Efficiency and safety of bivalirudin in patients undergoing emergency percutaneous coronary intervention via radial access: A subgroup analysis from the bivalirudin in acute myocardial infarction versus heparin and GPI plus heparin trial.
OBJECTIVE
To explore the efficiency and safety of bivalirudin in patients undergoing emergency percutaneous coronary intervention via radial access.


BACKGROUND
Bivalirudin reduces bleeding risks over heparin in patients undergoing PCI. However, bleeding advantages of bivalirudin in patients undergoing transradial intervention is uncertain.


METHODS
In the BRIGHT trial, 1,723 patients underwent emergency PCI via radial access, with 576 patients in the bivalirudin arm, 576 in the heparin arm and 571 in the heparin plus tirofiban arm. The primary outcome was 30-day net adverse clinical event (NACE), defined as a composite of major cardiac and cerebral events or any bleeding.


RESULTS
30-day NACE occurred in 5.7% with bivalirudin, 7.8% with heparin alone (vs. bivalirudin, P = 0.159), and 10.3% with heparin plus tifofiban (vs. bivalirudin, P = 0.004). The 30-day bleeding rate was 0.9% for bivalirudin, 2.3% for heparin (vs. bivalirudin, P = 0.057), and 5.8% for heparin plus tirofiban (vs. bivalirudin, P < 0.001). Major cardiac and cerebral events (4.9 vs. 5.7 vs. 4.6%, P = 0.899), stent thrombosis (0.5 vs. 0.5 vs. 0.7%, P = 0.899) and acquired thrombocytopenia (0.2 vs. 0.5 vs. 0.9%, P = 0.257) at 30 days were similar among three arms. The interaction test for PCI access and randomized treatment showed no significance on all bleeding (P > 0.05).


CONCLUSIONS
The bleeding benefit of bivalirudin was independent of artery access. Bivalirudin lead to statistical reduction on bleeding risks in comparison to heparin plus tirofiban, and only small numerical difference in comparison to heparin, with comparable risks of ischemic events and stent thrombosis in patients with acute myocardial infarction (AMI) undergoing emergency transradial PCI. © 2016 Wiley Periodicals, Inc.
Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, 110016, China.
Heyang
H
Wang
Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, 110016, China.
Yi
Y
Li
Department of Cardiology, Tianjin Chest Hospital, Tianjin, 300051, China.
Hongliang
H
Cong
Department of Cardiology, Wuhan General Hospital of Guangzhou Military, Wuhan, China.
Shifang
S
Ding
Department of Orthopedics, The Second Hospital, Jilin University, Changchun, China.
Bin
B
Liu
First Department of Cardiology, Shenzhou Hospital, Shenyang Medical College, Shenyang, 110002, China.
Lu
L
Li
Department of Cardiology, Chinese PLA General Hospital, Beijing, China.
Yundai
Y
Chen
Department of Cardiology, Affiliated Hospital of Ningxia Medical College, Yinchuan, China.
Shaobin
S
Jia
Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, 110016, China.
Quanmin
Q
Jing
Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, 110016, China.
Xin
X
Zhao
Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, 110016, China.
Haiwei
H
Liu
Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, 110016, China.
Zhenyang
Z
Liang
Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, 110016, China.
Jing
J
Li
Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, 110016, China.
Dan
D
Bao
Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, 110016, China.
Yaling
Y
Han
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D000991:Antithrombins / Q000008:administration & dosage* / Q000009:adverse effects; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D002681:China; D004630:Emergencies; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006629:Hirudins / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D000072658:Non-ST Elevated Myocardial Infarction / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D010446:Peptide Fragments / Q000008:administration & dosage* / Q000009:adverse effects; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D017534:Radial Artery / Q000000981:diagnostic imaging; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D018570:Risk Assessment; D012307:Risk Factors; D000072657:ST Elevation Myocardial Infarction / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D013997:Time Factors; D000077466:Tirofiban; D016896:Treatment Outcome; D014443:Tyrosine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D014859:Warfarin / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D014443:Tyrosine; D014859:Warfarin; D000077466:Tirofiban; C074619:bivalirudin
acute myocardial infarction; bivalirudin; transradial intervention