Paclitaxel-Eluting Balloon Results in High Patency Rate at 1 Year in Below-the-Knee Lesions

MIAMI BEACH, FLA.—In patients with critical limb ischemia or life-limiting claudication, use of a drug-eluting balloon to treat below-the-knee arterial lesions is safe, feasible and produces favorable clinical results at 1 year, according to results from a single-center trial.

Grigore Popusoi, MD, of Montevergine Clinic in Mercogliano, Italy, presented the data on 75 consecutive patients who were treated with balloon angioplasty for below-the-knee arterial lesions at his institution between December 2008 and December 2010. All 98 lesions were treated initially with predilation using an undersized standard balloon followed by a paclitaxel-eluting balloon (In.Pact Amphirion, Medtronic).

Procedural success as measured by angiographic evidence of restored antegrade flow was 94%, with bail-out stenting for flow-limiting dissection or abrupt target vessel occlusion required in 10%. At 1-year follow-up, the primary patency rate was 84% with a secondary patency rate of 94% and a limb salvage rate of 96%. “This suggests that previous randomized controlled trials [of this treatment] are reproducible in the real-world population,” Popusoi told TCT Daily.

Procedural complications included distal embolization (2.5%), access site complication (1.5%) and one in-hospital death. At 12 months, the rate of angiographic restenosis was 24%, with nine symptomatic patients requiring reintervention.

Safety, efficacy confirmed

According to Popusoi, the main goals in restoring flow in below-the-knee ischemic vascular disease are to relieve pain, allow wound healing, regain or maintain ambulatory ability and potentially prolong survival. Endovascular treatment should be considered before surgery in these patients, he said, because it is associated with lower morbidity and mortality risk, especially in the growing population of patients with multiple cardiovascular risk factors, such as diabetes, kidney failure, and older age.

Balloon angioplasty continues to be the established endovascular treatment for below-the-knee lesions, he said, adding that the study “confirms the safety and effectiveness of [drug-eluting balloons] for the treatment of below-the-knee arterial lesions. Indeed, it may be time for the wide use of [drug-eluting balloons] for these lesions,” Popusoi concluded.

Study details

At baseline, the majority of patients were Rutherford class 4 or 5 and the mean treated lesion length was 89±25 mm. In 47% of patients, the total occlusion was the target lesion, and knee arteries had been previously treated in 22 cases. The target lesion sites varied: popliteal (n=17), anterior tibial artery (n=28), posterior tibial artery (n=23) and peritoneal artery (n=16).

Disclosures
  • Dr. Popusoi reports no relevant conflicts of interest.

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