Table 1.
Study Name (Ref) | ||||||
---|---|---|---|---|---|---|
HORIZONS‐AMI15 | EUROMAX16 | BRAVE 417 | HEAT‐PPCI18 | BRIGHT19 | MATRIX20 | |
Study design | Multicenter, open label | Multicenter, open label | Multicenter, open label | Single‐center, open label | Multicenter, open label | Multicenter, open label |
Year of publication | 2008 | 2013 | 2014 | 2014 | 2015 | 2015 |
Patients (n) ITT | 3602 | 2198 | 544a | 1812 | 1925b | 7213c |
Age, y | 60 | 62 | 61 | 63 | 57 | 65 |
Radial access (%) | na | 47 | 0 | 81 | 78 | 50 |
Clopidogrel (%) | 96 | 51 | 97 with Heparin | 11 | 100 | 38 |
Thienopyridine (%) | 0 | 49 | 99 with Bivalirudin | 89 | 0 | 55 |
Initial heparin bolus, IU/kg | 60 | 100 without GPI, 60 with GPI | 70 to 100 | 70 | 100 without GPI, 60 with GPI | 70 to 100 without GPI, 50 to 70 with GPI |
Prolonged bivalirudin infusion after PCI (dose, n%, mean duration) | Stopped immediately after PCI | 1.75 mg/kg per hour (22.5%), 0.25 mg/kg per hour (77.5%), 4.5 hours | Stopped immediately after PCI | Stopped immediately after PCI | 1.75 mg/kg per hour (100%), 3 hours | 1.75 mg/kg per hour (34.4%), 0.25 mg/kg per hour (59.0%), 6.2 hours |
GPI use in bivalirudin arm (%) | 8 | 12 | 3 | 13 | 5 | 5 |
GPI use in heparin arm (%) | 98 | 69 | 6 | 15 | 6 and 100 | 26 |
Definition major bleeding | TIMI major bleedingd at 30 days | TIMI major bleedingd at 30 days | TIMI major bleedingd at 30 days | BARC type 3 to 5e at 28 days | BARC type 3 to 5e at 30 days | BARC type 3 and 5e at 30 days |
BARC indicates Bleeding Academic Research Consortium; BRAVE 4, Bavarian Reperfusion Alternatives Evaluation 4; BRIGHT, Bivalirudin in Acute Myocardial Infarction versus Heparin and GPI Plus Heparin; CABG, coronary artery bypass graft; EUROMAX, European Ambulance Acute Coronary Syndrome Angiography; GPI, glycoprotein IIb/IIIa inhibitors; HEAT‐PPCI, How Effective are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention; HORIZONS‐AMI, Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction; ITT, intention‐to‐treat; MATRIX, Minimizing Adverse Hemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox; na, not available; NSTEMI, non‐ST‐segment‐elevation myocardial infarction; PCI, percutaneous coronary intervention; STEMI, ST‐segment‐elevation myocardial infarction; TIMI, thrombolysis in myocardial infarction.
Randomized to bivalirudin plus prasugrel and heparin plus clopidogrel but stopped early due to slow recruitment.
Randomized to bivalirudin, heparin alone, and heparin plus GPI.
STEMI 56% and NSTEMI 44%.
TIMI major bleeding: intracranial bleeding, overt bleeding with hemoglobin drop of >5 g/dL, fatal bleeding.
BARC bleeding: Type 3: overt bleeding with hemoglobin drop of >3 g/dL or requiring transfusion, cardiac tamponade, bleeding requiring intervention or vasoactive agents, intracranial bleeding; Type 4: CABG‐related bleeding within 48 hours; Type 5: fatal bleeding.