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Screening Failures in the Best Endovascular versus Surgical Therapy in Critical Limb Ischemia (BEST-CLI) Randomized Controlled Trial Provides Perspective for Trial Implementation
Alik Farber, MD1, Kenneth Rosenfield, MD2, Michael Conte, MD3, Christopher White, MD4, Sandi Siami, MPH, RAC5, Susan Assmann, PhD5, Suzanne Granger5, Meaghan Dunn6, Matthew Menard, MD6.
1Boston Medical Center, Boston, MA, USA, 2Massachusetts General Hospital, Boston, MA, USA, 3University of California San Francisco Medical Center, San Francisco, CA, USA, 4Ochsner Health System, Jefferson, LA, USA, 5New England Research Institute, Watertown, MA, USA, 6Brigham & Women's Hospital, Boston, MA, USA.
Screening Failures in the Best Endovascular versus Surgical Therapy in Critical Limb Ischemia (BEST-CLI) Randomized Controlled Trial Provides Perspective for Trial Implementation
Objective: Screening is an essential step in enrollment for a randomized controlled trial (RCT) and, as such, reflects on multiple aspects of trial design and implementation. We evaluated screening logs of the Best Endovascular versus Surgical Therapy in Critical Limb Ischemia (BEST-CLI) trial to assess trends that could support optimization of trial execution.
Methods: BEST-CLI is a prospective, NHLBI-sponsored, pragmatic RCT that aims to compare treatment efficacy, functional outcomes and cost for patients with CLI undergoing best open surgical versus best endovascular revascularization. Screening logs from the first 12 months of the trial were evaluated and defined reasons for screen failure were recorded. Frequency of screen failure (ineligibility or lack of consent) was assessed.
Results: Over a course of 12 months 122 sites were activated into BEST-CLI. Of 2756 subjects screened for the trial, 245 were successfully enrolled and randomized. There were 2511 screen failures and some patients had more than one reason for not being enrolled. To date, 21 sites have neither screened nor randomized a subject. Another 25 sites have confirmed that they are screening patients but have not yet randomized a subject. The remaining 76 sites have all randomized at least one subject. The most common distinct reasons for screen failure included a history of ipsilateral vascular procedure within 6 months (336), excessive risk for surgical bypass(288), prior index limb stent with restenosis(204), inadequate aortoiliac inflow(190), refusal to be in a surgical arm(143) or endovascular arm(38), refusal to participate in the trial due to research, travel or time commitment(217), severe ipsilateral common femoral artery disease(142), inadequate popliteal or tibial revascularization target(126) and disease limited to the femoropopliteal segment(126). Less common reasons included known bleeding disorder(28), popliteal aneurysm in index limb(22), not severe enough occlusive disease(13) and contraindication to iodinated contrast(4). No site clustering was observed.
Conclusion: Screen failures provide perspective into the implementation of a RCT. Evaluation of associated reasons shed light on the population of CLI patients with revascularization strategy equipoise, suggest need for both further site investigator education and future protocol amendment for revised exclusion criteria.
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