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Although bivalirudin has been recently made available for purchase in China, large-scale analyses on the safety profile of bivalirudin among Chinese patients is lacking. Thus, this study aimed to compare the safety profile of bivalirudin and heparin as anticoagulants in Chinese ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI). A total of 1063 STEMI patients undergoing PCI and receiving bivalirudin (n=424, bivalirudin group) or heparin (n=639, heparin group) as anticoagulants were retrospectively enrolled. The net adverse clinical events (NACEs) within 30 days after PCI were recorded, including major adverse cardiac and cerebral events (MACCEs) and bleeding events (bleeding academic research consortium (BARC) grades 2-5 (BARC 2-5)). The incidences of NACEs (10.1 vs 15.6%) (P=0.010), BARC 2-5 bleeding events (5.2 vs 10.3%) (P=0.003), and BARC grades 3-5 (BARC 3-5) bleeding events (2.1 vs 5.5%) (P=0.007) were lower in the bivalirudin group compared to the heparin group, whereas general MACCEs incidence (8.9 vs 6.4%) (P=0.131) and each category of MACCEs (all P>0.05) did not differ between two groups. Furthermore, the multivariate logistic analyses showed that bivalirudin (vs heparin) was independently correlated with lower risk of NACEs (OR=0.508, P=0.002), BARC 2-5 bleeding events (OR=0.403, P=0.001), and BARC 3-5 bleeding events (OR=0.452, P=0.042); other independent risk factors for NACEs, MACCEs, or BARC bleeding events included history of diabetes mellitus, emergency operation, multiple lesional vessels, stent length >33.0 mm, and higher CRUSADE score (all P<0.05). Thus, bivalirudin presented a better safety profile than heparin among Chinese STEMI patients undergoing PCI.
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Objective: To compare the safety and efficacy of bivalirudin versus unfractionated heparin during perioperative period of percutaneous coronary intervention(PCI) in real-world. Methods: A total of 13 097 serial patients who underwent PCI from January 2016 to November 2018 in the Northern Theater Command were enrolled in the present study. Patients were stratified as the bivalirudin group or the heparin group according to antithrombotic therapy during PCI. The primary efficiency endpoint was 30-day net adverse clinical event(NACE), defined as all-cause death, re-infarction, urgent target lesion revascularization (uTLR), stroke or any bleeding. The second efficiency endpoint was 30-day major cardiac and cerebral events (MACCE), defined as all-cause death, re-infarction, uTLR and stroke. Additional end points included the rates of stent thrombosis at 30 days. Propensity scores included clinical and demographic variables, with 1∶2 matching. Compared the incidence of events above between the two groups before and after matching. Results: Among the 13 097 included patients(age was (61±10) years old), 3 421 (26.1%) were female. And 2 734 patients were divided into the bivalirudin group, and 10 363 patients to the heparin group(5 468 after matching). Before propensity score matching, patients in bivalirudin group were older and received higher levels of CRUSADE score than heparin group. These patients were more likely to have hypertension and more with ST-segment elevation acute coronary syndromes（all P＜0.05）. After propensity score matching, the incidence of 30-day NACE(3.8%(103/2 734) vs.5.0%(271/5 468), P=0.015) and any bleeding (2.0%(54/2 734) vs. 2.8%(151/5 468), P=0.032) in the bivalirudin group were lower than that in the heparin group, but the incidence of MACCE (1.9%(51/2 734) vs. 2.3%(127/5 468), P=0.180) and stent thrombosis (0.1%(2/2 734) vs. 0.1%(3/5 468), P=1.000) were comparable between the two groups. Conclusion: The risk of bleeding and the incidence of NACE are significantly lower for patients using bivalirudin during perioperative period of PCI compared to heparin, without significant differences in ischemic events.
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Aged , Female , Humans , Middle Aged , Anticoagulants/therapeutic use , Heparin/therapeutic use , Hirudins , Peptide Fragments , Percutaneous Coronary Intervention , Perioperative Period , Recombinant Proteins , Treatment OutcomeABSTRACT
Objective To compare the efficacy of heparin and bivalirudin in patients with acute coronary syndrome undergoing emergency percutaneous coronary intervention ( PCI ) .Methods A total of 90 patients with acute coronary syndrome were included in this study .They were divided into the study group and control group according to the requirements of random envelope method ,45 cases in each group .The study group received bivalirudin during PCI,the control group was given heparin .The Fbg,APTT,TT and PT were detected in the two groups ,and the inci-dence of adverse reactions ( heart failure , cardiac death , platelet reduction , hemorrhage of digestive tract ) was analyzed.Results After treatment,there were no statistically significant differences between the two groups in various blood coagulation indicators (all P>0.05).The incidence rate of adverse events of the study group was 4.44％, which was significantly lower than 24.44％of the control group ,and the difference was statistically significant (χ2 =7.28,P<0.05).Conclusion Application of heparin and bivalirudin in PCI has similar efficacy ,but the safety of bivalirudin is higher ,which is worthy of clinical promotion .
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Objective@#To investigate the effects and related mechanism of bivalirudin on the survival of random skin flap on the back of rat.@*Methods@#Thirty SD rats were divided into bivalirudin group and normal saline group according to the random number table, with 15 rats in each group. The random flap model with size of 9 cm×3 cm was reproduced on the back of rats in two groups. Immediately post injury, rats in bivalirudin group were intraperitoneally injected with 5 mg/mL bivalirudin (0.8 mL/kg), while rats in normal saline group were intraperitoneally injected with normal saline (0.8 mL/kg) once a day. The continuous injection lasted for 7 days. The flap was divided into distal area, middle area and proximal area averagely based on the flap blood supply. On post injury day (PID) 1, 3, and 7, the overall survival of each area of flap was observed with naked eyes. On PID 7, the survival rate of flap was calculated, and then the morphology of skin tissue at the center of the three areas of flap was observed by HE staining, the microvessel density (MVD) of the middle area of flap was calculated, and the expression of vascular endothelial growth factor (VEGF) of the middle area of flap was detected with immunohistochemical staining. Data were processed with t test.@*Results@#(1) On PID 1, flaps of rats in two groups had different degrees of swelling, mainly concentrated in distal area, but there was no obvious necrosis. The middle area and proximal area of flaps in two groups were survived. On PID 3, the necrosis of flaps of rats in two groups was concentrated in the middle area, while the proximal area of flap was still in survival state, and most distal area of flap was necrosis with a little scab. On PID 7, the necrosis of middle area of flaps of rats in two groups was gradually fused, and the survival area of flap of rats in bivalirudin group was larger than that in normal saline group. The distal area of flap was almost necrotic, and the proximal area of flap was almost survived. (2) On PID 7, the survival rate of flap of rats in bivalirudin group was (64±4)%, significantly higher than that in normal saline group [(45±3)%, t=13.49, P<0.01]. (3) On PID 7, the histological morphology of distal area of flap of rats in two groups was similar, the inflammatory cells were infiltrated abundantly, and tissue edema was obvious. A large number of new blood vessels appeared in the middle area of flap of rats in bivalirudin group, with the formation of collateral vessels, and basic dilation of new blood vessels was seen. There were fewer new blood vessels appeared in the middle area of flap of rats in normal saline group, and dilation of new blood vessels was not obvious. There was little inflammatory cells infiltration in the proximal area of flap of rats in two groups. Compared with that in normal saline group, tissue edema extent of proximal area of flap of rats in bivalirudin group was less, and expansion was observed in more blood vessels. (4) The MVD of middle area of flap of rats in bivalirudin group was (26±5)/mm2, significantly higher than that in normal saline group [(18±3)/mm2, t=5.43, P<0.05]. (5) The expression of VEGF of middle area of flap of rats in bivalirudin group was 6 534±384, significantly higher than that in normal saline group (4 659±448, t=12.31, P<0.05).@*Conclusions@#Bivalirudin can promote the survival of random skin flap in rats, and the mechanisms may include reducing the formation of thrombosis, improving the blood supply of flap, and increasing the expression of VEGF, promoting the formation of new blood vessels.
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Objective To study effects of bivalirudin and heparin plus tirofiban on plasma P-selectin in patients with ST-segment elevation acute myocardial infarction (STEMI) undergoing emergency percutaneous coronary intervention (PCI) and compare the clinical effects on bleeding and thrombosis.Methods 260 hospitalized patients with acute STEMI who accepted emergency PCI were enrolled in the study.They were randomly divided into the bivalirudin group (129 cases) and the heparin plus tirofiban group (131 cases).Blood samples were taken before operation,during operation (about 20 minutes after medicacion injection) and after operation (three hours after the end of operation).Serum P-selectin levels were measured.All patients were followed-up for 30 days.The main events included hemorrhage within 30 days,acquired thrombocytopenia and stent thrombosis.Results The level of P-selectin increased significantly in the heparin group during operation compared to the preoperative level and remained statistically higher at three hours after the end of operation than preoperative level (P ＜ 0.05).Compared with preoperative level,the P-selectin level of the bivalirudin group was significantly lower than that of heparin group (P ＜ 0.05).After 30 days of follow-up,bivalirudin had lower rates bleeding events compared to the heparin group(5.4％ vs.15.3％,P =0.009).The need of medical intervention for bleeding events (BRAC2-5 hemorrhage) was less in the bivalirudin group(0.8％ vs.5.3％,P =0.029).There was no significant difference in the major bleeding events between the 2 groups (BRAC3-5 hemorrhage) (0 vs.0.8％,P =0.32).No significant difference found between the two groups in acquired thrombocytopenia (P ＞ 0.05).Conclusion Bivalirudin may reduce P-selectin levels in STEMI patients undergone emergency PCI during perioperative period.Heparin increases perioperative P-selectin.Bivalirudin may reduce the bleeding events.
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Objective To evaluate the efficacy of bivalirudin on reperfusion of coronary artery in patients with acute myocardial infarction undergoing percutaneous coronary intervention. Methods In our study, we evaluated 245 patients with acute myocardial infarction who underwent percutaneous coronary intervention between April 2012 to May 2015. Based on the therapy during operation, bivalirudin were used in 122 patients and heparin was used in 123 patients. Study outcomes included immediate TIMI(thrombolysis in myocardial infarction)flow and CTFC(Corrected TIMI Frame Count)by angiogrophy once the target lesion was opened rates of ,in-hospital thrombocytopenia, bleeding events myocardial infarction, repeat revascularization and the incidence of MACE(major adverse cardiac events)in 30 days and 1 year. Results The mean heart rate was higher in the bivalirudin group(P=0.034). There was no significant difference between the two groups in laboratory results or interventional data(P>0.05). After the target vessel was opened, the effect of bivalirudin on slow/no-reflow in primary PCI has no difference between heparin in terms of TIMI blood evaluation or CTFC (P>0.05). Hospitalization data analysis showed that bivalirudin was able to obtain a higher activated whole blood coagulation time(ACT)value(P<0.001)with lower decrease in the number of platelets. Follow-up data of 30 days and 1 year showed no difference in the incidence of MACE and net adverse clinical events(NACE)between the two groups(P>0.05). Conclusions Bivalirudin has well efficacy and safety in patients with acute myocardial infarction in patients with acute myocardial infarction undergoing PPCI without increasing the incidence of slow/no-reflow.
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OBJECTIVE:To compare clinical efficacy of bivalirudin vs. tirofiban combined with heparin in the treatment of acute ST elevation myocardial infarction (STEMI) complicated with diabetes mellitus (DM). METHODS:195 patients diagnosed as STEMI complicated with DM were selected for retrospective study,and divided into bivalirudin group(100 cases)and tirofiban group(95 cases)according to the different treatment plan. All patients received emergency PCI within 12 hours and conventionally took aspirin and clopidogrel before and after PCI. Bivalirudin group was given bivalirudin 0.75 mg/kg intravenously before PCI, and continuous intravenous dripping of 1.75 mg/(kg·h)till the end of operation. Tirofiban group was given heparin 100 U/kg and ti-rofiban 10 μg/kg intravenously before PCI,and continuous intravenous dripping of 0.75 μg/(kg·h)tirofiban for 36 h. Postoperative reperfusion indexes,UCG monitoring indexes and safety were compared between 2 groups,and the content of serum BNP were compared before and after treatment. RESULTS:For the TIMI grade,TIMI frame count,the peak of CK-MB and peak time,ST segment decline percentage immediately after PCI,contents of serum BNP,LVEF,LVESD,LVEDD 7,30 d after treatment,the differences were not statistically significant between 2 groups (P>0.05). The incidence of MACE events was 36.8% in tirofiban group and 41.0% in bivalirudin group,there was no statistical significance between 2 groups(P>0.05). The incidence of bleeding events was 24.2% in tirofiban group and 7.0% in bivalirudin group,the difference was statistically significant (P<0.05). CON-CLUSIONS:Bivalirudin and tirofiban combining with heparin have same efficacy in the treatment of STEMI complicated with DM,while bivalirudin may significantly reduce the incidence of bleeding events during primary PCI.
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Objective To evaluate the safety and efficacy of bivalirudin in patients with acute myocardial infarction ( AMI) and diabetes undergoing primary percutaneous coronary intervention ( PCI) . Methods BRIGHT was a multicenter , randomized , controlled study which enrolled AMI patients underwent primary PCI in 83 Chinese centers between August 2012 and June 2013.All patients were randomly assigned to receive bivalirudin , heparin or heparin plus tirofiban. This study was a prespecified subgroup analysis of the BRIGHT study.A total of 465 diabetics in the BRIGHT study were included , consisted of 168 in the bivalirudin group , 137 in the heparin group and 160 in the heparin plus tirofiban group .Primary endpoint was net adverse clinical event ( NACE) at 30 days, which was defined as a composite of major adverse cardiac and cerebral events ( MACCE ) and any bleedings .Results The incidences of NACE at 30 days were significantly different among three arms ( Bivalirudin:10.1% vs.heparin:16.1% vs.Heparin plus tirofiban 20.6%, P=0.031 ) .Compared with heparin plus tirofiban , bivalirudin was associated with a significantly lower NACE rate (P0.05 ) . Conclusions The use of bivalirudin has dramatically reduced the rate of bleeding and did not increase the incidence of ischemic events compared with heparin and heparin plus tirofiban , indicating a better safety and efficacy profile of bivalirudin during primary PCI in patients with AMI and diabetes .
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Objective To observe the bleeding risk of bivalirudin combined with ticagrelor in patients with acute ST segment elevation myocardial infarction (STEMI) during emergency percutaneous coronary intervention (PCI) .Methods A retrospective a‐nalysis of 458 patients with STEMI who underwent emergency PCI in our hospital was performed .All patients were divided into the bivalirudin group (217 cases) and the standard heparin group(241 cases) according to the anticoagulation scheme during PCI opera‐tion .All patients administered the dual antiplatelet therapy of aspirin 100 mg and ticagrelor 180 mg before surgery .Then ,all pa‐tients were administered dual antiplatelet therapy of aspirin 100 mg once daily and ticagrelor 90 mg twice daily for a long time .The clinical data were analyzed and the bleeding situation within 72 h after PCI was compared between the two groups .Results There were no statistically significant differences in gender ,age ,body mass ,smoking proportion ,occurrence rates of accompanying and complicating diseases ,RBC count ,platelet count ,Hb and PT before PCI between the two groups(P>0 .05) .The bleeding incidence rate in the bivalirudin group was significantly lower than that in the standard heparin group ,and the difference was statistically sig‐nificant (χ2 =8 .455 ,P<0 .05) .Conclusion Compared with standard heparin ,on the basis of ticagrelor use ,giving bivalirudin dur‐ing PCI process can reduce the bleeding risk of patients .
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Objective:To explore influence of thrombus aspiration combined bivalirudin during emergency PCI on my- ocardial tissue perfusion and clinical prognosis in patients with acute ST elevation myocardial infarction (STEMI). Methods:A total of 102 patients with acute STEMI,who were confirmed with thrombus burden by CAG in our hos- pital from Jan 2012 to Jun 2014,were selected.According to random number table,they were randomly divided into thrombus aspiration + bivalirudin group (n=52,thrombus aspiration group)and heparin group (n=50,routine PCI group).TIMI blood flow grade 3 rate,TIMI myocardial perfusion grade (TMPG)after PCI,ST segment re- gression rate 2h after PCI,peak value and peak time of cTnI after PCI,LVEF,LVEDd,incidence rates of bleeding and major adverse cardiovascular events (MACE)on one week and one month after PCI were compared between two groups.Results:Compared with routine PCI group,there were significant rise in postoperative TMPG grade 3 rate (56.00% vs.88.46%),TIMI grade 3 rate (58.00% vs.88.46%)and ST segment regression rate (52.00% vs. 76.92%)in thrombus aspiration group,P0.05. Conclusion:Thrombus aspiration combined bivalirudin during emergency PCI is safe and fea- sible for acute STEMI patients,it can effectively reduce incidence rate of bleeding,remove coronary thrombus,im- prove myocardial tissue perfusion and doesn't increase incidence rate of MACE.
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Objective: To observe the efifcacy and safety of bivalirudin on primary percutaneous coronary intervention (PCI) in patients with acute ST-elevation myocardial infarction (STEMI). Methods: A total of 159 patients with acute STEMI treated by emergent PCI in our hospital from 2011-09 to 2014-01 were retrospectively studied. The patients were divided into 2 groups according to procedural bivalirudin application as Bivalirudin group and Heparin group, and the application of GPI (glycoprotein IIb/IIIa inhibitor) was decided by the operator. The baseline condition, coronary artery imaging condition, peri-operative and 30-day post-operative bleeding, the occurrence rate of MACE were compared between 2 groups. Results: There were 153 patients completed the follow-up study including 72 in Bivalirudin group and 81 in Heparin group. The peri-operative bleeding rates in Bivalirudin group and Heparin group were 6.5% vs 11.0%, the in-stent thrombosis rates were 0% vs 1.2%, 30-day post-operative bleeding rates were 9.7% vs 13.5% and the occurrence of MACE were 1.4% vs 7.4% allP>0.05. Conclusion: THE application of bivalirudin in emergent PCI is safe and effective in patients with acute STEMI, it has certain trend to reduce bleeding in relevant patients.
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Objective:To explore the impact of domestic bivalirudin on platelet function during emergency percutane-ous coronary intervention (PCI) .Methods :A total of 100 patients with acute ST segment elevation myocardial in-farction who recieved emergency PCI were randomly divided into unfractionated heparin group (UFH group ,n=53) and bivalirudin group (n=47) .Adenyl diphosphoric acid (ADP)-induced platelet aggregation rate was meas-ured and statistically compared between two groups before and after PCI .Results:Before emergency PCI ,there was no significant difference in ADP-induced platelet aggregation rate between two groups (P=0.99) .After emergency PCI ,ADP-induced platelet aggregation rate in bivalirudin group was significantly lower than that of UFH group [ (16.46 ± 10.23)% vs .(25.21 ± 15.91) % , P<0.01] .Conclusion:During percutaneous coronary intervention , compared with routine heparin anticoagulation , bivalirudin , as an anticoagulant , can more significantly inhibit platelet aggregation and possess antiplatelet effect .
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Objective: To evaluate the safety and anticoagulant efficacy of domestic bivalirudin injection during emergent percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). Methods: A total of 75 STEMI patients were randomly divided into 2 groups according to anticoagulant used in emergent PCI procedure. Bivalirudin group, the patients received intravenous domestic bivalirudin, n=40 and Heparin group, n=35. The activated clotting time (ACT) was tested at pre-PCI, 5 minutes after medication, immediately after PCI, 30 minutes, 1 hour and 2 hours after medication respectively. The activated partial thromboplastin time (APTT), prothrombin time (PT), thrombin time (TT) and ifbrinogen (FIB) level were measured at before medication and 6, 24, 72 hours after medication. Results: All patients in Bivalirudin group had ACT>225s at 5min after medication as PCI requirement, while 1 patient in Heparin group could not reach the requirement and the extra dose was added. Both groups maintained ACT>225s during PCI procedure. Bivalirudin group had the lower ACT levels than those in Heparin group at 30 min, 1-and 2-hour after the medication, P0.05. The no-cardiac event surviving rate at 30 days after PCI in Bivalirudin group and in Heparin group were similar P>0.05 and the mild bleeding at 24 hours after PCI in Bivalirudin group was lower (0 vs 11.43)%, P Conclusion: Compared with heparin, domestic bivalirudin may take faster effect, with shorter half-life period for anticoagulation during emergent PCI procedure in STEMI patients.
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Objective To evaluate the safety and efficacy of bivalirudin during perioperation of percutaneous coronary intervention (PCI) in patients older than 80 years old with acute coronary syndrome. Methods A total of 64 patients were randomly divided into two groups, respectively received heparin(n=32), or bivalirudin (n=32). We compared the activated coagulation time (ACT), procedural success rate, bleeding rate between two groups. Results The two groups ACT, PCI success rates are not statistically different, No signiifcant difference in the incidence of mild hemorrhage which is 4 (12.5%) for heparin and 1(3.1%) for bivalirudin and severe bleeding which is 2 (6.2%) for heparin and 0 for bivalirudin. However there are signiifcant differences in the overall incidence of bleeding between the two groups with lower incidence of beeding in the bivalirudin group than the heparin group (P<0.05). Conclusions Bivalirudin has comparable anticoangulation effect as heparin during perioperation of percutaneous coronary intervention (PCI) among patients older than 80 years of age with acute coronary syndrome with lower bleeding incidence than heparin dose.
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BACKGROUND: Bivalirudin is a direct thrombin inhibitor for patients with unstable angina undergoing percutaneous coronary intervention. METHODS: A sensitive liquid chromatography-tandem mass spectrometry (LC/MS/MS) method was developed and validated for the determination of bivalirudin, in human plasma using nafarelin as internal standard (IS). Chromatographic separation was performed using a Shiseido MG3 mm column (2.0 x 50 mm) with a gradient mobile phase consisting of water and acetonitrile containing 0.1 % formic acid at a flow rate of 0.4 mL/min, and total run time was within 5 min. Detection and quantification was performed by the mass spectrometer using a multiple reaction-monitoring mode at m/z 1091.0 --> 650.3 for bivalirudin, and m/z 662.1 --> 249.3 for IS. RESULTS: The assay was linear over a concentration range of 10 - 10000 ng/mL with a lower limit of quantification of 10 ng/mL in human plasma. CONCLUSION: This method was successfully applied for pharmacokinetics study after intravenous administration of bivalirudin to healthy Korean male volunteers.
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Humans , Male , Administration, Intravenous , Angina, Unstable , Chromatography, Liquid , Mass Spectrometry , Methods , Nafarelin , Percutaneous Coronary Intervention , Pharmacokinetics , Plasma , Thrombin , WaterABSTRACT
OBJECTIVE: To establish an HPLC-MS/MS method for the determination of blood-bivalirudin concentration. METHODS: Following a SPE method, the analytes were separated on a C18 column interfaced with a triple-quadrupole tandem mass spectrometer using positive electrospray ionization. RESULTS: The calibration linear rang of blood-bivalirudin concentration was 25-20000 μg · L-1 (r = 0.9969). The between-day and within-day RSD% were less than 6.63%. The recoveries were more than 80%. CONCLUSION: The rapid, sensitive and reliable HPLC-MS/MS method can be applied to monitor blood- bivalirudin profile.
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Purpose To establish a HPLC method for determination of the content of trifluoroacetic acid in bivalirudin.Methods Kromasil 100-5 C_(18) column(4.6 mm×200 mm,5 μm)and 0.07% phosphoric acid solution(pH 3.0)-methanol(98:2)as the mobile phase at a flow rate of 1.0 mL/min were used with a column temperature of 30 ℃,a detection wavelength of 210 nm and a injection volume of 20 μL.Results The standard curve of trifluomacetic acid was linear in the range of 198.4-992.0 μg/mL,r=0.999 9.The detection limit Was 40 ng.The average recovery rate of method was 99.9%,and RSD was 0.41%.Conclusion The method of content determination was practicable and accurate.It can be used for content determination of trifluoroacetic acid in bivalirudin.
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JUSTIFICATIVA E OBJETIVOS: As síndromes coronarianas agudas (SCA) estão entre as principais causas de admissão em unidades de terapia intensiva (UTI). Novos fármacos vêem sendo desenvolvidos para o manuseio das SCA. O uso combinado destes medicamentos tem reduzido de forma considerável a morbimortalidade desta síndrome, no entanto seus efeitos adversos ou mesmo seu manuseio incorreto podem levar à maior incidência de sangramento. O objetivo deste estudo foi apresentar os principais aspectos terapêuticos, indicações e manuseio dos fármacos em síndromes coronárias agudas. MÉTODO: Foi realizada uma busca por artigos originais cruzando os unitermos acute coronary syndromes e antitrombotic therapy na base de dados -MedLine; busca de artigos e diretrizes nacionais e internacionais no endereço eletrônico: http://sumsearch.uthscsa.edu. RESULTADOS: No tratamento de angina instável e infarto sem supradesnivelamento de ST, a enoxaparina mostrou-se tão eficaz quanto à heparina não fracionada (HNF) e de manuseio mais simples (estudos SYNERGY e A a Z). Neste cenário, o fondaparinux também não foi inferior à enoxaparina e; no entanto, promoveu menor taxa de sangramento (OASIS-5), a bivalirudina também foi não inferior combinada ou não à GPIIB/IIIa comparada a outras heparinas (ACUITY). No infarto com supradesnivelamento do segmento ST, a enoxaparina foi superior à HNF em pacientes submetidos à trombólise (EXTRACT TIMI 25), e no estudo OASIS 6, o fondaparinux foi superior à HNF em pacientes submetidos à trombólise e os não submetidos à reperfusão. CONCLUSÕES: A correta administração das doses dos antitrombóticos e a escolha individualizada da combinação de fármacos são imprescindíveis para a redução de óbito e eventos cardiovasculares maiores, reduzindo o desconfortável risco de sangramento adicional.
BACKGROUND AND OBJECTIVES: Acute coronary syndromes (ACS) are one of the most common causes of ICU admissions. New drugs have been developed for management of ACS. These drugs reduced morbidity and mortality; however their adverse effects or their incorrect use may cause excessive bleeding. The objective of this review is to present the principal peculiarities, doses, and indications of these drugs in ACS settings. METHODS: Original articles were retrieved crossing the terms acute coronary syndromes and antithrombotic therapy in the MedLine database as well as search for Brazilian and international guidelines in http://sumsearch.uthscsa.edu. RESULTS: In the treatment of acute coronary syndromes with non-ST-segment elevation enoxaparin was as efficient as UFH, but with a simpler management (SYNERGY and A to Z studies). In this same setting, fondaparinux was non inferior to enoxaparin and had lesser bleedings (OASIS 5), bivalirudin, combined or not with GPIIbIIIa blockers, was not inferior when compared with other heparins (ACUITY). In ST-segment elevation ACS, enoxaparin was superior to HNF in patients treated with fibrinolysis (EXTRACT TIMI 25); in OASIS 6 fondaparinux was superior to UFH in patients treated with thrombolytic therapy and not submitted to reperfusion. CONCLUSIONS: The correct management and individual combination of antithrombotic drugs are mandatory for decreased mortality and of major cardiovascular events, reducing the undesirable risk of additional bleeding.
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Enoxaparin/therapeutic use , Fibrinolytic Agents/therapeutic use , Heparin/therapeutic use , Acute Coronary Syndrome/drug therapyABSTRACT
Our objectives were to discuss a general overview on the description and recognition of heparin–induced thrombocytopenia (HIT) and present a critical review of the traditional and most recent advances in its pharmacotherapy. Computerized searches were done on MEDLINE and Iowa Drug Information Service (IDIS) databases from June 2001 until June 2007 and from May 2005 until May 2007, respectively. Search terms used included ‘heparin-induced thrombocytopenia’, ‘heparin-associated thrombocytopenia’, therapeutics, HIT, HAT. We largely selected publications within the timeframe above, but did not exclude commonly referenced and highly regarded older publications. The commonly referenced published articles were obtained through manual searches derived from bibliographic citations and retrievals from the authors’ personal files. Pertinent literatures (89 key articles) that were thought to have substantially contributed new information to the therapeutics of HIT within the last 6 years were identified, reviewed and presented. The following limits were used for the MEDLINE and IDIS searches: ‘human’, drug therapy’, ‘review’, ‘meta-analysis’, ‘clinical trial’, and case reports. The therapeutics of HIT is rapidly evolving and needs to consider an evidence – based approach. It is imperative that practitioners be aware of the associated risk and be up-to-date with the current advances in the management of this fatal clinical condition.