The COMPLIANCE 360° Trial: a randomized, prospective, multicenter, pilot study comparing acute and long-term results of orbital atherectomy to balloon angioplasty for calcified femoropopliteal disease.

Compared to BA alone, OA plus BA yields better luminal gain by improving lesion compliance and decreases adjunctive stenting in the treatment of calcified FP disease. At 12 months, the occurrence of TLR or restenosis was similar in both groups despite the large disparity in stent usage at the time of initial treatment.