Experiences with the Best-CLI Trial

This trial has also moved me to see things more objectively; I am now more aware of my personal treatment biases and try more consciously to suspend them when I have equipoise between treatment options. I also continue to follow patients that I enrolled and treated over 4 years ago. This trial will challenge many wide-spread beliefs, anecdotes, and urban legends in the field of peripheral arterial disease. The results will be scrutinized and analyzed and the results will be debated – particularly by some who do not find their preconceived biases confirmed. 

A trial of this magnitude looking at limb threatening ischemia will most likely never happen again in this country. This is the one time for us as a group of professionals who care for patients with CLTI to do this correctly, rather than rely solely on data from single-arm studies, often industry-sponsored, that are typically focused on device approvals.  

It is key, as we get close to the finish line, that we suspend our preconceived notions and finish enrollment. We need to ensure this trial has adequate power to give us the answers we need the most – how to best take care of the most vulnerable and ill patients that we treat; they will greatly benefit from a clear answer as to how best we should address their limb- and life-threatening problems.  

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Jeffrey J. Siracuse, MD
Associate Professor of Surgery
Division of Vascular and Endovascular Surgery
Boston University, School of Medicine
Boston Medical Center