Paclitaxel-coated devices do not reduce rates of major amputations in chronic limb-threatening ischemia

1. All-cause mortality and reduction in major amputations were similar between groups.

2. The rate of target vessel reintervention was similar in paclitaxel-coated and uncoated devices groups at 5 years.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Drug-coated devices are commonly used in coronary and peripheral artery interventions, but their impact on amputation risk in peripheral artery disease remains unclear. This randomized controlled trial aimed to compare the rate of major ipsilateral amputation among patients with chronic limb-threatening ischemia who were treated with paclitaxel-coated versus uncoated devices. The primary outcome of this study was ipsilateral major amputation (above the ankle), while key secondary outcome was all-cause mortality. According to study results, there was no significant difference in the rate of major amputation or all-cause mortality between the two treatment groups. Although this study was well done, it was limited by a relatively short median follow-up time, limiting its validity.

Click to read the study in The Lancet

Relevant Reading: Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia

In-depth [randomized controlled trial]: From Nov 5, 2014, to Sept 29, 2023, 14 845 patients were assessed for eligibility across 22 Swedish centers. Included were adults with Rutherford category 4–6 peripheral artery disease scheduled for infrainguinal endovascular revascularization. Altogether, 2400 patients (1206 in the paclitaxel-coated group and 1194 in the uncoated group) were included in the final analysis. The primary outcome of this study showed no significant difference in the rate of ipsilateral major amputation between the two groups (7.05 events per 100-person-year for paclitaxel-coated devices vs. 6.62 events for 100 person-years for uncoated devices, hazard ratio [HR] 1.05, p=0.61). The secondary outcome of all-cause mortality also showed no significant difference between paclitaxel-coated and uncoated devices (15.01 vs. 13.99 events per 100 person-years, HR 1.04, p=0.54). Findings from this study suggest that paclitaxel-coated devices do not reduce major amputations or mortality in patients with chronic limb-threatening ischemia.

Image: PD

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