Table 2. Safety and effectiveness with DCS and BMS in the pooled LEADERS FREE & LEADERS FREE II ARC-HBR subgroups.
| Endpoints | ARC-HBR | Non-ARC-HBR | Interaction p-value | ||||||
| BMS (N=975) | DCS (N=1,923) | Adjusted hazard ratio* (95% CI) | p-value | BMS (n=236) | DCS (n=501) | Adjusted hazard ratio* (95% CI) | p-value | ||
| Primary safety endpoint (composite of cardiac death, MI or definite/probable stent thrombosis) | 132 (13.8%) | 184 (9.8%) | 0.72 (0.57-0.91) | 0.006 | 19 (8.1%) | 37 (7.5%) | 1.07 (0.60-1.88) | 0.828 | 0.206 |
| Primary effectiveness endpoint (clinically driven target lesion revascularisation) | 81 (8.8%) | 112 (6.2%) | 0.70 (0.52-0.94) | 0.016 | 26 (11.2%) | 27 (5.6%) | 0.49 (0.29-0.84) | 0.009 | 0.260 |
| Cardiac death | 56 (5.9%) | 82 (4.4%) | 0.77 (0.54-1.09) | 0.145 | 5 (2.1%) | 8 (1.6%) | 0.83 (0.27-2.52) | 0.737 | 0.908 |
| Myocardial infarction | 85 (9.1%) | 116 (6.2%) | 0.70 (0.53-0.93) | 0.015 | 18 (7.7%) | 29 (5.9%) | 0.87 (0.48-1.58) | 0.648 | 0.521 |
| Definite/probable stent thrombosis | 21 (2.2%) | 39 (2.1%) | 1.02 (0.59-1.77) | 0.934 | 5 (2.1%) | 8 (1.6%) | 0.95 (0.30-3.1) | 0.937 | 0.918 |
| Definite or probable stent thrombosis or MI | 90 (9.6%) | 125 (6.7%) | 0.71 (0.54-0.94) | 0.017 | 19 (8.1%) | 32 (6.5%) | 0.92 (0.51-1.64) | 0.771 | 0.435 |
| All-cause mortality | 95 (9.8%) | 167 (8.8%) | 0.96 (0.74-1.24) | 0.738 | 10 (4.2%) | 15 (3.0%) | 0.74 (0.33-1.65) | 0.460 | 0.549 |
| *Adjusted using inverse probability of treatment weighting according to propensity score. ARC-HBR: Academic Research Consortium High Bleeding Risk; BMS: bare metal stent; CI: confidence interval; DCS: drug-coated stent; MI: myocardial infarction | |||||||||