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Drug-coated balloon shows promise for treatment of infrapopliteal artery lesions
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Treatment with a drug-coated balloon yielded favorable safety and efficacy outcomes among patients with infrapopliteal artery lesions in a single-center retrospective study.
The researchers reviewed data from 208 patients with symptomatic peripheral artery disease treated with a DCB (Lutonix, Bard/Lutonix) between May 2013 and October 2014 (mean age, 74.1 years; 138 men). The cohort included patients with critical limb ischemia (61.4% of patients) or severe claudication (38.6%) in 220 limbs. The majority of treated lesions (63.6%) were total occlusions, and 46.4% of patients had ischemia of category 5 at baseline.
Outcomes of interest included procedure success, death, amputation, changes to category, target lesion revascularization and need for ipsilateral below-the-knee reintervention. Follow-up visits were conducted every 6 months (median, 9 months).
The procedure was successful for all treated limbs, with residual stenosis greater than 50% observed in two patients. Twenty-two patients died during follow-up, with a mortality rate of 14.8% among those with critical limb ischemia and of 3.8% in those with severe claudication. No deaths were considered related to the treatment device. A total of 39 amputations were performed in 31 limbs, all of which occurred among patients with critical limb ischemia and nine of which were major amputations.
Patients were free of a composite endpoint of death and major amputation in 92% of cases at 6 months and 85% at 12 months. The researchers wrote that the estimated rates of major amputation and mortality were comparable to those observed with below-the-knee percutaneous transluminal angioplasty in prior study.
Ipsilateral reintervention was performed in 22.7% of cases after a mean of 7.6 months. TLR occurred in 15.9% of patients (17.8% of patients with critical limb ischemia; 12.9% of those with severe claudication), with a mean of 8.1 months to revascularization.
More than half of treated limbs (59.1%) improved by one or more Rutherford category either upon last follow-up or at 12 months, with 80% of these limbs improving by two or more categories. Among 89 patients with category 5 or 6 and evaluable follow-up data, 76.4% exhibited complete wound healing.
“From this single-center experience, the Lutonix DCB shows therapeutic promise in a disease state where new treatment options are needed,” the researchers wrote. “Data from the ongoing randomized controlled trial are highly anticipated to further support both the safety and efficacy in this population.” – by Adam Taliercio
Disclosure: The researchers report financial relationships with Abbott Vascular, Biotronik, Boston Scientific, Cook Medical, Cordis, Covidien, C.R. Bard, Hemoteq, IDEV Technologies, Medtronic, Spectranetics and Upstream Peripheral.
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