Thirty-Day Results Presented From CSI's COAST IDE Study

February 22, 2016—Cardiovascular Systems, Inc. (CSI) announced the presentation of 30-day results from the COAST study of its coronary orbital atherectomy system (OAS) in a late-breaking presentation at the 2016 Cardiovascular Research Technologies (CRT) conference in Washington, DC.

According to the company, the COAST study is CSI’s prospective, single-arm, multicenter, global investigational device exemption (IDE) trial to evaluate the safety and efficacy of the next-generation Micro Crown OAS in treating patients with severely calcified coronary lesions. The coronary OAS Micro Crown is limited by federal law to investigational use and is currently not commercially available in the United States.

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

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.

Richard A. Shlofmitz, MD, of St. Francis Hospital in Roslyn, New York, presented the 30-day results at CRT, including the primary endpoints of procedural success and freedom from major adverse cardiac events (MACE), including target lesion revascularization at 30 days after the procedure.

Dr. Shlofmitz advised that the COAST 30-day outcomes included: procedural success, 85%; successful stent delivery, 99%; < 50% residual stenosis, 99%; in-hospital MACE, 14%; freedom from MACE at 30-days, 85%; myocardial infarction (MI; defined as CK-MB > 3x ULN), 14%; non–Q-wave MI, 12%; Q-wave MI, 2%; target vessel/lesion revascularization, 1%; and cardiac death, 1%.

In the company’s press release, Dr. Shlofmitz commented, “Adequate modification of severely calcified plaque is an important step to achieve successful stent delivery and expansion. The Diamondback 360° coronary OAS Micro Crown is designed to engage tight lesions with distal sanding. The results from the COAST IDE study resulted in 99% successful stent delivery and 85% freedom from 30-day MACE.”