Major adverse cardiac events at follow-up
| On-label (n=496) | Off-label (n=713) | Adjusted HR (95% CI) | p Value | |
|---|---|---|---|---|
| 6 Months–death | 5 (1.01) | 4 (0.56) | 0.554 (0.148 to 2.074) | 0.374 |
| MI | 3 (0.6) | 3 (0.42) | 0.694 (0.140 to 3.454) | 0.654 |
| TVR | 7 (1.41) | 11 (1.54) | 1.095 (0.421 to 2.844) | 0.853 |
| MACE | 15 (3.02) | 18 (2.52) | 0.645 (0.322 to 1.291) | 0.212 |
| 12 Months–death | 8 (1.61) | 7 (0.98) | 0.605 (0.218 to 1.679) | 0.329 |
| MI | 10 (2.02) | 8 (1.12) | 0.551 (0.216 to 1.407) | 0.207 |
| TVR | 15 (3.02) | 50 (7.01) | 1.858 (1.032 to 3.344) | 0.036 |
| MACE | 33 (6.65) | 65 (9.12) | 1.407 (0.910 to 2.176) | 0.123 |
| 24 Months–death | 10 (2.02) | 16 (2.24) | 1.116 (0.502 to 2.479) | 0.788 |
| MI | 13 (2.62) | 13 (1.82) | 0.690 (0.317 to 1.501) | 0.347 |
| TVR | 26 (5.24) | 71 (9.96) | 1.999 (1.256 to 3.182) | 0.003 |
| MACE | 49 (9.88) | 100 (14.03) | 1.488 (1.035 to 2.139) | 0.031 |
| 36 Months–death | 15 (3.02) | 28 (3.93) | 1.311 (0.693 to 2.481) | 0.404 |
| MI | 15 (3.02) | 26 (3.65) | 1.214 (0.636 to 2.316) | 0.556 |
| TVR | 35 (7.06) | 88 (12.34) | 1.855 (1.231 to 2.794) | 0.003 |
| MACE | 65 (13.1) | 142 (19.92) | 1.649 (1.199 to 2.269) | 0.002 |
| 48 Months–death | 21 (4.23) | 35 (4.91) | 1.168 (0.671 to 2.031) | 0.583 |
| MI | 18 (3.63) | 30 (4.21) | 1.166 (0.643 to 2.117) | 0.612 |
| TVR | 44 (8.87) | 100 (14.03) | 1.583 (1.088 to 2.305) | 0.016 |
| MACE | 83 (16.73) | 165 (23.14) | 1.498 (1.118 to 2.008) | 0.007 |
| 60 Months–death | 23 (4.64) | 36 (5.05) | 1.094 (0.640 to 1.869) | 0.744 |
| MI | 20 (4.03) | 31 (4.35) | 1.082 (0.609 to 1.921) | 0.788 |
| TVR | 48 (9.68) | 104 (14.59) | 1.594 (1.109 to 2.292) | 0.011 |
| MACE | 91 (18.35) | 171 (23.98) | 1.404 (1.056 to 1.867) | 0.019 |
Results are shown as number (%).
MACE, major adverse clinical events; MI, myocardial infarction; TVR, target vessel revascularisation.