Table 3.
Summary of randomized controlled trials of sirolimus-eluting stent vs bare metal stent
| RAVEL | SIRIUS | E-SIRIUS | C-SIRIUS | |||||
|---|---|---|---|---|---|---|---|---|
| Sirolimus (n = 120) | Control (n = 118) | Sirolimus (n = 533) | Control (n = 525) | Sirolimus (n = 175) | Control (n = 177) | Sirolimus (n = 50) | Control (n = 50) | |
| Mean lesion length (mm) | 9.56 | 9.61 | 14.4 | 14.4 | 14.9 | 15.1 | 14.5 | 12.6 |
| Mean RVD (mm) | 2.6 | 2.64 | 2.79 | 2.81 | 2.6 | 2.51 | 2.65 | 2.62 |
| Angiographic follow-up | 6 mon | 9 mon | 9 mon | 9 mon | ||||
| Mean late luminal loss* (mm) | −0.01 | 0.80 | 0.24 | 0.81 | 0.19 | 0.80 | 0.12 | 0.79 |
| Binary restenosis(%) | 0 | 26.6 | 8.9 | 36.3 | 5.9 | 42.3 | 2.3 | 52.3 |
| Subacute stent thrombosis (%) | 0 | 0 | 0.4 | 0.8 | 1.1 | 0 | 2.0 | 2.0 |
| TVR (%) | 0 | 26 | 3.4 | 4.8 | 4.0 | 20.9 | – | – |
| TLR (%) | 0 | 23.7 | 4.1 | 16.6 | 4.0 | 20.9 | 4.0 | 18.0 |
| Overall MACE (%) | 5.8 | 28.8 | 7.1 | 18.9 | 8.0 | 22.6 | 4.0 | 18.3 |
Abbreviations: RAVEL, Randomized study with sirolimus-eluting Velocity balloon-expandable stent in the treatment of patients with de novo native coronary artery lesion; SIRIUS, Sirolimus-coated BX Velocity stent in the treatment of patients with de novo coronary artery lesions; E- & C-SIRIUS, European- & Canadian-SIRIUS; MACE, major adverse cardiac events; mon, months; RVD, reference vessel diameter; TLR, target lesion revascularization; TVR, target vessel revascularization.
note: All mean late luminal loss were in-segment except for RAVEL which was in-stent.