Cost-effectiveness analysis of the orbital atherectomy system: Two-year follow-up

Background: The presence of coronary artery calcification is associated with a significant burden of coronary artery disease along with being a predictor of increased adverse ischemic events. The Diamondback 360® Coronary Orbital Atherectomy System (OAS) is a novel device designed to facilitate treatment of calcified lesions. This study aimed to evaluate the cost-effectiveness of OAS compared to standard treatment.

Methods: A decision tree model utilizing ORBIT II clinical trial and Medicare data from the health system perspective was constructed. Target population was U.S. patients age≥65 with coronary atherosclerosis due to a calcified coronary lesion, both inpatients and outpatients, and combined over a time horizon of two years for costs and lifetime for mortality. OAS was compared to standard treatment (use of balloon angioplasty to prepare stent-placement site). Outcomes were costs of index event and target vessel revascularization in two years, life-years gained, and incremental cost-effectiveness ratios (ICERs).

Results: On average, OAS was projected to cost $1702 less than standard treatment for inpatients, $2360 more than standard treatment for outpatients, and $959 more than standard treatment overall; the projected mortality reduction implies 0.41 life-years gained. Compared to standard treatment, OAS was dominant in an inpatient setting, had an ICER of $5759 per QALY in the outpatient setting, and had an ICER of $2340 per QALY overall. These ICERs are below the accepted threshold for highly cost-effective interventions of $50,000 per QALY.

Conclusions: Compared to standard treatment, OAS is likely to be cost-effective and was projected to be cost-saving in an inpatient setting.

Summary: A decision tree from the health system perspective was used to evaluate the cost-effectiveness of Diamondback 360® Coronary Orbital Atherectomy System (OAS), a novel device designed to facilitate treatment of calcified lesions. OAS was projected to cost $1702 less than standard treatment for inpatients, $2360 more than standard treatment for outpatients, and $959 more than standard treatment overall; the projected mortality reduction implies 0.41 life-years gained. Compared to standard treatment, OAS was dominant in an inpatient setting, had an ICER of $5759 per QALY in the outpatient setting, and overall had an ICER of $2340 per QALY.