Positive results in study of Diamondback 360 OAS in CAD patients-Cardiovascular Systems

New data from the ORBIT II trial of the Diamondback 360 Orbital Atherectomy System (OAS) catheter, from Cardiovascular Systems, shows positive results in CAD patients with severely calcified plaque in the coronary arteries prior to stenting. ORBIT II is the first atherectomy study to exclusively investigate severely calcified lesions. It included patients who are usually excluded from large clinical trials, such as patients on hemodialysis or with low left ventricular ejection fraction (<25 percent.>

In patients treated with percutaneous coronary intervention (PCI), calcified lesions may prevent the stent from fully expanding in the artery and patients may need a repeat coronary intervention or coronary artery bypass graft surgery (CABG). The device's eccentric crown creates an elliptical orbit in the artery to sand the calcified portion of the plaque into minuscule particles.

Results showed 19.4 percent of patients experienced a major adverse cardiac event (MACE), including cardiac death (4.3 percent) and the need for a repeat procedure to open the target vessel (8.1%). Further, the study found similar rates of MACE in both diabetic and non-diabetic patients, even though diabetics typically have higher rates of MACE than non-diabetics post-PCI.

A cost analysis presented by study investigators found OAS is a cost-effective treatment at one year. The Diamondback 360 OAS was FDA approved in 2013. For the clinical trial, investigators enrolled 443 patients at 49 US sites. Data were presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 2015 Scientific Sessions.