Abstract
Background
Treatment of lesions in small coronary arteries by percutaneous transluminal coronary intervention is limited by a high recurrence rate. We assessed the use of a paclitaxel-coated balloon in this indication.
Methods
One-hundred eighteen patients with stenoses in small coronary vessels were treated by a paclitaxel-coated balloon (3 μg/mm2). The main inclusion criteria encompassed diameter stenosis of ≥70% and ≤22 mm in length with a vessel diameter of 2.25–2.8 mm. Follow-up angiography was performed at scheduled 6-month post-intervention or whenever driven by clinical or electrocardiographic signs of ischemia. The primary endpoint was angiographic in-segment late lumen loss.
Results
Eighty-two of 118 patients (70%) with a vessel diameter of 2.35 ± 0.19 mm were treated with the drug-coated balloon only, while 32 patients required additional stent deployment. The mean in-segment late lumen loss was 0.28 ± 0.53 mm. In patients treated with the drug-coated balloon only, the in-segment late lumen loss was 0.16 ± 0.38 mm. At 12 months, the rate of major adverse cardiac events was 15% which was primarily due to the need for target lesion revascularization in 14 patients (12%). In those with additional bare metal stent implantation geographical mismatch between coated-balloon dilatation and stent implantation was significantly associated with the occurrence of restenosis.
Conclusion
Treatment of coronary stenosis in small coronary vessels with the paclitaxel-coated balloon was well tolerated. It may offer an alternative to the implantation of a drug-eluting stent (ClinicalTrials.gov Identifier: NCT00404144).
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Acknowledgments
The study was supported by B. Braun Melsungen, Germany. Dr. Unverdorben receives salaries from the Institut für Klinische Forschung, Herz- und Kreislaufzentrum, Rotenburg an der Fulda, Germany; end of 2008 (after finishing this trial) he became an employee of B. Braun USA (orthopedics and medical affairs). Prof. Scheller reports being co-inventor of a patent application for various methods of restenosis inhibition, including the technique employed in this trial, by Charité University Hospital, Berlin.
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Appendix: PEPCAD I Study Group
Appendix: PEPCAD I Study Group
Principal Investigator: Martin Unverdorben, Institut für Klinische Forschung, Herz- und Kreislaufzentrum, Rotenburg an der Fulda, Germany
CRO and Angiographic Core Lab: Ralf Degenhardt, Institut für Klinische Forschung, Herz- und Kreislaufzentrum, Rotenburg an der Fulda, Germany. Staff: Tina Iffland, Melanie Häußler
Statistical Advisor: Hanns Ackermann, Zentrum für medizinische Informatik, Abteilung für Biomathematik, Universität Frankfurt/Main, Germany
Klinik für Innere Medizin, Unfallkrankenhaus Berlin, Charité Universitätsmedizin, Berlin, Germany: Franz X. Kleber, Sascha Rux, Daniel Grund; Heike Bull; 50 patients
Medizinische Klinik, Kardiologie, St. Johannes Hospital, Dortmund, Germany: Hubertus Heuer, Norbert Schulze Waltrup, Joachim Weber-Albers, Maritta Marks, Axel Bünemann, Dietmar Schmitz, Mathias Stratmann; Martin Schulz, Claudia Rosendahl, Birgit Laschewski, Alexandra Thrun, Kathrin Euler, Ute Dieckheuer; 35 patients
Klinik für Innere Medizin, Universitätsklinikum Jena, Germany: Stefan Betge, Hans-Reiner Figulla; 13 patients
Kardiologische Klinik, Herz- und Kreislaufzentrum, Rotenburg an der Fulda, Germany: Christian Vallbracht, Manfred Scholz, Henning Köhler, Bernd Abt, Eberhard Wagner; seven patients
Klinik für Kardiologie, Pneumologie und Angiologie, Klinikum Esslingen, Germany: Matthias Leschke, Jean Rieber; Birgit Blaich; eight patients
Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany: Bruno Scheller, Bodo Cremers, Michael Kindermann, Michael Böhm; Nicole Hollinger, Bianca Werner; four patients
Innere Medizin III, Universitätsklinikum Heidelberg, Germany: Helmut Kücherer, Stefan Hardt; Christiane Selter; two patients
Universitätsklinik und Poliklinik für Innere Medizin III, Halle, Germany: Michael Buerke; Michaela König; one patient
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Unverdorben, M., Kleber, F.X., Heuer, H. et al. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol 99, 165–174 (2010). https://doi.org/10.1007/s00392-009-0101-6
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DOI: https://doi.org/10.1007/s00392-009-0101-6