Drug Coated Balloon
Klinische Daten

First in Man

1: N Engl J Med. 2006 Nov 16;355(20):2113-24. Epub 2006 Nov 13
Comment in:
N Engl J Med. 2006 Nov 16;355(20):2149-51
N Engl J Med. 2007 Mar 8;356(10):1071-2; author reply 1072-3
N Engl J Med. 2007 Mar 8;356(10):1071; author reply 1072-3

Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter

Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm M, Speck U

Universitätsklinikum des Saarlandes, Homburg/Saar, Germany

BACKGROUND: Treatment of coronary in-stent restenosis is hampered by a high incidence of recurrent in-stent restenosis. We assessed the efficacy and safety of a paclitaxel-coated balloon in this setting. METHODS: We enrolled 52 patients with in-stent restenosis in a randomized, double-blind, multicenter trial to compare the effects of a balloon catheter coated with paclitaxel (3 microg per square millimeter of balloon surface area) with those of an uncoated balloon catheter in coronary angioplasty. The primary end point was late luminal loss as seen on angiography. Secondary end points included the rates of restenosis (a binary variable) and major adverse cardiac events. RESULTS: Multivessel disease was present in 80% of patients in both groups. Quantitative coronary angiography revealed no significant differences in baseline measures. At 6 months, angiography showed that the mean (+/-SD) in-segment late luminal loss was 0.74+/-0.86 mm in the uncoated-balloon group versus 0.03+/-0.48 mm in the coated-balloon group (P=0.002). A total of 10 of 23 patients (43%) in the uncoated-balloon group had restenosis, as compared with 1 of 22 patients (5%) in the coated-balloon group (P=0.002). At 12 months, the rate of major adverse cardiac events was 31% in the uncoated-balloon group and 4% in the coated-balloon group (P=0.01). This difference was primarily due to the need for target-lesion revascularization in six patients in the uncoated-balloon group (P=0.02). CONCLUSIONS: Treatment of coronary in-stent restenosis with paclitaxel-coated balloon catheters significantly reduced the incidence of restenosis. These data suggest that the inhibition of restenosis by local drug delivery may not require stent implantation and sustained drug release at the site of injury. (ClinicalTrials.gov number, NCT00106587 [ClinicalTrials.gov].).

PMID: 17101615 [PubMed – indexed for MEDLINE]

Late Breaking Studies and First Report Investigations

PACCOCATH ISR 1 and 2: A Prospective, Randomized Trial of a Paclitaxel-Eluting Balloon in In-Stent Restenosis: 2-Year Results

Bruno Scheller for the Paccocath ISR Study Group
Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany

Clin Res Cardiol (2008)

Hotline update of clinical trials and registries presented at the ACC and SCAI-ACCi2 meeting 2008 in Chicago

Yvonne P. Clever, Stephan Rosenkranz, Michael Böhm, Bruno Scheller

B. Braun Clinical Program

PEPCAD I

Clin Res Cardiol. 2010 Jan 6. [Epub ahead of print]

Treatment of small coronary arteries with a paclitaxel-coated balloon catheter

Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B.

Institut für Klinische Forschung, Herz- und Kreislaufzentrum, Rotenburg an der Fulda, Germany.

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 mug/mm(2)). 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).

PMID: 20052480 [PubMed – as supplied by publisher]

PEPCAD II

(Circulation. 2009;119:2986-2994.)

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

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