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, 04/13/2012

Paclitaxel–coated balloon angioplasty is superior to balloon angioplasty alone for treatment of drug–eluting 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.

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