CHOICE Trial Favors Balloon-Expandable Over Self-Expanding TAVR Devices

March 30, 2014—The American College of Cardiology (ACC) announced that a first-ever randomized head-to-head comparison of two devices commonly used to treat aortic stenosis finds that balloon-expandable transcatheter valves result in more successful procedures and relieve symptoms more frequently than self-expanding valves. The CHOICE trial is a randomized comparison of self-expandable versus balloon-expandable prostheses in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR).

Mohamed Abdel-Wahab, MD, presented the CHOICE trial at ACC.14: the 63rd annual scientific session of the ACC being held March 29–31, in Washington, DC. Dr. Abdel-Wahab et al published the data simultaneously online ahead of print in the Journal of the American Medical Association. Dr. Abdel-Wahab is Head of the Cardiac Catheterization Laboratory at Segeberger Kliniken in Bad Segeberg, Germany.

In the ACC press release, Dr. Abdel-Wahab commented, “We know in general that the transcatheter approach works and that patients benefit from it. But we have two main types of valves available for this procedure, and until now, there was no conclusive data about their relative effectiveness. This study is important because it’s the first randomized comparison of these two technologies.” 

The ACC noted that in the absence of conclusive studies comparing balloon-expandable and self-expanding valves, interventionists have typically selected valves based on availability and the operator’s level of comfort with the technology. TAVR has been used routinely in Europe since 2007 and in the United States since 2011.

The CHOICE investigators tracked 241 TAVR procedures at five major hospitals in Germany. Half of the patients received a balloon-expandable valve and the other half received a self-expanding valve. The average age of patients in the study was 80 years. 

The CHOICE investigators will continue to monitor the patients for 5 years to compare long-term health outcomes in the two patient groups. As summarized by the ACC, the CHOICE results show the balloon-expandable valve results in more successful procedures (the study’s primary endpoint) and improved patient symptoms (one of the study’s secondary endpoints). There was no significant difference between the groups for cardiovascular mortality at 30 days, bleeding and vascular complications, or stroke. Successful procedures were those in which the valve was implanted in the correct position and provided a tight enough seal to prevent blood from leaking across the valve. Procedures using a balloon-expandable valve had a success rate of 95.9% as compared to 77.5% for the self-expanding valve. 

Additionally, patients receiving the balloon-expandable valve reported improvements in symptoms 30 days after the procedure at a rate of 94.3% compared to 86.7% in patients receiving a self-expanding valve.

In the ACC announcement, Dr. Abdel-Wahab speculated that the mechanics of the two valves may explain why the balloon-expandable option was generally more successful. The balloon-expandable valve may be better able to provide the amount of force needed to achieve a tight seal and prevent leakage. 

Dr. Abdel-Wahab added, “This is a very dynamic field. We now have new valves coming out that will probably be even better, but we do not have enough data about them yet. These results can help to inform the design of future devices."