Prospective Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus Conventional Balloon Angioplasty in Treating Below the Knee Arterial Lesions in Chronic Limb Threatening Ischemia: The CRURAL DEB Study

OBJECTIVE: Drug-coated balloons (DCB) might improve the results of below the knee (BTK) angioplasty, but sufficient randomized data comparing DCB and conventional angioplasty in treating patients with chronic limb threatening ischemia (CLTI) are lacking. This study aimed to perform a randomized comparison between a paclitaxel-coated angioplasty balloon catheter and a conventional balloon angioplasty catheter in treating BTK arterial lesions.

DESIGN: A single-center prospective 1:1 randomized, single-blinded, parallel group, superiority trial.

CLINICAL TRIAL REGISTRATION: NCT02750605.

METHODS: Patients presenting with CLTI scheduled for endovascular treatment of BTK arterial lesions were assigned to DCB or conventional angioplasty. The primary endpoint was primary patency at 12 months. Secondary endpoints were target lesion revascularization (TLR), technical success, clinical success, amputation free survival (AFS), and serious adverse events.

RESULTS: A total of 64 CLTI patients, 70 limbs, and 122 lesions were enrolled, with 35 limbs in each group. Demographics, comorbidities, and Rutherford class were similar in both treatment arms. The rates of chronic total occlusions were 81% and 89% (NS) in the DCB and control group, respectively, with corresponding median lesion lengths of 150 and 100 mm (NS) in the two groups. No significant differences were detected between groups regarding primary limb patency (hazard ratio [HR]=0.64, p=0.24, confidence interval [CI]=0.30-1.35).

CONCLUSIONS: This single-center prospective randomized study could not demonstrate superiority of DCB compared with conventional balloon angioplasty regarding the primary endpoint, as primary patency, when treating BTK arterial lesions in patients with CLTI.Clinical ImpactThis randomised trial aims to pragmatically investigate whether there is a clinically relevant difference between drug eluting angioplasty and standard plain old balloon angioplasty in treating below the knee arterial lesions in subjects with chronic limb threatening ischemia. Regarding the primary endpoint variable, the study was not able to reveal a significant DCB superiority in primary patency.