Drug-eluting stents are a major advance in percutaneous coronary intervention (PCI) because they reduce the need for repeat target lesion revascularization several-fold compared with bare-metal stents.
Early randomized clinical trials separately testing sirolimus-eluting stents1,2 and paclitaxel-eluting stents3,4 against their bare-metal counterparts demonstrated that rates of target lesion revascularization were reduced from approximately 10% to 15% to approximately 4% to 5%, whereas the rates of death, myocardial infarction, and stent thrombosis were similar between bare-metal and drug-eluting stents. Because these studies were performed for device regulatory approval, they enrolled patients and lesions with relatively low risk for restenosis and adverse events. Subsequent head-to-head trials of sirolimus- and paclitaxel-eluting stents in cohorts with a broader risk profile have provided inconsistent results; some trials have suggested equivalent rates of target lesion revascularization for these stents,5,6 whereas others have reported superiority of sirolimus-eluting stents.7- 9
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