Clinical outcomes during randomisation period (from 1 to 12 months)
| Variables | Group A 10/10 (n=95) | Group B 10/5 (n=98) | All (n=193) | OR | 95% CI | p Value |
|---|---|---|---|---|---|---|
| Primary safety end points | ||||||
| BARC | ||||||
| Any bleeding | 45 (47.3) | 31 (31.6) | 76 (39) | 0.51 | 0.28 to 0.92 | 0.025 |
| Type 1 | 33 (34.7) | 27 (27.5) | 60 (31.0) | 0.71 | 0.39 to 1.31 | 0.280 |
| Type 2 | 10 (10.5) | 2 (2.0) | 12 (6.2) | 0.17 | 0.03 to 0.83 | 0.014 |
| Type 1 and 2 | 43 (45.3) | 29 (29.6) | 72 (37.3) | 0.51 | 0.28 to 0.91 | 0.024 |
| Type 3 | ||||||
| Type 3a | 2 (2.1) | 2 (2.0) | 4 (2.0) | 0.96 | 0.13 to 7.02 | 0.974 |
| Type 3b | 0 (0) | 0 (0) | 0 (0) | – | – | – |
| Type 3c | 0 (0) | 0 (0) | 0 (0) | – | – | – |
| Type 2 and 3 | 12 (12.6) | 4 (4.1) | 16 (8.2) | 0.29 | 0.09 to 0.94 | 0.031 |
| Type 4 | 0 (0) | 0 (0) | 0 (0) | – | – | – |
| Type 5 | ||||||
| Type 5a | 0 (0) | 0 (0) | 0 (0) | – | – | – |
| Type 5b | 0 (0) | 0 (0) | 0 (0) | – | – | – |
| Secondary efficacy composite end points | ||||||
| MACE | 2 (2.1) | 1 (1.0) | 3 (1.6) | 0.542 | ||
| Cardiac death | 0 (0) | 0 (0) | 0 (0) | – | ||
| Myocardial infarction | 1 (1.1) | 1 (1.0) | 2 (1.0) | 0.982 | ||
| TIA or stroke | 1 (1.1) | 0 (0) | 1 (0.5) | 0.309 | ||
| Other secondary end points | ||||||
| Definite/probable stent thrombosis | 0 (0) | 0 (0) | 0 (0) | – | – | – |
| Prasugrel discontinuation* | 2 (2.1) | 0 (0) | 2 (1.0) | 0.149 | ||
| Non cardiac death† | 1 (1.1) | 0 (0) | 1 (0.5) | 0.309 | ||
| Urgent TVR | 1 (1.1) | 0 (0) | 1 (0.5) | 0.309 | ||
| Angiographic sixth month follow-up | 83 (87.4) | 79 (80.6) | 162 (83.9) | 0.201 | ||
| Definite stent thrombosis | 0 (0) | 0 (0) | 0 (0) | – | – | – |
| Restenosis | 13 (15.7) | 8 (10.1) | 21 (13.0) | 0.294 | ||
Values are expressed as mean±SD or n (%).
*Gastric bleeding at 6 months and haemorrhagic stroke at 7 months.
†Creutzfeldt-Jakob disease.
BARC, Bleeding Academic Research Consortium; MACE, major adverse cardiovascular event; TIA, transient ischaemic attack; TVR, target vessel revascularisation.