Study Demonstrates Cost Effectiveness of CSI's Diamondback 360 OAS

April 18, 2016—Cardiovascular Systems, Inc. (CSI) announced that a study published by Jeffrey Chambers, MD, et al in Therapeutic Advances in Cardiovascular Disease concluded that CSI’s Diamondback 360 orbital atherectomy system (OAS) is a highly cost-effective treatment for severely calcified coronary lesions (2016;10:74-85). 

According to CSI, the investigators reported that the Diamondback 360 OAS demonstrated its value across three separate analyses: a cost-savings analysis, an incremental cost-effectiveness ratio calculation (ICER), and a cost-effectiveness plane scatterplot of simulations.

According to the company, the investigators constructed an economic model using outcomes data from the ORBIT II clinical trial and evaluated the index procedure costs, costs at 30 days, and costs at 1 year then compared this data to a cohort of Medicare patients who underwent percutaneous coronary interventions (PCI) (including balloon angioplasty and stenting), which are the standard of care for these patients. The ORBIT II trial demonstrated the safety and effectiveness of the Diamondback 360 OAS in treating patients with severely calcified coronary.

The device offers a cost savings of up to $4,913 when compared to PCI, which is enough to cover the higher cost of the device and still provide a savings of $1,118. This “strongly supports the use of OAS technology for severely calcified patients,” advised the investigators.

The company also noted that the investigators calculated the ICER to determine the overall value of the device and found that even in a low-value scenario, OAS offers a cost per life-year gained of $11,895. In the United States, treatments are generally considered high-value when they cost < $50,000 per life-year gained, and the OAS result was well below that threshold. The economic model predicts that OAS would save an additional 2.6 lives or gain 29.9 life-years per 100 patients. It also predicts the average patient gained 0.36 life-years with OAS.

In Therapeutic Advances in Cardiovascular Disease, the investigators stated, “On average, the documented lower cost with better outcomes, technically termed as ‘dominant,’ suggests that the use of OAS technology is the clear treatment of choice.”

The major cost-saving drivers for OAS included fewer major adverse cardiac events (MACE), fewer complications, a shorter stay in the hospital, and lower costs during the index procedure. Also, patients undergoing OAS were less likely to require revascularization on the same coronary lesion than patients with other interventions (4.9% vs 11.4%).

To determine the cost effectiveness of OAS across a variety of patient scenarios, the researchers conducted a Monte Carlo simulation, which looked at 5,000 simulations varying mortality as low as 1% and as high as 3% and increasing and decreasing cost offsets by 25%. The research concluded that OAS technology would be less costly and more effective than the standard treatment in 58.5% of simulation cases and would be considered cost effective and high value in 99.9% of simulation cases.

The investigators stated, “Given the expectation of better health outcomes in terms of improved survival and fewer MACE episodes, it is highly likely that this intervention will be cost effective from a health system perspective that considers both payer medical care costs and health benefits to patients themselves.”

At the conclusion, study authors write: “The OAS device likely represents both significant clinical and highly cost-effective improvements in the care of patients with severely calcified lesions undergoing PCI.”