Lower Early Restenosis Rate With Drug-Eluting Balloons

DEB is effective for treating long infrapopliteal lesions in terms of restenosis, clinical outcome

WEDNESDAY, Aug. 31 (HealthDay News) -- Drug-eluting balloons (DEBs) seem to be safe and effective for treating long infrapopliteal lesions, according to a study published online Aug. 29 in the Journal of the American College of Cardiology.

Andrej Schmidt, M.D., from Park Hospital Leipzig in Germany, and colleagues examined the efficacy of DEBs for treating long infrapopliteal lesions with regard to the short-term restenosis rate and midterm clinical result. In 104 patients, 109 limbs were treated for critical limb ischemia or severe claudication (82.6 and 17.4 percent, respectively), and infrapopliteal angioplasty was performed with a paclitaxel-eluting balloon. The mean lesion length of the arteries treated was 176 ± 88 mm. Binary restenosis was assessed in 84 arteries during clinical and angiographic follow-up at three months, with subsequent clinical assessment over a 12-month period.

The investigators found that in angiography carried out at three months, 27.4 percent of the arteries had a restenosis (19.1 percent had restenosis of more than 50 percent, 8.3 percent were totally occluded), and these usually occurred focally. The entire treated segment was restenosed or reoccluded in only 9.5 percent of all angiographically followed-up arteries. Clinical improvement was found in 83 out of 91 limbs that remained in the analysis, after one patient was lost and 17 died during 378 ± 65 days of follow-up. Complete wound healing took place in 74.2 percent of patients, with four patients undergoing major amputation, resulting in limb salvage of 95.6 percent for patients with critical limb ischemia.

"The early restenosis rate of long-segment infrapopliteal disease is significantly lower after treatment with DEBs compared with historical data using uncoated balloons," the authors write.

Two of the study authors disclosed financial ties with Medtronic.

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