COAST IDE Study Presented for CSI's Diamondback 360° Micro Crown Technology

February 21, 2017—Cardiovascular Systems, Inc. (CSI), released 1-year results from its Coronary Orbital Atherectomy System Study (COAST) in a late-breaking presentation at CRT 2017, the Cardiovascular Research Technologies conference in Washington, DC.

CSI's COAST study is a prospective, single-arm, multicenter, global investigational device exemption (IDE) trial that is evaluating the safety and efficacy of the company’s Micro Crown orbital atherectomy system (OAS) technology in treating patients with severely calcified coronary lesions. In July 2015, CSI completed COAST enrollment of 100 patients, including 74 patients at 12 sites in the United States and 26 patients at five sites in Japan.

At CRT 2017, Samin K. Sharma, MD, presented the 1-year outcomes versus 30-day outcomes in COAST for freedom from major adverse cardiac events (MACE; 77.8% vs 85%); myocardial infarction (14% vs 14%); non–Q-wave (12% vs 12%); Q-wave (2% vs 2%); target vessel or lesion revascularization (9.4% vs 1%); target lesion revascularization (6.3% vs 1%); and cardiac death (1% vs 1%).

In CSI's announcement, Dr. Sharma commented, “Incidence of severe coronary arterial calcium is significant and underappreciated. These 1-year results from the COAST IDE study resulted in 77.8% freedom from 1-year MACE, therefore concluding that the Diamondback 360° coronary OAS Micro Crown technology may address this unmet treatment need for this difficult to treat population.”

CSI advised that the coronary OAS Micro Crown is limited by federal law to investigational use and is not commercially available in the United States. The device is currently under review for commercial approval in the United States and Japan.

COAST follows the pivotal ORBIT II trial of the company’s Diamondback 360° coronary OAS Classic Crown, which received premarket approval from the US Food and Drug Administration in 2013 as a primary treatment for severely calcified coronary arteries when facilitating stent delivery, noted CSI.