Table 1.
Trial | Date | Number of patients | Design of the study and comparator | Longer follow-up available and results |
---|---|---|---|---|
NOBORI CORE54 | 2008 | 43 Stable angina 100% |
Prospective, multicenter, and comparative. Vasomotion study after implantation of a BES Nobori® stent and an SES | Nine months follow-up. Endothelium-dependent vasomotion is preserved after BES implantation as compared with SES and may reduce thrombotic events. |
NOBORI I57 | 2009 | 243 UA 28% Stable angina 72% |
RCT BES Nobori® stent versus PES Taxus® Liberté | Nine months follow-up. Nobori® stent showed greater degree of neointimal hyperplasia inhibition. Reduction of ISR. No ST up to 9 months. |
SORT OUT V59 | 2013 | 2,458 STEMI 18% NSTEMI and UA 30% Stable angina 52% |
RCT BES Nobori® stent versus first-generation SES Cypher® stent to treat coronary artery stenosis | Twelve months follow-up. BES did not show non-inferiority and did not improve clinical outcomes when compared with SES. Higher early ST in the BES group. |
COMPARE II60 | 2013 | 2,707 STEMI 22% NSTEMI 27% UA 10% Stable angina 41% |
RCT BES Nobori® stent versus second-generation EES Xience® or Prime® | At 12 months follow-up, BES Nobori® stent showed non-inferiority as compared with EES. Procedural failure higher in the BES group. |
NEXT61 | 2013 | 3,235 STEMI and NSTEMI 5% UA 12% Stable angina 83% |
RCT BES Nobori® stent as compared with EES Xience® or Prime® | Twelve months follow-up. Outcome after implantation of BES is non-inferior to EES, with very low rate of ST. |
Abbreviations: BES, biolimus-eluting stent; DES, drug-eluting stent; EES, everolimus-eluting stent; ISR, in-stent restenosis; NSTEMI, non-ST-segment elevation myocardial infarction; PES, paclitaxel-eluting stent; RCT, randomized clinical trial; SES, sirolimus-eluting stent; ST, stent thrombosis; STEMI, ST-segment elevation myocardial infarction; UA, unstable angina.