The Safety And Efficiency Of Applying Bivalirudin During The Perioperation Period Of Emergent Percutaneous Coronary Interventions(PCI)in Acute Myocardio Infarction For Female Patients

Objective: To evaluated the safety and efficiency of bivalirudin during emergency percutaneous coronary interventions(PCI)in female patient with acute myocardial infarction(AMI).Methods: Study population was derived from Bivalirudin in Acute Myocardial Infarction versus Heparin and GPI plus Heparin Trial(BRIGHT). BRIGHT was a multi-center, randomized, active drug-controlled clinical trial. Between August 2012 and June 2013, a total of 2194 AMI patients with planned emergency PCI were enrolled in in 82 Chinese centers. All enrolled patients were randomly assigned in a 1:1:1 ratio to receive bivalirudin, heparin or heparin plus tirofiban. The present study was a post hoc analysis of female patient subgroup of BRIGHT trial. Data of 392 female patients enrolled in the BRIGHT trial were analyzed, including 127 patients randomized to the bivalirudin group and 265 patients randomized to the control group(heparin with or without tirofiban). The primary efficiency endpoint was 30-day net adverse clinical event(NACE), defined as all-cause death, re-infarction, ischemia-driven target vessel revascularization, stroke or any bleeding. The second efficiency endpoints was 30-day major cardiac and cerebral events(MACCE), defined as all-cause death, re-infarction, ischemia-driven target vessel revascularization and stroke. The safety endpoints were 30-day stent thrombosis and thrombocytopenia. Bleeding and stent thrombosis were classified according to the definition of Bleeding Academic Research Consortium(BARC) and Academic Research Consortium(ARC), respectively. Thrombocytopenia was defined as a decline of platelet count more than 50% or 150×109/L from baseline.Results: A total of 392 female and 1802 male patients were enrolled in BRIGHT. Compared with male patients, females were older(64.1±10.3 vs. 56.5±11.6, p<0.001), with lower body mass index(24.7±4.1 vs. 25.5±3.4,p<0.001) and higher rates of comorbidities such as diabetes(30.1% vs. 19.3%, p<0.001), hypertension(54.1% vs. 39.5%, p<0.001), anemia(10.3% vs. 4.3%, p<0.001) and moderate to severe kidney dysfunction(creatinine clearance rate [CCR]≤60ml/min,23.2% vs. 9.6%, p<0.001). The average CRUSADE bleeding score(32.7±12.1 vs. 17.5±10.3, p<0.001) and the ratio of patients with score above 30(7.7% vs. 4.7%, p=0.018) were higher in female patients compared with male patients. The results of 30-day follow-up showed that, the incidence of NACE(16.6% vs. 12.2%, p=0.020), MACCE(7.7% vs. 4.7%, p=0.018), BARC 2-5 type bleeding(5.4% vs. 2.8%, p=0.011), BARC 3-5 type bleeding(2.3% vs. 1.2%, p=0.081), thrombocytopenia(1.3% vs. 0.5%, p=0.088)were higher than in female patients compared with male patients. Subgroup analysis of female patients showed that the incidence of 30-day NACE(6.3% vs. 21.5%, p<0.001), any bleeding(2.4% vs. 12.8%, p=0.001) and BARC 2-5 type bleeding(1.6% vs. 7.2%, p=0.021) in the bivalirudin group were lower than that in the control-group. The incidence of MACCE(3.4% vs. 9.4%, p=0.55)and stent thrombosis(0% vs. 1.1%, p=0.229)were comparable between the two groups. Multivariate COX analysis showed that, bivalirudin(odds ratio [OR]:0.245, 95% confidence interval [CI]: 0.113-0.532, p < 0.001), transradial access(OR:0.119, 95%CI: 0.067-0.211, p<0.001), and statin(OR:0.254, 95%CI: 0.08-0.807, p=0.02) were independent protective factors for 30-day NACE in female patients. Hypertension(OR:3.136, 95%CI:1.48-6.646, p=0.03) and renal insufficiency(OR:1.904, 95%CI:1.027-3.53, p=0.03) were independent risk factors of 30-day NACE. Statin(OR:0.098, 95%CI: 0.034-0.282, p < 0.001) was the independent protective factor and diabetes(OR:2.443, 95%CI:1.163-5.133, p=0.018) was the independent risk factors for 30-day MACCE.Conclusion: Female patients with AMI underwent emergent PCI were older, with lower body mass and higher rates of comorbidities compared with male patients. The risk of bleeding and the incidence of 30-day adverse events were higher in femalepatients compared to male patients. In this high risk patient cohort, compared to heparin with or without tirofiban, use of bivalirudin during the perioperative period of emergency PCI significantly reduces the incidence of bleeding with similar anticoagulation effects.