R E V I E W Sirolimus-eluting coronary stents: a review Alexandre Abizaid Institute Dante Pazzanese of Cardiology, Sao Paulo, Brazil Correspondence: Alexandre Abizaid Instituto Dante Pazzanese de Cardiologia, Av. Dr. Dante Pazzanese 500, Setor Angioplastia, Sao Paulo - SP- 04012-180, Brazil Tel +55 11 5085 4141 Fax +55 11 5549 7807 Email aabizaid@uol.com.br Abstract: The sirolimus-eluting coronary stent received CE Mark approval in Europe in April 2002. In the US, FDA approval followed in April 2003. Since the preliminary results from the First-in-Man feasibility study were presented, several randomized, controlled trials have documented the profound antiproliferative effects of sirolimus, a macrolide antibiotic and potent cytostatic inhibitor of smooth muscle cell proliferation. Subsequently, the body of clinical evidence was increased by the second wave of evidence from trials in more complex lesions (such as in-stent restenosis, small vessels, chronic total occlusions) and “high-risk” patients such as those with diabetes. More recently we have had the opportunity to compare the two commercially available drug-eluting stents following the presentation of data from six head-to-head trials. As a result of numerous single and multi-center, national and international studies in which the safety and efﬁcacy of sirolimus-eluting coronary stents have been subjected to close scrutiny, the global interventional cardiology community now has a wealth of evidence in support of the use of this technology resulting in dramatically improved patient outcomes after percutaneous intervention. Keywords: angioplasty, restenosis, percutaneous coronary intervention, rapamycin, sirolimus- eluting stent Introduction When the ﬁndings from the ﬁrst 50 patients treated with angioplasty were ﬁrst pub- lished, few would have predicted the dramatic increase in the use of percutaneous coronary interventions (PCI) with the associated explosion of clinical research and attendant information (Gruntzig et al 1979). There is no doubt that after the introduc- tion of balloon angioplasty in 1977, intracoronary stenting was the most important development in the ﬁeld of percutaneous coronary revascularization. Nevertheless, the problem of post-angioplasty restenosis, or lumen re-narrowing several months after the index procedure, continued to challenge interventional cardiologists (Serruys et al 1994, 2005). The consequences of restenosis are many and varied, affecting every aspect of the perception and reality of angioplasty as a deﬁnitive therapeutic intervention. The recurrence of symptoms has a major impact on both the patient and the healthcare system. Repeat intervention (sometimes requiring coronary bypass graft surgery), repeat hospitalization, sometimes myocardial infarctions, and time off work, or in the case of the retiree, lost recreational time, impact on the quality of life of the patient, and the attendant costs all add to the economical burden of healthcare systems (Van Hout et al 1996; Morice et al 2002; Serruys et al 2005). Pathophysiology of restenosis Stent-induced restenosis involves a complex interplay of biological events. We now know that stent placement causes endothelial injury as well as deeper injury due to Vascular Health and Risk Management 2007:3(2) 191–201 © 2007 Dove Medical Press Limited. All rights reserved 191