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Abstract

Objectives

To evaluate 36-month outcomes of drug-eluting balloons in infrapopliteal (=below-the-knee) arterial segments, we made a prospective registry enrolling patients (Rutherford class 2 to 5, ankle–brachial index 0.4–0.7) who were revascularized with drug-eluting balloon from August 2011 to December 2014.

Methods

Three hundred and seven infrapopliteal arteries were revascularized only with drug-eluting balloon. Endpoints included target lesion revascularization, primary patency rate, and changes in ankle–brachial index and Rutherford class.

Results

Both ankle–brachial index improvement and Rutherford reduction were statistically significant (p < 0.001). At 36 months control, ankle–brachial index improvement was 59.3% (p = 0.032). The clinically driven target lesion revascularization rate was 28% at 36 months. Limb salvage was accomplished in 73.6% of the critical limb ischemia cases, and complete wound healing was detected in 67.8% of cases with Rutherford category 5. Overall, the 1-year primary patency rate was 32.5%.

Conclusions

Drug-eluting balloons have shown successful performance in infrapopliteal arteries in mid-term, and evidence regarding clinical effectiveness and safety supports drug-eluting balloon angioplasty as the first line therapy in this segment.

Keywords

Drug-eluting balloons peripheral arterial disease atherosclerosis claudication femoropopliteal arteries angioplasty

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Thirty-six-month outcomes of drug-eluting balloon angioplasty in the infrapopliteal arteries

Abstract

Objectives

Methods

Results

Conclusions

Keywords

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