The use of paclitaxel-coated vs uncoated endovascular devices for the treatment of peripheral artery disease was not associated with increased mortality, according to study results published in the New England Journal of Medicine.
This was an interim analysis of data from a multicenter, randomized, open-label clinical trial, the Swedish Drug-elution Trial in Peripheral Arterial Disease (ClinicalTrials.gov Identifier: NCT02051088).
Patients requiring new or recurrent flow-limiting stenosis (N=2289) were recruited between 2014 and 2018 at 22 vascular centers in Sweden and stratified based on the severity of disease: chronic limb-threatening ischemia (n=1480; mean age, 76.8±9.3 years; 55.1% men; 75.2% on statin therapy), or intermittent claudication (n=809; mean age, 72.7±7.6 years; 54.3% men; 88.0% on statin therapy). Participants were randomly assigned to receive a paclitaxel-coated (n=1149) or uncoated (n=1140) device. Patients were assessed for mortality and quality of life.
Of participants who had received a drug-coated and uncoated device, 2.0% and 2.2%, respectively required an additional intervention prior to index revascularization, and 7.7% and 7.5%, respectively, after index revascularization. All procedures, with 14 exceptions, were percutaneous endovascular interventions. A total of 175 surgeons implanted a drug-coated device and 171 surgeons implanted an uncoated device.
After a mean follow-up of 2.49 years, 25.5% and 24.6% of patients who had received a drug-coated or uncoated device, respectively, had died (hazard ratio [HR], 1.06; 95% CI, 0.92-1.22). The mortality rate per 100 person-years was 10.4% for paclitaxel-coated and 9.8% for uncoated device recipients.
Mortality rates were comparable for both types of device coating among patients with ischemia (drug-coated: 33.4%; uncoated: 33.1%) or claudication (drug-coated: 10.9%; uncoated: 9.4%). The overall HR for mortality was 1.04 (95% CI, 0.90-1.21) among patients with chronic limb-threatening ischemia and 1.18 (95% CI, 0.72-1.93) among patients with intermittent claudication.
Study limitations include a high rate of use of low-dose paclitaxel-coated devices and low rate of high-dose devices.
Despite evidence reported by a meta-analysis, this study failed to detect significantly elevated mortality rates among patients who received a paclitaxel-coated device for the treatment of peripheral artery disease for up to 4 years after implantation.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Nordanstig J, James S, Andersson M, et al. Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease. N Engl J Med. 2020;383:2538-2546.doi:10.1056/NEJMoa2005206