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(Circulation. 2009;119:2986-2994.)
© 2009 American Heart Association, Inc.

Interventional Cardiology

Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Coated Stent for the Treatment of Coronary In-Stent Restenosis

Martin Unverdorben, MD; Christian Vallbracht, MD; Bodo Cremers, MD; Hubertus Heuer, MD; Christian Hengstenberg, MD; Christian Maikowski, MD; Gerald S. Werner, MD; Diethmar Antoni, MD; Franz X. Kleber, MD; Wolfgang Bocksch, MD; Matthias Leschke, MD; Hanns Ackermann, PhD; Michael Boxberger, PhD; Ulrich Speck, PhD; Ralf Degenhardt, PhD; Bruno Scheller, MD

From the Institut für Klinische Forschung (M.U., R.D.) and Kardiologische Klinik (C.V.), Herz- und Kreislaufzentrum, Rotenburg an der Fulda, Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes (B.C., B.S.), Homburg/Saar, Medizinische Klinik, Kardiologie, St. Johannes Hospital (H.H.), Dortmund, Klinik und Poliklinik für Innere Medizin II, Universitätsklinikum Regensburg (C.H.), Kerckhoff Klinik (C.M.), Bad Nauheim, Medizinische Klinik I, Klinikum Darmstadt (G.S.W.), I. Medizinische Abteilung, Krankenhaus Bogenhausen (D.A.), München, Klinik für Innere Medizin, Unfallkrankenhaus Berlin (F.X.K.), Medizinische Klinik mit Schwerpunkt Kardiologie, Campus Virchow-Klinikum, Universitätsklinikum Charité (W.B.), B. Braun Melsungen AG, Vascular Systems (M.B.), Institut für Radiologie, Campus Charité Mitte, Charité - Universitätsmedizin Berlin (U.S.), Berlin, Klinik für Kardiologie, Pneumologie und Angiologie, Klinikum Esslingen (M.L.), and Zentrum für medizinische Informatik, Abteilung für Biomathematik, Universität Frankfurt/Main (H.A.), Germany.

Correspondence to Dr Bruno Scheller, University of Saarland, Kirrberger Strasse, Homburg/Saar, Germany 66421. E-mail bruno.scheller{at}uks.eu

Received November 28, 2008; accepted April 1, 2009.

Background— Treatment of in-stent restenosis with paclitaxel-coated balloon catheter as compared with plain balloon angioplasty has shown surprisingly low late lumen loss at 6 months and fewer major adverse cardiac events up to 2 years. We compared the efficacy and safety of a paclitaxel-coated balloon with a paclitaxel-eluting stent as the current standard of care.

Methods and Results— One hundred thirty-one patients with coronary in-stent restenosis were randomly assigned to treatment by a paclitaxel-coated balloon (3 µg/mm²) or a paclitaxel-eluting stent. The main inclusion criteria encompassed diameter stenosis of 70% and 22 mm in length, with a vessel diameter of 2.5 to 3.5 mm. The primary end point was angiographic in-segment late lumen loss. Quantitative coronary angiography revealed no differences in baseline parameters. At 6 months follow-up, in-segment late lumen loss was 0.38±0.61 mm in the drug-eluting stent group versus 0.17±0.42 mm (P=0.03) in the drug-coated balloon group, resulting in a binary restenosis rate of 12 of 59 (20%) versus 4 of 57 (7%; P=0.06). At 12 months, the rate of major adverse cardiac events were 22% and 9%, respectively (P=0.08). This difference was primarily due to the need for target lesion revascularization in 4 patients (6%) in the coated-balloon group, compared with 10 patients (15%) in the stent group (P=0.15).

Conclusions— Treatment of coronary in-stent restenosis with the paclitaxel-coated balloon was at least as efficacious and as well tolerated as the paclitaxel-eluting stent. For the treatment of in-stent restenosis, inhibition of re-restenosis does not require a second stent implantation.

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