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08.07.2019 | Clinical Investigation | Ausgabe 10/2019

CardioVascular and Interventional Radiology 10/2019

Drug-Coated Balloon Angioplasty of Infrapopliteal Lesions in Patients with Critical Limb Ischaemia: 1-Year Results of the APOLLO Trial

Zeitschrift:
CardioVascular and Interventional Radiology > Ausgabe 10/2019
Autoren:
Ulf Teichgräber, Thomas Lehmann, Marcus Thieme, Kersten-Uwe Wahl, Christian Stelzner, Albrecht Bormann, Linda Götz, Tobias Kroeßner, Harald Boden, Lars Maiwald, René Aschenbach
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Abstract

Purpose

This study intended to assess effectiveness and safety of the drug-coated balloon (DCB) angioplasty of infrapopliteal atherosclerotic lesions in patients with critical limb ischaemia (CLI) in a real-world setting.

Methods

Consecutive patients with critical limb ischaemia who underwent infrapopliteal drug-coated balloon angioplasty with the ELUTAX SV DCB were enrolled into the prospective, multicentre, single-arm observational registry. Primary outcome was clinical improvement at 6 and 12 months. Secondary outcomes were change in quality of life, primary patency, freedom from repeat revascularisation, and amputation-free survival at 6 and 12 months.

Results

A total of 164 patients (74.7 ± 9.2 years) with CLI were included at nine German sites between November 2015 and September 2017. The majority (79.9%) of patients had diabetes mellitus, 57.3% had renal insufficiency, and 35.3% had coronary artery disease. Mean lesion length was 71.2 ± 76.5 mm. The Rutherford category improved by 3.0 ± 2.0 (p < 0.0001) within 12 months, resulting in a clinical improvement by at least one Rutherford category in 80.2% of the patients. Walking impairment questionnaire score, European Quality of Life index, and patient-reported pain improved significantly from baseline to 6 and 12 months. Primary patency was 68.5%, freedom from target lesion revascularisation 90.6%, and amputation-free survival 83.5% at 12 months.

Conclusion

Infrapopliteal drug-coated balloon angioplasty with the ELUTAX SV DCB in patients with critical limb ischaemia was efficacious and safe over the medium term. The study is registered with Clinical.Trials.gov (Identifier: NCT02539940).

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