Lower Extremity Revascularization Using Directional Atherectomy: 12-Month Prospective Results of the DEFINITIVE LE Study

Study Questions:

What is the safety and effectiveness of directional atherectomy (DA) for endovascular treatment of peripheral arterial disease (PAD) in infrainguinal arteries in patients with claudication or critical limb ischemia (CLI)?


DEFINITIVE LE (Determination of EFfectiveness of the SilverHawk® PerIpheral Plaque ExcisioN System (SIlverHawk Device) for the Treatment of Infrainguinal VEssels/Lower Extremities) prospectively enrolled subjects at 47 multinational centers with an infrainguinal lesion length up to 20 cm. Primary endpoints were defined as primary patency at 12 months for claudicants and freedom from major unplanned amputation for CLI subjects. A prespecified statistical hypothesis evaluated noninferiority of primary patency in diabetic versus nondiabetic claudicants. Independent angiographic and sonographic core laboratories assessed outcomes, and events were adjudicated by a clinical events committee.


A total of 800 subjects were enrolled. The 12-month primary patency was 78% (95% confidence interval, 74.0%-80.6%) in claudicants, with a 77% rate in the diabetic subgroup versus 78% in the nondiabetic subgroup (noninferior, p < 0.001). The rate of freedom from major unplanned amputation of the target limb at 12 months in CLI subjects was 95% (95% confidence interval, 90.7%-97.4%). Periprocedural adverse events included embolization (3.8%), perforation (5.3%), and abrupt closure (2.0%). The bail-out stent rate was 3.2%.


The authors concluded that DA is a safe and effective treatment modality at 12 months for a diverse patient population with either claudication or CLI.


This nonrandomized study reports that directional atherectomy (DA) is a safe and effective treatment modality through 12 months for patients with claudication and CLI. Furthermore, DA was shown to be noninferior for treating PAD in patients with diabetes compared with nondiabetic patients. It appears that DA has results comparable to those of other contemporary technologies treating infrainguinal PAD, but with the distinct advantage of rarely leaving a permanent implant in place. Studies with randomization of all Food and Drug Administration–approved treatment modalities such as the recent National Institutes of Health–funded BEST (Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia) trial will help further clarify the role of each of the treatment modalities for PAD.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery

Keywords: United States Food and Drug Administration, Atherectomy, Ischemia, Confidence Intervals, Leg, Diabetes Mellitus, Stents

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