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.

The potential cost-effectiveness of the Diamondback 360® Coronary Orbital Atherectomy System for treating de novo, severely calcified coronary lesions: an economic modeling approach.

BACKGROUND: Patients who undergo percutaneous coronary intervention (PCI) for severely calcified coronary lesions have long been known to have worse clinical and economic outcomes than patients with no or mildly calcified lesions. We sought to assess the likely cost-effectiveness of using the Diamondback 360(®) Orbital Atherectomy System (OAS) in the treatment of de novo, severely calcified lesions from a health-system perspective. METHODS AND RESULTS: In the absence of a head-to-head trial and long-term follow up, cost-effectiveness was based on a modeled synthesis of clinical and economic data. A cost-effectiveness model was used to project the likely economic impact. To estimate the net cost impact, the cost of using the OAS technology in elderly (⩾ 65 years) Medicare patients with de novo severely calcified lesions was compared with cost offsets. Elderly OAS patients from the ORBIT II trial (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) [ClinicalTrials.gov identifier: NCT01092426] were indirectly compared with similar patients using observational data. For the index procedure, the comparison was with Medicare data, and for both revascularization and cardiac death in the following year, the comparison was with a pooled analysis of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI)/Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trials. After adjusting for differences in age, gender, and comorbidities, the ORBIT II mean index procedure costs were 17% (p < 0.001) lower, approximately US$2700. Estimated mean revascularization costs were lower by US$1240 in the base case. These cost offsets in the first year, on average, fully cover the cost of the device with an additional 1.2% cost savings. Even in the low-value scenario, the use of the OAS is cost-effective with a cost per life-year gained of US$11,895. CONCLUSIONS: Based on economic modeling, the recently approved coronary OAS device is projected to be highly cost-effective for patients who undergo PCI for severely calcified lesions.

The clinical and cost burden of coronary calcification in a Medicare cohort: An economic model to address under-reporting and misclassification.

BACKGROUND: Coronary artery calcification (CAC) is a well-established risk factor for the occurrence of adverse ischemic events. However, the economic impact of the presence of CAC is unknown. OBJECTIVES: Through an economic model analysis, we sought to estimate the incremental impact of CAC on medical care costs and patient mortality for de novo percutaneous coronary intervention (PCI) patients in the 2012 cohort of the Medicare elderly (≥65) population. METHODS: This aggregate burden-of-illness study is incidence-based, focusing on cost and survival outcomes for an annual Medicare cohort based on the recently introduced ICD9 code for CAC. The cost analysis uses a one-year horizon, and the survival analysis considers lost life years and their economic value. RESULTS: For calendar year 2012, an estimated 200,945 index (de novo) PCI procedures were performed in this cohort. An estimated 16,000 Medicare beneficiaries (7.9%) were projected to have had severe CAC, generating an additional cost in the first year following their PCI of $3500, on average, or $56 million in total. In terms of mortality, the model projects that an additional 397 deaths would be attributable to severe CAC in 2012, resulting in 3770 lost life years, representing an estimated loss of about $377 million, when valuing lost life years at $100,000 each. CONCLUSIONS: These model-based CAC estimates, considering both moderate and severe CAC patients, suggest an annual burden of illness approaching $1.3 billion in this PCI cohort. The potential clinical and cost consequences of CAC warrant additional clinical and economic attention not only on PCI strategies for particular patients but also on reporting and coding to achieve better evidence-based decision-making.