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

Cardiovasc Revasc Med. 2010 Jul-Sep;11(3):140-8. doi: 10.1016/j.carrev.2009.07.004.

Abstract

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 (Deltaminimum lumen area, mm(2): -1.2+/-1.0, -1.1+/-1.1, -0.8+/-0.9, P=.48; Deltavessel 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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Analysis of Variance
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Angioplasty, Balloon, Coronary / methods
  • Brachytherapy / methods
  • Chi-Square Distribution
  • Coronary Angiography / methods*
  • Coronary Restenosis / diagnostic imaging
  • Coronary Restenosis / mortality
  • Coronary Restenosis / therapy*
  • Coronary Stenosis / diagnostic imaging
  • Coronary Stenosis / mortality
  • Coronary Stenosis / therapy*
  • Drug-Eluting Stents*
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Metals
  • Middle Aged
  • Paclitaxel / pharmacology
  • Pilot Projects
  • Prospective Studies
  • Prosthesis Failure
  • Risk Assessment
  • Severity of Illness Index
  • Stents
  • Survival Rate
  • Time Factors
  • Treatment Outcome
  • Ultrasonography, Interventional / methods*
  • Vascular Patency / physiology

Substances

  • Metals
  • Paclitaxel