Comparison In Curative Effect Between Bivalirudin And Heparin In PCI For Patients With Non-ST-Segment Elevation Acute Coronary Syndrome And Renal Insufficiency

BackgroundPeople who suffer from coronary atherosclerotic heart disease(CHD)increase in China these years.Acute coronary syndrome(ACS)is one of the most serious coronary heart disease of CHD.Renal insufficiency relates closely to CHD.Patients with renal insufficiency are often associated with hypertension,diabetes and other diseases,which have complex metabolic and physiological disorders,leading to changes in pharmacokinetics.In addition,it affects the choice of drugs,long-term vascular restenosis rate and mortality.Currently,percutaneous coronary intervention(PCI)is widely used in the treatment of CHD,which can effectively open coronary arteries,restore coronary blood flow,and improve the prognosis.Coronary artery lesions in patients with non-ST-segment elevation acute coronary syndrome(NSTE-ACS)and renal insufficiency become more complicated.Pathological changes are easier to occur at bifurcations and bends of coronary arteries,and are easier to be complicated with calcification.At present,how to choose a safe and effective anticoagulant drug for PCI of patients with NSTE-ACS and renal insufficiency has became a research hotspot.ObjectiveThe purpose of this study was to compare the curative effect between bivalirudin and heparin in PCI for patients with non-ST-segment elevation acute coronary syndrome and renal insufficiency.MethodsA total of 80 patients diagnosed as NSTE-ACS combined with renal insufficiency receiving PCI in the First Affiliated Hospital of Zhengzhou University from June 2018 to June 2019 were included in this study,ranging in age from 18 to 85 years,including 40 patients in the bivalirudin group and 40 patients in the heparin group which were screened by a 1:1 propensity score matching method.Before the PCI,the patients were given oral load dose of antiplatelet drugs according to the relevant guidelines:aspirin enteric-coated tablets,clopidogrel or ticagrelor tablets and other adjuvant drugs according to the patients' needs.During the PCI,the patients were given bivalirudin or heparin according to clinical guidelines recommended.Bivalirudin was administered as a bolus of 0.75 mg/kg prior to the start of the PCI,followed by an infusion of 1.75 mg/kg per hour for the duration of the procedure,prolonging the bivalirudin infusion at PCI-dose(1.75 mg/kg per hour)for 2-4 hours.Heparin was administered as a bolus of 100 U/kg prior to the start of the PCI,1000 U per hour after the first dose until the end of the operation.We closely monitored the activation clotting time(ACT)during the operation in all patients to determine the anticoagulant effect of bivalirudin or heparin.If the ACT of five minutes after medication was less than 250 seconds,an additional bivalirudin(0.3 mg/kg)or heparin(20 U/kg)bolus was given.After the PCI,these patients were given oral antiplatelet agents:aspirin enteric-coated tablets,clopidogrel or ticagrelor tablets and other adjuvant drugs according to the patients' needs.We compared the two groups'activated clotting time(ACT)before the PCI,five minutes after medication,30 minutes after medication,immediately after PCI,1 and 2 hours after drug withdrawal.To compare the efficacy and safety between bivalirudin and heparin,we observed the incidence of net adverse clinical event in the two groups within 6 months after PCI:major hemorrhage events,minor hemorrhage events and the main adverse cardiovascular and cerebrovascular events(MACCE).All the collected data was using SPSS 22.0 statistical software for statistical analysis.Results1.Of the 80 patients enrolled in this study,40 were in the bivalirudin group,including 23 males and 17 females,with an average age of(60.50±8.12)years;40 patients in the heparin group,including 24 males and 16 females with an average age of(62.05 ± 9.51)years.There was no significant difference in age between the two groups of patients,P>0.05.Comparison between the bivalirudin group and the heparin group:body weight(64.93 ± 9.95 kg vs 64.83± 8,79 kg,P=0.962),low-density lipoprotein(1.91±0.82 mmol/L vs 2.07±0.74 mmol/L,P=0.949),creatinine(140.93+15.36 ?mol/L vs 142.10±15.10 ?mol/L,P=0.731),estimated glomerular filtration rate[43.24±7.34 mL/(min·1.73m2)vs 43.27±7.40 mL/(min·1.73m2),P=0.985]?left ventricular ejection fraction(57.85%± 7.40 vs 58.60 ± 3.18%,P=0.750),hemoglobin(127.53 ± 18.15 g/L vs 127.80 ±11.75 g/L,P=0.275)and other basic data were not statistically different,P>0.05.2.The comparison of the past history of the two groups of patients:there were 14 diabetic patients in the bivalirudin group and 14 patients in the heparin group(35.0%vs 35.0%,P=1.000);22 patients with hypertension in the bivalirudin group and 24 patients in the heparin group(22.0%vs 24.0%,P=0.656);4 patients with previous cerebral infarction in the bivalirudin group and 3 patients in the heparin group(10.00%vs 7.50%,P=0.697);3 patients with prior revasularization in the bivalirudin group and 4 patients in the heparin group(7.50%vs 10.00%,P=0.697).There were no significant difference in these areas between the two groups,P>0.05.3.The comparison of the location of vascular lesions in the two groups:left anterior descending branch:28 patients in the bivalirudin group and 30 patients in the heparin group(70.0%vs.75.0%,P=0.622);left circumflex branch:27 patients in the bivalirudin group and 29 patients in the heparin group(67.50%vs.72.50%,P=0.631),right coronary artery:25 patients in the bivalirudin group and 29 patients in heparin group(62.50%vs.72.50%,P=0.346).There was no statistical difference of these aspects between the two groups,P>0.05.4.The ACT of both groups of patients reached the anticoagulant standard of PCI(ACT>250 s)within 5 minutes after administration.We compared the preoperative ACT of bivalirudin group and heparin group(156.08± 13..47 s vs.157.08 ± 15.69 s,P=0.761),the difference was not statistically significant,P>0.05.The comparison of intraoperative ACT of bivalirudin group and heparin group:5 minutes after administration(366.13 ± 27.73 s vs.261.00±23.36 s,P<0.001);30 minutes after administration(425.55±28.03 s vs 286.78 ± 30.62 s,P<0.001);immediate postoperative(442.65 ± 28.43 s vs 304.60 ± 26.21 s,P<0.001),the difference was statistically significant,P<0.05.The comparison of postoperative ACT of bivalirudin group and heparin group:1 hour after withdrawal(232.05 ± 22.65 s vs 266.00 ± 28.17 s,P<0.001);2 hours after withdrawal(175.43 ± 21.23 s vs 208.88±23.96 s,P<0.001),the difference was statistically significant,P<0.05.5.There were 4 patients with ACT>500 s during the PCI in bivalirudin group who were reduced the bivalirudin dose and increased the frequency of ACT monitoring in the operation.6.The PCI of all patients were successful.During the 6 months follow-up period after the PCI:minor hemorrhage events(20 cases occurred in the bivalirudin group and 24 cases with heparin group,50.0%vs 60.0%,P=0.375),the difference was not statistically significant,P>0.05.No major hemorrhage events occurred in both groups.7.The occurrence of MACCEs in the 6 months follow-up was as follows:the patients in both groups successfully completed the PCI.No cardiogenic death,acute heart failure,stent thrombosis,cerebral hemorrhage,or stroke occurred.1 patient in the bivalirudin group had perioperative myocardial infarction,compared with 2 patients in the heparin group(2.50%vs 5.00%,P=0.562).0 patient in the bivalirudin group had revascularization,compared with 1 patient in the heparin group(0.00%vs 2.50%,P=0.320),the differences were not statistically significant,P>0.05.ConclusionCompared with heparin,the anticoagulant effect of bivalirudin is faster,stronger and more stable in PCI for patients with NSTE-ACS complicated by renal insufficiency.Meanwhile,bivalirudin is equivalent to heparin in safety.Also,it does not increase the incidence of MACCEs for bivalirudin within 6 months follow-up.Some patients' ACT in bivalirudin group was significantly higher during operation,so we should adjust the drip dose of bivalirudin and increase the frequency of ACT monitoring.