A meta-analysis of randomized trials found that treating infrapopliteal arteries with drug-coated balloons was associated with similar clinical outcomes and favorable angiographic efficacy compared with using uncoated balloons or drug-eluting stents.

Lead researcher Salvatore Cassese, MD, PhD, of the German Heart Center in Munich, and colleagues published their findings online in the Journal of the American College of Cardiology: Cardiovascular Interventions on April 27.

The researchers noted that guidelines recommend the use of uncoated balloon angioplasty as first-line treatment in patients with clinically relevant atherosclerotic disease of the infrapopliteal arteries.

For this analysis, they searched databases, scientific sessions abstracts and relevant websites to identify randomized trials that evaluated clinical and angiographic outcomes associated with drug-coated balloon-based revascularization in patients with atherosclerotic disease of the infrapopliteal arteries.

They evaluated 641 patients from five studies. Of the patients, 378 received drug-coated balloons and 263 received uncoated balloons or drug-eluting stents.

After a median follow-up period of 12 months, the groups had similar risks for target lesion revascularization, amputation, death, major adverse events and Rutherford class 5 or 6. In addition, lesions treated with drug-coated balloons showed lower late lumen loss than those treated with uncoated balloons or drug-eluting stents.

Target lesion revascularization occurred in 23.6 percent of patients (18.3 percent in the drug-coated balloon group vs. 29.1 percent in the control group); amputation occurred in 14.6 percent of patients (13.3 percent vs. 14.9 percent); death occurred in 11.5 percent of patients (11.4 percent vs. 10.6 percent); major adverse events occurred in 37.2 percent of patients (29.9 percent vs. 38.5 percent); and 62 percent of patients reported Rutherford class 5 or 6 (66.0 percent vs. 55.6 percent).

The researchers cited a few limitations of the study, including that it relied on aggregate data and evaluated difference devices. They also noted that the protocol mandated surveillance angiography, which could have magnified the differences in the absolute proportion of revascularizations across groups. In addition, they mentioned that they did not perform a cost-effective analysis comparing drug-coated balloons with uncoated balloons or drug-eluting stents.

“Further studies in larger numbers of patients receiving standardized wound care management and longer follow-up are still required to disclose the role of DCBs in atherosclerotic disease of the infrapopliteal arteries,” the researchers wrote.