COMPLIANCE 360º Economic Evidence | CSI360

COMPLIANCE 360º Economic Evidence

Complaince360-Economic

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)
Minimum
Maximum
OAS+BA success$10,516
$5,390
$21,867
OAS+BA failure$12,030
$12,030
$12,030
BA success$6,951
$5,257
$9,468
BA failure$9,860
$6,529
$31,077
1 Year - cost to treat restenosis
OAS revascular­ization$13,735
$9,491
$18,254
BA revascular­ization$20,609
$19,808
$21,411

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

 

Incremental cost-effectiveness ratio (single-lesion population)

TreatmentCosts (USD)QALYIncremental costs (USD)Incremental QALYICER (USD)
BA$12,9392.17
OAS$13,4872.33$5490.16$3,441

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.


Other Studies

  • ORBIT II Economic Evidence
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    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  
  • CONFIRM Series Economic Evidence
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    The CONFIRM registry series is a database of patients with peripheral artery disease (PAD) who were treated with orbital atherectomy in both office-based laboratories (OBLs) and hospital settings. Statistical analyses assessed the outcomes of atherectomies performed in OBL compared to hospitals. Key Takeaways Final residual stenosis after adjunctive therapy was 10%±11% in the hospital group and 11±17% in the OBL group Dissections occurred in 11.4% of the lesions in the hospital group vs. 6.5% in the OBL group Adjusted logistic regressions showed no difference in any individual or overall complication rate Orbital atherectomy treatment of PAD in an OBL was found comparable to treatment in a hospital setting Study Design Procedural data collected for 3,135 PAD patients at 212 sites in the US treated with OAS for at least one lesion Statistical analyses included Student t test for continuous measures, Chi-square test for categorical measures and logistic regression for complication rates Designed to assess the procedural outcomes of atherectomy in the OBL setting
  • Complaince360-Economic
    COMPLIANCE 360º Economic Evidence
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    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)