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DEFINITIVE LE substudy: Directional atherectomy performs well in infrapopliteal arteries
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Results from a substudy of the DEFINITIVE LE trial show promising clinical and technical outcomes at 1 year for directional atherectomy in infrapopliteal artery lesions.
The aim of the subanalysis of the prospective, multicenter, single-arm DEFINITIVE LE trial was to assess the 1-year efficacy of directional atherectomy in infrapopliteal artery lesions. Patients were included in the substudy if they demonstrated presence of a de novo or restenotic target lesion (occlusion or stenosis) in the infrapopliteal arteries (reference vessel diameter, 1.5 mm-7 mm) with stenosis of at least 50%.
In all, of the 800 patients enrolled in the trial, 145 (189 infrapopliteal lesions) met inclusion criteria for the subanalysis.
At baseline, 48.3% of patients had critical limb ischemia (CLI), 51.7% had intermittent claudication and 68.3% had diabetes. Mean lesion length was 58 ± 44 mm.
Duplex ultrasound-derived primary patency served as the primary endpoint for patients with claudication. Freedom from major amputation of the target limb at 1 year was the primary endpoint for patients with CLI. Independent assessment was performed on the endpoints and adverse events.
In the treated lesions, the rate of procedure success, defined as 30% or less residual stenosis, was 84%.
At 1 year, the primary patency rate was 84% — 89.6% among claudicants and 78% among patients with CLI (P = .11) — and the rate of freedom from major amputation was 97.1% — 100% among claudicants and 93.8% among patients with CLI (P = .03).
Krishna J. Rocha-Singh
Krishna J. Rocha-Singh, MD, director of the Prairie Vascular Institute at St. John’s Hospital, Springfield, Ill., and colleagues also reported significant 1-year improvements in Rutherford category and objective measures of walking distance and quality of life in patients with claudication, as well as those with CLI.
“The present analysis supports the statement that infrapopliteal lesions can be treated safely and successfully with directional atherectomy,” the researchers concluded. “Moreover, the 1-year technical and clinical results are comparable with published results from [drug-eluting stents] in focal lesions and [drug-coated balloons] in diffuse lesions. However, randomized trials are needed to clarify the potential of directional atherectomy in comparison to DES and DCB in the treatment of infrapopliteal lesions.” – by Brian Ellis
Disclosure: The study was funded by Covidien. The researchers report no relevant financial disclosures.
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