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. 2021 Jun 25;17(3):240–247. doi: 10.4244/EIJ-D-20-00749

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