Primary stenting of occluded native coronary arteries II--rationale and design of the PRISON II study: a randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of chronic total coronary occlusions

Am Heart J. 2005 Mar;149(3):e1-3. doi: 10.1016/j.ahj.2004.10.027.

Abstract

Primary intracoronary stent placement after successfully crossing chronic total occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. Several studies have shown the efficacy of sirolimus-eluting stents in selected groups of patients. Whether sirolimus-eluting stents are superior to bare metal stents in CTO is unknown. In this prospective randomized trial, bare metal stent implantation will be compared with sirolimus-eluting stent implantation for the treatment of CTO. A total of 200 patients will be followed up for 12 months with angiographic follow-up at 6 months. Quantitative coronary analysis will be performed by an independent core laboratory. The primary end point is the binary angiographic restenosis and reocclusion rate.

Publication types

  • Comparative Study

MeSH terms

  • Angioplasty, Balloon / methods
  • Chronic Disease
  • Coronary Angiography
  • Coronary Restenosis / diagnostic imaging*
  • Coronary Stenosis / diagnostic imaging
  • Coronary Stenosis / therapy*
  • Delayed-Action Preparations
  • Follow-Up Studies
  • Humans
  • Multicenter Studies as Topic / methods*
  • Patient Selection
  • Randomized Controlled Trials as Topic / methods*
  • Research Design
  • Sirolimus / administration & dosage*
  • Stents / classification*

Substances

  • Delayed-Action Preparations
  • Sirolimus