A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis
JACC - Journal of the American College of Cardiology, 04/13/2012Rittger H et al.
Paclitaxel–coated balloon angioplasty is superior to balloon angioplasty alone for treatment of drug–eluting 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.
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