John Libbey Eurotext




Coronary stents : from concept to usage
Sang Thrombose Vaisseaux. Volume 12, Number 2, 89-96, Février 2000, Mini-revues
Résumé Article gratuit
Author(s) : Patrick Dupouy, Eduardo Aptecar, Abdel Belarbi, Jean-Luc Dubois-Randé, Isabelle Lanoue, Monique Lespès, Jean-Marc Pernès, Emmanuel Teiger, Françoise Veyssière
Summary : European interventional cardiologists have the choice of using 71 types of stent. The results in terms of flexibility, of profile or resistance have improved over the last 15 years. The different types of stent are characterised essentially by the design of the links wich are responsible for the qualities of shortening on expansion, of metallic density or covering of the artery which are different although they are all manufactured from the same material of 316 L steel. The era when a stent passed “directly” from the designer’s workshop to the human coronary artery has changed, and rightly so. In agreement with the recommendations of the European Society of Cardiology, all new stents must be tested for mechanical resistance in vitro, followed by animal experimentation in authorised laboratories, before clinical trials. This is similar to models of drug experimentation which have been shown to be effective. The present questions concern the parameters to be studied and the size of the required studies. Care must be taken not to penalise small companies whose dynamic innovation has been demonstrated. A well conducted animal study in comparison with a reference stent should allow rapid evolution of the stent’s effect on intimal proliferation and the risk of occlusion. In the absence of major structural modifications and, above all, of the material of the stent, clinical trials with one month of follow-up should indicate the innocuity of the material tested. The degree of testing should be determined with respect to the proposed technological innovation.
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Coronary stents : from concept to usage