Abstract 2639: A Randomized Comparison of Paclitaxel-Eluting Stents vs. Intra-coronary Brachytherapy in the Treatment of In-stent Restenosis: Intravascular Ultrasound Results from the TAXUS-V ISR Trial
Background: The TAXUS-V in-stent restenosis (ISR) trial demonstrated that the polymer-based, paclitaxel-eluting TAXUS stent (PES) is effective for the treatment of bare metal stent restenosis. The aim of this intravascular ultrasound (IVUS) substudy was to compare 9-month in-stent neointimal hyperplasia in PES vs. balloon angioplasty with beta source intra-coronary brachytherapy (IBT).
Methods: The TAXUS-V ISR trial was a 37-center, randomized trial comparing PES vs. IBT. IVUS analysis was performed for the entire stent segment; neointima was calculated as stent minus lumen. Complete 9-month IVUS data are available in 83 randomized patients (41 IBT, 42 PES).
Results: As expected, PES implantation resulted in a significant increase in mean lumen area (5.4±1.8 mm2 IBT vs. 6.5±1.8 mm2 PES; p<0.01) and a significant decrease in mean neointimal area (2.3±1.3 mm2 IBT vs. 0.0±0.0 mm2 PES; p<0.001) immediately post-procedure, with no difference in mean vessel area. At 9-month follow-up, mean neointimal area was significantly reduced with PES implantation (2.5±1.2 mm2 IBT vs. 0.9±0.8 mm2 PES; p<0.001), corresponding to a significant decrease in in-stent net volume obstruction (32.4±11.7% IBT vs. 12.2±10.3% PES; p<0.001).
Conclusion: Previous reports demonstrate significant clinical and angiographic benefits of PES for the treatment of ISR. IVUS results suggest these benefits correlate with greater acute luminal gain and reduced neointimal hyperplasia compared to IBT, with a subsequent marked reduction in in-stent volumetric obstruction.