1.A randomized comparative study of using enoxaparin or UFH adjunctive to percutaneous coronary intervention in patients with CHD (ROUTE).
Ji-lin CHEN ; Jue CHEN ; Shu-bin QIAO ; Yong-jian WU ; Jun DAI ; Jin-qing YUAN ; Xue-wen QIN ; Min YAO ; Yue-jin YANG ; Run-lin GAO
Chinese Journal of Cardiology 2006;34(2):127-129
OBJECTIVETo evaluate the efficacy and safety of using Enoxaparin instead of UFH for patients with coronary heart disease (CHD) underwent coronary angiogram with or without percutaneous coronary intervention (PCI).
METHODSFrom Oct. 2003 to Feb. 2005, 966 patients with CHD underwent coronary angiogram (CAG) were randomized to receive enoxaparin (1 mg/kg subcutaneously, Q12 h, at least twice before CAG and the sheath was withdrawn immediately after the procedure, n = 484) or UFH (25 mg, iv, before CAG with additional 65 mg iv if PCI indicated and the sheath was withdrawn 4 hours after the procedure, n = 482).
RESULTS(1) PCI was not performed in 511 patients due to mild lesions or patients were suitable for CABG. In 455 patients underwent PCI (227 in enoxaparin and 228 in UFH group), 1 patient in enoxaparin group developed acute thrombosis and resulted in AMI during PCI and underwent successful urgent revascularization. The incidence of in-hospital major adverse cardiac events were 0.44% in the enoxaparin group and 0 in the UFH group. (2) Hematoma at the puncture site happened in 8 patients (3.5%) in enoxaparin group and in 20 patients (8.8%, P < 0.05) in UFH group. (3) One patient had AMI caused by subacute thrombosis in UFH group during 1 month follow-up.
CONCLUSIONSOur results suggest that the effects and safety are comparable for enoxaparin and UFH, it is also safe and efficient to give enoxaparin at least twice before CAG/PCI and the sheath can be withdrawn immediately after PCI. For ACS patients received more than twice enoxaparin and the last dose was given within 8 hours before PCI, PCI could be performed directly without additional UFH.
Angioplasty, Balloon, Coronary ; methods ; Coronary Disease ; therapy ; Enoxaparin ; therapeutic use ; Female ; Heparin ; therapeutic use ; Humans ; Male ; Middle Aged
2.Safety and Cost-Effectiveness of Bridge Therapies for Invasive Dental Procedures in Patients with Mechanical Heart Valves.
Ki Bum WON ; Seung Hyun LEE ; Hyuk Jae CHANG ; Chi Young SHIM ; Gue Ru HONG ; Jong Won HA ; Namsik CHUNG
Yonsei Medical Journal 2014;55(4):937-943
PURPOSE: Bridge anticoagulation therapy is mostly utilized in patients with mechanical heart valves (MHV) receiving warfarin therapy during invasive dental procedures because of the risk of excessive bleeding related to highly vascular supporting dental structures. Bridge therapy using low molecular weight heparin may be an attractive option for invasive dental procedures; however, its safety and cost-effectiveness compared with unfractionated heparin (UFH) is uncertain. MATERIALS AND METHODS: This study investigated the safety and cost-effectiveness of enoxaparin in comparison to UFH for bridge therapy in 165 consecutive patients (57+/-11 years, 35% men) with MHV who underwent invasive dental procedures. RESULTS: This study included 75 patients treated with UFH-based bridge therapy (45%) and 90 patients treated with enoxaparin-based bridge therapy (55%). The bleeding risk of dental procedures and the incidence of clinical adverse outcomes were not significantly different between the UFH group and the enoxaparin group. However, total medical costs were significantly lower in the enoxaparin group than in the UFH group (p<0.001). After multivariate adjustment, old age (> or =65 years) was significantly associated with an increased risk of total bleeding independent of bridging methods (odds ratio, 2.51; 95% confidence interval, 1.15-5.48; p=0.022). Enoxaparin-based bridge therapy (beta=-0.694, p<0.001) and major bleeding (beta=0.296, p=0.045) were significantly associated with the medical costs within 30 days after dental procedures. CONCLUSION: Considering the benefit of enoxaparin in cost-effectiveness, enoxaparin may be more efficient than UFH for bridge therapy in patients with MHV who required invasive dental procedures.
Aged
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Anticoagulants/*therapeutic use
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Dentistry, Operative/*methods
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Enoxaparin/therapeutic use
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Female
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*Heart Valve Prosthesis
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Heparin, Low-Molecular-Weight/*therapeutic use
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Humans
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Male
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Middle Aged
3.A randomized comparative study of using enoxaparin instead of unfractionated heparin in the intervention treatment of coronary heart disease.
Ji-lin CHEN ; Jue CHEN ; Shu-bin QIAO ; Yuan-lin GUO ; Yong-jian WU ; Jun DAI ; Jin-qing YUAN ; Xue-wen QIN ; Yue-jin YANG ; Run-lin GAO
Chinese Medical Journal 2006;119(5):355-359
BACKGROUNDLow molecular weight heparin (LMWH) was more effective than unfractionated heparin (UFH) in treating acute coronary syndrome (ACS). However, it remains uncertain whether LMWH can be used in patients undergoing percutaneous coronary intervention (PCI) instead of UFH. This study aimed to evaluate the efficacy and safety of using enoxaparin instead of UFH in the intervention treatment of patients with coronary heart disease (CHD).
METHODSFrom October 2003 to Febuary 2005, 966 patients with CHD were enrolled into this study. Among 966 patients, 455 patients received the PCI, including 283 patients with Non-ST segment elevation ACS (NSTEACS), 511 patients did not received PCI due to mild, moderate lesions or were suitable for coronary artery bypass graft (CABG). The 966 patients were randomized to enoxaparin group (484 patients) and UFH group (482 patients). Patients in the enoxaparin group were given enoxaparin at least twice subcutaneously (1 mg/kg, q12 h) before catheterization. Plasma anti-Xa activity was determined 1 - 8 hours after the last dose of enoxaparin was determined. The catheterization was performed within 8 hours after the last dose of enoxaparin. The sheath was removed immediately after the procedure. Patients in the UFH group were given UFH 25 mg intravenously before coronary angiography. Additional 65 mg was given intravenously if PCI was to be performed. The sheath was removed 4 hours after the procedure.
RESULTSA total of 227 patients in the enoxaparin group and 228 patients in the UFH group received PCI. In the enoxaparin group, one patient developed acute thrombosis during PCI and resulted in acute myocardial infarction (AMI), no acute or subacute thrombosis was found during hospitalization. In the UFH group, no acute or subacute thrombosis occurred during PCI procedure and hospitalization. Therefore, the incidence of major adverse cardiovascular events (MACEs) during the hospitalization was 0.44% in the enoxaparin group and 0 in the UFH group. In the enoxaparin group, the sheath was removed immediately after the procedure and 8 patients had hematoma on the puncture site. In the UFH group, the sheath was removed 4 hours after the procedure and 20 cases had hematoma on the puncture site. The incidence of hematoma on the puncture site was significantly higher in the UFH group than that in the enoxaparin group (P < 0.05). Anti-Xa activity was determined in 174 patients in LMWH group. The mean anti-Xa activity was (0.87 +/- 0.23) U/ml, and 94.8% of them had anti-Xa activity >0.5 U/ml and 6.9% of the patient >1.2 U/ml. There was no death and AMI occurred in enoxaparin group, but one patient had AMI caused by subacute thrombosis in UFH group during 30-day follow-up. MACE rate at 30-day follow-up was 0 in enoxaparin group and 0.43% in UFH group.
CONCLUSIONSThe results of the study suggest that it is safe and efficient to give enoxaparin at least twice before the PCI procedure, and the sheath can be removed immediately after PCI. For NSTEACS patient who has received enoxaparin more than twice during the hospitalization can undergo PCI directly and no UFH is necessary before or during PCI.
Angioplasty, Balloon, Coronary ; Anticoagulants ; therapeutic use ; Coronary Disease ; therapy ; Enoxaparin ; adverse effects ; therapeutic use ; Factor Xa Inhibitors ; Female ; Heparin ; therapeutic use ; Humans ; Male ; Middle Aged
4.Efficacy and safety of fondaparinux versus enoxaparin for preventing venous thromboembolism after major orthopedic surgery: a meta-analysis.
Hu LI ; Jian WANG ; Jun XIAO ; Zhanjun SHI
Journal of Southern Medical University 2013;33(3):370-375
OBJECTIVETo systematically review the efficacy and safety of fondaparinux and enoxaparin in the prevention of venous thromboembolism (VTE) after major orthopedic surgery.
METHODSThe MEDLINE, EMbase, the Cochrane Library, CNKI, CBM, VIP and Wanfang databases (from their establishment to October, 2012) were searched for randomized controlled trials (RCTs) comparing the effects of fondaparinux and enoxaparin in preventing VTE after major orthopedic surgery. The related journals and conference papers were manually searched. The outcome measurements were the incidence of total VTE, deep venous thrombosis (DVT), symptomatic VTE, pulmonary embolism (PE), major bleeding and any other adverse event. The quality of literatures was evaluated and the data were extracted for meta-analysis.
RESULTSFive RCTs involving 7611 patients were included pertaining to major knee surgery (1 RCT), hip fracture surgery (2 RCTs) and total hip arthroplasty (3 RCTs). The incidences of total VTE and DVT were significantly lower in fondaparinux group than in enoxaparin group [RR=0.52, 95%CI (0.40,0.67), P<0.00001; RR=0.49, 95%CI (0.42, 0.58), P<0.00001]. The incidence of symptomatic VTE was similar between the two groups [RR=1.52, 95%CI (0.80,2.88), P=0.20]. Fondaparinux was associated with a significantly increased incidence of major bleeding compared to enoxaparin group [RR=1.55, 95%CI (1.14,2.12), P=0.006], but the mortality rates were comparable between the two groups [RR=0.93, 95%CI (0.63,1.37), P=0.72].
CONCLUSIONCompared with enoxaparin, fondaparinux can reduce the risk of postoperative VTE and do not increase the mortality rate following major orthopedic surgery though with an increased risk of major bleeding.
Enoxaparin ; adverse effects ; therapeutic use ; Humans ; Orthopedic Procedures ; adverse effects ; Polysaccharides ; adverse effects ; therapeutic use ; Randomized Controlled Trials as Topic ; Treatment Outcome ; Venous Thromboembolism ; etiology ; prevention & control
6.Apixaban versus enoxaparin for thromboprophylaxis after total hip or knee arthroplasty: a meta-analysis of randomized controlled trials.
Xiu-Min LI ; Shi-Guang SUN ; Wei-Dong ZHANG
Chinese Medical Journal 2012;125(13):2339-2345
BACKGROUNDEnoxaparin is routinely used for prevention of venous thromboembolism (VTE) after total hip or knee arthroplasty. The purpose of this study was to compare the efficacy and safety of apixaban, a newly oral direct inhibitor of factor Xa versus enoxaparin.
METHODSWe performed a meta-analysis of relevant randomized-controlled trials (RCTs) identified in PubMed, Cochrane Library, Embase China Biological Medical Literature database, Countries Journal full-text database, VIP database, and WanFang database. The primary efficacy outcome for our meta-analysis was all VTE and all-cause mortality. The secondary efficacy outcomes included major VTE, non-fatal pulmonary embolism, and mortality. The primary safety outcome was bleeding events, categorized as major, clinically relevant non-major, or minor events.
RESULTSFour RCTs, involving 14 065 patients, were included in our meta-analysis. Compared to enoxaparin, thromboprophylaxis with apixaban was associated with significantly fewer VTE and all-cause mortality (8346 patients, risk ratio (RR): 0.63, 95%CI 0.42 - 0.95) and similar incidence of bleeding events (major bleeding, 11 525 patients, RR 0.76, 95%CI 0.43 - 1.33; clinically relevant non-major bleeding, 11 525 patients, RR 0.83, 95%CI 0.69 - 1.01; and minor bleeding, 11 828 patients, RR 0.93, 95%CI 0.79 - 1.09). However, our meta-analysis revealed similar effects of apixaban with enoxaparin for thromboprophylaxis with regard to the secondary efficacy outcomes.
CONCLUSIONSApixaban was more effective than recommended dose of enoxaparin and had a similar safety profile for thromboprophylaxis after hip and knee arthroplasty. But more evidence, especially well designed head-to-head RCTs, is needed to confirm the superior efficacy of apixaban.
Arthroplasty, Replacement, Hip ; adverse effects ; methods ; Arthroplasty, Replacement, Knee ; adverse effects ; methods ; Enoxaparin ; therapeutic use ; Humans ; Pyrazoles ; therapeutic use ; Pyridones ; therapeutic use ; Randomized Controlled Trials as Topic ; Venous Thromboembolism ; etiology ; prevention & control
7.Low-Dose Unfractionated Heparin with Sequential Enoxaparin in Patients with Diabetes Mellitus and Complex Coronary Artery Disease during Elective Percutaneous Coronary Intervention.
Ji HUANG ; Nan LI ; Zhao LI ; Xue-Jian HOU ; Zhi-Zhong LI
Chinese Medical Journal 2018;131(7):764-769
BackgroundDespite its limitations, unfractionated heparin (UFH) has been the standard anticoagulant used during percutaneous coronary intervention (PCI). This study compared the safety of low-dose UFH with sequential enoxaparin with that of UFH in patients with diabetes mellitus (DM) and complex coronary artery disease receiving elective PCI.
MethodsIn this retrospective study, 514 consecutive patients with atherosclerotic cardiovascular diseases and type 2 DM were admitted to the hospital and received selective PCI, from January 2013 to December 2015. All patients with PCI received low-dose UFH with enoxaparin (intraductal 50 U/kg UFH and 0.75 mg/kg enoxaparin, n = 254; UFH-Enox group) or UFH only (intraductal 100 U/kg UFH, n = 260; UFH group). The study endpoints were major adverse cardiac events (MACEs), namely death, myocardial infarction (MI), stroke, target-vessel immediate revascularization (TVR), and thrombolysis in MI (TIMI) major bleeding, within 30 days and 1 year after PCI. Any catheter thrombosis during the procedure was recorded.
ResultsOnly one patient had an intraductal thrombus in the UFH group. At the 30-day follow-up, no MACE occurred in any group; seven and five cases of recurrent angina and/or rehospitalization were reported in the UFH-Enox and UFH groups, respectively; there was no significant difference between the two groups (χ = 0.11, P = 0.77). There was no TIMI major bleeding in the groups. With respect to the 1-year endpoint, two cases of recurrent MI and two of TVRs were reported in the UFH-Enox group, whereas in the UFH group, one case of recurrent MI and three of TVRs were reported; no significant difference existed between the two groups (χ = 0, P = 0.99). There were 30 and 25 recurrent angina and/or rehospitalizations in the UFH-Enox and UFH groups, respectively; there was no significant difference between the two groups (χ = 0.37, P = 0.57).
ConclusionIn elective PCI, low-dose UFH with sequential enoxaparin has similar effects and safety to the UFH-only method.
Aged ; Aged, 80 and over ; Anticoagulants ; therapeutic use ; Coronary Artery Disease ; drug therapy ; surgery ; Diabetes Mellitus ; drug therapy ; surgery ; Enoxaparin ; therapeutic use ; Female ; Heparin ; therapeutic use ; Humans ; Male ; Middle Aged ; Percutaneous Coronary Intervention ; methods ; Retrospective Studies
8.Antifactor Xa Levels in Critically Ill Korean Patients Receiving Enoxaparin for Thromboprophylaxis: A Prospective Observational Study.
So Yeon LIM ; Kyeongman JEON ; Hee Jin KIM ; Seon Mi KIM ; Junwhi SONG ; Jung Min HA ; Sang Won UM ; Won Jung KOH ; Man Pyo CHUNG ; Hojoong KIM ; O Jung KWON ; Gee Young SUH
Journal of Korean Medical Science 2013;28(3):466-471
The aim of this study was to investigate antifactor Xa (aFXa) levels after once daily dose of 40 mg of enoxaparin and to evaluate factors influencing aFXa levels among Korean intensive care unit (ICU) patients. This prospective observational study was conducted between August and December 2011 in medical ICUs at Samsung Medical Center. AFXa levels between 0.1 and 0.3 U/mL were considered to be effective for antithrombotic activity. Fifty-five patients were included. The median aFXa levels were 0.22 (IQR 0.17-0.26) at 4 hr, 0.06 (IQR 0.02-0.1) at 12 hr, and 0 U/mL (IQR 0-0.03) at 24 hr. The numbers of patients showing effective antithrombotic aFXa levels were 48 (87.3%), 18 (32.7%), and 0 (0%) at 4, 12 and 24 hr, respectively. At 12 hr, higher sequential organ failure assessment (SOFA) scores and hyperbilirubinemia were significantly associated with low aFXa levels (OR, 0.58; 95% CI, 0.36-0.93; P = 0.02 and 0.06; 0.003-0.87; 0.04, respectively). Once daily dose of 40 mg of enoxaparin is inadequate for maintaining effective antithrombotic aFXa levels, and the inadequacy is more salient for patients with high SOFA scores and hyperbilirubinemia.
Aged
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Asian Continental Ancestry Group
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Critical Illness
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Enoxaparin/*therapeutic use
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Factor Xa/analysis/*antagonists & inhibitors
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Female
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Fibrinolytic Agents/*therapeutic use
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Humans
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Hyperbilirubinemia/metabolism
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Intensive Care Units
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Male
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Middle Aged
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Odds Ratio
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Prospective Studies
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Regression Analysis
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Republic of Korea
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Risk Factors
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Venous Thromboembolism/*drug therapy