A rapid and sensitive method based on liquid chromatographtandem mass spectrometry （LC-MS/MS） for the determination of a novel anticoagulant peptide bivalirudin in human plasma has been developed and validated. Plas...A rapid and sensitive method based on liquid chromatographtandem mass spectrometry （LC-MS/MS） for the determination of a novel anticoagulant peptide bivalirudin in human plasma has been developed and validated. Plasma samples were precipitated protein with acetonitrile and reextracted with dichloromethane, after which the analyte and triptorelin as an internal standard （IS） were separated on a 300SB-Cl8 column （150 mm x 4.6 mm i.d., 5 gm particle size） using 0.1% formic acid：methanol （45：55, v/v） as mobile phase. The triple-quadrupole mass spectrometer, equipped with electrospray ionization （ESI） interface, was operated in the positive ion mode, and the multiplereaction monitoring （MRM） transitions of bivalirudin and IS were at m/z 1091.0-650.4 and m/z656.5 - 249.3, respectively. The lower limit of quantification （LLOQ） was 1 ng/mL for 100 ng/mL plasma sample and the assay was linear over the concentration range 1 1000 ng/mL. The accuracy was within a range from -0.4% to 0.5% in terms of relative error （RE） and the intra- and inter-day precisions in terms of relative standard deviation （RSD） were 〈2.92 and 〈 3.36, respectively. The method was successfully applied to a pharmacokinetic study involving intravenous administration of bivalirudin （0.5 mg/kg） to Chinese volunteers.展开更多
AIM To review the early and more recent studies of Bivalirudin, to assess the safety, effectiveness, and cost benefits of this drug.METHODS Literature search of MEDLINE and Pub Med databases from 1990 to 2017 using ke...AIM To review the early and more recent studies of Bivalirudin, to assess the safety, effectiveness, and cost benefits of this drug.METHODS Literature search of MEDLINE and Pub Med databases from 1990 to 2017 using keywords as "bivalirubin" and "angiomax", combined with the words "safety", "effectiveness", "efficiency", "side effects", "toxicity", "adverse effect", and "adverse drug reaction".RESULTS A total of 66 publications were reviewed. The changes in clinical practice and differences in clinical protocols make it difficult to do direct comparisons of studies among each other. However, most trials showed decreased bleeding complications with bivalirudin, although ischemic complications and mortality were mostly comparable, with some favor towards bivalirudin.CONCLUSION Bivalirudin and heparin are both acceptable options according to current ACA/AHA guidelines. Authors conclude however, that that due to bivalirudin safer bleeding profile, it should be the preferred medication for anticoagulation.展开更多
Anticoagulation is imperative to reduce the incidence of thrombotic complications in patients undergoing percutaneous interventional cardiovascular procedures;however,this is at the expense of increased risk of bleedi...Anticoagulation is imperative to reduce the incidence of thrombotic complications in patients undergoing percutaneous interventional cardiovascular procedures;however,this is at the expense of increased risk of bleeding.The optimal anticoagulation strategy for these procedures remains unclear.Unfractionated heparin is the most commonly used anticoagulant during interventional procedures,but has several limitations,such as relatively high incidence of bleeding events,occurrence of heparin-induced thrombocytopenia,and a paradoxical thrombotic effect.Contemporary studies have demonstrated that bivalirudin decreases the occurrence of bleeding complications,but potentially increases the risk of acute stent thrombosis.This review discusses the pharmacology of bivalirudin and its current clinical application in patients undergoing percutaneous coronary intervention and transcatheter aortic valve replacement procedures.展开更多
Background Bivalirudin was widely used as an anticoagulant during coronary interventional procedure in western countries.However,it was not available in China before this clinical trial was designed.This randomized,si...Background Bivalirudin was widely used as an anticoagulant during coronary interventional procedure in western countries.However,it was not available in China before this clinical trial was designed.This randomized,single-blind and multicenter clinical trial aimed to evaluate the efficacy and the safety of domestic bivalirudin during percutaneous coronary intervention （PCI）.Methods A randomized,single-blind,multicenter trial was designed.Elective PCI candidates in five centers were randomized into a bivalirudin group and a heparin group,which were treated with domestic bivalirudin and non-fractional heparin during the PCI procedure.The efficacy was evaluated by comparing the activated coagulation time （ACT）,the procedural success rate （residual stenosis ＜20％ in target lesions without any coronary artery related adverse events within 24 hours after PCI）,and the survival rate without major adverse cardiac events at 30 days after PCI between the two groups.Safety was evaluated by the major/minor bleeding rate.Results A total of 218 elective PCI patients were randomized into a bivalirudin group （n=110） and heparin group （n=108）.Except for two patients needing additional dosing in the heparin group,the ACT values of all other patients in both groups were longer than 225 seconds at 5 minutes after the first intravenous bolus.Procedural success rates were respectively 100.0％ and 98.2％ in the bivalirudin group and heparin group （P＞0.05）.Survival rates without major adverse cardiac events at 30 days after PCI were 100.0％ in the bivalirudin group and 98.2％ in the heparin group （P＞0.05）.Mild bleeding rates were 0.9％ and 6.9％ （P＜0.05） at 24 hours,and 1.9％ and 8.8％ （P＜0.05） at 30 days after PCI in the bivalirudin group and heparin group respectively.There was one severe gastrointestinal bleeding case in the heparin group.Conclusions Domestic bivalirudin is an effective and safe anticoagulant during elective PCI procedures.The efficacy is not inferior to heparin,but the safety is superior to heparin.展开更多
Background It.s an effective treatment to implement percutaneous coronary intervention in acute myocardial infarction patients,which rapidly achieve coronary reperfusion. However,many patients with no-reflow,leading t...Background It.s an effective treatment to implement percutaneous coronary intervention in acute myocardial infarction patients,which rapidly achieve coronary reperfusion. However,many patients with no-reflow,leading to cardiovascular events,even sudden death. Bivalirudin has been used in anticoagulant therapy in PCI,which was characterized by rapid onset,strong anticoagulant effect and good safety. The HORIZONS-AMI study showed that bivalirudin reduced the risk of bleeding and death after PCI compared with heparin and glycoprotein IIb/IIIa antagonists. However,bivalirudin increased the risk of acute stent rethrombosis compared to unfractionated heparin and glycoprotein Ⅱb/Ⅲa antagonists. Therefore,the use of bivalirudin in emergency PCI was worth exploring. EUROMAX trial prompted that the patients who underwent emergency PCI and received intravenous use of bivalirudin during transit,might reduce the risk of bleeding. But there were few studies about bivalirudin on the effects of coronary reperfusion. This study was designed to investigate the effects of bivalirudin on coronary blood flow in patients with AMI and the safety of the drug. Methods All 120 AMI patients were divided into treatment group(n=60)and control group(n=60)according to random number method 1:1. In the treatment group,after coronary angiography and before PCI,the intravenous injection of bivalirudin(0.75mg/kg)was proportional,and then the intravenous maintenance was continued(1.75 mg·kg-1·h-1)for 5 h. In the control group,after coronary angiography and before PCI,intravenous injection of tirofiban(10 μg/kg)and unfractionated heparin(100 U/kg),followed by continuous intravenous injection of tirofiban(0.75 μg·kg-1·min-1)for 24 h. The TIMI blood flow classification,corrected TIMI frame number,TIMI myocardial perfusion grade(TMPG),Cardiac ultrasound parameters,serum NT-ProBNP and hs-CRP were recorded in the two groups before and after PCI. Major cardiovascular events(MACE),bleeding event,etc. were recorded. Results The ratio of coronary blood flow TIMI3 and TMPG3 after coronary intervention were significantly higher in treatment group than in control group(P<0.05);TIMI frame number showed that the coronary blood flow of treatment group was significantly faster than the control group(P<0.05). The LVEF value of the treatment group was higher than the control group after 30 d(P<0.05). Postoperative serum NT-ProBNP and hs-CRP in the treatment group were significantly lower than those in the control group(P<0.05). Conclusion Compared to tirofiban with heparin,using bivalirudin during acute PCI in AMI patients significantly improved coronary blood flow,reduced inflammatory response,reduced the incidence of MACE and bleeding,and improved the short-term prognosis.展开更多
Background and Aims:Unfractionated heparin(UFH)and bivalirudin are widely used as anticoagulants in cardiovascular medicine,including for thrombosis prevention during coronary angiography(CAG)and percutaneous coronary...Background and Aims:Unfractionated heparin(UFH)and bivalirudin are widely used as anticoagulants in cardiovascular medicine,including for thrombosis prevention during coronary angiography(CAG)and percutaneous coronary intervention(PCI).Little is known of the effects of UFH and bivalirudin on liver and kidney function in patients subjected to these procedures.This study compared the effects of bivalirudin and UFH on liver/renal function in patients with coronary artery disease who underwent CAG,with or without PCI.Methods:The study comprised 134 consecutive patients(40–89 years-old),who underwent CAG(or CAG and PCI);among them,66 and 68 patients were subject to,respectively,bivalirudin or UFH.The following indicators of liver/renal function were measured before and after the procedures:plasma alanine aminotransferase(ALT),aspartate aminotransferase(AST),blood urea nitrogen,estimated glomerular filtration rate(eGFR),creatinine clearance,and serum creatinine.Patients were further stratified by severity of chronic kidney disease(CKD),based on original eGFR.Results:Relative to baseline,in the bivalirudin group,ALT and AST were higher after CAG(p=0.005,0.025),while blood urea nitrogen and serum creatinine were lower(p=0.049,<0.001).In the UFH group,ALT,AST,eGFR,and creatinine clearance were lower after CAG(p≤0.001,all).Patients given bivalirudin with moderate or severe CKD,but not those with mild CKD,gained significant improvement in kidney function.Conclusions:Relative to UFH,bivalirudin may better safeguard the renal function of patients with coronary artery disease who undergo CAG,especially patients with moderate-to-severe renal insufficiency.UFH may cause less liver damage than bivalirudin.展开更多
Background Prior randomized trials have shown reduced bleeding with bivalirudin compared with unfractionated heparin （UFH） in patients undergoing percutaneous coronary intervention （PCI）. However, it is not known ...Background Prior randomized trials have shown reduced bleeding with bivalirudin compared with unfractionated heparin （UFH） in patients undergoing percutaneous coronary intervention （PCI）. However, it is not known if this benefit is also present when UFH doses are more tightly controlled （as measured by activated clotting time, ACT）.展开更多
Intravenous anticoagulant therapy is critical to prevent ischemic recurrences and complications without increasing the risk of bleeding in patients with ST-segment elevation myocardial infarction (STEMI) undergoing pr...Intravenous anticoagulant therapy is critical to prevent ischemic recurrences and complications without increasing the risk of bleeding in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). It includes the indirect thrombin inhibitor heparins and the direct thrombin inhibitor bivalirudin. However, the ideal anticoagulant for patients undergoing PPCI remains controversial. In this review, we provide an overview of currently available anticoagulant therapies used in STEMI patients undergoing PPCI, including describing the rationale for their use, pivotal clinical trial data, and treatment recommendations of guidelines, providing much-needed clarity to guide the selection of the safest and most effective anticoagulant regimens for PPCI.展开更多
Background Renal insufficiency is associated with an excess risk of vascular complications and bleeding events in patients who undergo PCI. Heparin is still used commonly for PCI, but the bleeding complications is hig...Background Renal insufficiency is associated with an excess risk of vascular complications and bleeding events in patients who undergo PCI. Heparin is still used commonly for PCI, but the bleeding complications is high. However, Bivalirudin is similar to heparin in ischemic complications and superior to the bleeding complica- tions. Methods A total of 181 patients with coronary artery disease and renal insufficiency were randomly as- signed two treatment groups： Bivalirudin （n = 90）, unfractionated heparin （n = 91）. Activated clotting time （ACT） was determined in patients at 5 min after undergoing PCI at the end of operation immediately （stopping drug im- mediately） , and 30 min,1 h, 2 h after stopping drug. Activated partial thromboplastin time （APTT）, thrombin time （TT）, proth rombin time （PT）, fibrinogen （FIB） index were measured before treatment, 6 h, 24 h and 72 h af- ter the treatment through an automated coagulation analyzer. Platelet count was monitored before treatment and 24 h after treatment. The end points were the proportion of net adverse clinical events （NACE） and stent throm- bosis at 30 days. Results The use of bivalirudin was associated with a statistically significant higher at 5 min af- ter treatment, end of operation immediately （P 〈 0.05）, with statistically significant lower at lh after stopping drug , 2h after stopping drug （P 〈 0.05）. There were no differences between patients at blood coagulation and platelet after operation （P 〉 0.05）, no differences in the 30-day rates of stent thrombosis （0% vs. 0%, P = 1）. Elev- en patients（12.22%） treated with bivalirudin vs. 24 （26.38%） treated with heparin experienced an adverse clinical events at 30 days （relative risk[RR], 0.46; 95%CI, 0.36-0.56; P 〈 0.025）. There were no differences in the major adverse cardiac or cerebral event at the 30-day end point（1.11% vs. 2.20%, P 〉 0.05）. The bleeding at 30 days was abated by using bivalirudin compared with unfracfionated heparin （11.11% vs. 24.18%, P 〈 0.05）. Conclu- sions Compared with the unfractionated heparin, bivalirudin is more quickly in taking effect and recovering and more efficient for PCI in patients with coronary artery disease and renal insufficiency.展开更多
Background The combination of glycoprotein Ⅱb/Ⅲ a inhibitors and heparin has not been compared with bivalirudin in studies specifically involving patients with non-ST-segment elevation myocardial infarction undergoi...Background The combination of glycoprotein Ⅱb/Ⅲ a inhibitors and heparin has not been compared with bivalirudin in studies specifically involving patients with non-ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention （PCI）. We compared the two treatments in this patient population.展开更多
In the HORIZONS-AMI （Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction） trial, 3,602 patients undergoing primary percutaneous coronary intervention （PCI） for ST-segment elevatio...In the HORIZONS-AMI （Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction） trial, 3,602 patients undergoing primary percutaneous coronary intervention （PCI） for ST-segment elevation myocardial infarction （STEMI） treated with bivalirudin had lower bleeding and mortality rates, but higher acute stent thrombosis rates compared with heparin ＋ a glycoprotein Ⅱ b/Ⅲ a inhibitor （GPI）. Subse- quent changes in primary PCI, including the use of potent P2Y_12 inhibitors, frequent radial intervention, and pre-hospital medication administration, were incorporated into the EUROMAX （European Ambulance Acute Coronary Syndrome Angiography） trial, which assigned 2,218 patients to bivalirudin versus heparin ±GPI before primary PCI.展开更多
基金the National Natural Science Foundation (30973587)the China Postdoctoral Science Foundation (20110491328)the National Natural Science Funds for Young Scholar (81102383)for financial support
文摘A rapid and sensitive method based on liquid chromatographtandem mass spectrometry （LC-MS/MS） for the determination of a novel anticoagulant peptide bivalirudin in human plasma has been developed and validated. Plasma samples were precipitated protein with acetonitrile and reextracted with dichloromethane, after which the analyte and triptorelin as an internal standard （IS） were separated on a 300SB-Cl8 column （150 mm x 4.6 mm i.d., 5 gm particle size） using 0.1% formic acid：methanol （45：55, v/v） as mobile phase. The triple-quadrupole mass spectrometer, equipped with electrospray ionization （ESI） interface, was operated in the positive ion mode, and the multiplereaction monitoring （MRM） transitions of bivalirudin and IS were at m/z 1091.0-650.4 and m/z656.5 - 249.3, respectively. The lower limit of quantification （LLOQ） was 1 ng/mL for 100 ng/mL plasma sample and the assay was linear over the concentration range 1 1000 ng/mL. The accuracy was within a range from -0.4% to 0.5% in terms of relative error （RE） and the intra- and inter-day precisions in terms of relative standard deviation （RSD） were 〈2.92 and 〈 3.36, respectively. The method was successfully applied to a pharmacokinetic study involving intravenous administration of bivalirudin （0.5 mg/kg） to Chinese volunteers.
文摘AIM To review the early and more recent studies of Bivalirudin, to assess the safety, effectiveness, and cost benefits of this drug.METHODS Literature search of MEDLINE and Pub Med databases from 1990 to 2017 using keywords as "bivalirubin" and "angiomax", combined with the words "safety", "effectiveness", "efficiency", "side effects", "toxicity", "adverse effect", and "adverse drug reaction".RESULTS A total of 66 publications were reviewed. The changes in clinical practice and differences in clinical protocols make it difficult to do direct comparisons of studies among each other. However, most trials showed decreased bleeding complications with bivalirudin, although ischemic complications and mortality were mostly comparable, with some favor towards bivalirudin.CONCLUSION Bivalirudin and heparin are both acceptable options according to current ACA/AHA guidelines. Authors conclude however, that that due to bivalirudin safer bleeding profile, it should be the preferred medication for anticoagulation.
文摘Anticoagulation is imperative to reduce the incidence of thrombotic complications in patients undergoing percutaneous interventional cardiovascular procedures;however,this is at the expense of increased risk of bleeding.The optimal anticoagulation strategy for these procedures remains unclear.Unfractionated heparin is the most commonly used anticoagulant during interventional procedures,but has several limitations,such as relatively high incidence of bleeding events,occurrence of heparin-induced thrombocytopenia,and a paradoxical thrombotic effect.Contemporary studies have demonstrated that bivalirudin decreases the occurrence of bleeding complications,but potentially increases the risk of acute stent thrombosis.This review discusses the pharmacology of bivalirudin and its current clinical application in patients undergoing percutaneous coronary intervention and transcatheter aortic valve replacement procedures.
文摘Background Bivalirudin was widely used as an anticoagulant during coronary interventional procedure in western countries.However,it was not available in China before this clinical trial was designed.This randomized,single-blind and multicenter clinical trial aimed to evaluate the efficacy and the safety of domestic bivalirudin during percutaneous coronary intervention （PCI）.Methods A randomized,single-blind,multicenter trial was designed.Elective PCI candidates in five centers were randomized into a bivalirudin group and a heparin group,which were treated with domestic bivalirudin and non-fractional heparin during the PCI procedure.The efficacy was evaluated by comparing the activated coagulation time （ACT）,the procedural success rate （residual stenosis ＜20％ in target lesions without any coronary artery related adverse events within 24 hours after PCI）,and the survival rate without major adverse cardiac events at 30 days after PCI between the two groups.Safety was evaluated by the major/minor bleeding rate.Results A total of 218 elective PCI patients were randomized into a bivalirudin group （n=110） and heparin group （n=108）.Except for two patients needing additional dosing in the heparin group,the ACT values of all other patients in both groups were longer than 225 seconds at 5 minutes after the first intravenous bolus.Procedural success rates were respectively 100.0％ and 98.2％ in the bivalirudin group and heparin group （P＞0.05）.Survival rates without major adverse cardiac events at 30 days after PCI were 100.0％ in the bivalirudin group and 98.2％ in the heparin group （P＞0.05）.Mild bleeding rates were 0.9％ and 6.9％ （P＜0.05） at 24 hours,and 1.9％ and 8.8％ （P＜0.05） at 30 days after PCI in the bivalirudin group and heparin group respectively.There was one severe gastrointestinal bleeding case in the heparin group.Conclusions Domestic bivalirudin is an effective and safe anticoagulant during elective PCI procedures.The efficacy is not inferior to heparin,but the safety is superior to heparin.
基金supported by Qingdao Municipal Health Commission Planning Project(No.2015-WJZD066)
文摘Background It.s an effective treatment to implement percutaneous coronary intervention in acute myocardial infarction patients,which rapidly achieve coronary reperfusion. However,many patients with no-reflow,leading to cardiovascular events,even sudden death. Bivalirudin has been used in anticoagulant therapy in PCI,which was characterized by rapid onset,strong anticoagulant effect and good safety. The HORIZONS-AMI study showed that bivalirudin reduced the risk of bleeding and death after PCI compared with heparin and glycoprotein IIb/IIIa antagonists. However,bivalirudin increased the risk of acute stent rethrombosis compared to unfractionated heparin and glycoprotein Ⅱb/Ⅲa antagonists. Therefore,the use of bivalirudin in emergency PCI was worth exploring. EUROMAX trial prompted that the patients who underwent emergency PCI and received intravenous use of bivalirudin during transit,might reduce the risk of bleeding. But there were few studies about bivalirudin on the effects of coronary reperfusion. This study was designed to investigate the effects of bivalirudin on coronary blood flow in patients with AMI and the safety of the drug. Methods All 120 AMI patients were divided into treatment group(n=60)and control group(n=60)according to random number method 1:1. In the treatment group,after coronary angiography and before PCI,the intravenous injection of bivalirudin(0.75mg/kg)was proportional,and then the intravenous maintenance was continued(1.75 mg·kg-1·h-1)for 5 h. In the control group,after coronary angiography and before PCI,intravenous injection of tirofiban(10 μg/kg)and unfractionated heparin(100 U/kg),followed by continuous intravenous injection of tirofiban(0.75 μg·kg-1·min-1)for 24 h. The TIMI blood flow classification,corrected TIMI frame number,TIMI myocardial perfusion grade(TMPG),Cardiac ultrasound parameters,serum NT-ProBNP and hs-CRP were recorded in the two groups before and after PCI. Major cardiovascular events(MACE),bleeding event,etc. were recorded. Results The ratio of coronary blood flow TIMI3 and TMPG3 after coronary intervention were significantly higher in treatment group than in control group(P<0.05);TIMI frame number showed that the coronary blood flow of treatment group was significantly faster than the control group(P<0.05). The LVEF value of the treatment group was higher than the control group after 30 d(P<0.05). Postoperative serum NT-ProBNP and hs-CRP in the treatment group were significantly lower than those in the control group(P<0.05). Conclusion Compared to tirofiban with heparin,using bivalirudin during acute PCI in AMI patients significantly improved coronary blood flow,reduced inflammatory response,reduced the incidence of MACE and bleeding,and improved the short-term prognosis.
基金This study received support from the National Natural Science Foundations of China(No.81970302).
文摘Background and Aims:Unfractionated heparin(UFH)and bivalirudin are widely used as anticoagulants in cardiovascular medicine,including for thrombosis prevention during coronary angiography(CAG)and percutaneous coronary intervention(PCI).Little is known of the effects of UFH and bivalirudin on liver and kidney function in patients subjected to these procedures.This study compared the effects of bivalirudin and UFH on liver/renal function in patients with coronary artery disease who underwent CAG,with or without PCI.Methods:The study comprised 134 consecutive patients(40–89 years-old),who underwent CAG(or CAG and PCI);among them,66 and 68 patients were subject to,respectively,bivalirudin or UFH.The following indicators of liver/renal function were measured before and after the procedures:plasma alanine aminotransferase(ALT),aspartate aminotransferase(AST),blood urea nitrogen,estimated glomerular filtration rate(eGFR),creatinine clearance,and serum creatinine.Patients were further stratified by severity of chronic kidney disease(CKD),based on original eGFR.Results:Relative to baseline,in the bivalirudin group,ALT and AST were higher after CAG(p=0.005,0.025),while blood urea nitrogen and serum creatinine were lower(p=0.049,<0.001).In the UFH group,ALT,AST,eGFR,and creatinine clearance were lower after CAG(p≤0.001,all).Patients given bivalirudin with moderate or severe CKD,but not those with mild CKD,gained significant improvement in kidney function.Conclusions:Relative to UFH,bivalirudin may better safeguard the renal function of patients with coronary artery disease who undergo CAG,especially patients with moderate-to-severe renal insufficiency.UFH may cause less liver damage than bivalirudin.
文摘Background Prior randomized trials have shown reduced bleeding with bivalirudin compared with unfractionated heparin （UFH） in patients undergoing percutaneous coronary intervention （PCI）. However, it is not known if this benefit is also present when UFH doses are more tightly controlled （as measured by activated clotting time, ACT）.
基金supported by the Key Research and Development Program of Liaoning Province(2020JH 2/10300167)Project of Science and Technology Plan of Shenyang(19-112-4-051)Cardiacare Sponsored Optimizing Antithrombotic Research Fund(BJUHFCSOARF201901-06).
文摘Intravenous anticoagulant therapy is critical to prevent ischemic recurrences and complications without increasing the risk of bleeding in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). It includes the indirect thrombin inhibitor heparins and the direct thrombin inhibitor bivalirudin. However, the ideal anticoagulant for patients undergoing PPCI remains controversial. In this review, we provide an overview of currently available anticoagulant therapies used in STEMI patients undergoing PPCI, including describing the rationale for their use, pivotal clinical trial data, and treatment recommendations of guidelines, providing much-needed clarity to guide the selection of the safest and most effective anticoagulant regimens for PPCI.
文摘Background Renal insufficiency is associated with an excess risk of vascular complications and bleeding events in patients who undergo PCI. Heparin is still used commonly for PCI, but the bleeding complications is high. However, Bivalirudin is similar to heparin in ischemic complications and superior to the bleeding complica- tions. Methods A total of 181 patients with coronary artery disease and renal insufficiency were randomly as- signed two treatment groups： Bivalirudin （n = 90）, unfractionated heparin （n = 91）. Activated clotting time （ACT） was determined in patients at 5 min after undergoing PCI at the end of operation immediately （stopping drug im- mediately） , and 30 min,1 h, 2 h after stopping drug. Activated partial thromboplastin time （APTT）, thrombin time （TT）, proth rombin time （PT）, fibrinogen （FIB） index were measured before treatment, 6 h, 24 h and 72 h af- ter the treatment through an automated coagulation analyzer. Platelet count was monitored before treatment and 24 h after treatment. The end points were the proportion of net adverse clinical events （NACE） and stent throm- bosis at 30 days. Results The use of bivalirudin was associated with a statistically significant higher at 5 min af- ter treatment, end of operation immediately （P 〈 0.05）, with statistically significant lower at lh after stopping drug , 2h after stopping drug （P 〈 0.05）. There were no differences between patients at blood coagulation and platelet after operation （P 〉 0.05）, no differences in the 30-day rates of stent thrombosis （0% vs. 0%, P = 1）. Elev- en patients（12.22%） treated with bivalirudin vs. 24 （26.38%） treated with heparin experienced an adverse clinical events at 30 days （relative risk[RR], 0.46; 95%CI, 0.36-0.56; P 〈 0.025）. There were no differences in the major adverse cardiac or cerebral event at the 30-day end point（1.11% vs. 2.20%, P 〉 0.05）. The bleeding at 30 days was abated by using bivalirudin compared with unfracfionated heparin （11.11% vs. 24.18%, P 〈 0.05）. Conclu- sions Compared with the unfractionated heparin, bivalirudin is more quickly in taking effect and recovering and more efficient for PCI in patients with coronary artery disease and renal insufficiency.
文摘Background The combination of glycoprotein Ⅱb/Ⅲ a inhibitors and heparin has not been compared with bivalirudin in studies specifically involving patients with non-ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention （PCI）. We compared the two treatments in this patient population.
文摘In the HORIZONS-AMI （Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction） trial, 3,602 patients undergoing primary percutaneous coronary intervention （PCI） for ST-segment elevation myocardial infarction （STEMI） treated with bivalirudin had lower bleeding and mortality rates, but higher acute stent thrombosis rates compared with heparin ＋ a glycoprotein Ⅱ b/Ⅲ a inhibitor （GPI）. Subse- quent changes in primary PCI, including the use of potent P2Y_12 inhibitors, frequent radial intervention, and pre-hospital medication administration, were incorporated into the EUROMAX （European Ambulance Acute Coronary Syndrome Angiography） trial, which assigned 2,218 patients to bivalirudin versus heparin ±GPI before primary PCI.
