LAS VEGAS — In this video, Jeffrey Chambers, MD, FSCAI, interventional cardiologist and director of the cath lab at Mercy Hospital in Minneapolis, discusses the 1-year results of the ORBIT II trial, presented at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.
The prospective, single-arm, multicenter ORBIT II trial assessed the Diamondback 360 Orbital Atherectomy System for the treatment of severely calcified coronary lesions, in order to enable stent placement. The study included 443 patients from 49 US sites.
Initial results at 30 days indicated that the device had a 98% efficacy rate for stent delivery, with nearly 99% of cases having less than 50% residual stenosis. At 1 year, the cardiac death rate was 2.8%, target lesion revascularization was 4.5%, and there were no new incidences of MI between the 30-day and 1-year endpoints. Chambers said that the overall rate of major adverse cardiac events was 16.4%, compared with 10.4% observed at 30 days.
He concluded that the Diamondback system is the first new device in nearly 20 years for the treatment of severely calcified lesions, and that its use yielded beneficial and durable results, as well as offering a potential to reduce costs.