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Management of peripheral arterial interventions with mono or dual antiplatelet therapy—the MIRROR study: a randomised and double-blinded clinical trial

  • Vascular-Interventional
  • Published:
European Radiology Aims and scope Submit manuscript

Abstract

Objectives

To investigate the influence of dual antiplatelet therapy vs. aspirin alone on local platelet activation and clinical endpoints in patients with PAD treated with endovascular therapy.

Methods

Patients received either 500 mg aspirin and 300 mg clopidogrel before intervention followed by a daily dose of 100 mg aspirin and 75 mg clopidogrel for 6 months, or the same doses of aspirin plus placebo instead of clopidogrel. Primary endpoints were local concentrations of platelet activation markers β-thromboglobulin and CD40L, and the rate of patient’s resistant to clopidogrel. Secondary endpoints included the clinical development 6 months after the intervention.

Results

Eighty patients, 40 in each group, were enrolled. The median peri-interventional concentration of β-TG was 224.5 vs. 365.5 (P = 0.03) in the clopidogrel and placebo group. The concentration of CD40L was 127 and 206.5 (P = 0.05). Thirty per cent of patients who had received clopidogrel were resistant. Two clopidogrel and eight placebo patients required TLR (P = 0.04). The clopidogrel patients who needed revascularisation were both resistant to clopidogrel. Minor bleeding complications occurred in one clopidogrel and two placebo patients.

Conclusion

Dual antiplatetet therapy reduces peri-interventional platelet activation and improves functional outcome without higher bleeding complications. An individual tailored dual antiplatelet therapy seems desirable for endovascularly treated patients with PAD.

Key Points

• The role of clopidogrel and aspirin following endovascular therapy was investigated.

• Dual antiplatelet therapy reduces peri-interventional platelet activation more than aspirin alone.

• Dual antiplatelet therapy improves the outcome of endovascularly treated patients.

• Clopidogrel resistance is important when treating peripheral arterial disease endovascularly.

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Abbreviations

ABI:

ankle-brachial index

ß-TG:

ß-thromboglobulin

CD40L:

human soluble CD40 ligand

PAD:

peripheral arterial disease

PTA:

percutaneous transluminal angioplasty

SAE:

serious adverse events

SD:

standard deviation

TLR:

target lesion revascularisation

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Acknowledgments

Relationship with industry: The study was an investigator-initiated study supported by Sanofi-Aventis S.A., Paris, France

F.F. Strobl received a grant from Interfakultäres Zentrum für Klinische Forschung (IZKF), Tübingen, Germany, for this study.

We thank Christoph Meissner, Institute for Medical Information Processing, Tübingen, Germany, for statistical analysis.

Author information

Authors and Affiliations

  1. Radiologische Klinik, Diagnostische und Interventionelle Radiologie, Eberhard-Karls-Universität, Tübingen, Germany

    Gunnar Tepe, Rüdiger Bantleon, Klaus Brechtel, Jörg Schmehl, Claus D. Claussen & Frederik F. Strobl

  2. Kardiologie & Angiologie, Herzzentrum Bad Krozingen, Bad Krozingen, Germany

    Thomas Zeller

  3. Institut für Klinische Radiologie, Klinikum der Universität München, Munich, Germany

    Frederik F. Strobl

  4. RoMed Klinikum Rosenheim, Pettenkoferstr. 10, 83022, Rosenheim, Germany

    Gunnar Tepe

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  1. Gunnar Tepe
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  2. Rüdiger Bantleon
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  3. Klaus Brechtel
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  4. Jörg Schmehl
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  7. Frederik F. Strobl
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Correspondence to Gunnar Tepe.

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Tepe, G., Bantleon, R., Brechtel, K. et al. Management of peripheral arterial interventions with mono or dual antiplatelet therapy—the MIRROR study: a randomised and double-blinded clinical trial. Eur Radiol 22, 1998–2006 (2012). https://doi.org/10.1007/s00330-012-2441-2

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  • DOI: https://doi.org/10.1007/s00330-012-2441-2

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