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ESC Congress 2003: Advocating the use of drug-eluting stents in all patients with coronary disease

September 02, 2003

IMPORTANT: This press release accompanies both a presentation and an ESC press conference given at the ESC Congress 2003. Written by the investigator himself/herself, this press release does not necessarily reflect the opinion of the European Society of Cardiology

ESC Congress 2003: Drug-eluting stents - a universal panacea

Coronary artery disease is the number one cause of death in the Western world. Over the past 25 years, percutaneous balloon angioplasty has become the treatment of choice for patients with flow-reducing lesions in their coronary arteries whatever the clinical presentation. Since the early nineties, the implantation of metallic stents during percutaneous revascularization procedures has gradually become routine practice. It is estimated that about 600,000 stents are implanted each year in Europe in patients with chronic to acute coronary artery disease. We believe that the routine use of drug-eluting stents which represent the latest development in stent technology may revolutionize the management of patients with coronary artery disease.

The Achilles' heel of percutaneous coronary interventions is the occurrence of restenosis in about 17% to 30% patients within 6 months of the first procedure. Though stents have proved efficient in preventing elastic recoil and remodeling of treated arteries, their placement causes injury to the vessel wall and, therefore, triggers a healing process inducing tissue proliferation and potential reduction of artery diameter.

Various strategies and techniques both mechanical and pharmaceutical as well as the use of radiation have been investigated in order to address this issue. However, none of these options has shown real efficacy. In this context, drug-eluting stent technology has emerged as a revolutionary concept. Drug-eluting stents are standard stents coated with a thin layer of polymer containing a high concentration of an antiproliferative drug which inhibits the restenosis process without causing toxic effects in the body.

The Sirolimus-eluting stent was the first stent evaluated in clinical studies. The first pilot study, known as the First in Man study (FIM) was followed by the RAVEL, double blind randomized study. The results of this study, namely the 0% restenosis rate in patients treated with the sirolimus stent, were disclosed during the ESC congress in 2001 and aroused considerable enthusiasm.

The efficacy of the sirolimus stent was later confirmed by the larger-scale SIRIUS randomized trial conducted in more complex patients. Several substudies are currently being conducted in more complex clinical settings (diabetes, multivessel disease, small vessels, myocardial infarction).

In parallel, other significant clinical studies have been conducted with Taxol (Paclitaxel) , another antiproliferative agent widely used in the treatment of cancer. All these studies (ELUTES, ASPECT, DELIVER) and especially the TAXUS research program have shown a clear benefit associated with the Paclitaxel-eluting stents. Several clinical programs (BRILLIANT, SCORE, ACTION) were discontinued in view of the poor or even deleterious results observed. At present, PACLITAXEL- and SIROLIMUS- eluting stents are viewed as the most promising tools in the interventional cardiologist's arsenal.

The question has been raised as to whether the results observed so far are sufficiently durable to warrant systematic use of drug-eluting stents. The follow-up periods of the clinical studies conducted with sirolimus now exceeds 3 years for the FIM study, 2 years for RAVEL, and 1 year for SIRIUS; and all the data collected show the stability of the results, and especially the absence of the catch-up phenomenon observed in the porcine model. The early results of the subgroups trials are also extremely encouraging.

The high initial cost of these new stents, 3 to 4 times that of a standard stent, is currently one of the main obstacles to their widespread use. However, it is essential to understand, that the reduction in repeat interventions and rehospitalization leads to significant savings.

All the financial analyses performed so far on the basis of the RAVEL and SIRIUS trials have demonstrated the cost-effectiveness of drug-eluting stents. Although these stents were approved for commercial use in Europe over a year ago, they are not reimbursed in most European countries, which precludes their use. Conversely, in the United States where drug-eluting stents have been approved for commercial use only recently, the FDA gave their immediate approval for their reimbursement, thus allowing the operators to include them in their routine practice.

One can easily imagine the daily frustration of European interventional cardiologists when they find themselves unable to provide their patients with the best existing treatment. It is a matter of urgency that the Health authorities make a sound decision in view of the clinical results and financial analyses associated with drug-eluting stents so that patients with coronary artery disease may quickly benefit from this irrefutable technological and therapeutic progress.

Dr Marie-Claude Morice
Institut Cardiovasculaire Paris Sud, Massy
France

European Society of Cardiology (ESC)