Abstract 13689: Effectiveness of Paclitaxel-eluting Balloon Catheter in Patients with Sirolimus-eluting Stent Restenosis: Results of a Prospective, Single-blind, Randomized Study.
Background: As drug-eluting stents (DESs) are being used in increasingly complicated settings, DES restenosis is no longer an uncommon phenomenon, and its optimal treatment is not known.
Methods and Results: This study was a prospective, single-blind, randomized trial conducted in 50 patients with sirolimus-eluting stent (SES) restenosis. Patients were randomly assigned to Paclitaxel-eluting balloon group (PEB group, n=25) or Conventional balloon angioplasty group (BA group, n=25). The primary endpoint was late lumen loss at 6-month follow-up. Secondary endpoints included the rate of binary restenosis (in-segment analysis) and major adverse cardiac events (MACE) at 6-month follow-up. At 6-month angiographic follow-up (follow-up rate: 94%), in-segment late lumen loss was lower in PEB group than in BA group (0.18 +/− 0.45 mm vs. 0.72 +/− 0.55 mm, p= 0.001). The incidence of recurrent restenosis (8.7% vs. 62.5%, p=0.0001) and target lesion revascularization (4.3% vs. 41.7%, p=0.003) was lower in PEB group than in BA group. The cumulative MACE-free survival was significantly better in PEB group than in BA group (96% vs. 68%, p= 0.009).
Conclusions: In patients with SES restenosis, PEB provided much better clinical, angiographic outcomes than conventional balloon angioplasty.
- © 2010 by American Heart Association, Inc.