Type of clinical event | Patients (%; 95% CI)* | Patients (%; 95% CI)* Relative event risk; 95% CI* | ||
H-GPI arm, 1 year | H-GPI arm, 3 years | Bivalirudin arm, 1 year Bivalirudin versus H-GPI | Bivalirudin arm, 3 years Bivalirudin versus H-GPI | |
HORIZONS-AMI trial | ||||
Non-CABG-related major bleeding† |
| 185 (10.3; 8.9 to 11.8) |
|
|
Non-CABG-related major access site bleeding‡ | 64 (3.6; 2.7 to 4.5) | 67 (3.7; 2.9 to 4.7) |
|
|
Non-CABG-related major non-access site bleeding‡ | 101 (5.6; 4.6 to 6.8) | 118 (6.5; 5.4 to 7.8) |
|
|
Non-CABG-related minor bleeding | 256 (14.2; 12.6 to 15.9) | 262 (14.5; 12.9 to 16.3) |
|
|
Ischaemic stroke | 18 (1.0; 0.6 to 1.6) | 31 (1.7; 1.2 to 2.4) |
|
|
Repeat myocardial infarction | 76 (4.2; 3.3 to 5.3) | 135 (7.5; 6.3 to 8.8) |
|
|
Repeat revascularisation | 155 (8.6; 7.3 to 10.0) | 302 (16.8; 15.1 to 18.6) |
|
|
Death | 86 (4.8; 3.8 to 5.9) | 134 (7.4; 6.3 to 8.7) |
|
|
Estimates for 42.5% radial arterial access use as assumed in the base case analysis§ | ||||
Non-CABG-related major bleeding† | 138 (7.7; 6.5 to 9.0) | 157 (8.7; 7.5 to 10.1) |
|
|
Non-CABG-related major access site bleeding‡ | 37 (2.1; 1.4 to 2.8) | 39 (2.2; 1.5 to 2.9) |
|
|
Non-CABG-related minor bleeding | 147 (8.2; 6.9 to 9.5) | 151 (8.4; 7.1 to 9.8) |
|
|
↵* Based on Kaplan–Meier estimates of event numbers for the HORIZONS-AMI intention-to-treat population. H-GPI arm, N=1802; bivalirudin arm, N=1800. Limits of 95% CIs were used as ranges of variation in sensitivity analysis. In probabilistic sensitivity analysis, absolute (comparator strategy) event risks were represented by β distributions and relative event risks by lognormal distributions.
↵† The HORIZONS-AMI definition of major bleeding included any intracranial bleeding; intraocular bleeding; retroperitoneal bleeding; access site haemorrhage requiring surgery; haematoma ≥5 cm; reduction in haemoglobin of ≥4 g/dl without overt source; reduction in haemoglobin of ≥3 g/dl with overt source; re-operation for bleeding; use of any blood transfusion.5
↵‡ Patients with a non-CABG major bleeding were classified as ‘access site’ if they had a reported arterial access site or retroperitoneal bleeding, but no other major bleeding. The remainder of patients with a major bleeding were classified as ‘non-access site’. An equivalent definition was recently used by Verheugt et al.14
↵§ Estimates based on assumption of no access site bleedings in patients with radial arterial access (see methods, section on clinical event risks).
CABG, coronary artery bypass graft; H-GPI, heparin and glycoprotein IIb/IIIa inhibitor; HORIZONS-AMI, Harmonizing Outcomes with Revascularisation and Stents in Acute Myocardial Infarction.