A combination of directional atherectomy and embolitic protection filter to treat calcification in peripheral artery disease (PAD) patients showed a 97.2 percent success rate, according to a study published Aug. 1 in Catheterization and Cardiovascular Interventions.
SilverHawk and TurboHawk plaque excision systems and SpiderFXTM embolic protection devices (Covidien) were used in the DEFINITIVE Ca++ (Determination of Safety and Effectiveness of the SilverHawk Peripheral Plaque Excision System for Calcium [SilverHawk LS-C] and the SpiderFXEmbolic Protection Device for the Treatment of Calcified Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries) trial.
The intent of the research team was to treat and collect debris from severely calcified lesions to reduce risks of distal embolization and major adverse events while increasing target vessel diameter, returning it to 50 percent or better residual stenosis.
Between October 2008 and October 2010, David Roberts, MD, of the Sutter Heart and Vascular Institute of Sacramento, Calif., and colleagues across the U.S. treated 168 lesions in 133 patients in this one-arm trial. Ischemic rest pain was reported in 15.8 percent of patients, moderate claudication in 31.6 percent of patients and severe claudication in 52.6 percent of patients. Occlusions occurred in 17.9 percent of lesions and 81 percent of lesions were severely calcified.
In 98.3 percent of patients, outflow vasculature was conserved. No amputations were reported. Bail-out stenting occurred in 4.1 percent of lesions treated. Within the 30-day postprocedure period, the freedom from major adverse events rate was 93.1 percent. Prevention of embolism using successful deployment of the filter device occurred in 97.5 percent of patients.
However, there were some questions about this study and its findings. Gary Ansel, MD, of Riverside Methodist Hospital in Columbus, Ohio, wrote in an editorial that a notable lack of evaluation against comparable alternative procedures and a design that only evaluated the singular procedure for acute and 30-day outcomes was not enough.
“With the current cost pressures on the health care systems, developing appropriate use criteria and the need for insight into ‘value care’ we need more comparative efficacy data,” Ansel wrote. “Future DA [directional atherectomy] trial designs are now more appropriately directed at comparing DA to or in combination with developing ‘gold standards’ of drug coated balloon such as those completed abroad and whose results should be reported later this year.”
Roberts et al recognized the lack of long-term follow-up and use of a control.
Thw study was funded by Covidien.