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)