A randomized controlled trial of drug-coated balloon versus conventional balloon angioplasty in diabetic patients with lower extremity arteriosclerosis obliterans: outcomes in ankle-brachial index and restenosis rate.

BACKGROUND

Diabetic lower extremity arteriosclerosis obliterans (DLASO) is a severe complication with high risks of limb loss and mortality. While drug-coated balloons (DCBs) are effective in peripheral artery disease, robust evidence for their use in specifically diabetic populations is limited.

OBJECTIVE

To evaluate the efficacy and safety of paclitaxel-coated balloon angioplasty versus conventional plain balloon angioplasty (POBA) for the treatment of DLASO in a randomized controlled trial.

METHODS

In this prospective, single-blind, randomized controlled trial, 60 patients with DLASO were equally assigned to the DCB group or the POBA (control) group. The primary endpoints were primary patency rate and change in ankle-brachial index (ABI) at 12 months. Secondary endpoints included Rutherford classification, target lesion revascularization (TLR), and complications. Follow-up assessments occurred at 1, 3, 6, and 12 months.

RESULTS

The primary patency rate at 12 months was significantly higher in the DCB group (83.3% [95% CI, 71.8% to 96.7%]) than in the control group (56.7% [95% CI, 41.2% to 78.0%]) (hazard ratio 0.32; log-rank P = 0.023). The mean increase in ABI from baseline to 12 months was also greater in the DCB group (0.31 ± 0.12 vs. 0.21 ± 0.11; mean difference 0.10 [95% CI, 0.04 to 0.16]; P < 0.001). Clinical improvement (Rutherford classification) was more pronounced, and the 12-month TLR rate was lower (0% vs. 3.33%) in the DCB group. Complication rates were comparable between groups (10.00% vs. 13.33%, P > 0.05).

CONCLUSION

For patients with DLASO, paclitaxel-coated balloon angioplasty is superior to conventional balloon angioplasty in maintaining vessel patency, improving perfusion, and promoting clinical outcomes at 12 months, with a similar safety profile.