(HealthDay News) — For patients with symptomatic femoropopliteal peripheral artery disease, percutaneous transluminal angioplasty with a paclitaxel-coated balloon is associated with a superior rate of primary patency at 12 months vs. angiography with a standard balloon, according to a study published online June 24 in the New England Journal of Medicine.
Kenneth Rosenfield, MD, from Massachusetts General Hospital in Boston, and colleagues conducted a single-blind randomized trial at 54 sites. Four hundred seventy-six patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions were randomized in a 2:1 ratio to angioplasty with a paclitaxel-coated balloon or standard angioplasty.
The researchers found that the rate of primary patency at 12 months was superior among patients who had undergone angioplasty with the drug-coated balloon vs. conventional angioplasty (65.2 vs. 52.6%; P=0.02). Overall, 83.9 and 79.0% of patients were free from primary safety events with the drug-coated balloon and standard angioplasty, respectively (P=0.005 for noninferiority). No significant between-group differences were seen in functional outcomes, or in the rates of death, amputation, thrombosis, or reintervention.
“Treatment of femoropopliteal peripheral artery disease with a paclitaxel-coated balloon provided superior vessel patency through 12 months, as compared with a strategy of conventional percutaneous transluminal angioplasty with a standard balloon,” the authors write.
The study was funded by Lutonix-Bard, manufacturer of the paclitaxel-coated balloon used in the study.