Cardiovascular Systems has released two-year data from its ORBIT II study of the company’s Diamondback 360 coronary orbital atherectomy system (OAS) in treating severely calcified lesions in a late-breaking presentation at the at the 2015 Cardiovascular Research Technologies (CRT) conference in Washington, DC, USA.
CSI completed ORBIT II enrolment of 443 patients at 49 US medical centres in November 2012. The pivotal study evaluated the safety and efficacy of the company’s orbital atherectomy technology in treating patients with de novo severely calcified coronary lesions. ORBIT II was the first investigational device exemption study in history to evaluate this problematic subset of patients. In October 2013, CSI received pre-market approval from the US Food and Drug Administration (FDA) to market its Diamondback 360 Coronary OAS as a treatment for severely calcified coronary arteries.
Jeffrey Chambers of Metropolitan Heart and Vascular Institute, USA, highlighted new data that demonstrated low major adverse cardiac events rates, including target lesion revascularisation and target vessel revascularisation, at two years for this difficult-to-treat patient population.
“ORBIT II two-year data reaffirms that Cardiovascular Systems’ orbital atherectomy technology is a safe and effective treatment option for severely calcified arteries,” said Chambers. “Results continue to show the clinical and economic benefits of this device. Furthermore, we now know that using the coronary OAS device prior to stent placement in severely calcified arteries has shown positive long-term results in a complex and problematic patient population.”
Chambers presented the following two-year data:
- Major adverse cardiac events (two-year)* = 19.4%
- Myocardial infarction (CK-MB >3x ULN)* = 9.7%
- Non Q-wave = 8.8%
- Q-wave = 0.9%
- Target vessel/lesion revascularisation = 8.1%
- Target vessel revascularisation = 2.9%
- Target lesion revascularisation = 6.2%
- Cardiac death = 4.3%
*Based on reported CK-MB > 3X ULN
Long-term patient outcomes are critical to understanding rates of hospital readmission when evaluating cost savings for the treating institutions and overall healthcare system. The Diamondback 360 has been associated with a lower length of stay for patients when the device was used to treat severely calcified lesions compared to treating without the Diamondback 360. A lower incidence of readmission and lower length of stay provide an estimated cost savings in excess of US$3,100 per patient to the treating institution.
“The two-year results of the ORBIT II study continue to demonstrate positive results following treatment with the Diamondback 360 device in treating severely calcified arteries,” said David L Martin, Cardiovascular Systems president and chief executive officer. “Coronary arterial calcium often results in poor clinical outcomes and higher treatment costs, but our two-year results demonstrate significant improvements in both of these areas when our orbital atherectomy technology is employed.”