Anatomic profile of arterial occlusive disease in the BEST-CLI trial.

OBJECTIVE: The results of BEST-CLI trial indicated that, when eligible for both open surgical or endovascular therapy, a single-segment great saphenous vein bypass is the superior revascularization strategy for patients with chronic limb-threatening ischemia (CLTI). Having detailed anatomic information about the burden of arterial occlusive disease is important in understanding the technical difficulty of the cases performed in the trial, and what trial investigators considered equally suitable for either revascularization strategy. METHODS: The BEST-CLI trial, an international multi-site randomized controlled trial (RCT) comparing endovascular with open surgical revascularization in patients who were candidates for both, was analyzed. At the time of each participant's trial enrollment, anatomic location and the degree of arterial occlusive disease was characterized by the combination of stenosis severity (<50%, 50%-69%, 70%-99%, occluded). Participants were classified as having severe arterial occlusive disease in a vessel segment if they had 70% to 99% stenosis or a chronic total occlusion. Descriptive statistics and data visualization were used for the analysis of the entire BEST-CLI trial cohort. RESULTS: Of the 1830 BEST-CLI trial participants, 1786 (98%) had severe arterial occlusive disease in at least one infrainguinal artery. There were no differences in observed severity or patterns of occluded vessel segments between the open surgical and endovascular treatment groups, indicating that randomization was effective with regard to anatomic complexity. Long-segment disease was predominant regardless of whether patients had arterial occlusive disease in femoral, popliteal, or tibial segments, or a combination of those vessels. Forty-four percent of patients had total occlusions in more than one artery, and 9.5% had total occlusions in all three femoral, popliteal, and tibial arterial segments. Only 17.1% of patients had isolated femoropopliteal disease. Nearly one-half of the participants with multi-level or isolated tibial disease (46.2% and 48.7%, respectively) had concomitant pedal arterial occlusive disease. CONCLUSIONS: The subjects enrolled in the BEST-CLI trial had multi-focal and severe atherosclerosis throughout the infrainguinal arterial tree.

Duke Scholars

Author Nikki Freeman Biostatistics & Bioinformatics, Division of Biostatistics