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Previous Volume 355:2113-2124 November 16, 2006 Number 20 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Camenzind, E. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

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 µg 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] .)

Source Information

From Universitätsklinikum des Saarlandes, Homburg/Saar (B.S., M.B.); Universitätsklinikum, Freiburg (C.H.); Campus Virchow-Klinikum (W.B.) and Campus Charité Mitte (W.R., U.S.), Universitätsklinikum Charité, Berlin; Universitätsklinikum Mannheim, Ruprecht Karls Universität Heidelberg, Mannheim (D.H.); and Deutsche Klinik für Diagnostik, Wiesbaden (U.D.) — all in Germany.

This article was published at www.nejm.org on November 13, 2006.

Address reprint requests to Dr. Scheller at the Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany, or at bruno.scheller{at}uniklinikum-saarland.de.

Full Text of this Article

Related Letters:

Treatment of Restenosis with a Paclitaxel-Coated Balloon Catheter
Sun J. C.J., Eikelboom J. W., Agostoni P., Sangiorgi G. M., Biondi-Zoccai G. G., Scheller B., Böhm M., Camenzind E.
Extract | Full Text | PDF  
N Engl J Med 2007; 356:1071-1073, Mar 8, 2007. Correspondence

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