CoreValve US Pivotal Trial: 2-year results of the self-expanding valve on inoperable patients

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. 

Original title: The CoreValve US Pivotal Trial: Two-Year Results with A Self-Expanding Bioprosthesis in Extremely High-Risk Patients with Aortic Stenosis.