A new study found no statistically significant difference in amputation-free survival among three primary endovascular revascularization strategies among patients with chronic limb-threatening ischemia.

In a randomized, multicenter phase III trial, published in BMJ Journals and conducted across 35 UK NHS vascular units, investigators compared plain balloon angioplasty with or without bare metal stenting (PBA ± BMS), drug-coated balloon angioplasty with or without bare metal stenting (DCBA ± BMS), and drug-eluting stents (DES).

Between January 29, 2016, and August 31, 2021, 481 participants (167 women, mean age = 71.8 years) were randomly assigned to undergo the procedures. In the PBA ± BMS group, 66% (n = 106/160) of the pateitns experienced major amputation or mortality compared with 60% (n = 97/161) of those in the DCBA ± BMS group and 58% (n = 93/159) of those in the DES group. Adjusted hazard ratios (HR) showed no statistically significant differences: PBA ± BMS vs DCBA ± BMS (HR = 0.84, 97.5% confidence interval [CI] = 0.61–1.16, P = .22) and PBA ± BMS vs DES (HR = 0.83, 97.5% CI = 0.60–1.15, P = .20). Serious adverse events were comparable across all groups.

Secondary endpoints included overall survival, major adverse limb and cardiovascular events, additional revascularization, and quality-of-life measures. Death occurred in 60% of the patients in the PBA ± BMS group, 56% of those in the DCBA ± BMS group, and 50% of those in the DES group. Major amputation rates were 14%, 11%, and 16%, respectively, with no statistically significant differences in cardiovascular events, further revascularization, or pain relief.

"Neither DCBA ± BMS nor DES conferred significant clinical benefit over PBA ± BMS in the femoro-popliteal segment in patients with chronic limb-threatening ischemia undergoing endovascular femoro-popliteal, with or without infra-popliteal, revascularisation," said lead study author Andrew W. Bradbury, MBA, the Sampson Gamgee Professor (Emeritus) of Vascular Surgery at the University of Birmingham, in the United Kingdom, and his colleagues.

The results suggested that physicians may not achieve superior patient outcomes using drug-coated devices in this setting.

The findings did not support the routine use of drug-coated balloons or drug-eluting stents over plain balloon angioplasty in this patient population.

Full disclosures are detailed in the study.