Outcomes of Drug-Coated vs Non-Drug-Coated Balloon Revascularization Strategy in Chronic Limb Threatening Ischemia

Purpose:
Endovascular therapy is often the preferred first treatment option for chronic limb threatening ischemia (CLTI) patients. Drug coated balloons (DCB) reduce restenosis rates compared to percutaneous transluminal angioplasty (PTA); however, DCB use has not been studied systematically in patients with CLTI. Thus, the optimal treatment option for these complex lesions remains controversial.

Material and Methods:
We report on 327 patients with CLTI treated either with DCB (n=105) or non-DCB (n=222) for femoropopliteal disease. Data were retrieved from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851). Two DCB types were used at the discretion of the operator: Lutonix^â (BARD Peripheral Vascular, Inc., Tempe, AZ, USA) and IN.PACT AdmiralTM (Medtronic, Santa Rosa, CA, USA). Odds ratios and the respective 95% confidence interval were synthesized to examine the association between the two groups in terms of all-cause mortality, target limb repeat endovascular or surgical revascularization, target vessel revascularization (TVR), major and minor amputation at 12 months of follow up.

Results:
The mean lesion length was 150.0 mm (SD:123.2) and 151.2 mm (SD:108.3) for the DCB and non-DCB group respectively. No difference between the two groups was detected in terms of all-cause mortality (2.86% vs 2.7%, P=0.94), target limb repeat endovascular or surgical revascularization (16.19% vs 12.61%, P=0.25), TVR (16.19% vs 11.71%, P=0.26) or minor amputation (15.24% vs 10.81%, P=0.25) at 12 months of follow up. Although a higher incidence of 12 months major amputation was observed in the DCB group (11% vs 4%,   P=0.01), after adjusting for several risk factors the odds of major amputation were not statistically different between the DCB and non-DCB groups (OR:1.54; 95%CI:0.53-4.51; P=0.43).

Conclusions:
Both DCB and non-DCB strategies are effective modalities for revascularization of patients with CLTI. No differences were identified between the DCB and non-DCB group in terms of late outcomes during 12 months of follow-up.