| Objectives Coronary heart disease(CHD) is one of the most common cardiovascular disease. In surgical treatment or medication, anticoagulant therapy are as important as antiplatelet therapy, Heparin(UFH), low molecular weight heparin(LMWH) and bivalirudin are the mainly anticoagulant drugs in clinical use. This study was to explore the safety and efficacy of bivalirudin in patients who was administered bivalirudin during percutaneous coronary intervention(PCI), giving theoretical basis and standard for the time of administering bivalirudin after PCI and demonstrating the advantage of bivalirudin compared with other anticoagulant drugs.Methods A total of 94 pateints with CHD, who were performed PCI, including 67(71.3%) men and 27(28.7%) women. average age 68.15±10.39(18-85) years old, were enrolled into this study from March 2015 to March 2016. They were randomly divided into unfractionated heparin plus tirofiban(group A, n=44) group, routine use of bivalirudin(group B, n=30) group and the group of delayed use of bivalirudin after PCI(group C, n=20). Heparin was administered as an intravenous bolus of 3000 U before the coronary angiography(CAG) and an supplementary bolus to100U/kg. If the operation time maitained for more than 1 hour, the extra dose(1000U/h) would be needed. Routine use of bivalirudin was administered as an intravenous bolus of 0.75 mg/kg, then maintained of 1.75 mg/kg/h during PCI until 2 hours after PCI. In the group of delayed use of bivalirudin after PCI, bivalirudin was administered as an intravenous bolus of 0.75 mg/kg, then maintained of 1.75 mg/kg/h during PCI, at least 2 hours after PCI and then the end time is determined by the performer. The ACT time was tested frequency in the three groups(Immediately after PCI, thirty minutes, one hour and two hour after PCI or drug withdrawal) to evaluate the instant anticoagulant effect. The adverse clinical events and bleeding events were observed and recorded(according to BARC bleeding standard) after primary PCI during hospitalization and 30 days. The major adverse cardiac events were defined as:malignant arrhythmia, severe heart failure, reinfarction, target vessel revascularization, and cardiac death.Results 1 Baseline data between the three groups including gender(men:75.0%vs70.0%vs65.0%, P=0.70), height(P=0.78), weight(P=0.43), systolic blood pressure(P=0.21), diastolic blood pressure(P=0.42) heart rate(P=0.35), high blood pressure(P=0.41), hyperlipidemia(P=0.96), coronary heart disease(P=0.28), PCI(P=0.28), diabetes(P=0.47), cerebral infarction(P=0.29), lower limb arteriosclerosis(P=0.86), smoking history(P=0.62), family genetic disease(P=0.72) and coronary heart disease(CHD) classification(UA: 77.3%vs66.7%vs60.0%, NSTEMI: 11.4%vs30.0%vs25.0%, STEMI: 11.4%vs3.3%vs15.0%, P=0.19) and no significant statistical difference.Compared with group A, the ages of group B and group C are older(62.20±8.54vs73.40±8.89vs73.35±9.47, P=0.00). Clinical laboratory indexes including platelet count(P=0.28), erythrocyte deposited(P=0.02), red blood cell count(P=0.01), hemoglobin(P=0.04), troponin I(c Tn I)(P=0.17)and myoglobin(P=0.11) and creatine kinase(CK-MB) concentration(P=0.27), NT-pro BNP(P=0.05), D-dimer(P=0.01), creatinine(P=0.94), total cholesterol(P=0.69), triglycerides(P=0.94), high-density lipoprotein cholesterol(P=0.84), low density lipoprotein(P=0.48), apolipoprotein A(P=0.11), fasting glucose(P=0.55), APTT(P=0.45), Left atrial diameter(P=0.56), left ventricular end-diastolic diameter(P=0.44), left atrial ventricular septal diameter(P=0.56), heart function(P=0.87) etc. There were no significantdifferences between the three groups except erythrocyte deposited, red blood cell count, hemoglobin and D-dimer. The erythrocyte deposited, red blood cell count and hemoglobin of group A are higher then group B and group C. The D-dimer of group A are lower then group B and group C. 2 Contrast between the three groups of drug treatment and imaging: before and after the admission and discharge from the application of the drug aspirin(100.0%vs93.3%vs100.0%, P=0.11), clopidogrel sulfate(86.4%vs93.4%vs100.0%, P=0.18), statins(100.0%vs100.0%vs100.0%), ACEI and ARB(36.4%vs53.3%vs35.0%, P=0.28), beta blockers(45.5%vs70.0%vs50.0%, P=0.11) drugs such as no significant statistical difference; Left main coronary heart disease(CHD) criminal blood vessels(LM: 2.3%vs0.0%vs0.0%, LAD: 38.6%vs46.7%vs40.0%, LCX: 20.5%vs36.8%vs25.0%, RCA: 30.0%vs20.0%vs25%, double branches: 11.4%vs3.3%vs10.0%, P=0.87), Number of stent placement(one stent placement: 74.4%vs66.7%vs75.0%, two pieces of stent placement: 25.6%vs33.3%vs25.0%, P=0.73), no significant statistical differences of PCI postoperative TIMI flow level 3 proportion(100%vs100%vs100%) are not seen significantly statistical differences. 3 Comparison of bivalirudin application time: the median of bivalirudin group total duration was 125 minutes, the median of PCI postoperative duration was 65 minutes, then the median of bivalirudin delayed group total duration was 190 minutes, the median of postoperative medication time was 145 minutes. 4 Comparison of the safety between the three groups. According to BARC bleeding standard, compared with group A, group B and group C had a significantly lower rate of bleeding(31.8%vs16.7%vs5.0%, P=0.039). There were no significant differences in the rates of 2-5 type bleeding(11.4%vs6.7%vs0.0%, P=0.27), 3-5 type bleeding(4.5%vs0.0%vs0.0%, P=0.31). There were no significant differences in the rates of major adverse cardiovascular events(4.5%vs0.0%vs0.0%, P=0.31), thrombocytopenia(0.0%vs0.0%vs0.0%) and acute stent thrombosis(0.0%vs3.3%vs0.0%, P=0.34) between the three groups. There was a case with severe bleeding and a case with MACE(cardiac rupture) in group A. There was a case with acute stent thrombosis in group B. Compared with group A, there were more high-risk patients in group B and group C(52.3%vs86.7%vs90.0%, P=0.001). 5 Comparison of the incidence of total adverse clinical events among different subgroups according to GRACE risk score for CHD. There was no significant difference in low-risk subgroup(2.3%vs5.0%vs0.0%, P=0.58) between the three groups. In high-risk subgroup, compared with group A, group B and group C had a significant lower rate of bleeding(according to BARC bleeding standard)(52.3%vs86.7%vs90.0%, P=0.001). 6 Comparison of the ACT value, the value of Immediately after the PCI(198.18±43.86vs272.33±70.53vs304.00±118.26, P=0.00), thirty minutes(178.73±32.75vs210.59±48.78vs226.00±46.27, P=0.00) and two hour after the PCI or drug withdrawal(148.00±34.15vs166.56±23.89vs167.42±18.15, P=0.02) in group B and group C were higher then group A. The ACT drop in group B and group C were significantly greater than in group A.Conclusions 1 Domestic bivalimdin results in similar efficacy and the major adverse cardiovascular events, as compared with heparinin patients with CHD undergoing PCI, while significantly reduces the incidence of bleeding at 30 day follow up. Especially domestic bivalirudin is also suitable for high-risk CHD patients. 2 It is safe and effective that extending the time of administering bivalirudin after PCI. Bleeding risk does not increase with the increase of the duration. 3 Bivalirudin can be applied to all kinds of ACS patients, including acute ST segment elevation myocardial infarction, but the specific use needs further research. |
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