Peripheral artery disease (PAD) affects an estimated 8 million people in the U.S. However, severity of symptoms can vary widely.
Patients with relatively mild PAD may experience cramping in their limbs during exercise—known as claudication. Patients with the most severe PAD are afflicted with ischemic ulcers and gangrene as cells and tissues that are deprived of oxygen-rich blood begin to die.
Several devices, like stents or balloons, are available to help relieve the blockages that cause PAD. But because most of the data on their use comes from clinical trials aimed at regulatory approval, and because such trials utilize patients with a relatively standardized severity of symptoms, there is often little guidance for clinicians whose patients have milder or more severe PAD.
One UNC REX Healthcare doctor is leading the effort to change that.
George Adams, MD, MHS, Director of Cardiovascular and Peripheral Vascular Research at UNC REX Hospital, is leading a prospective, observational, multicenter study called LIBERTY 360. In February 2016, the study completed enrollment 1,204 patients at 51 sites across the U.S. The enrolled patients had symptoms that ranged from mild to severe (physicians use the Rutherford scale to rate severity) requiring endovascular treatment for an arterial blockage located within the target area beginning slightly above the knee, through the foot.
“In the guidelines currently, you are supposed to manage the symptoms of patients with mild PAD and amputate in the most severe cases,” said Adams. “So the question we’re trying to answer is if we accept all classes of patients, what can we do for them and what is the outcome?”
The study hopes to gather data on the clinical and economic impact of endovascular device interventions – like stents or balloons – by following patients for up to five years. During that time, patient risk scores will be developed as a clinical predictor of outcomes to provide guidance for future interventions.
Initial 30-day results, which Adams recently presented in a late-breaking presentation at the Amputation Prevention Symposium in Chicago, have already suggested a new way of looking at treatment.
The results saw quality of life improvements in patients from across the Rutherford scale. “The take home message is maybe we should be intervening earlier and trying to intervene in more severe cases,” said Adams.
Ideally, intervening with endovascular devices among a wider range of patients will improve outcomes all around, including reducing the number of amputations required in patients with the most severe PAD. But for now more data need to be gathered.