001 for noninferiority; p = 0.04 for superiority). The results were similar in the intention-to-treat analysis. In a hierarchical testing procedure, TAVR was noninferior with respect to echocardiographic indexes of valve stenosis, functional status, and quality of life. TAVR was associated with an increase in vascular complications and permanent pacemaker use, whereas bleeding, kidney injury, and atrial fibrillation were more common in the surgical group. There was no increase in the risk of stroke with TAVR.
Conclusions:
The authors concluded that TAVR with a self-expanding valve is superior to surgical valve replacement in patients with severe aortic stenosis and increased risk of death during surgery.
Perspective:
This study establishes the safety and efficacy of TAVR in high-risk patients. The improved survival with the self-expanding CoreValve without an increased risk of stroke is a paradigm shift in the management of aortic stenosis. The patients in this trial had better outcomes with surgery than expected, and this indirectly suggests that the valve is safe and effective in patients who are at moderate to high risk (rather than just extreme risk). The next logical step would be to test this therapy in low- to moderate-risk patients.
Keywords: Surgical Instruments, Stroke, Quality of Life, Intention to Treat Analysis, Risk Factors, Constriction, Pathologic, Heart Valve Prosthesis Implantation
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