Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial

The ORBIT II trial enrolled 443 subjects to study orbital atherectomy followed by stenting for de novo severely calcified coronary lesions. The overall cumulative 3-year MACE rate was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%); the 3-year target lesion revascularization rate was 7.8%. Orbital atherectomy of heavily calcified coronary lesions followed by stenting results in a low rate of adverse ischemic events compared with historical controls; it represents a reasonable revascularization strategy for patients with severely calcified coronary lesions.