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CardioVascular and Interventional Radiology
Published in: CardioVascular and Interventional Radiology 4/2019

01-04-2019 | Clinical Investigation

Impact of Patient and Lesion Characteristics on Drug-Coated Balloon Angioplasty in the Femoropopliteal Artery: A Pooled Analysis of Four Randomized Controlled Multicenter Trials

Authors: Thomas Albrecht, Antonia Ukrow, Michael Werk, Gunnar Tepe, Thomas Zeller, Dirk-Roelfs Meyer, Maren Kutschera, Ulrich Speck, Matthias Waliszewski

Published in: CardioVascular and Interventional Radiology | Issue 4/2019

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Abstract

Objectives

The principal objective of this pooled analysis was to investigate various patient and lesion characteristics on late lumen loss (LLL) after drug-coated balloon (DCB) angioplasty.

Background

Four randomized controlled trials (THUNDER, FEMPAC, PACIFIER, CONSEQUENT) were pooled to investigate the influence of various patient and lesion characteristics on DCB angioplasty and on plain old balloon angioplasty (POBA) in patients with femoropopliteal artery disease.

Methods

Angiographic data from 355 patients were pooled to assess the impact of patient (demographics, cardiovascular risk factors, cardiovascular co-morbidities, Rutherford stages) and lesion-/procedure-related (location, occlusion, length, restenosis, calcification, subintimal crossing, post-dilatation, dissection, stenting) characteristics on LLL. Linear regression models were utilized with LLL as the dependent variable to determine the predictive value of cardiovascular and lesion-/procedure-related factors.

Results

Observational statistics revealed that LLL was lower in the DCB group as compared to POBA independent of all tested patient variables. LLL after DCB was also independent of most lesion and procedural characteristics except for lesion length and bailout stenting. LLL increased with lesion length in both treatment groups. Bailout stenting did not improve LLL in the DCB group but did so in the POBA group (0.74 ± 1.07 mm vs. 1.22 ± 1.36 mm, p = 0.043).

Conclusions

DCB was superior to POBA for all tested patient subgroups and lesion subgroups. Our results suggest that all patients and lesions benefit to a similar degree from the use of DCB. DCB-PTA should therefore be preferred to POBA in all patients with steno-occlusive femoropopliteal lesions.
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Metadata
Title
Impact of Patient and Lesion Characteristics on Drug-Coated Balloon Angioplasty in the Femoropopliteal Artery: A Pooled Analysis of Four Randomized Controlled Multicenter Trials
Authors
Thomas Albrecht
Antonia Ukrow
Michael Werk
Gunnar Tepe
Thomas Zeller
Dirk-Roelfs Meyer
Maren Kutschera
Ulrich Speck
Matthias Waliszewski
Publication date
01-04-2019
Publisher
Springer US
Published in
CardioVascular and Interventional Radiology / Issue 4/2019
Print ISSN: 0174-1551
Electronic ISSN: 1432-086X
DOI
https://doi.org/10.1007/s00270-018-2137-3

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