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Drug eluting balloons as stand alone procedure for coronary bifurcational lesions: results of the randomized multicenter PEPCAD-BIF trial

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Abstract

Objectives

We set out to investigate the benefit of distal main or side branch treatment with a DCB compared to POBA in coronary bifurcation lesions.

Background

The standard treatment of bifurcation lesions is application of a DES to the main branch with provisional side branch stenting. While this resulted in considerable improvement in overall MACE rate suboptimal side branch results remained a problem.

Methods

The study was performed from 2011 to 2013 in six German centers. Native bifurcation lesions were included if side branch vessel diameter was ≥2 and ≤3.5 mm and no proximal main branch lesions was found. After successful predilatation randomization was performed to either DCB application or no further treatment. Follow-up angiograms for QCA analysis were done after 9 months. Primary endpoint was late lumen loss (LLL).

Results

64 patients were successfully randomized. Minimal lumen diameter and grade of stenosis were equal in both groups. Only five stents were used as bail out. Angiographic follow-up was achieved in 75 % of patients. No patient died. There was one NSTEMI in the POBA group. Restenosis rate was 6 % in the DCB group vs 26 % in the POBA group (p = 0.045). TLR was necessary in one patient of the DCB group vs three patients of the POBA. The primary endpoint LLL was 0.13 mm in the DCB vs 0.51 mm in the POBA group (p = 0.013).

Conclusion

In bifurcation lesions that show only class A or B dissection and recoil not beyond 30 % the use of DCBs is a sound strategy.

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Authors and Affiliations

  1. Cardio Centrum Berlin, Academic Teaching Institution, Charité University Medicine Berlin, Unter den Linden 21, 10117, Berlin, Germany

    Franz X. Kleber & Antonia Schulz

  2. Universitätsklinikum Erlangen, Erlangen, Germany

    Harald Rittger & Josef Ludwig

  3. Universitäres Herz- und Gefäßzentrum Hamburg, Hamburg, Germany

    Detlef G. Mathey

  4. Medical Scientific Affairs, B. Braun Melsungen AG, Melsungen, Germany

    Michael Boxberger

  5. Center for Cardiovascular Diseases, Rotenburg a.d. Fulda, Germany

    Ralf Degenhardt

  6. Universitätsklinikum des Saarlandes, Homburg, Saar, Germany

    Bruno Scheller

  7. Technische Universität Dresden, Herzzentrum Dresden, Universitätsklinik Dresden, Dresden, Germany

    Ruth H. Strasser

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  1. Franz X. Kleber
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  2. Harald Rittger
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Corresponding author

Correspondence to Franz X. Kleber.

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Conflict of interest

The authors declare the following conflicts of interest: Franz X. Kleber is a consultant to B.Braun and has received institutional grant support by Medtronic and B. Braun. Antonia Schulz received travel expenses from B. Braun. Bruno Scheller is a consultant to B. Braun, received lecture honoraria by Medtronic and B. Braun and is co-inventor on a patent application by Charité University Hospital. Ralf Degenhardt is employee of the Clinical Research Institute that is paid for conduct of the study. Michael Boxberger is employee as medical director at B. Braun. Harald Rittger, Josef Ludwig, Detlef G. Mathey and Ruth H. Strasser declare no conflict of interest.

Funding

The study was financially supported in part by B. Braun Melsungen AG.

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Kleber, F.X., Rittger, H., Ludwig, J. et al. Drug eluting balloons as stand alone procedure for coronary bifurcational lesions: results of the randomized multicenter PEPCAD-BIF trial. Clin Res Cardiol 105, 613–621 (2016). https://doi.org/10.1007/s00392-015-0957-6

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  • DOI: https://doi.org/10.1007/s00392-015-0957-6

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