Table 1.
Randomised clinical trials of bivalirudin in patients with STEMI.
| Main Trials | HORIZONS-AMI [68] | EUROMAX [69] | HEAT-PPCI [71] | BRIGHT [72] | BRAVE 4 [73] | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Year | 2008 | 2013 | 2014 | 2015 | 2014 | ||||||
| Enrolment | 2005–2007 | 2010–2013 | 2012–2013 | 2012–2013 | 2009-2013 | ||||||
| Centres | 123 | 65 | 1 | 82 | 3 | ||||||
| Treatment |
Bivalirudin: 0.75 mg/kg bolus followed by an infusion of 1.75 mg/kg/h for the duration of PCI. Heparin: UFH 60 UI/kg bolus with additional bolus to target ACT 200–250 s. |
Bivalirudin: 0.75 mg/kg bolus followed by an infusion of 1.75 mg/kg/h for at least 4 h after (0.25–1.75 mg/kg/h). Heparin: UFH 100 UI/kg bolus without GPI or 60 UI/kg with GPI; or enoxaparin 0.5 mg/kg bolus. |
Bivalirudin: 0.75 mg/kg bolus followed by an infusion of 1.75 mg/kg/h for the duration of PCI. Heparin: UFH 70 UI/kg bolus with additional doses if ACT < 200 s. |
Bivalirudin: 0.75 mg/kg bolus followed by an infusion of 1.75 mg/kg/h for at least 4 h. After reduced infusion 0.2 mg/kg/h for up 20 h. Heparin: UFH 60 UI/kg bolus with additional doses if ACT < 200 s. Heparin + GPI: UFH 60 UI/kg bolus + tirofiban 10 µg/kg bolus followed by infusion 0.15 µg/kg/min for 18 to 36 h. |
Bivalirudin + Prasugrel: Prasugrel loading dose of 60 mg + 10 mg daily. Bivalirudin: 0.75 mg/kg bolus followed by an infusion of 1.75 mg/kg/h for the duration of PCI. Heparin + Clopidogrel: Clopidogrel loading dose 600 mg + 75 mg daily. UFH 70–100 UI/kg |
||||||
| HORIZONS-AMI [68] | EUROMAX [69] | HEAT-PPCI [71] | BRIGHT [72] | BRAVE 4 [73] | |||||||
| Bivalirudin | Heparin | Bivalirudin | Heparin | Bivalirudin | Heparin | Bivalirudin | Heparin | Heparin + GPI | Bivalirudin | Heparin | |
| Patients | 1800 | 1802 | 1089 | 1109 | 905 | 907 | 735 | 729 | 730 | 271 | 277 |
| Age | 59.8 (26.0–92.3) | 60.7 (21.6–91.6) | 61 (52–71) | 62 (52–72) | 62.9 (53.7–74.0) | 63.6 (54.0–73.8) | 57.3 ± 11.6 | 58.1 ± 11.7 | 58.2 ± 11.8 | 61.4 (51.9–71.7) | 61.4 (52.9–71.5) |
| Male | 77.1% | 76.1% | 74.7% | 77.6% | 71.0% | 73.0% | 82.7% | 81.6% | 82.1% | 76% | 79% |
| Clopidogrel | 95.7% | 95.1% | 50.0% | 51.5% | 11.8% | 10.0% | 100% | 100% | 99.9% | 3.7% | 90.2% |
| Prasugrel | 0% | 0% | 30.8% | 28.9% | 27.3% | 27.6% | 0% | 0% | 0% | 94.6% | 7.1% |
| Ticagrelor | 0% | 0% | 19.2% | 19.4% | 61.2% | 62.7% | 0% | 0% | 0% | 0% | 0% |
| GPI use | 7.2% | 94.5% | 11.5% | 69.1% | 13.5% | 15.5% | 4.4% | 5.6% | 100% | 3.0% | 6.1% |
| Radial access | 5.7% | 5.4% | 47.7% | 46.3% | 80.3% | 82.0% | 78.4% | 79.0% | 78.2% | <1% | <1% |
| Drug-eluting stent | NA | NA | 57.1% | 55.9% | 79.7% | 79.8% | 99.3% | 99.3% | 99.6% | 82.3% | 82.3% |
| PCI perform | 93.2% | 92.2% | 87.1% | 85.4% | 83.0% | 81.6% | 98.4% | 98.6% | 98.9% | 88.6% | 86.6% |
| NACE | 9.2% | 12.1% | 5.1% | 8.5% | 8.7% | 5.7% | 8.8% | 13.2% | 17.0% | 15.6% | 14.5% |
| Bleeding events | 4.9% | 8.3% | 2.6% | 6.0% | 3.5% | 3.1% | 4.1% | 7.5% | 12.3% | 14.1% | 12.0% |
UHF. Unfractionated Heparin. PCI: Percutaneous coronary intervention. ACT: Activated clotting time. GPI: Glycoprotein IIb/IIIa inhibitors. NACE: Net Adverse Clinical Events at 30-days.