Characteristics of predominantly NSTE-ACS studies
| Study | Patients (n)/population | PCI (%) | Bivalirudin (n) | UFH (n) | Bivalirudin design | UFH design | Female (%) | Mean age (year) | Follow-up (days) | GPI use (%) | Transradial (%) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bivalirudin | UFH | |||||||||||
| REPLACE-2, 20033 | 6010 Elective or urgent PCI | 98 | 2999 | 3011 | Intravenous bolus of 0.75 mg/kg, followed by a continuous infusion of 1.75 mg/kg/h | Intravenous bolus of 65 U/kg | 26 | 63 | 30 | 7 | 97 | 0 |
| REPLACE-1, 200420 | 1056 Elective or urgent PCI | 100 | 532 | 524 | Intravenous bolus of 0.75 mg/kg, followed by a continuous infusion of 1.75 mg/kg/h | Intravenous bolus of 60–70 U/kg adjusted to achieve and maintain an ACT of 200–300 s | 30 | 64 | 2 | 71 | 73 | 3 |
| PROTECT-TIMI 30, 200618 | 857 NSTEMI or UA | 100 | 284 | 573 | Intravenous bolus of 0.75 mg/kg, followed by a continuous infusion of 1.75 mg/kg/h with additional boluses to maintain ACT>200 s | Intravenous bolus of 50 U/kg adjusted to achieve and maintain an ACT of 200–250 s | 33 | 60 | 2 | 3 | 99 | NR |
| ACUITY-PCI*, 20074 | 7789 NSTEMI | 100 | 5228 | 2561 | Intravenous bolus of 0·1 mg/kg and an infusion of 0·25 mg/kg/h. An additional intravenous bolus of 0·5 mg/kg was administered before PCI, and the infusion was increased to 1·75 mg/kg/h | Intravenous bolus of 60 U/kg followed by an infusion of 12 U/kg/h to achieve and maintain an ACT of 200–250 s | 27 | 63 | 30 | 53 | 97 | 6 |
| ARNO, 200821 | 850 UA or elective PCI | 86 | 425 | 425 | Intravenous bolus of 0.75 mg/kg, followed by a continuous infusion of 1.75 mg/kg/h | Intravenous bolus of 100 U/kg with or without additional boluses to achieve an ACT of 250–300 s | 24 | 69 | 30 | NR | NR | 2 |
| ISAR-REACT 3, 200822 | 4570 Elective or urgent PCI | 100 | 2289 | 2281 | Intravenous bolus of 0.75 mg/kg, followed by a continuous infusion of 1.75 mg/kg/h | Intravenous bolus of 140 U/kg followed by a placebo infusion for the duration of the procedure | 24 | 67 | 30 | <1 | <1 | 68 |
| NAPLES, 200923 | 335 Elective or urgent PCI | 100 | 167 | 168 | Intravenous bolus of 0.75 mg/kg, followed by a continuous infusion of 1.75 mg/kg/h with additional boluses to maintain ACT>250 s | Intravenous bolus of 70 U/kg with additional boluses to maintain ACT>250 s | 35 | 65 | 30 | 1 | 100 | 3 |
| TENACITY, 201124 | 383 Elective or urgent PCI | 100 | 185 | 198 | Intravenous bolus of 0.75 mg/kg, followed by a continuous infusion of 1.75 mg/kg/h | Intravenous bolus of 50 U/kg adjusted to achieve and maintain an ACT of 225 s | 27 | 63 | 30 | 100 | 100 | NR |
| ISAR-REACT 4, 201112 | 1721 NSTEMI | 100 | 860 | 861 | Intravenous bolus of 0.75 mg/kg, followed by a continuous infusion of 1.75 mg/kg/h | Intravenous bolus of 70 U/kg | 23 | 68 | 30 | 0 | 100 | <1 |
| ARMYDA-7 BIVALVE, 201225 | 401 Elective or urgent PCI | 93 | 198 | 203 | Intravenous bolus of 0.75 mg/kg, followed by a continuous infusion of 1.75 mg/kg/h | Intravenous bolus of 75 U/kg | 28 | 70 | 30 | 12 | 14 | 2 |
| Deshpande et al26 | 101 Elective or urgent PCI | 100 | 49 | 52 | Intravenous bolus of 0.75 mg/kg, followed by a continuous infusion of 1.75 mg/kg/h | Intravenous bolus of 70 U/kg followed by an infusion of 20 U/kg/h to achieve and maintain an ACT of 200–250 s | 13 | 56 | 30 | 100 | 100 | 0 |
| SWITCH III, 201319 | 100 NSTEMI | 98 | 51 | 49 | Intravenous bolus of 0.75 mg/kg, followed by a continuous infusion of 1.75 mg/kg/h | Intravenous bolus of 60 U/kg with subsequent boluses to maintain an ACT>200 s | 32 | 63 | 30 | 4 | 12 | 68 |
| Xiang et al27 | 218 UA or elective PCI | 100 | 110 | 108 | Intravenous bolus of 0.75 mg/kg, followed by a continuous infusion of 1.75 mg/kg/h If ACT was <225 s, an additional bolus of 0.3 mg/kg was added | Intravenous bolus of 130 U/kg. If ACT was <225 s, an additional bolus of 300 U/kg was added | 17 | 58 | 30 | 1 | 4 | 25 |
| NAPLES III, 201528 | 837 Elective or urgent PCI | 100 | 418 | 419 | Intravenous bolus of 0.75 mg/kg, followed by a continuous infusion of 1.75 mg/kg/h If ACT was <250 s, an additional bolus of 0.3 mg/kg was added | Intravenous bolus of 70 U/kg. If ACT was <250 s, an additional bolus of 20 U/kg was added | 48 | 78 | 30 | 1 | 1 | 1 |
*The trial involved three arms; bivalirudin alone, bivalirudin plus GPI, and UFH alone.
ACT, activated clotting time; GPI, glycoprotein IIb/IIIa inhibitors; NR, not reported; NSTE-ACS, non-ST segment elevation acute coronary syndrome; NSTEMI, non-ST segment elevation myocardial infarction; PCI, percutaneous coronary intervention; UFH, unfractionated heparin, UA, unstable angina.