E-ISSN 1305-3612
Interventional Radiology - Original Article
Treatment of Femoro-Popliteal Lesions with Scoring- and Drug-Coated-Balloon-Angioplasty 12 months results of the DCB-Trak-Registry
1 CaritasKlinikum St. Theresia Saarbrücken Klinik für Interventionelle Kardiologie/Angiologie Saarbrücken, Germany  
Diagn Interv Radiol ; : -

Abstract

Purpose: Debulking strategies prior to DCB-angioplasty were suggested to improve clinical results in femoro-popliteal lesions. Currently, there are no data regarding plaque modification with a scoring balloon (SBA) with subsequent DCB-angioplasty. Recently published 6-months results of the DCB-Trak registry in patients treated with SBA and DCB-angioplasty were promising without any safety concerns. Herein, we report the 12 months follow-up data.

 

Methods: In a single center registry, 29 consecutive patients with 32 femoro-popliteal lesions were treated with a scoring-balloon (VascuTrak®) and a DCB subsequently. The primary endpoint was the clinically driven target lesion revascularization (TLR). Secondary endpoints were clinically driven target vessel revascularization (TVR), binary restenosis (PSV>2.4), change in rutherford classification and ABI. Safety endpoints were major cardiovascular events (cardiovascular death, MI, stroke, death) and need for amputation.

 

Results: The procedure was successful in 29 lesions. There were no clinically driven TLRs after 12 months. Two patients required clinically driven TVR, one patient had a binary re-stenosis. ABI significantly increased after the procedure (0.87±0.24 to 1.04±0.18, p<0.01) without a relevant change after 6 months (1.01±0.15, n.s.)  or 12 months (1.01±0.20, n.s.). Rutherford classification improved in more than 90% of patients after 6 and 12 months follow-up. There was one major cardiovascular event at 6 months follow-up, but no amputations after 6 or 12 months follow-up.

 

Conclusion: Vessel preparation with a scoring-balloon and subsequent DCB-angioplasty was safe and efficient in patients with femoro-popliteal lesions. Further multi-center trials have to validate these results. 

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