Harald Rittger,
Johannes Brachmann,
Anil-M Sinha, Matthias Waliszewski,
Marc Ohlow,
Andreas Brugger,
Holger Thiele,
Ralf Birkemeyer,
Volkhard Kurowski,
Ole-A Breithardt,
Martin Schmidt,
Stefan Zimmermann,
Sandra Lonke,
Moritz von Cranach,
The-Vinh Nguyen,
Werner G Daniel,
Jochen Wöhrle
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ABSTRACT: This study sought to define the impact of paclitaxel-coated balloon angioplasty for treatment of drug-eluting stent restenosis compared with uncoated balloon angioplasty alone.
Drug-coated balloon angioplasty is associated with favorable results for treatment of bare-metal stent restenosis.
In this prospective, single-blind, multicenter, randomized trial, the authors randomly assigned 110 patients with drug-eluting stent restenoses located in a native coronary artery to paclitaxel-coated balloon angioplasty or uncoated balloon angioplasty. Dual antiplatelet therapy was prescribed for 6 months. Angiographic follow-up was scheduled at 6 months. The primary endpoint was late lumen loss. The secondary clinical endpoint was a composite of cardiac death, myocardial infarction attributed to the target vessel, or target lesion revascularization.
There was no difference in patient baseline characteristics or procedural results. Angiographic follow-up rate was 91%. Treatment with paclitaxel-coated balloon was superior to balloon angioplasty alone with a late loss of 0.43 ± 0.61 mm versus 1.03 ± 0.77 mm (p < 0.001), respectively. Restenosis rate was significantly reduced from 58.1% to 17.2% (p < 0.001), and the composite clinical endpoint was significantly reduced from 50.0% to 16.7% (p < 0.001), respectively.
Paclitaxel-coated balloon angioplasty is superior to balloon angioplasty alone for treatment of drug-eluting stent restenosis. (PEPCAD DES-Treatment of DES-In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting PTCA Catheter [PEPCAD-DES]; NCT00998439).
Journal of the American College of Cardiology 02/2012; 59(15):1377-82. · 14.16 Impact Factor
