Review of Randomized Clinical Trials of Drug-Eluting Stents for the Prevention of In-Stent Restenosis

Drug-eluting stents (DESs) have shown significant promise at reducing rates of restenosis and subsequent revascularization compared with bare metal stents (BMSs). The purpose of this report is to provide a systematic review of the randomized clinical trials that have evaluated the efficacy and safety of DESs. A total of 28 randomized clinical trials were identified: 21 comparing a DES (sirolimus, paclitaxel, ABT-578, actinomycin, everolimus, or 7-hexanoyltaxol) with a BMS and 7 comparing a DES with another DES (sirolimus vs paclitaxel). Early sirolimus and polymeric paclitaxel studies in low-risk populations demonstrated marked reductions in restenosis according to angiographic and clinical parameters, compared with BMSs. These promising findings led to the more recent evaluations of DESs in higher risk patients in controlled and head-to-head comparisons. In these subsequent trials, sirolimus and paclitaxel DESs continued to exceed the therapeutic potential of BMSs, with a slight but consistent angiographic advantage being observed with the sirolimus DESs.