Debulking and atherectomy are such good intuitive ideas that their success was assumed to be almost inevitable when first advanced in the mid-late 1980s, but their journey to evidenced clinical benefit and wide adoption has proven anything but easy or expeditious – especially in the infrainguinal vasculature.
Today, there are several atherectomy devices available in the United States, at least two of the rotational/orbital type: the Jetstream Navitus atherectomy system (Bayer Radiology & Interventional) and the Diamondback atherectomy system (Cardiovascular Systems, Inc.). Directional atherectomy, on the other hand, is the best-known type, with an ever-expanding family of SilverHawk devices (Covidien).
Responding to the obvious unmet need for high-level scientific evidence, Covidien and an impressive group of endovascular experts partnered recently to design and conduct the important DEFINITIVE LE clinical trial that enrolled 800 patients and almost 1100 arterial lesions (up to 20 cm in length) that received treatment with the SilverHawk and TurboHawk devices in claudication and critical limb ischemia cases. The primary endpoint was primary patency at 12 months, or freedom from major unplanned amputation at 12 months on patients with critical limb ischemia. The preliminary results (at 6 months) were quite encouraging.1 The 1-year results are expected to be presented this Fall.
We remain hopeful that this and other ongoing studies, and perhaps others in the near future, will fill the significant data gaps that have characterized the atherectomy space from its inception. The all-important question to be answered is whether atherectomy (and what type) can be used as stand-alone endovascular therapy, obviating the need for adjunctive stent placement, and if so, how do we select patients and lesions for such an approach?
Undeniably, atherectomy has already earned a significant niche role in cases and situations where placement of a stent is deemed to be undesirable or outright contraindicated, and for some heavily calcified lesions, but anything outside such narrow confines remains unclear or lacks evidence basis.This makes the associated cost and technical complexity difficult to justify.
- Garcia LA. Late Breaking Clinical Trials: DEFINITIVE LE 6 month outcomes. Presented at VIVA 2011. October 2011; Las Vegas, NV.