Drug-Coated Balloon Angioplasty for Femoropopliteal In-Stent Restenosis.

Cassese, Salvatore; Wolf, Florian; Ingwersen, Maja; Kinstner, Christian M; Fusaro, Michele; Ndrepepa, Gjin; Ibrahim, Tareq; Ott, Ilka; Lammer, Johannes; Krankenberg, Hans; Fusaro, Massimiliano

doi:10.1161/CIRCINTERVENTIONS.118.007055

2018

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Document type:: Article; Journal Article
Author(s):: Cassese, Salvatore; Wolf, Florian; Ingwersen, Maja; Kinstner, Christian M; Fusaro, Michele; Ndrepepa, Gjin; Ibrahim, Tareq; Ott, Ilka; Lammer, Johannes; Krankenberg, Hans; Fusaro, Massimiliano
Title:: Drug-Coated Balloon Angioplasty for Femoropopliteal In-Stent Restenosis.
Abstract:: BACKGROUND: The optimal revascularization therapy for in-stent restenosis (ISR) of femoropopliteal arteries represents a matter of debate. We investigated the outcomes of patients treated with drug-coated balloon (DCB) angioplasty for ISR of femoropopliteal arteries. METHODS AND RESULTS: Patient-level data from 3 randomized trials of DCB angioplasty for ISR of femoropopliteal arteries were pooled. The primary outcome was target lesion revascularization. The main secondary outcome was recurrent ISR. Other outcomes of interest were ipsilateral amputation, death, Rutherford class improvement, and ankle-brachial index at follow-up. A total of 263 patients randomly assigned to DCB (n=133) or plain balloon angioplasty (n=130) were included in the analysis. After a follow-up of 12 months, patients treated with DCB angioplasty displayed a lower risk for target lesion revascularization (hazard ratio [95% CIs]: 0.25 [0.14-0.46]; P<0.001) and recurrent ISR (0.19 [0.10-0.35]; P<0.001) as compared with those treated with plain balloon angioplasty. There was no significant interaction between the treatment effect for target lesion revascularization and high-risk subgroups of patients such as those with diabetes mellitus, longer lesions, small vessels, moderate to severe underlying calcification, and occlusive pattern of ISR. DCB and plain balloon angioplasty were comparable with respect to other secondary outcomes. CONCLUSIONS: In case of femoropopliteal ISR, the percutaneous treatment with DCB angioplasty is associated with superior clinical and antirestenotic efficacy as compared with plain balloon angioplasty at 1-year follow-up, without attrition of efficacy in high-risk subgroups of patients. The long-term durability of DCB angioplasty in this setting remains to be further investigated.
Journal title abbreviation:: Circ Cardiovasc Interv
Year:: 2018
Journal volume:: 11
Journal issue:: 12
Fulltext / DOI:: doi:10.1161/CIRCINTERVENTIONS.118.007055
Pubmed ID:: http://view.ncbi.nlm.nih.gov/pubmed/30562083
Print-ISSN:: 1941-7640
TUM Institution:: I. Medizinische Klinik und Poliklinik (Kardiologie); Klinik für Herz- und Kreislauferkrankungen im Erwachsenenalter (Prof. Schunkert)
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mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Klinik und Poliklinik für Innere Medizin I, Kardiologie (Prof. Laugwitz)2018

mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Lehr- und Forschungskooperationen mit den Kliniken und Instituten am Deutschen Herzzentrum Klinik für Herz- und Kreislauferkrankungen im Erwachsenenalter (DHM) (Prof. Schunkert)2018