Response to Letter Regarding Article,“Paclitaxel

Correspondence
Response to Letter Regarding Article,
“Paclitaxel-Coated Balloon Catheter Versus
Paclitaxel-Coated Stent for the Treatment of
Coronary In-Stent Restenosis”
We appreciate the comments by Dr Alfonso and colleagues on
the Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease II (PEPCAD II) trial. Intracoronary radiation was the
first successful treatment option for in-stent restenosis avoiding
the stent-in-stent approach. However, implantation of a second
(drug-eluting) stent has since become the first treatment option
for in-stent restenosis. The implantation of a drug-eluting stent in
a restenotic stent results in better acute lumen gain and lower
restenosis rates compared with conventional balloon angioplasty
or brachytherapy.1,2
The main determinant of restenosis after coronary stent implantation is neointimal hyperplasia. Other factors such as elastic vessel
recoil and negative remodeling have no relevant impact on this
scenario. Therefore, late lumen loss has been accepted as the most
important measure for evaluating stent-based local drug delivery by
angiography. For comparability, this measure has to be used to
evaluate new antirestenotic treatments. Therefore, we decided to
assess the efficacy of a drug-eluting stent or a drug-coated balloon in
the treatment of coronary in-stent restenosis using the same angiographic measure.
We agree with Dr Alfonso et al that late lumen loss has obvious
limitations in comparing stent implantation and balloon angioplasty.
The advantage of stent implantation over angioplasty in short-term
results is well known and was also seen in our trial. Despite the lower
late lumen loss in the drug-coated balloon group, the difference
between the 2 treatments in angiographic and clinical end points is
not explained by the average minimal lumen diameter at follow-up.
However, frequency distribution of the in-segment minimal lumen
diameters shows a slight parallel shift at follow-up in the drug-coated
balloon group versus a shoe-shaped configuration in the drug-eluting
stent group. This means that almost all patients in the drug-coated
balloon group benefited from non–stent-based local drug delivery to
a similar extent. In the drug-eluting stent group, the majority of
patients had a clear benefit from stent-based sustained drug release.
However, a subgroup of patients did not respond to this therapy
(Figure 1 in the article3). This difference between the 2 groups
explains the results with regard to secondary angiographic parameters, such as binary restenosis rate and clinical outcome.
First-in-human data on the treatment of coronary in-stent restenosis using the prototype “Paccocath” balloon are available from 2
randomized studies with identical designs. A total of 108 patients
were enrolled: 52 patients in the Treatment of In-Stent Restenosis by
Paclitaxel-Coated Balloon Catheters (Paccocath ISR I) trial4 and 56
patients in the Paccocath ISR II trial.5 Patients enrolled in the second
trial were older, were more often female, had a higher incidence of
diabetes mellitus, and had longer lesions than the patients included in
the ISR I study. In-segment late lumen loss in the drug-coated
balloon groups was 0.03⫾0.48 mm and 0.18⫾0.41 mm, respectively,4,5 which compares well with the late lumen loss seen in the
present study using a newer-generation drug-coated balloon.
In conclusion, treatment of coronary in-stent restenosis with a
drug-coated balloon avoids the stent-in-stent approach with the
introduction of a second layer of metal in a native coronary artery.
Furthermore, it reduces the need for antiplatelet therapy. Finally, the
PEPCAD II trial showed favorable angiographic measures for the
drug-coated balloon compared with a drug-eluting stent in this
indication.
Disclosures
Prof Scheller and Prof Speck are coinventors of a patent application
for various methods of restenosis inhibition, including drug-coated
balloons, by Charité University Hospital, Berlin. Prof Speck receives
research support from B. Braun; he is also serving as a consultant to
Bayer-Schering AG, Berlin. Prof Scheller and Dr Cremers receive
insignificant lecture fees from B. Braun. Dr Unverdorben has
become an employee of B. Braun USA after finishing the trial.
Bruno Scheller, MD
Bodo Cremers, MD
Klinik für Innere Medizin III
Universitätsklinikum des Saarlandes
Homburg/Saar, Germany
Martin Unverdorben, MD
Ralf Degenhardt, PhD
Institut für Klinische Forschung
Herz-und Kreislaufzentrum
Rotenburg an der Fulda, Germany
Christian Vallbracht, MD
Kardiologische Klinik
Herz-und Kreislaufzentrum
Rotenburg an der Fulda, Germany
Hubertus Heuer, MD
Medizinische Klinik
Kardiologie, St. Johannes Hospital
Dortmund, Germany
Christian Hengstenberg, MD
Klinik und Poliklinik für Innere Medizin II
Universitätsklinikum Regensburg
Regensburg, Germany
Christian Maikowski, MD
Kerckhoff Klinik
Bad Nauheim, Germany
Gerald S. Werner, MD
Medizinische Klinik I
Klinikum Darmstadt
Darmstadt, Germany
Diethmar Antoni, MD
I. Medizinische Abteilung
Krankenhaus Bogenhausen
München, Germany
Franz X. Kleber, MD
Klinik für Innere Medizin
Unfallkrankenhaus Berlin
Berlin, Germany
Wolfgang Bocksch, MD
Medizinische Klinik mit Schwerpunkt Kardiologie
Universitätsklinikum Charité
Berlin, Germany
Matthias Leschke, MD
Klinik für Kardiologie
Pneumologie und Angiologie
Klinikum Esslingen
Esslingen, Germany
(Circulation. 2010;121:e34-e35.)
© 2010 American Heart Association, Inc.
Circulation is available at http://circ.ahajournals.org
DOI: 10.1161/CIR.0b013e3181d22bef
e34
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Correspondence
Hanns Ackermann, PhD
Zentrum für Medizinische Informatik
Abteilung für Biomathematik
Universität Frankfurt/Main
Frankfurt/Main, Germany
Michael Boxberger, PhD
B. Braun Melsungen AG
Vascular Systems
Berlin, Germany
Ulrich Speck, PhD
Institut für Radiologie
Campus Charité Mitte
Charité-Universitätsmedizin Berlin
Berlin, Germany
References
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Dibra A, Kastrati A, Alfonso F, Seyfarth M, Pérez-Vizcayno MJ, Mehilli
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Coll Cardiol. 2007;49:616 – 623.
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Response to Letter Regarding Article, ''Paclitaxel-Coated Balloon Catheter Versus
Paclitaxel-Coated Stent for the Treatment of Coronary In-Stent Restenosis''
Bruno Scheller, Bodo Cremers, Martin Unverdorben, Ralf Degenhardt, Christian Vallbracht,
Hubertus Heuer, Christian Hengstenberg, Christian Maikowski, Gerald S. Werner, Diethmar
Antoni, Franz X. Kleber, Wolfgang Bocksch, Matthias Leschke, Hanns Ackermann, Michael
Boxberger and Ulrich Speck
Circulation. 2010;121:e34-e35
doi: 10.1161/CIR.0b013e3181d22bef
Circulation is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231
Copyright © 2010 American Heart Association, Inc. All rights reserved.
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