So far, there had been no published randomized studies comparing balloon-expandable Edwards’s prosthesis and self-expandingCoreValve. The aim of this study was to compare the results between the two thin aortic prosthesis in high-risk surgical patients with severe symptomatic aortic stenosis undergoing valve replacement by percutaneous transfemoral access. This was a multicenter work (five centers in Germany) not sponsored by industry which randomized 121 patients to receive Edwards Sapien XT and 120 patients receiving CoreValve.
The primary endpoint was the device success defined by VARC (Valve AcademicResearchConsortium) criteriapost procedure.The success of the device was 95.9 % for the balloon-expandable valve versus 77.5% for the self-expanding valve (p < 0.001) and this difference was based on the significantly lower frequency of moderate / severe aortic regurgitation (4.1 % versus 18.3 %, P < 0.01) and less need for a second prosthesis (0.8 % versus 5.8 %, P = 0.03).Cardiovascular mortality at 30 days was 4.1 % for Edwards and 4.3 % for CoreValve (p = 0.99). Bleeding and vascular complications were also similar.The need for permanent pacemaker was also lower for balloon expandable valve (17.3 % versus 37.6 %, P = 0.001).
Conclusion
In patients with severe aortic stenosis at high surgical risk undergoing percutaneous valve replacement, balloon expandable prosthesis showed a higher success rate of the device.
Mohamed Abdel-Wahab
2014-03-31
Original title: A Randomized Comparison of Self-Expandable and Balloon-Expandable Prostheses in Patients Undergoing TransfemoralTranscatheter Aortic Valve Replacement – The CHOICE Trial.
