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. 2016 Jul 22;5(7):e003515. doi: 10.1161/JAHA.116.003515

Table 1.

Study Characteristics

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.

a

Randomized to bivalirudin plus prasugrel and heparin plus clopidogrel but stopped early due to slow recruitment.

b

Randomized to bivalirudin, heparin alone, and heparin plus GPI.

c

STEMI 56% and NSTEMI 44%.

d

TIMI major bleeding: intracranial bleeding, overt bleeding with hemoglobin drop of >5 g/dL, fatal bleeding.

e

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.