A study of peripheral vascular interventions in patients with peripheral artery disease (PAD) has demonstrated “high freedom” from major amputation at three years, according to study sponsor Cardiovascular Systems.
The Liberty 360° study enrolled more than 1,200 patients at 51 sites across the U.S. It followed patients across the spectrum of symptomatic PAD, and included 100 patients with the most severe form of critical limb ischemia (CLI). Although most patients were treated with St. Paul, Minn.-based Cardiovascular Systems’ orbital atherectomy system (OAS), the study was open to patients treated with any FDA-cleared endovascular device for the treatment of PAD.
The study showed that 98.5% of patients with claudication, 93.9% of patients with critical limb ischemia and nearly 80% of patients with severe critical limb ischemia were free from major amputation at three years. A sub-analysis of outcomes in patients treated with Cardiovascular Systems’ OAS showed that 100% of patients with claudication, 95.3% of patients with critical limb ischemia and 88.6% of patients with severe critical limb ischemia had no additional amputations after the two-year visit.
Dr. Jihad A. Mustapha of Advanced Cardiac & Vascular Amputation Prevention Centers in Grand Rapids, Michigan, presented the study results in a late-breaking session at the 2019 Amputation Prevention Symposium (AMP) in Chicago.
The study was among the first to investigate patients across the spectrum of symptomatic PAD and will assess numerous parameters including procedural success, rate of major adverse events, duplex ultrasound findings, quality of life, six-minute walk test, wound status and economic outcomes, according to Cardiovascular Systems.
“Liberty 360° represents as close to a real-world experience as possible with various endovascular strategies across Rutherford Classifications,” Mustapha said in a news release. “In addition to demonstrating durable clinical outcomes, Liberty 360° also demonstrated a positive quality-of-life impact to the PAD patients in the study. Quality-of-life scores improved significantly by 30 days post-procedure and were maintained out to three years.
“The durable outcomes from the endovascular-first approach demonstrated in Liberty 360° are indicative of key findings from other recent studies published in the Journal of the American Heart Association and Circulation: Cardiovascular Quality and Outcomes,” Mustapha added. “Compared to primary amputation, revascularization approaches have shown to be associated with longer survival time, lower risk of subsequent amputation, and lower healthcare costs. Furthermore, within revascularization strategies, an endovascular approach has been associated with a lower risk of amputation than surgical bypass. Additionally, the importance of atherectomy as a treatment option for CLI is being reinforced based on a new analysis of Medicare data that I first presented at AMP where atherectomy showed statistically lower rates of mortality and major amputation relative to percutaneous transluminal angioplasty, stent placement, or surgical bypass among patients with CLI.”
“The body of evidence in the field of peripheral arterial disease is building and yielding new insights for the optimal care of patients,” said Cardiovascular Systems president & CEO Scott Ward. “CSI is committed to serving as a leader in the study of PAD and CLI patients and to continually advancing the technology used to treat this underserved patient population.”