COMPLIANCE 360º Economic Evidence

The clinical outcomes from COMPLIANCE 360º5 – a prospective, multicenter, randomized pilot study comparing Diamondback 360® Peripheral Orbital Atherectomy System (OAS) + balloon angioplasty (BA) vs. BA alone for treatment of calcified femoropopliteal lesions – were correlated with cost data and published quality of life data.

Key Takeaways

  • Stent utilization was higher with BA-alone treatment for all patients
  • Stent placement effects subsequent procedures and increases the costs for reintervention, while limiting future treatment options
  • The 1-year incremental cost of OAS+BA vs. BA alone was USD $549, resulting in an incremental cost-effectiveness ratio (ICER) of USD $3,441

Study Design

  • Utilized data from COMPLIANCE 360º study subjects from nine US centers
  • Study subjects who met all inclusion criteria and no exclusion criteria were equally randomized into the two study arms, one for OAS followed by BA and one for BA alone
    • Key inclusion criterion: Rutherford Class  2-4 patients who had de novo lesions of ≥70% stenosis and fluoroscopically visible calcium
  • Analyzed OAS+BA and BA-alone procedure charges, procedure time, length of stay, and stent and balloon utilization
    • Utilized uniform billing statements (UB-04s) for hospital charges, site of service and associated medical resource utilization (MRU)
  • Constructed a decision tree based on procedural success and outcomes through 1 year with endpoints of patency, target lesion revascularization or target vessel revascularization, and claudication with no subsequent treatment

Patient Population:

  • OAS+BA study arm: 25 subjects with 38 lesions (17 outpatient and 8 inpatient procedures)
  • BA-alone study arm: 25 subjects with 27 lesions (19 outpatient and 6 inpatient procedures)

Estimated procedure costs and future costs (single-lesion population)

Index ProcedureMean Cost (USD)
Range (USD)
OAS+BA success$10,516
OAS+BA failure$12,030
BA success$6,951
BA failure$9,860
1 Year - cost to treat restenosis
OAS revascular­ization$13,735
BA revascular­ization$20,609

Abbreviations: BA, balloon angioplasty; OAS, orbital atherectomy system.


Incremental cost-effectiveness ratio (single-lesion population)

TreatmentCosts (USD)QALYIncremental costs (USD)Incremental QALYICER (USD)

Abbreviations: BA, balloon angioplasty; OAS, orbital atherectomy system; QALY, quality-adjusted life years; ICER, incremental cost-effectiveness ratio

Weinstock B, Dattilo R, & Diage T. Cost-effectiveness analysis of orbital atherectomy plus balloon angioplasty vs balloon angioplasty alone in subjects with calcified femoropopliteal lesions. Clinicoecon Outcomes Res. 2014;6:133-139.

Dattilo R, Himmelstein SI, Cuff RF. The COMPLIANCE 360 Trial: A randomized, prospective, multicenter, pilot study comparing acute and long-term results of orbital atherectomy to balloon angioplasty for calcified femoropopliteal disease. J Invasive Cardiol. 2014;26:355-360.

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