A new era in the treatment of coronary disease?

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Abstract
The technique of coronary stenting introduced in the early 1990s contributed widely to the enhancement of percutaneous interventions' outcomes in patients with coronary artery disease. However, the phenomenon of in-stent restenosis has long been the stumbling block of interventional cardiology and the target of many research projects in this field including the use of various devices or radiation therapy, and systemic or local delivery of biochemical substances and drugs. Indeed, angiographic restenosis, defined as a stenosis or narrowing of the vessel diameter by ≥50% at follow-up evaluation (binary restenosis), is still reported in 17–30% of patients followingcardiac stenting with uncoated or bare stents.1,2 Restenosis following stenting is largely due toneointimal hyperplasia, which is the healingresponse to the vascular injury induced by stent implantation and mechanical dilatation and translates into proliferation of smooth muscle cells.3–6 It is in this context that the technology of site-specific, stent-based drug delivery to inhibit the restenosis process has emerged. The ability of a wide variety of pharmaceuticals to inhibit restenosis following coronary interventions has been assessed. Evaluation of some of these agents, (actinomycin D, Batismastat and QP2) was discontinued in view of the poor results obtained in the preliminary phases of clinical trials. Among the various drugs investigated, Sirolimus and Paclitaxel stood out as yielding very promising results. So far, however, the longest follow-up study available in the largest group of patients has been conducted with Sirolimus. Indeed, the local delivery of Sirolimus (rapamycin), a natural macrocyclic lactone whichinhibits cytokine and growth factor-mediated cell proliferation in lymphocytes and smooth muscle cells, was shown to reduce neointimal proliferation in animal models as well as in a small, uncontrolled series of patients with coronary artery disease: the First-in-Man pilot study.7 A total of 45 patients were included in this non-randomized trial conducted in Sao …

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