CHOICE Outcomes at 1 Year Show No Difference Between Self-Expandable and Balloon-Expandable TAVR Devices

August 14, 2015—One-year results from the CHOICE trial evaluating transcatheter aortic valve replacement (TAVR) were published by Mohamed Abdel-Wahab, MD, et al in the Journal of American College of Cardiology (JACC; 2015;66:791–800). The CHOICE trial was a randomized comparison of TAVR in high-risk patients with severe aortic stenosis using the self-expandable CoreValve (Medtronic plc) versus the balloon-expandable Sapien XT (Edwards Lifesciences).

The background of the study is that the use of the balloon-expandable TAVR device previously resulted in a greater rate of device success compared with the self-expandable TAVR device. In April 2014, Dr. Abdel-Wahab and the CHOICE investigators published the 30-day outcomes in JAMA: Journal of the American Medical Association.

The CHOICE investigators sought to evaluate clinical and echocardiographic outcome data at longer-term follow-up.

As summarized in JACC, 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 TAVR with either device. Patients were followed for 1 year, with assessment of clinical outcomes and echocardiographic evaluation of valve function.

At 1 year, the rates of death of any cause (17.4% vs 12.8%) and of cardiovascular causes (12.4% vs 9.4%) were not statistically significantly different in the balloon- and self-expandable groups, respectively. The frequencies of all strokes (9.1% vs 3.4%) and repeat hospitalization for heart failure (7.4% vs 12.8%) did not statistically significantly differ between the two groups. Elevated transvalvular gradients during follow-up were observed in four patients in the balloon-expandable group (3.4% vs 0%); 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%), reported the investigators in JACC.

Despite the higher device success rate with the balloon-expandable valve, 1-year follow-up of patients in CHOICE, with limited statistical power, revealed that clinical outcomes after transfemoral TAVR with both balloon- and self-expandable prostheses were not statistically significantly different, concluded the investigators in JACC.