LIBERTY 360 degrees sub-analysis shows high freedom from adverse events with orbital artherectomy

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Diamondback 360

A new sub-analysis from Cardiovascular System’s LIBERTY 360 study supports the use of the company’s Diamondback 360 peripheral orbital atherectomy system (OAS) during endovascular intervention for Rutherford Class 2–6 patients.

The results were presented as part of a late-breaking presentation at the 2017 Amputation Prevention Symposium (AMP) in Chicago, USA.

The LIBERTY 360° study is designed to evaluate the acute and long-term clinical and economic outcomes of peripheral vascular interventions (PVI) in patients with symptomatic lower extremity peripheral artery disease (PAD). Physicians were able to use any US Food and Drug Administration (FDA)-approved device, including CSI’s Diamondback 360 Peripheral OAS, which was the most frequently used atherectomy device in the study.

The sub-analysis highlights 12-month freedom from major adverse events (MAE) and major amputation.

In a post hoc analysis, patients treated with OAS as part of their PVI showed high freedom from MAE in all groups with statistically similar MAE outcomes at 12 months in RC 4-5 and RC 6, as well as high freedom from major amputation in all Rutherford Classes (RC 2-3, 100%; RC 4-5, 95.8%; and RC 6, 91.2%).

Table 1: High freedom from MAEs at 12 months in patients treated with OAS across all Rutherford Classes. Kaplan-Meier method used to estimate event-free rates. MAE defined as death (≤30 days after index procedure), major amputation of the target limb, and TVR.

In addition, patients receiving vessel prep with OAS prior to drug-coated balloon (DCB) therapy resulted in high freedom from MAE (95.2%; N=21) at 12 months with no major amputations reported.

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