1-Year Outcomes After Transcatheter Aortic Valve Replacement With Balloon-Expandable Versus Self-Expandable Valves Results From the CHOICE Randomized Clinical Trial

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:66

Article

Abdel-Wahab, Mohamed¹  Neumann, Franz-Josef²  Mehilli, Julinda³  Frerker, Christian⁴  Richardt, Doreen⁵  Landt, Martin¹  Jose, John¹  Toelg, Ralph¹  Kuck, Karl-Heinz⁴  Massberg, Steffen³  Robinson, Derek R.⁶  El-Mawardy, Mohamed¹  Richardt, Gert¹ 

[1] Segeberger Kliniken, Ctr Heart, Bad Segeberg, Germany

[2] Univ Heart Ctr Freiburg Bad Krozingen, Bad Krozingen, Germany

[3] Munich Univ Clin, Munich, Germany

[4] Asklepios Clin St Georg, Cardiol Dept, Hamburg, Germany

[5] Lubeck Univ Hosp, Cardiosurg Dept, Lubeck, Germany

[6] Univ Sussex, Dept Math, Brighton, E Sussex, England

关键词: aortic stenosis;    balloon-expandable;    self-expandable;    TAVR;   

DOI  :  10.1016/j.jacc.2015.06.026

来源: Elsevier

【 摘 要 】

BACKGROUND The use of a balloon-expandable transcatheter heart valve previously resulted in a greater rate of device success compared with a self-expandable transcatheter heart valve. OBJECTIVES The aim of this study was to evaluate clinical and echocardiographic outcome data at longer term follow-up. METHODS The investigator-initiated trial randomized 241 high-risk patients with symptomatic severe aortic stenosis and anatomy suitable for treatment with both balloon-and self-expandable transcatheter heart valves to transfemoral transcatheter aortic valve replacement with either device. Patients were followed-up for 1 year, with assessment of clinical outcomes and echocardiographic evaluation of valve function. RESULTS At 1 year, the rates of death of any cause (17.4% vs. 12.8%; relative risk [RR]: 1.35; 95% confidence interval [CI]: 0.73 to 2.50; p = 0.37) and of cardiovascular causes (12.4% vs. 9.4%; RR: 1.32; 95% CI: 0.63 to 2.75; p = 0.54) were not statistically significantly different in the balloon- and self-expandable groups, respectively. The frequencies of all strokes (9.1% vs. 3.4%; RR: 2.66; 95% CI: 0.87 to 8.12; p = 0.11) and repeat hospitalization for heart failure (7.4% vs. 12.8%; RR: 0.58; 95% CI: 0.26 to 1.27; p = 0.19) did not statistically significantly differ between the 2 groups. Elevated transvalvular gradients during follow-up were observed in 4 patients in the balloon-expandable group (3.4% vs. 0%; p = 0.12); all were resolved with anticoagulant therapy, suggesting a thrombotic etiology. More than mild paravalvular regurgitation was more frequent in the self-expandable group (1.1% vs. 12.1%; p = 0.005). CONCLUSIONS Despite the higher device success rate with the balloon-expandable valve, 1-year follow-up of patients in CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT Trial), with limited statistical power, revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with both balloon-and self-expandable prostheses that were not statistically significantly different. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial; NCT01645202) (J Am Coll Cardiol 2015; 66: 791-800) (C) 2015 by the American College of Cardiology Foundation.

【 授权许可】

Free