Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS)

Sirolimus-eluting stents have been developed to prevent restenosis in the treatment of coronary artery disease. We investigated the risk of restenosis with use of sirolimus-eluting stents compared with bare-metal stents to assess possible differences. Methods We enrolled 352 patients in whom one coronary artery required treatment, with diameter 2•5–3•0 mm and lesion length 15–32 mm. We randomly assigned patients sirolimus-eluting stents (n=175) or bare-metal stents (control, n=177). At 8 months we assessed differences in minimum lumen diameter and binary restenosis within the lesion (restenosis of ≤50% diameter, including 5 mm vessel segments proximal and distal to stented segment). Patients were also followed up for 9 months for major adverse cardiac events. Analysis was by intention to treat. Findings Stent implantation was successful in 100% of sirolimus-stent patients and 99•4% of controls. The mean diameter of treated coronary arteries was 2•55 mm (SD 0•37) and mean lesion length was 15•0 mm (6•0). Multiple stents were implanted in 170 (48%) patients. At 8 months, minimum lumen diameter was significantly higher with sirolimus-eluting stents than with control stents (2•22 vs 1•33 mm, p<0•0001). The rate of binary restenosis was significantly reduced with sirolimus-eluting stents compared with control stents (5•9 vs 42•3%, p=0•0001). Significantly fewer patients with sirolimus-eluting stents had major adverse cardiac events at 9 months than did controls (8•0 vs 22•6%, p=0•0002), due mainly to a lower need for target-lesion revascularisations (4•0 vs 20•9%, p<0•0001). Interpretation Sirolimus-eluting stents are better than bare-metal stents for treatment of single long atherosclerotic lesions in a coronary vessel smaller than 3 mm in diameter. Published online Sept 30, 2003. http://image.thelancet.com/extras/03art9099web.pdf