Authors' objectives:

This report aims to provide advice on the state of play of the introduction and use of stents coated with various substances as a solution to restenosis among patients undergoing procedures to improve coronary artery function.

Authors' recommendations: Treatment of coronary heart disease accounts for a significant component of the budget for the Australian public hospital system. Treated stents have the potential to reduce costs through decreasing the number of repeat procedures to treat restenosis, however there is insufficient evidence based data on the efficacy of the stents to allow an assessment of cost effectiveness. While positive, the results of trials using Sirolimus coated stents are from a small number of patients over a relatively short period of time. Further longer term studies are required to substantiate the early results. The results of studies trialing Paclitaxel coated stents in porcine and rabbit coronary instent restenosis models, and in humans are mixed. Human studies demonstrated low restenosis rates in the treatment groups, and early (four week) assessment of porcine arteries showed no restenosis. However studies in rabbit arteries over a longer period found incomplete healing and a regrowth of neointimal cells at 90 days. Heparin coated stents have been in use in Australia for some time. However while the results from early studies examining the efficacy of these stents were positive, more recent reports suggest that there is no difference in clinical outcomes between heparin coated and non-coated stents. While gold coated stents are used routinely in some European countries, results of studies in the porcine and human models are far from conclusive, with some studies suggesting that the stents may actually increase the risk of restenosis. Similarly, radioactive stents are problematic with a high incidence of edge restenosis. Stents are used routinely in interventional cardiology. However the efficacy of new generation treated stents is not proven. In the absence of long term clinical trial follow-up data, the use of treated stents is essentially experimental and as such, should be subject to ethics committee approval, and informed consent by patients with a system for ongoing monitoring and evaluation established to assess long term efficacy and safety.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.msac.gov.au/reports.htm

Year Published: 2002

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Medical Services Advisory Committee

Contact Address: MSAC (MDP 107), GPO Box 9848, Canberra, ACT 2601, Australia. Tel: +61 2 6289 6811; Fax: +61 2 6289 8799.

Contact Name: msac.secretariat@health.gov.au

Contact Email: msac.secretariat@health.gov.au

Copyright: Medical Services Advisory Committee (MSAC)