CHICAGO – Treatment of calcified femoropopliteal lesions with orbital atherectomy led to 12-month patency similar to that of balloon angioplasty but with a substantially reduced need for stenting, in a randomized, controlled study of 50 patients.
Orbital atherectomy changed vessel compliance, which allowed lower pressure balloon dilatation and hence less vessel disruption, which appeared to produce a low rate of restenosis with minimal stent use. "Lower dissection rates and reduced use of bailout stents preserves treatment options in the future," Dr. Raymond Dattilo noted in a poster at the annual meeting of the American College of Cardiology. Minimizing stent use in distal, superficial femoral and popliteal arteries also reduces the risk of stent fracture, said Dr. Dattilo, a cardiologist and director of endovascular medicine at St. Francis Health Center in Topeka, Kan.
He ran the COMPLIANCE 360° study to determine whether orbital atherectomy of calcified femoropopliteal lesions using the Diamondback Orbital Atherectomy System reduced the need for stenting without diminishing 12-month vessel patency when compared with percutaneous balloon angioplasty and selected stent use. The study enrolled 50 patients with 65 femoropopliteal lesions. Randomization resulted in two treatment arms with similar patients and types of lesions (based on degree of calcification and plaque morphology). The only statistically significant difference between the two treatment arms was in the percentage of patients with diabetes, which affected 18 (72%) patients randomized to orbital atherectomy and 10 (40%) patients treated with balloon angioplasty and bail-out stenting.
Maximum balloon pressure used during angioplasty was 4 atmospheres in the 25 patients treated with orbital atherectomy, and 9 atmospheres in the 25 patients who did not undergo atherectomy. Among the patients treated with atherectomy, two (8%) required a bailout stent, compared with 21 (84%) in the angioplasty-only group, a statistically significant difference.
At 6 months after treatment, 16 of 22 patients (73%) in the atherectomy group with 6-month follow-up had avoided stent placement, were free from target lesion revascularization, and had no restenosis as assessed by duplex ultrasound. Among 24 patients in the balloon angioplasty group assessed after 6 months, two patients (8%) met these same efficacy criteria.
After 12 months, 5 patients in the atherectomy group out of 20 with 12-month follow-up had restenosis or required repeat target lesion revascularization, compared with 5 of 21 patients in the angioplasty group. The 12-month results showed that the two strategies resulted in similar rates of long-term vessel patency, but the atherectomy patients avoided stent placement, Dr. Dattilo reported.
The COMPLIANCE 360° study was sponsored by Cardiovascular Systems. Dr. Dattilo said that he has been a consultant to, a speaker for, and has received research grants from Cardiovascular Systems.