OBJECTIVES: 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. BACKGROUND:Drug-coated balloon angioplasty is associated with favorable results for treatment of bare-metal stent restenosis. METHODS: 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 topaclitaxel-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. RESULTS: 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. CONCLUSIONS: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).
RCT Entities:
OBJECTIVES: 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. BACKGROUND:Drug-coated balloon angioplasty is associated with favorable results for treatment of bare-metal stent restenosis. METHODS: 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. RESULTS: 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. CONCLUSIONS: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).
Authors: Anthony N DeMaria; Jeroen J Bax; Gregory K Feld; Barry H Greenberg; Jennifer L Hall; Mark A Hlatky; Wilbur Y W Lew; João A C Lima; Ehtisham Mahmud; Alan S Maisel; Sanjiv M Narayan; Steven E Nissen; David J Sahn; Sotirios Tsimikas Journal: J Am Coll Cardiol Date: 2013-01-22 Impact factor: 24.094
Authors: Bruno Scheller; Dieter Fischer; Yvonne P Clever; Franz X Kleber; Ulrich Speck; Michael Böhm; Bodo Cremers Journal: Clin Res Cardiol Date: 2013-03-20 Impact factor: 5.460
Authors: Franz X Kleber; Antonia Schulz; Matthias Waliszewski; Telse Hauschild; Michael Böhm; Ulrich Dietz; Bodo Cremers; Bruno Scheller; Yvonne P Clever Journal: Clin Res Cardiol Date: 2014-10-28 Impact factor: 5.460