This study evaluated the safety and effectiveness of the CoreValve transcatheter valve replacement in patients with severe aortic stenosis with extreme risk for surgery.
The primary end point was a composite of all-cause mortality and stroke at 24 months. The rate of death from any cause or cerebrovascular accident at 24 months was 38% for CoreValve versus 57.9% for medical treatment (p <0.0001). Cardiovascular mortality was 26.5% and mortality from all causes of 36.5%. The risk of stroke at 2 years was 5.1% but within the first year the biggest risk was concentrated with 4.3%, after first year the occurrence of the event was only 0.9%.
92% of patients improved functional class at 2 years. No association between mild or moderate valvular insufficiency and mortality was observed.
Conclusion
2-year results confirm the improvement in survival of inoperable patients undergoing TAVR with self-expandable CoreValve.
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Steven J. Yakubov
2014-09-14
Original title: The CoreValve US Pivotal Trial: Two-Year Results with A Self-Expanding Bioprosthesis in Extremely High-Risk Patients with Aortic Stenosis.