Vascular responses to the multiple overlapped paclitaxel- eluting stents for the treatment of bare- metal in- stent restenotic lesions: angiographic and intravascular ultrasound analysis from the TAXUS-V ISR Trial

Background: Although effective coverage of coronary diffuse in-stent restenosis (ISR) lesions has warranted the use of multiple drug-eluting stents, the vessel response to paclitaxel-eluting stent (PES) overlap is not fully understood. Methods and materials: In the TAXUS-V ISR, i.e., comparing PES versus brachytherapy for the treatment of bare-metal ISR, angiographic analyses at 9-month follow-up were available in 184 ISR lesions treated with PES. Results: In-stent late loss in entire stented segment of multiple PES (n-50) was 0.45 +/- 0.48 mm, whereas that of single PES (n(-)134) was 0.3 +/- 0.47 mm, P-.06. No aneurysm was observed at overlapping PES segments at 9 months. Stent thrombosis up to 9 months was observed in one in each group (single PES, 0.7% vs. multiple PES, 1.8%; P=.47). In a subset of 30 patients, volumetric intravascular ultrasound analysis demonstrated that in-stent net volume obstruction was 12.3 +/- 12.4 in single PES (n=20) and 14.9 +/- 9.8 in multiple PES (n=10), P=.60. The changes of vessel and lumen at the overlapping PES segment were similar to those of the adjacent 5-mm segments (Delta minimum lumen area, mm(2): -1.2 +/- 1.0, -1.1 +/- 1.1, -0.8 +/- 0.9, P=.48;.vessel volume, mm(3)/mm: -0.2 +/- 1.4, 0.1 +/- 1.7, 0.3 +/- 1.3, P=.37; proximal, overlap, distal segment, respectively). There was no late incomplete stent apposition at overlapping PES segments. Conclusions: No in vivo evidence of adverse local vessel response at the site of overlapping PES for the treatment of bare-metal ISR has been demonstrated. (C) 2010 Elsevier Inc. All rights reserved.