Thirty-day results of Cardiovascular System’s Coronary Orbital Atherectomy System Study (COAST) have been reported at a late-breaking presentation at the 2016 Cardiovascular Research Technologies Conference (CRT) in Washington, USA.
This prospective, single-arm, multi-centre, global investigational device exemption trial is desdigned to assess the safety and efficacy of Cardiovasculay System’s Micro Crown orbital atherectomy technology, in treating patients with severely calcified coronary lesions
COAST follows the ORBIT II pivotal trial of the company’s Diamondback 360 coronary OAS classic crown, which received PMA approval from the US Food and Drug Administration (FDA) in 2013 as a primary treatment for severely calcified coronary arteries when facilitating stent delivery.
CSI completed COAST enrolment of 100 patients, including 74 patients at 12 sites in the United States and 26 patients at five sites in Japan, in July 2015.
Richard A Shlofmitz of St Francis Hospital in Roslyn, USA, presented the 30-day results, including the primary endpoints of procedural success and the freedom from major adverse cardiac events (MACE), including target lesion revascularisation (TLR) at 30 days after the procedure.
COAST 30-day outcomes:
Procedural success: 85.0%
Successful stent delivery: 99.0%
Less than 50% residual stenosis: 99.0%
In-hospital major adverse cardiac events (MACE): 14.0%
Freedom from MACE (30-Day): 85.0%
Myocardial infarction (defined as creatine kinase-MB fraction as more than three times the upper limit of normal): 14.0%
Non Q-wave: 12.0%
Target vessel/lesion revascularisation: 1.0%
Target lesion revascularisation: 1.0%
Cardiac death: 1.0%
“Adequate modification of severely calcified plaque is an important step to achieve successful stent delivery and expansion,” says Shlofmitz. “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.”