Table 2.
Two-year clinical event rates in BIO-RESORT and BIONYX trial participants with known diabetes.
| BIO-RESORT patients with diabetes (N = 624) |
BIONYX patients with diabetes (N = 510) |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| SES N = 211 | RI-ZES N = 210 | EES N = 203 | Hazard ratio (95% CI) SES vs. RI-ZES | P-logrank SES vs. RI-ZES | Hazard ratio (95% CI) EES vs. RI-ZES | P-logrank EES vs. RI-ZES | SES N = 250 | RO-ZES N = 260 | Hazard ratio (95% CI) SES vs. RO-ZES | P-logrank SES vs. RO-ZES | |
| Cardiac death | 3 (1.5) | 9 (4.4) | 4 (2.0) | 0.32 (0.09–1.19) | 0.07 | 0.45 (0.14–1.44) | 0.17 | 7 (2.9) | 7 (2.8) | 1.05 (0.37–2.99) | 0.93 |
| Target vessel myocardial infarction | 6 (2.9) | 7 (3.4) | 10 (5.0) | 0.84 (0.28–2.51) | 0.76 | 1.48 (0.56–3.87) | 0.43 | 11 (4.5) | 11 (4.4) | 1.05 (0.46–2.43) | 0.90 |
| Target vessel revascularization | 16 (7.8) | 13 (6.5) | 8 (4.1) | 1.21 (0.58–2.52) | 0.61 | 0.60 (0.25–1.46) | 0.26 | 14 (5.8) | 20 (8.0) | 0.73 (0.37–1.44) | 0.36 |
| Target lesion revascularization | 10 (4.8) | 6 (3.0) | 7 (3.6) | 1.65 (0.60–4.53) | 0.33 | 1.17 (0.39–3.47) | 0.78 | 9 (3.7) | 15 (6.0) | 0.62 (0.27–1.42) | 0.25 |
| Target vessel failure⁎ | 21 (10.2) | 26 (12.7) | 20 (10.0) | 0.79 (0.44–1.40) | 0.42 | 0.78 (0.44–1.40) | 0.40 | 26 (10.7) | 31 (12.2) | 0.88 (0.52–1.48) | 0.63 |
| Target lesion failure | 15 (7.2) | 20 (9.7) | 19 (9.5) | 0.73 (0.38–1.43) | 0.36 | 0.97 (0.52–1.83) | 0.93 | 21 (8.7) | 26 (10.2) | 0.84 (0.47–1.50) | 0.56 |
| Definite-or-probable stent thrombosis | 3 (1.4) | 4 (1.9) | 3 (1.5) | 0.75 (0.17–3.34) | 0.70 | 0.76 (0.17–3.38) | 0.71 | 4 (1.6) | 1 (0.4) | 4.18 (0.47–37.43) | 0.16 |
| Definite stent thrombosis | 3 (1.4) | 1 (0.5) | 3 (1.4) | 2.99 (0.31–28.70) | 0.32 | 2.00 (0.18–22.01) | 0.57 | 3 (1.2) | 1 (0.4) | 3.14 (0.33–30.18) | 0.30 |
Data are n (%).
Abbreviations: CI = confidence interval; EES = Synergy everolimus-eluting stent; RI-ZES = Resolute Integrity zotarolimus-eluting stent; RO-ZES = Resolute Onyx zotarolimus-eluting stent; SES = Orsiro sirolimus-eluting stent.
Target vessel failure is the main endpoint consisting of cardiac death, target vessel myocardial infarction, or target vessel revascularization.