COMPLIANCE 360 Study | CSI360
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COMPLIANCE 360º

Compliance360

A prospective, randomized, multi-center study that compared the acute and long-term results of Orbital Atherectomy System (OAS) + percutaneous transluminal angioplasty (PTA) versus PTA alone in calcified above-the-knee (ATK) lesions.

Key Takeaways

  • Lower mean maximum balloon inflation pressure in OAS+PTA arm
  • Lower adjunctive stent rate in OAS+PTA arm
  • OAS demonstrated reduced stenting with durable results out to 12 months versus PTA alone

Study Design

  • 50 patients enrolled at 9 U.S. sites
  • Patients randomized to either OAS+PTA (25 pts) or PTA alone (25 pts) and followed for 12 months

Patient Population

ComorbidityOAS + PTA
N = 25		PTA Alone
N = 25		p-value
Mean Age ± SD68.0 ± 11.071.3 ± 10.50.27
Female gender, n (%)18 (72)16 (64)0.76
Non-Caucasian, n (%)9 (36)4 (16)0.19
Coronary artery disease, n (%)12 (48)16 (64)0.39
Diabetes, n (%)18 (72)10 (40)0.05
Hypertension, n (%)22 (88)18 (72)0.29
Hyperlipidemia, n (%)23 (92)21 (84)0.67
Smoker
(current or former), n (%)		22 (88)22 (88)>0.99

Study Results

Compliance Mean Maximum Balloon Inflation Pressure | amCharts
Compliance Adjunctive Stenting | amCharts

 

 

Compliance Patency at 12 Months | amCharts

Patency definition: Freedom from TLR or restenosis (Peak Systolic Velocity Ratio (PSVR) ≥2.5)

Dattilo R, et al. 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(8):355-60.

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