The aim of this study was to compare percutaneous aortic valve replacement (TAVR) with the self-expanding Valve Core with conventional surgery in patients at high surgical risk. Patients with a valve area < 0.8 cm2 , valvular index ≤ 0.5 cm2 , a mean gradient of > 40 mmHg or peak speeds above 4m /s at rest or with pharmacological stress with dobutamine. The risk of death at 30 days with surgery should be> 15% with a risk of morbidity and mortality in the same period of time less than 50%. Risk validation included an assessment by a Heart Team and the score of the Society of Thoracic Surgeons (STS) and other factors. Patients were randomized 1:1 to TAVR or surgery with the primary objective of all-cause mortality per year. Analysis of both non-inferiority and superiority was performed. A total of 795 patients were enrolled at 45 centers in the United States. In 323 patients, the prosthesis was implanted by femoral approach and in 67 patients by other access. Mortality by any cause per year was significantly lower in the TAVR group compared with surgery (14.2 % versus 19.1 %, P < 0.001 for noninferiority and P = 0.04 for superiority). This represents an absolute risk reduction of 4.9 %. In addition, a reduction in cardiovascular and cerebrovascular events without increasing the risk of stroke in the TAVR group (20.4 % versus 27.3 %) was also observed. After a year the TAVR group had greater need for permanent pacemaker (22.3 % versus 11.3 %, p < 0.001 ) and surgery increased risk of bleeding (38.4 % versus 16.6 %, P < 0.001 ), increased risk of new atrial fibrillation (32.7 % versus 15.9 %, P < 0.001 ) and higher rate of deterioration of renal function ( 15.1 % versus 6%, p < 0.001 ). Another difference between the groups was moderate / severe paravalvular leak that resulted from 6.1 % for TAVR versus 0.5 % for surgery (p < 0.001).
Conclusion
In patients with severe aortic stenosis and high surgical risk, percutaneous aortic valve replacement with the self-expanding prosthesis was associated with higher year survival compared with conventional surgery.
Editorial comment
Patients included in this study had a slightly lower surgical risk than the PARTNER cohort A. Core Valve recently received FDA approval for its use in inoperable patients (extreme risk) based on the study results Core Valve extreme risk trial presented at TCT 2013 conference and now awaits approval for use in operable patients at high risk based on this study. Thus, the Core Valve (Medtronic) and Sapien (Edwards) prostheses are the only approved in the U.S. for use in inoperable patients and high-risk operable patients.
Results of the CHOICE trial (A Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve v Edwards SAPIEN XT) will be presented at the ACC 14.
david_adams
David Adams
2014-03-29
Original title: A Randomized Comparison of Self-expanding Transcatheter and Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis Deemed High-Risk for Surgery. Presenter: Dr David H Adams (Mount Sinai Medical Center, New York, NY) on Behalf of the US Corevalve Investigators.
