Historical perspective of sirolimus and paclitaxel-eluting stent clinical studies

Bare metal stents (BMS) were developed and significantly improved the acute success and reproducibility of percutaneous coronary intervention (PCI) results compared to balloon angioplasty. Drug-eluting stents (DES) with antiproliferative drugs attached via polymer on the stent surface were developed as a logical next step in the evolution of PCI. First-generation DES including sirolimus and paclitaxel have shown clear evidence of clinical success with the application of the right dose and release kinetics. This chapter discusses the clinical data on sirolimus and paclitaxel-eluting stents from pivotal trial to multivessel disease treatment, focusing on their historical contribution to interventional cardiology. DES has shown benefits with respect to reduced repeat revascularization and other restenosis-related endpoints in more complex lesions, including acute myocardial infarction (MI), chronic total occlusions, in-stent restenosis, diffuse disease, saphenous vein grafts, and bifurcation lesions. Historical approaches to sirolimus and paclitaxel-eluting stents development and clinical data are reviewed in this chapter.