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The manufacturer-sponsored, randomized SIRIUS trial (JW Cardiol Nov 14 2003) was the first to document a reduction in 1-year restenosis rates with sirolimus-eluting stents (SES) compared with bare-metal stents (BMS). The lesions treated in that study informed the on-label indications for this device and were generally less complex than those treated with SES in current, real-world practice. The SIRIUS investigators now report 5-year clinical outcomes in the 1058 participants.
The relative reductions in restenosis and adverse cardiovascular events with SES versus BMS were maintained at 5 years, although all clinical endpoints gradually increased in both groups. The target-lesion revascularization rate increased in both groups by about 4% afte…