In the past few months the BEST-CLI study has continued to energetically enroll patients. More than 100 of the planned 120 trial sites have been activated across the U.S. and Canada, and more than 150 patients have been successfully enrolled.
The BEST-CLI trial will be a landmark trial that defines practice for CLI care. It is the largest CLI trial to date, and is poised to answer questions that the original BASIL trial in England could not. The largest cohort of patients will provide clarification on the role of open surgical bypass when optimal conduit, a single continuous segment of greater saphenous vein, is available.
A second, independently powered cohort will compare endovascular treatment to surgical bypass using a so-called disadvantaged conduit (i.e. arm vein, composite vein, lesser saphenous vein, cryopreserved vein and prosthetic conduit) and will provide vascular surgeons with valuable information for those clinical situations in which good saphenous vein is absent.
Given ongoing questions regarding best practice in this difficult patient population, the need to define efficacy and value as it relates to specific revascularization techniques for CLI has never been higher.
The recent New York Times article, which cast a spotlight on the misguided application of current endovascular technology, “only serves to accent the associated clinical and financial challenges we routinely face when treating patients with CLI,” noted Dr. Matthew Menard, who is co-principal investigator of the study.
The trial will assess outcomes following revascularization across a range of demographic, anatomic and clinical variables, and provide much-needed information on the impact of such factors as tibial disease, diabetes, renal dysfunction and the degree of tissue loss on specific treatment strategies.
BEST-CLI includes additional components that will:
• Capture the hemodynamic impact of different therapeutic approaches,
• Validate the recently designed SVS WIfI classification schema,
• Quantify the clinical and functional impact of all re-interventions,
• Assess cost-effectiveness, particularly important given the financial burden associated with both surgical and endovascular interventions,
• Use novel endpoints based on the SVS-defined Outcome Performance Goals, including MALE-free survival and Re-intervention and Amputation-free Survival (RAS).
Study leads are grateful for the sustained enthusiasm from SVS members.
“The progress to date represents a tremendous effort from all who have risen to the challenge to support the trial,” said Dr. Menard.
“The enrollment targets for the trial remain formidable, however,” cautioned study co-PI Dr. Alik Farber, “and given the specter of study termination by the NHLBI if enrollment continues to lag behind expectations, there is an ongoing imperative to consider all patients with CLI as potential candidates for the trial.”
If you have a busy CLI practice and are not yet participating in the trial, please join this landmark study. Contact BEST@neriscience.com for more information.