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Title: Restenosis in Leg Arteries Prevented With Use of Drug-Eluting Balloon Catheters: Presented at ISET

"Restenosis in Leg Arteries Prevented With Use of Drug-Eluting Balloon Catheters: Presented at ISET"

By Ed Susman HOLLYWOOD, FL -- February 1, 2007 -- The use of drug-eluting balloon catheters appears to prevent leg restenosis when compared with angioplasty for treatment of blockages in leg arteries, researchers said here at the 19[^th International Symposium on Endovascular Therapy (ISET).

Angioplasty to open occluded superficial femoral and/or popliteal arteries in the legs has been tried previously, but historically, these blood vessels tend to re-stenose rapidly. Failure to keep these arteries open can make walking difficult and can lead to amputation.

Animal studies suggested that use of balloons coated with paclitaxel (Taxol) appeared to slow or halt the restenosis process.

"Paclitaxel-coated balloons could significantly reduce the restenosis rate after angioplasty in the superficial femoral and in the popliteal artery," said study presenter Gunnar Tepe, MD, assistant professor of radiology, University of Tuebingen, Germany.

In his study of 102 patients who received either standard angioplasty or angioplasty with paclitaxel-eluting balloon catheterization, the patients treated with the coated-balloons had significantly less restenosis and less need for repeat procedures.

Patients were eligible to be enrolled in the multicenter trial if they had stenosis or an occlusion of the superficial femoral artery and/or popliteal artery. The blockages had to be minimum length of 2 cm. The primary endpoint of the study was late lumen loss.

Patients receiving the coated-balloons experienced an average of 0.4 mm of late lumen loss at the 6-month evaluation. However, in the patients given angioplasty with uncoated balloons, late lumen loss was 1.7 mm. The difference between the two groups was significant, producing a P < .05 value, Dr. Tepe said in his oral presentation on January 30^th.

Compared with controls, patients who were treated with the coated-balloons also came away with significantly better results in minimal lumen diameter, rate of binary restenosis, and need for re-interventions due to target vessel revascularization (P < .05).

"No major side effects were seen which were attributed to the local treatment with paclitaxel," Dr. Tepe said.

[Presentation title: Drug-Coated Balloons for the Prevention of SFA Restenosis.]

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