Table 2: Findings of clinical studies related to Orsiro biodegradable polymer drug-eluting stents.
| Study name | Year | Study type | Follow-up (months) | Stent comparator type | Patients (n) | Outcomes | Conclusion | |
|---|---|---|---|---|---|---|---|---|
| Orsiro BP-DES | Stent comparator | |||||||
| BIOFLOW I75 | 2013 | First-in-man study | 12 | N/A | 30 | N/A | - ST: 0% - MI: 0% - Cardiac death: 3.3% - TLR: 6.7% |
N/A |
| BIOFLOW II76 | 2015 | Non-inferiority RCT | 12 | Xience EES | 298 | 154 | - Definite or probable ST: 0% versus 0% - MI: 3.1% versus 2.6%; p=0.80 - Cardiac death: 0.7% versus 0.7%; p=0.98 - All-cause death: 1.0% versus 0.7%; p=0.71 - TLR: 3.8% versus 5.4%; p=0.46 - In-stent LLL at 9 months: 0.10 ± 0.32 mm versus 0.11 ± 0.29 mm; p=0.98 |
Non-inferior |
| BIOFLOW III77 | 2016 | All-comers registry analysis | 12 | N/A | 1,356 | N/A | - Definite ST: 0.2% - MI: 2.7% - Cardiac death: 1.3% - TLR: 3.0% |
N/A |
| SORT OUT VII56 | 2016 | Non-inferiority RCT | 12 | Nobori BP-DES | 1,261 | 1,264 | - Definite ST: 0.4% versus 1.2%; p=0.03 - MI: 1.6% versus 2.4%; p=0.16 - Cardiac death: 1.3% versus 1.4% p=0.75 - All-cause death: 3.0% versus 2.2%; p=0.21 - TLR: 2.0% versus 2.9%; p=0.13 |
Non-inferior Definite ST lower with Orsiro BP-DES than Nobori BP-DES |
| ORIENT78 | 2017 | Non-inferiority RCT | 12 | Resolute Integrity ZES | 250 | 122 | - Definite or probable ST: 0% versus 0% - MI: 0% versus 0.8%; p=0.13 - Cardiac death: 1.2% versus 0.8%; p=0.74 - All-cause death: 1.6% versus 0.8%; p=0.53 - TLR: 1.2% versus 2.5%; p=0.37 - In-stent LLL at 9 months: 0.06 mm (-0.09–0.24) versus 0.12 mm (-0.07–0.32); p=0.21 |
Non-inferior |
| PRISON IV79 | 2017 | Non-inferiority RCT (chronic total occlusion) | 12 | Xience EES | 165 | 165 | - Definite or probable ST: 0.6% versus 0.6% - MI: 0.6% versus 0.6% - Cardiac death: 0.6% versus 1.2% - All-cause death: 0.6% versus 1.8% - TLR: 10.5% versus 4.0%; p=0.04 - In-stent LLL at 9 months: 0.12 ± 0.59 mm versus 0.07 ± 0.46 mm; p=0.52 |
Non-inferior TLR higher with Orsiro BP-DES than Xience EES |
| BIOSCIENCE80 | 2018 | Non-inferiority RCT | 60 | Xience EES | 1,063 | 1,056 | - Definite or probable ST: 6.3% versus 7.7%; p=0.26 - MI: 10.4% versus 12.3%; p=0.23 - Cardiac death: 8.6% versus 7.5%; p=0.57 - All-cause death 14.1% versus 10.3%; p=0.02 - TLR: 11.5% versus 10.9%; p=0.61 |
Non-inferior All-cause death higher with Orsiro BP-dES than Xience EES |
| BIO-RESORT81 | 2018 | Non-inferiority RCT | 24 | Resolute Integrity ZES | 1,169 | 1,173 | - Definite or probable ST: 0.6% versus 0.8%; p=0.62 - MI: 3.1% versus 3.6%; p=0.50 - Cardiac death: 1.3% versus 1.5%; p=0.73 - All-cause death: 2.6% versus 3.3%; p=0.33 - TLR: 2.2% versus 3.0%; p=0.24 - TLR beyond 12 months: 0.6% versus 1.5%; p=0.04 |
Non-inferior TLR beyond 12 months lower with Orsiro BP-DES than Resolute Integity ZES |
| BIONYX82 | 2018 | Non-inferiority RCT | 12 | Resolute Onyx ZES | 1,245 | 1,243 | - Definite or probable ST: 0.7% versus 0.1%; p=0.01 - MI: 1.6% versus 1.6%; p=0.97 - Cardiac death: 1.1% versus 0.6%; p=0.18 - All-cause death: 2.1% versus 1.6%; p=0.37 - TLR: 2.0% versus 2.5%; p=0.35 |
Non-inferior Definite or probable ST higher with Orsiro BP-DES than Resolute Onyx ZES |
| BIOFLOW V83 | 2018 | Non-inferiority RCT | 24 | Xience EES | 884 | 450 | - Definite very late ST: 0.1% versus 1.0%; p=0.045 - MI: 5.3% versus 9.5%; p=0.01 - Cardiac death: 0.6% versus 0.5%; p=1.00 - All-cause death: 1.9% versus 2.2%; p=0.83 - TLR: 2.6% versus 4.9%; p=0.04 - TLF: 7.5% versus 11.9%; p=0.02 |
Non-inferior Definite very late ST, MI, TLR, and TLF lower with Orsiro BP-DES than Xience EES |
| BIOSTEMI84 | 2019 | Superiority RCT | 12 | Xience EES | 649 | 651 | - Definite or probable ST: RR, 0.69; 95% CrI, 0.32–1.69 - MI: RR, 1.21; 95% CrI, 0.60–2.46 - Cardiac death: RR, 0.77; 95% CrI, 0.43–1.40 - All-cause death: RR, 0.97; 95% CrI, 0.58–1.62 - TLR: RR, 0.57; 95% CrI, 0.28–1.12 - TLF: RR, 0.59; 95% CrI, 0.37–0.94 |
Non-superior TLF lower with Orsiro BP-DES than Xience EES |
Values are mean ± standard deviation or median (interquartile range).
BP-DES = biodegradable polymer drug-eluting stents; CrI = credibility interval; EES = everolimus-eluting stents; LLL = late lumen loss; MI = myocardial infarction;N/A = not available; RCT = randomised controlled trial; RR = risk ratio; ST = stent thrombosis; TLF = target lesion failure; TLR = target lesion revascularisation; ZES = zotarolimus-eluting stents.