To have the trial most accurately reflect contemporary practice, the results be accepted by the entire spectrum of CLI caregivers, and to help overcome treatment bias, the lead investigators felt it was important to have everyone providing CLI care at participating trial sites involved. To achieve this, each participating site was encouraged to create "CLI teams."

"A dedicated effort was undertaken to foster widespread multidisciplinary engagement and participation," said Menard, of Brigham and Women's Hospital. "We believe that investigators working in CLI teams will facilitate optimal outcomes both for patients and for the trial."


That posed a challenge for institutions with limited enthusiasm for cross-specialty collaboration, and in many cases, resulted in an entirely new model for decision-making and teamwork around CLI treatment. The study itself was designed with comprehensive input from expert trialists in the fields of vascular surgery, interventional radiology, interventional cardiology and vascular medicine, with the express goal of integrating the unique perspectives of each subspecialty. Sixty-six percent of investigators are vascular surgeons, 15 percent are interventional cardiologists, and 14 percent are radiologists; 72 percent of the sites are multidisciplinary.

An additional enrollment obstacle is patients' willingness to participate, which may be affected by both patient perceptions that endovascular options are less invasive than lower extremity bypass and provider bias.

The BEST-CLI principal investigators broadened eligibility criteria through a protocol amendment, which did not undermine the effect on pragmatic trial design. They also used social media, weekly coordinator calls, bi-monthly newsletters, articles in vascular periodicals and presentations at national and international meetings to enhance recruitment efforts. The site outreach program has included more than 105 individual site visits and 45 webinars led by the national trial chairs. During meetings with CLI teams, the BEST-CLI protocol was reviewed, misconceptions were corrected, treatment bias was exposed and discussed through specific case presentations and strategies to overcome such bias were highlighted.

"The BEST CLI trial is a versatile effort that aims to answer relevant, unresolved questions in the realm of peripheral arterial disease," said Rosenfield, of Massachusetts General Hospital. "We hope it will answer the principal question of how lower extremity bypass using a single segment of greater saphenous vein compares to endovascular therapy and will help providers treating patients with CLI clarify whether an endovascular-first approach is appropriate in patients who have a good autogenous vein."


Funding for the BEST-CLI trial was provided by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health.

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