HOLLYWOOD, Fla. — An interim demographic analysis of the LIBERTY 360° study population of patients with peripheral artery disease indicates that diabetes, renal disease and black race are more common with more severe disease, according to a presentation at the International Symposium on Endovascular Therapy.
LIBERTY 360° is a prospective, real-world study of more than 1,200 patients with symptomatic PAD that will evaluate clinical and economic outcomes of various endovascular device interventions, Jihad A. Mustapha, MD, FACC, FSCAI, director of cardiovascular catheterization laboratories at Metro Health Hospital in Wyoming, Michigan, said here.
Jihad A. Mustapha
The study population includes 500 patients with intermittent claudication (Rutherford class 2 or 3), 600 with critical limb ischemia (CLI; Rutherford class 4 or 5) and 100 with severe CLI (Rutherford class 6). Mustapha presented demographic data broken down by those categories.
“The high-risk patients, usually with advanced disease including CLI Rutherford class 6, are excluded from [trials of PAD treatments], and that’s been a problem that has limited our ability to study these types of patients,” Mustapha said. “As a result, physicians have limited evidence regarding the use of endovascular devices for this type of advanced disease.”
The trial will include all FDA-approved technologies to treat these populations, will follow patients for up to 5 years and will result in the development of a risk score to guide treatment for such patients, he said.
Outcomes will include procedural and lesion success, rates of major adverse events, wound status, quality of life and an economic analysis.
An interim analysis of the first 600 patients enrolled in the study found that men had higher risk for PAD, including advanced CLI, than women, and that, surprisingly, patients with Rutherford class 6 were younger than ones from less severe classes, Mustapha said.
The racial breakdown “was especially surprising,” he said. “We expected some racial discrepancy. White patients presented for care a lot earlier than black patients, and the difference [in percentage of class 6 black patients vs. percentage of class 2 or 3 black patients] was statistically significant.”
Thirty percent of the Rutherford class 6 population is black vs. 13.7% of the Rutherford class 2 or 3 population, according to Mustapha.
Similarly, Hispanics had higher proportional representation in the class 6 group than in the class 2 or 3 group.
The racial and ethnic discrepancies “warrant further investigation,” he said.
The class 6 group has a higher proportion of patients with diabetes than the other groups, but the difference is even more pronounced for renal disease.
Rates of hypertension and hyperlipidemia are high all around, and rates of prior amputation increase with higher Rutherford class, Mustapha said.
“This [study] will provide unprecedented evidence that [Rutherford class 6] patients can be treated,” he said. – by Erik Swain
Mustapha JA, et al. Concurrent Session V: Late-Breaking Trials and Other Interesting Topics. Presented at: International Symposium on Endovascular Therapy; Feb. 6-10, 2016; Hollywood, Fla.
Disclosure: The study is being funded by Cardiovascular Systems Inc. Mustapha reports receiving consultant and/or medical advisory fees from Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, Cardiovascular Systems Inc., Cook Medical, Medtronic, Spectranetics and Terumo.