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DEFINITIVE LE: Directional atherectomy effective for PAD
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Directional atherectomy was a safe and effective option for patients with femoropopliteal and below-the-knee peripheral arterial disease presenting with claudication or critical limb ischemia. These results were consistent regardless of whether the patients had diabetes.
The DEFINITIVE LE trial, which was presented at Vascular Interventional Advances, was designed to establish multicenter data on the long-term safety and effectiveness of directional atherectomy for the treatment of PAD. Researchers enrolled 800 patients and assessed safety and effectiveness of directional atherectomy using the SilverHawk and TurboHawk Peripheral Plaque Excision Systems (Covidien) for endovascular treatment of PAD in femoropopliteal and tibial-peroneal arteries.
The primary endpoint for claudicants was primary patency using both peak systolic velocity ratio (PSVR) ≤2.4 and PSVR ≤3.5 in the absence of clinically driven target lesion revascularization at 1 year. Freedom from major amputation at 1 year was the primary endpoint for patients with critical limb ischemia (CLI). Independent core laboratories assessed angiographic and duplex ultrasound imaging, and a clinical events committee adjudicated the adverse events.
Overall, 201 patients had CLI and 52% had diabetes. Mean lesion length was 7.4 cm, mean diameter stenosis was 74% and 21% of lesions were occluded. Researchers reported the following periprocedural complications: perforation (5.3%); distal embolization (3.8%); and flow-limiting dissection (2.3%).
Ninety-five percent of the CLI cohort did not require major amputation at 1 year. Eighty-two percent of the claudication cohort had primary patency at 1 year (PSVR ≤3.5).
When researchers applied the more conservative definition of PSVR ≤2.4, the primary patency rate at 1 year in claudicant patients with diabetes was noninferior to the rate for claudicant patients without diabetes (78% vs. 77%).
James F. McKinsey
“DEFINITIVE LE is the first global trial looking at the treatment of patients with PAD and gives us a new standard for how we should manage patients with this disease,” James F. McKinsey, MD, FACS, co-national principal investigator for the DEFINITIVE LE trial with New York-Presbyterian Hospital/Columbia University Medical Center, New York, told Cardiology Today Intervention.“The study showed that directional atherectomy performed with the SilverHawk or TurboHawk Peripheral Plaque Excision System is a safe and very effective technique, which improves the quality of patients’ lives, their ability to heal and can save their legs from amputation.”
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Garcia L. Presented at: Vascular Interventional Advances; Oct. 9-12, 2012; Las Vegas.
Disclosure: McKinsey is on the speakers’ bureau for Covidien, but has no stock or other financial relationship with Covidien.