As the BEST-CLI (Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia) trial enters its last phase of new patient enrollment, I thought it was important to reflect on what this trial has meant for both the Vascular Surgery field and for me personally. This trial has been closely examining one of the most commonly treated conditions that we take care of – critical limb ischemia (more recently better described as chronic limb threatening ischemia (CLTI). BEST-CLI (ClinicalTrials.gov Identifier: NCT02060630) has the potential to be one of the most meaningful and impactful trials in the history of our profession, and that of our colleagues who also treat CLTI.
Unlike many of the industry-sponsored endovascular device trials, vascular surgeons are at the table and are key leaders and enrollers. The results will be quoted for decades and there will be many questions answered that we have not been able to answer before – including questions that were not even on people’s minds when the trial began – such as paclitaxel-related outcomes. This trial will also provide the long-term follow-up that has limited the impact of many other peripheral arterial disease trials.
From a personal point of view, I feel like the BEST trial as always been closely connected to my practice. I have been fortunate to be partners with one of the national principal investigators, Dr. Alik Farber. We enrolled the first patient in the trial in my second month as an attending in August of 2014. Since then, I have been able to operate on 30 patients that were randomized into the trial. It not only allowed me, as a junior attending, to get involved in a major trial, but also forced me to further develop both my open and endovascular skills so that I could provide the best care to each patient as needed.
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.
Jeffrey J. Siracuse, MD
Associate Professor of Surgery
Division of Vascular and Endovascular Surgery
Boston University, School of Medicine
Boston Medical Center