October 14, 2020
Thirty-Day Data Presented From Large Study of CSI's Diamondback 360 Coronary Orbital Atherectomy System
October 14, 2020—Cardiovascular Systems, Inc. (CSI) announced results from a large, retrospective observational study of coronary orbital atherectomy with the company's Diamondback 360 device. The study, "Orbital Atherectomy System (OAS) for Treating De Novo, Severely Calcified Coronary Lesions: A Tertiary Center Experience" by Nirat Beohar, MD, et al, was presented at TCT Connect, the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14-18, 2020.
According to CSI, the study shows exceptional safety and high procedural success in 519 patients with severely calcified cardiac disease who were treated with orbital atherectomy before stent deployment. The investigators reported that at 30 days, the rates of major adverse cardiovascular events (MACE), cardiac death, and myocardial infarction (MI) were 1.3%, 0.8%, and 0.8%, respectively. MACE is defined as the composite of cardiac death, MI, ischemic cerebrovascular accident, and hemorrhagic cerebrovascular accident.
The patients lesion characteristics included: 86.8% stenosed, 53.5% type C, and average length of 22.6 mm. Angiographic complications were: 0.4% dissection, 0.8% perforation, and 0% slow/no reflow. Lesion cross, stent delivery, and deployment rates were 100% with average fluoroscopy time of 19.6 minutes.
In the company's announcement Dr. Beohar commented, “We studied over 500 patients with challenging coronary lesions. The lesions were heavily stenosed and calcified, measuring up to 60 mm in length. Over half were classified as ACC/AHA type C lesions, the most difficult anatomy. Despite treating these most complex cases, procedural and component angiographic complication rates were all below 1% and stents were successfully deployed in all procedures. In this contemporary real-world experience, OAS was found to be safe; successfully streamlining treatment for patients with the most significant coronary disease.”