Table 5: Randomised controlled trials including comparison of drug-eluting stents eluting different drugs.
| Study | Year | Stent 1 | Metal | BP/PP | Stent 2 | Metal | BP/PP | n | Primary endpoint | Result | Definite stent thrombosis at time of primary endpoint analysis |
|---|---|---|---|---|---|---|---|---|---|---|---|
| BES versus EES | |||||||||||
| BES | EES | ||||||||||
| COMPARE-II20 (NCT01233453) | 2013 | Nobori | SS | BP | XIENCE/Promus | CoCr/PtCr | PP | 2,707 | Cardiac death, MI and clinically indicated TVR at 12 months | 5.2% versus 4.8%, p<0.0001* | 0.7% versus 0.4%, p=0.38 |
| BASKET PROVE II45 (NCT01166685) | 2015 | Nobori | SS | BP | XIENCE | CoCr | PP | 1,530 | Cardiac death, MI and clinically indicated TVR within 2 years | 7.6% versus 6.8%, p=0.58 | 0.3% versus 0.7%, p=0.27 |
| BES versus SES | |||||||||||
| BES | SES | ||||||||||
| SORT OUT VII39 (NCT01879358) | 2016 | Nobori | SS | BP | Orsiro | CoCr | PP | 2,525 | Cardiac death, target lesion-related MI or TLR within 1 year | 4.6% versus 3.8%, p<0.0001*, p=0.34 (superiority) | 1.2% versus 0.4%, p=0.03 |
| SORT OUT V37 (NCT01254981) | 2013 | Nobori | SS | BP | CYPHER SELECT | SS | PP | 1,229 | Safety (cardiac death, MI, definite ST) and efficacy (TVR) at 9 months | 4.1% versus 3.1%, p=0.06* | 0.7% versus 0.2%, p=0.034 |
| NEXT21 (NCT01303640) | 2013 | Nobori | SS | BP | XIENCE/Promus | CoCr/PtCr | PP | 3,235 | TLR at 12 months | 4.2% versus 4.2%, p<0.0001*, p=0.93 (superiority) | 0.25% versus 0.06%, p=0.18 |
| BES versus ZES | |||||||||||
| BES | ZES | ||||||||||
| SORT OUT VI38 (NCT01956448) | 2017 | BioMatrix | SS | BP | Resolute | CoCr | PP | 1,502 | TLF at 12 months | 5.0% versus 5.3%, p=0.004* | 0.4% versus 0.6%, p=0.44 |
| BES versus SES | |||||||||||
| EES | SES | ||||||||||
| BIOSCIENCE33 (NCT01443104) | 2014 | XIENCE | E | PP | Orsiro | CoCr | BP | 2,119 | TLF at 12 months | 6.7% versus 6.7%, p=0.950 | 3.0% versus 2.0%, p=0.16 |
| CENTURY II34 (UMIN000006940) | 2014 | XIENCE | CoCr | PP | Ultimaster | CoCr | BP | 1,123 | Freedom from TLF at 9 months | 95.1% versus 95.6%, p<0.0001* | 0.91% versus 0.91%, p=0.99 |
| BES versus ZES | |||||||||||
| EES | ZES | ||||||||||
| EES versus ZES | |||||||||||
| EES | ZES | ||||||||||
| TWENTE II (DUTCH PEERS)46 | 2014 | Promus | PtCr | PP | Resolute | CoCr | PP | 1,811 | TVF at 12 months: composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (TVR) | 5% versus 6%, p=0.42 | 0.66% versus 0.33%, p=0.51 |
| RESOLUTE47 | 2015 | Resolute | CoCr | PP | XIENCE | CoCr | PP | 2,292 | TLF at 1 year | 8.2% versus 8.3%, p=0.94 | 1.2% versus 0.3% p=0.01 |
| SES versus ZES | |||||||||||
| SES | ZES | ||||||||||
| SORT OUT III48 (NCT00660478) | 2010 | CYPHER | SS | PP | Endeavor | CoCr | PP | 2,332 | Major adverse cardiac events within 9 months: cardiac death, MI and TVR | 3% versus 6%, p=0.0002 | 0.34% versus 1.12%, p=0.048 |
*P value for non-inferiority. BES = biolimus-eluting stent; BP = bioresorbable polymer; CoCr = cobalt–chromium; E = everolimus; EES = everolimus-eluting stent; MI = myocardial infarction; PP = permanent polymer; PtCr = platinum–chromium; S = sirolimus; SES = sirolimus-eluting stent; SS = stainless steel; ST = stent thrombosis; TLF = target lesion failure; TLR = target lesion revascularisation; TVF = target vessel failure; TVR = target vessel revascularisation; ZES = zotarolimus-eluting stent.