LIBERTY 360° Subanalysis Evaluates CSI's Diamondback 360 Peripheral OAS
August 10, 2017—Cardiovascular Systems, Inc. announced that a new subanalysis from the company's LIBERTY 360° study was presented as part of a late-breaking presentation at AMP 2017, the Amputation Prevention Symposium held August 9–12 in Chicago, Illinois.
The LIBERTY 360° study is designed to evaluate the acute and long-term clinical and economic outcomes of peripheral vascular interventions (PVIs) in patients with symptomatic lower extremity peripheral artery disease. Physicians were able to use any device approved by the US Food and Drug Administration, including CSI’s Diamondback 360 peripheral orbital atherectomy system (OAS), which was the most frequently used atherectomy device in the study.
According to the company, the subanalysis, composed of 493 patients, supports the value of the Diamondback 360 OAS during endovascular intervention for Rutherford classification 2 to 6 patients.
In the post hoc analysis of LIBERTY 360°, patients treated with the OAS as part of the PVI showed high freedom from major adverse events (MAEs) in all groups, including statistically similar MAE outcomes at 12 months in the setting of Rutherford classification 4 to 5 and 6, as well as high freedom from major amputation in all Rutherford classifications. MAEs were defined as death (≤ 30 days after index procedure), major amputation of the target limb, and target vessel revascularization.
For Rutherford classification 2 to 3 (n = 211), 4 to 5 (n = 226), and 6 (n = 56), respectively, the 12-month data showed overall freedom from MAEs of 87%, 75.9%, and 71.2%; freedom from major amputation of 100%, 95.8%, and 91.2%; freedom from target vessel revascularization of 87.9%, 78.9%, and 78.2%; and freedom from death (inclusive of all deaths after 30 days) of 97.1%, 91.1%, and 82.9%. The Kaplan-Meier method was used to estimate event-free rates.
In addition, patients who underwent vessel preparation with the OAS before drug-coated balloon therapy had high freedom from MAE rates (95.2%; n = 21) at 12 months with no reported major amputations, stated CSI.