The CLI Global Society Multidisciplinary Roundtable Discussion on BEST-CLI: Implications of the Available Data
Moderator/Interviewer: Barry T. Katzen, MD, FACR, FACC, FSIR, President of the CLI Global Society
Roundtable Participants: Walter Dorigo, MD; Anahita Dua, MBCHB, MBA, MSc; Andrew Holden, MBChB, FRANZCR, EBIR, ONZM; Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM; Jihad A. Mustapha, MD, FACC, FSCAI; Richard F. Neville, MD, FACS; John H. Rundback, MD, FAHA, FSVM, FSIR; Eric Secemsky, MD, MSc, RPVI, FACC, FAHA, FSCAI, FSVM; Jos C. van den Berg, MD, PhD; Thomas Zeller, MD
The long-awaited results of the BEST-CLI trial were recently published in the New England Journal of Medicine and presented at the 2022 American Heart Association Scientific Sessions.1 This prospective, randomized trial was sponsored by the National Institutes of Health and compared two standard-of-care treatments (surgical bypass and endovascular therapy) for patients at risk of leg amputation due to critical limb ischemia (CLI). BEST-CLI enrolled more than 1800 patients from the United States and abroad. Patients who were deemed adequate candidates for revascularization bypass surgery or endovascular therapy were randomized into the trial. Patients enrolled were randomized to receive bypass surgery or endovascular therapy in two parallel cohorts. Cohort 1 included patients with adequate great saphenous vein (GSV) as a bypass conduit. Cohort 2 included patients who did not have adequate vein conduit available. The initial primary conclusion of the trial reported that patients with good-quality saphenous vein available who were randomized to bypass had a statistically significant reduction in major adverse limb events or death compared with endovascular therapy. This included 65% fewer major reinterventions and 27% fewer amputations. Importantly, the trial demonstrated that both surgical bypass and endovascular intervention can be effective techniques for revascularization, and centers of excellence should offer both modalities.
The initial results have triggered active discussion among the vascular community regarding the design analysis, generalizability, and real-world application of the trial. Subgroup analysis is eagerly awaited. The CLI Global Society supports a multidisciplinary approach to the complex disease of critical limb threatening ischemia (CLTI), with the goal of improving the quality of life of patients with CLTI by reducing mortality and amputation rates, and questions whether this study provides the “last word” in patient management. Today, I am pleased to interview 10 experts on CLTI who bring their varied specialties, experiences, and opinions to the table to help us understand and utilize these results to assist practitioners in making the best choices for our patients.
-Barry Katzen, MD, President of the CLI Global Society
Dr Katzen: What is the key result you take away from the initial results of the BEST-CLI trial?
Dr Dorigo: In my opinion there are two key results. First, open surgical bypass and endovascular treatment are equally effective in preventing amputation in patients with CLTI at the price of a higher percentage of reinterventions among patients in the endovascular group. Second, there is no clear evidence of the superiority of autologous saphenous vein over alternative and prosthetic conduits in the surgical patients.
Dr Dua: The key result is that if there is a decent piece of vein and appropriate targets for a bypass, then a right saphenous vein graft, bypass should be the procedure of choice for this patient population assuming they can handle a surgical intervention.
Dr Holden: The obvious answer to this question is the main conclusion drawn by the authors—patients with CLTI and an adequate GSV had a significantly lower incidence of the primary outcome—a composite of major adverse limb events and death. However, I believe the most important conclusion is that both surgical and endovascular strategies showed similar effectiveness in patient survival and preventing amputation. Endovascular revascularization had a significantly higher rate of reintervention, which, interestingly, did not impact the patients’ quality of life (QoL).