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

  • Clinical Investigation
  • Arterial Interventions
  • Published:
CardioVascular and Interventional Radiology Aims and scope Submit manuscript

A Correction to this article was published on 12 March 2019

This article has been updated

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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Change history

  • 12 March 2019

    In their recently published pooled analysis of four drug-coated balloon (DCB) studies, which focused on the impact of patient and lesion characteristics on LLL at 6 months (Albrecht T et al. Cardiovasc Intervent Radiol. 2018 Dec 11. <ExternalRef><RefSource>https://doi.org/10.1007/s00270-018-2137-3</RefSource><RefTarget Address="10.1007/s00270-018-2137-3" TargetType="DOI"/></ExternalRef>), the authors reported slightly inaccurate 2-year mortality rates.

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Acknowledgements

The authors wish to thank the research team at InnoRa Berlin, Germany (Dr. Bettina Kelsch, Dr. Beatrix Schnorr, and Dr. Ines Gemeinhardt), for their support during the course of previously conducted RCT’s with angiographic primary endpoints.

Author information

Authors and Affiliations

  1. Department of Radiology and Interventional Therapy, Vivantes Klinikum Neukölln, Berlin, Germany

    Thomas Albrecht & Antonia Ukrow

  2. Department of Radiology, Martin-Luther-Hospital, Berlin, Germany

    Michael Werk

  3. Department of Radiology, RoMed Klinikum Rosenheim, Rosenheim, Germany

    Gunnar Tepe

  4. Department of Angiology, Herzzentrum Bad Krozingen, Bad Krozingen, Germany

    Thomas Zeller

  5. Department of Diagnostic and Interventional Radiology, Hubertus Hospital, Berlin, Germany

    Dirk-Roelfs Meyer

  6. Experimental Radiology, Department of Radiology, Charité, Berlin, Germany

    Maren Kutschera & Ulrich Speck

  7. Medical Scientific Affairs, B.Braun Melsungen AG, Berlin, Germany

    Matthias Waliszewski

  8. Department of Internal Medicine and Cardiology, Charité – Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany

    Matthias Waliszewski

  9. Institut für Radiologie und Interventionelle Therapie, Vivantes Klinikum Neukölln, Rudower Str. 48, 12351, Berlin, Germany

    Thomas Albrecht

Authors
  1. Thomas Albrecht
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  2. Antonia Ukrow
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  3. Michael Werk
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  4. Gunnar Tepe
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  5. Thomas Zeller
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  6. Dirk-Roelfs Meyer
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  7. Maren Kutschera
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  8. Ulrich Speck
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  9. Matthias Waliszewski
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Corresponding author

Correspondence to Thomas Albrecht.

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Conflict of interest

In the previously conducted randomized controlled trials that provided the raw data for this analysis, TA, MW, TZ and GT received research grants from Medtronic, whereas TA, TZ and GT obtained research funding from B.Braun. MWW is a full-time employee of the Medical Scientific Affairs department of B.Braun Melsungen AG.

Ethical Approval

All studies were approved by the Federal Institute for Drugs and Medical Devices, by the Federal Agency for Radiation Protection and by all relevant ethics committees of participating centers. Patients gave written informed consent prior to inclusion. An independent critical event committee was installed to adjudicate event rates. Blinded quantitative angiographic analysis was conducted by an independent core lab. All trials were registered with the US National Institutes of Health prior to recruitment. This trial was conducted in accordance with the updated Declaration of Helsinki and other relevant guidance.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

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Albrecht, T., Ukrow, A., Werk, M. et al. Impact of Patient and Lesion Characteristics on Drug-Coated Balloon Angioplasty in the Femoropopliteal Artery: A Pooled Analysis of Four Randomized Controlled Multicenter Trials. Cardiovasc Intervent Radiol 42, 495–504 (2019). https://doi.org/10.1007/s00270-018-2137-3

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  • DOI: https://doi.org/10.1007/s00270-018-2137-3

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