ORBIT II Economic Evidence | CSI360

ORBIT II Economic Evidence

Orbit II Clinical study

ORBIT II10 Cost-Effectiveness Analysis

The analysis model looked to determine the cost-effectiveness of using the Diamondback 360® Coronary Orbital Atherectomy System (OAS), compared to Medicare data and patients in the HORIZONS-AMI and ACUITY trials, in the treatment of de novo, severely calcified lesions.

Key Takeaways

  • The ORBIT II mean index procedure costs were 17% lower, approximately $2,700
  • Estimated mean revascularization costs were lower by $1,240 in the base case
  • The cost offsets in the first year, on average, fully cover the cost of the device with an additional 1.2% cost savings
  • The study presents low-value and high-value scenarios and concludes that in even the most pessimistic scenario, OAS offers good value with a cost per life-year gained of $11,895
  • For PCI patients with severely calcified coronary lesions, OAS technology is likely to result in lower inpatient costs, particularly for the initial procedure and first 30 days

Study Design

  • 297 patients ≥65 years from the ORBIT II trial of 443 patients
  • Indirectly compared to Medicare data of similar patients (n=308) using observational data for index procedure
  • For revascularization and cardiac death in the following year, used a pooled analysis of the HORIZONS-AMI and ACUITY trials
  • Primary objective: assess the potential cost-effectiveness of the Diamondback 360 OAS for severe coronary artery calcification by modeling:
    • Expected cost offsets during the acute and post-acute care periods
    • Potential reduction in patient mortality and morbidity
    • The comparison of mortality and morbidity impacts relating to the overall cost impact of device use

Variable/MeasureORBIT II (n=297)Medicare (n=308)
Mean age (years)74.6
Age Distribution (%)






Women (%)37.034.7
Mean Charlson comorbidity index1.12.6
Outpatient (%)48.255.8

Values are mean unless otherwise specified.

Orbit II Econ Evidence One Year Incidence | amCharts
Orbit II Econ Evidence Mean Procedure Costs | amCharts

Chambers JW, Feldman RL, Himmelstein SI, Bhatheja R, Villa AE, Strickman NE, Shlofmitz RA, Dulas DD, Arab D, Khanna PK, Lee AC, Ghali MGH, SHah RR, Davis TP, Kim CY, Tai Z, Patel KC, Puma JA, Makam P, Bertolet BD, Nseir GY. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II). J Am Coll Cardiol Intv. 2014;7:510-518.

Chambers J, Généreux P, Lee A, Lewin J, Young C, Crittendon J, Mann M & Garrison, LP. The potential cost-effectiveness of the Diamondback 360® Coronary Orbital Atherectomy System for treating de novo, severely calcified coronary lesions: an economic modeling approach. Ther Adv Cardiovasc Dis. 2016;10:74-85.

Généreux P, Madhavan M, Mintz G, Maehara A, Palmerini T, Lasalle L, et al. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes: pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Trials. J Am Coll Cardiol. 2014;63:1845–1854.

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