11 results on '"Bovill E"'
Search Results
2. Initial experience with factor-Xa inhibition in percutaneous coronary intervention: the XaNADU-PCI Pilot.
- Author
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Alexander JH, Dyke CK, Yang H, Becker RC, Hasselblad V, Zillman LA, Kleiman NS, Hochman JS, Berger PB, Cohen EA, Lincoff AM, Saint-Jacques H, Chetcuti S, Burton JR, Buergler JM, Spence FP, Shimoto Y, Robertson TL, Kunitada S, Bovill EG, Armstrong PW, and Harrington RA
- Subjects
- Aged, Anticoagulants blood, Anticoagulants pharmacokinetics, Blood Coagulation Tests, Dose-Response Relationship, Drug, Drug Monitoring methods, Feasibility Studies, Female, Heparin administration & dosage, Humans, International Normalized Ratio, Intraoperative Care, Male, Middle Aged, Naphthalenes blood, Naphthalenes pharmacokinetics, Pilot Projects, Postoperative Complications prevention & control, Propionates blood, Propionates pharmacokinetics, Thrombosis etiology, Anticoagulants administration & dosage, Cardiac Surgical Procedures adverse effects, Factor Xa Inhibitors, Naphthalenes administration & dosage, Propionates administration & dosage, Thrombosis prevention & control
- Abstract
Background: Direct factor (F)Xa inhibition is an attractive method to limit thrombotic complications during percutaneous coronary intervention (PCI)., Objectives: To investigate drug levels achieved, effect on coagulation markers, and preliminary efficacy and safety of several doses of DX-9065a, an intravenous, small molecule, direct, reversible FXa inhibitor during PCI., Patients and Methods: Patients undergoing elective, native-vessel PCI (n = 175) were randomized 4 : 1 to open-label DX-9065a or heparin in one of four sequential stages. DX-9065a regimens in stages I-III were designed to achieve concentrations of > 100 ng mL-1, > 75 ng mL-1, and > 150 ng mL-1. Stage IV used the stage III regimen but included patients recently given heparin., Results: At 15 min median (minimum) DX-9065a plasma levels were 192 (176), 122 (117), 334 (221), and 429 (231) ng mL-1 in stages I-IV, respectively. Median whole-blood international normalized ratios (INRs) were 2.6 (interquartile range 2.5, 2.7), 1.9 (1.8, 2.0), 3.2 (3.0, 4.1), and 3.8 (3.4, 4.6), and anti-FXa levels were 0.36 (0.32, 0.38), 0.33 (0.26, 0.39), 0.45 (0.41, 0.51), and 0.62 (0.52, 0.65) U mL-1, respectively. Stage II enrollment was stopped (n = 7) after one serious thrombotic event. Ischemic and bleeding events were rare and, in this small population, showed no clear relation to DX-9065a dose., Conclusions: Elective PCI is feasible using a direct FXa inhibitor for anticoagulation. Predictable plasma drug levels can be rapidly obtained with double-bolus and infusion DX-9065a dosing. Monitoring of DX-9065a may be possible using whole-blood INR. Direct FXa inhibition is a novel and potentially promising approach to anticoagulation during PCI that deserves further study.
- Published
- 2004
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3. The association of vitamin K status with warfarin sensitivity at the onset of treatment.
- Author
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Cushman M, Booth SL, Possidente CJ, Davidson KW, Sadowski JA, and Bovill EG
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- Aged, Female, Humans, International Normalized Ratio, Linear Models, Male, Middle Aged, Nutritional Status, Protein Precursors analysis, Prothrombin analysis, Treatment Outcome, Triglycerides analysis, Vitamin K 1 analysis, Anticoagulants therapeutic use, Biomarkers, Preoperative Care methods, Vitamin K metabolism, Vitamin K 1 analogs & derivatives, Warfarin therapeutic use
- Abstract
We investigated the association of vitamin K status with warfarin sensitivity among 40 orthopaedic patients beginning perioperative algorithm-dosed warfarin. Baseline vitamin K status was assessed using plasma vitamin K-1 and vitamin K-1 2,3 epoxide concentrations, and a questionnaire-based estimation of usual vitamin K intake. Warfarin sensitivity was assessed as the increase in the International Normalized Ratio (INR) after two doses of 5 mg of warfarin and as the 4-d accumulation of under-gamma-carboxylated prothrombin (PIVKA-II), adjusted for warfarin dose requirement. Multivariate models were used to assess vitamin K variables as predictors of warfarin sensitivity. The mean INR increase was 0.53 U and the mean PIVKA-II increase was 771 ng/ml/mg warfarin. Demographic factors were not associated with warfarin response. For each 1 standard deviation (SD) lower value of plasma vitamin K-1, but not the other vitamin K variables, the INR rose 0.24 U (P < or = 0.01). A higher usual vitamin K intake and plasma vitamin K-1, and lower plasma vitamin K-1 2,3 epoxide, were all associated with a lower PIVKA-II increase over 4 d. Respective differences in PIVKA-II accumulation per SD increase of each variable were -165, -218 and 236 ng/ml/mg warfarin (all P < or = 0.05). We concluded that dietary and biochemical measures of vitamin K status were associated with early warfarin sensitivity.
- Published
- 2001
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4. Oral anticoagulation in patients with atrial fibrillation: adherence with guidelines in an elderly cohort.
- Author
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White RH, McBurnie MA, Manolio T, Furberg CD, Gardin JM, Kittner SJ, Bovill E, and Knepper L
- Subjects
- Administration, Oral, Aged, Cerebrovascular Disorders etiology, Cross-Sectional Studies, Female, Humans, Logistic Models, Male, Odds Ratio, Practice Guidelines as Topic, Prospective Studies, Risk, Risk Factors, Anticoagulants administration & dosage, Atrial Fibrillation complications, Cerebrovascular Disorders prevention & control, Warfarin administration & dosage
- Abstract
Purpose: To determine adherence with practice guidelines in a population-based cohort of elderly persons aged 70 years or older with atrial fibrillation., Subjects and Methods: This was a cross-sectional analysis of a subgroup of participants in the Cardiovascular Health Study, a prospective observational study involving four communities in the United States. Subjects were participants with atrial fibrillation on electrocardiogram at one or more yearly examinations from 1993 to 1995. The outcome measure was self-reported use of warfarin in 1995., Results: In 1995, 172 (4.1%) participants had atrial fibrillation together with information regarding warfarin use and no preexisting indication for its use. Warfarin was used by 63 (37%) of these participants. Of the 109 participants not reporting warfarin use, 92 (84%) had at least one of the clinical risk factors (aside from age) associated with stroke in patients with atrial fibrillation. Among participants not taking warfarin, 47% were taking aspirin. Several characteristics were independently associated with warfarin use, including age [odds ratio (OR) = 0.6 per 5-year increment, 95% CI 0.5-0.9], a modified mini-mental examination score <85 points [OR = 0.3, 95% confidence interval (CI) 0.1-0.9], and among patients without prior stroke, female sex (OR = 0.5, 95% CI 0.2-1.0)., Conclusions: Despite widely publicized practice guidelines to treat patients who have atrial fibrillation with warfarin, most participants who had atrial fibrillation were at high risk for stroke but were not treated with warfarin. More studies are needed to determine why elderly patients with atrial fibrillation are not being treated with warfarin.
- Published
- 1999
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5. Use of bedside activated partial thromboplastin time monitor to adjust heparin dosing after thrombolysis for acute myocardial infarction: results of GUSTO-I. Global Utilization of Streptokinase and TPA for Occluded Coronary Arteries.
- Author
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Zabel KM, Granger CB, Becker RC, Bovill EG, Hirsh J, Aylward PE, Topol EJ, and Califf RM
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- Aged, Confounding Factors, Epidemiologic, Female, Humans, Male, Middle Aged, Prospective Studies, Time Factors, Anticoagulants administration & dosage, Heparin administration & dosage, Myocardial Infarction drug therapy, Partial Thromboplastin Time, Point-of-Care Systems, Thrombolytic Therapy
- Abstract
Background: The safety and efficacy of bedside monitors of activated partial thromboplastin time (aPTT) have not been examined in a large population receiving intravenous heparin after thrombolytic treatment for acute myocardial infarction. We compared outcomes among patients monitored with these devices versus standard monitoring methods., Methods and Results: Investigators chose the bedside device (n = 1713 patients) or their standard method (n = 26,162) for all aPTT measurements at their sites. Clinical outcomes at 30 days, 1-year mortality rate, and aPTT levels at 6, 12, and 24 hours were compared. Bedside-monitored patients had significantly less moderate/severe bleeding (10% vs 12%, P < .01), fewer transfusions (7% vs 11%, P < .001), and a smaller decrease in hematocrit (5.5% vs 6.7%, P < .001) but significantly more recurrent ischemia (22% vs 20%, P = .01). Fewer bedside-monitored patients had subtherapeutic aPTT levels at 12 and 24 hours. Among patients with subtherapeutic levels at 6 and 12 hours, more bedside-monitored patients had therapeutic levels when next monitored. After adjustment for baseline differences, no significant difference in mortality rate was observed in bedside-monitored patients at 30 days (4.3% vs 4.8%, P = .27) and at 1 year (7.1% vs 7.7%, P = .38). The groups had similar rates of reinfarction, shock, heart failure, and stroke., Conclusions: This prospective substudy supports the use of bedside monitoring of heparin anticoagulation after thrombolysis.
- Published
- 1998
- Full Text
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6. Dietary vitamin K1 and stability of oral anticoagulation: proposal of a diet with constant vitamin K1 content.
- Author
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Booth SL, Charnley JM, Sadowski JA, Saltzman E, Bovill EG, and Cushman M
- Subjects
- Administration, Oral, Anticoagulants administration & dosage, Anticoagulants adverse effects, Coumarins administration & dosage, Coumarins adverse effects, Drug Interactions, Humans, Nutritional Status, Warfarin administration & dosage, Warfarin adverse effects, Warfarin therapeutic use, Anticoagulants therapeutic use, Coumarins therapeutic use, Diet, Vitamin K 1 pharmacology
- Abstract
Case reports cited in Medline or Biological Abstracts (1966-1996) were reviewed to evaluate the impact of vitamin K1 dietary intake on the stability of anticoagulant control in patients using coumarin derivatives. Reported nutrient-drug interactions cannot always be explained by the vitamin K1 content of the food items. However, metabolic data indicate that a consistent dietary intake of vitamin K is important to attain a daily equilibrium in vitamin K status. We report a diet that provides a stable intake of vitamin K1 equivalent to the current U.S. Recommended Dietary Allowance, using food composition data derived from high-performance liquid chromatography. Inconsistencies in the published literature indicate that prospective clinical studies should be undertaken to clarify the putative dietary vitamin K1-coumarin interaction. The dietary guidelines reported here may be used in such studies.
- Published
- 1997
7. Hemorrhagic events during therapy with recombinant tissue plasminogen activator, heparin, and aspirin for unstable angina (Thrombolysis in Myocardial Ischemia, phase IIIB trial).
- Author
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Bovill EG, Tracy RP, Knatterud GL, Stone PH, Nasmith J, Gore JM, Thompson BW, Tofler GH, Kleiman NS, Cannon C, and Braunwald E
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- Aged, Hemorrhage classification, Humans, Random Allocation, Angina, Unstable drug therapy, Anticoagulants adverse effects, Aspirin adverse effects, Hemorrhage chemically induced, Heparin adverse effects, Plasminogen Activators adverse effects, Platelet Aggregation Inhibitors adverse effects, Tissue Plasminogen Activator adverse effects
- Abstract
This study assesses the effects of invasive procedures, hemostatic and clinical variables, and doses of recombinant tissue plasminogen activator (t-PA) on hemorrhagic events in the thrombolysis in myocardial ischemia (TIMI), phase 1B clinical trial (n = 1,425). Patients seen within 24 hours of the onset of ischemic chest pain at rest were randomized using a 2 x 2 factorial design for comparison of: (1) t-PA versus placebo as initial therapy, and (2) an early invasive (coronary arteriography with percutaneous angioplasty, if feasible) versus an early conservative strategy (coronary arteriography followed by revascularization if initial medical therapy failed). All patients received conventional medication for acute ischemic syndromes, including heparin, aspirin, beta blockers, nitrates, and calcium antagonists. The total dose of t-PA or placebo was 0.8 mg/kg, up to a maximum dose of 80 mg. In patients treated with t-PA, major and minor hemorrhagic events were more common than among those assigned to placebo (p < 0.001). Patients assigned to the invasive strategy arm had a higher hemorrhagic event rate than the noninvasive strategy, although the difference was not significant (p = 0.026). Patients > 75 years of age had higher intracranial hemorrhage rates than those < 75 years of age (6.7% vs 0.2%, respectively, p = 0.01). Major hemorrhagic events were more common in patients with higher heparin levels (p < 0.001), higher peak D-dimer levels (p = 0.007), and lower nadir fibrinogen levels (p = 0.005). Thus, increased morbidity due to hemorrhagic complications is associated with the use of t-PA, increased age, and selected hemostatic measures. Comparison to TIMI II demonstrates a significant association between the dose of t-PA and hemorrhagic complications.
- Published
- 1997
- Full Text
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8. Markers of in vivo activation of coagulation. Interrelationships change with intensity of oral anticoagulation.
- Author
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Solymoss S and Bovill EG
- Subjects
- Administration, Oral, Adult, Aged, Aged, 80 and over, Anticoagulants administration & dosage, Fibrinolysin analysis, Humans, Middle Aged, alpha-2-Antiplasmin analysis, Anticoagulants therapeutic use, Antithrombin III analysis, Blood Coagulation, Fibrinopeptide A analysis, Peptide Fragments analysis, Peptide Hydrolases analysis, Prothrombin analysis, Prothrombin Time
- Abstract
Measures of markers of in vivo activation of coagulation were assessed in patients on stable long-term oral anticoagulant therapy and analyzed with respect to the International Normalized Ratio (INR). The range of F1+2, FPA, and antithrombin--enzyme complex results (ATM) were significantly lower as compared to normals. Plasmin-antiplasmin complexes were unaffected by anticoagulation. An inverse correlation was evident between F1+2, FPA, and INR values at low intensity anticoagulation, and FPA and complexed antithrombin were correlated at high INRs. The relative ratio of plasma FPA/F1+2 and ATM/F1+2 increased with increasing INR. In conclusion, the interrelationship of these measures changes with intensity of anticoagulation as measured by INR, and appears complex. The utility of using these measures for patient monitoring awaits future clinical trials.
- Published
- 1996
- Full Text
- View/download PDF
9. Relation between systemic anticoagulation as determined by activated partial thromboplastin time and heparin measurements and in-hospital clinical events in unstable angina and non-Q wave myocardiaL infarction. Thrombolysis in Myocardial Ischemia III B Investigators.
- Author
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Becker RC, Cannon CP, Tracy RP, Thompson B, Bovill EG, Desvigne-Nickens P, Randall AM, Knatternud G, and Braunwald E
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- Aged, Angina, Unstable blood, Canada, Female, Heparin therapeutic use, Humans, Male, Middle Aged, Myocardial Infarction blood, Myocardial Ischemia blood, Plasminogen Activators therapeutic use, Prospective Studies, Tissue Plasminogen Activator therapeutic use, United States, Angina, Unstable drug therapy, Anticoagulants therapeutic use, Heparin blood, Myocardial Infarction drug therapy, Myocardial Ischemia drug therapy, Partial Thromboplastin Time, Thrombolytic Therapy
- Abstract
Although coronary thrombosis is thought to play a pivotal role in the pathogenesis of unstable angina and non-Q wave myocardial infarction and antithrombotic therapy is a mainstay in the early management of these patients, the relation between measures of systemic anticoagulation and clinical events has not been defined clearly. In the Thrombolysis in Myocardial Ischemia III trial, 1473 patients with ischemic chest pain at rest evaluated within 24 hours of symptom onset were randomized to (1) tissue plasminogen activator (TPA) or placebo and (2) an early invasive or an early conservative strategy. All patients received a full complement of anti-ischemic medication, aspirin, and continuous intravenous heparin titrated to an activated partial thromboplastin time (aPTT) of 1.5 to 2.0 times control for 72 to 96 hours. The median aPTT in all study groups exceeded the minimum threshold (45 seconds) by 24 hours and remained within the designated range during the protocol-directed heparin infusion. No differences in median aPTT values for the 72- to 96-hour study period were observed between groups (p=not significant). Median 12-hour heparin concentrations were >0.2 U/ml in all groups; however, values <0.2 U/ml were common thereafter, particularly in TPA-treated patients. Time-dependent covariate analyses failed to identify statistically significant differences in either aPTT or heparin levels between patients with in-hospital clinical events (spontaneous ischemia, myocardial infarction, or death) and those without events (p=0.27). Furthermore, early clinical events occurred in a similar percentage of patients with optimal anticoagulation (all aPTTs >60 seconds, all heparin levels>0.2 U/ml), and those with aPTTs or heparin levels below these thresholds. Aggressive (high-intensity) anticoagulation with heparin to achieve aPTTs >2.0 times control does not appear to offer additional clinical benefit to lower levels (1.5 to 2.0 times control) among patients with unstable angina and non-Q wave myocardial infarction receiving intravenous heparin and oral aspirin. Therefore, the optimal level of anticoagulation in this common clinical setting is between 45 and 60 seconds when heparin is included in the treatment strategy. Direct plasma heparin measurement does not offer an advantage to routine aPTT monitoring. The occurrence of spontaneous ischemia, myocardial infarction, and death in spite of antischemic therapy and optimal anticoagulation (as it is currently defined) with heparin supports ongoing efforts to develop more effective antithrombotic agents.
- Published
- 1996
- Full Text
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10. Transient thrombotic state after abrupt discontinuation of heparin in percutaneous coronary angioplasty.
- Author
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Smith AJ, Holt RE, Fitzpatrick JB, Palacios IF, Gold HK, Werner W, Bovill EG, Fuster V, and Jang IK
- Subjects
- Adult, Aged, Angina, Unstable blood, Angina, Unstable complications, Angina, Unstable drug therapy, Anticoagulants administration & dosage, Female, Heparin administration & dosage, Humans, Male, Middle Aged, Myocardial Ischemia blood, Myocardial Ischemia chemically induced, Partial Thromboplastin Time, Prospective Studies, Substance Withdrawal Syndrome, Thrombosis blood, Angioplasty, Balloon, Coronary, Anticoagulants adverse effects, Heparin adverse effects, Thrombosis chemically induced
- Abstract
Clinical and biochemical evidence of a rebound phenomenon after discontinuing thrombin inhibitors has been reported in patients with unstable angina. To investigate if a similar phenomenon occurs in patients undergoing coronary angioplasty, 14 patients were prospectively studied during and after discontinuation of heparin infusion. A transient thrombotic state identified by a significant increase in a polypeptide fragment and fibrinopeptide A was observed 3 hours after abruptly discontinuing heparin infusion. This observation may be clinically important in managing patients after coronary angioplasty.
- Published
- 1996
- Full Text
- View/download PDF
11. Antithrombotic therapy in children.
- Author
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Monagle, Paul, Michelson, Alan D., Bovill, Edward, Andrew, Maureen, Monagle, P, Michelson, A D, Bovill, E, and Andrew, M
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ANTICOAGULANTS ,HEPARIN ,PROSTHETIC heart valves ,THERAPEUTIC use of fibrinolytic agents ,PLATELET aggregation inhibitors ,ENOXAPARIN ,ORAL drug administration ,THERAPEUTICS - Abstract
Examines the differences between the interaction of antithrombotic agents with the hemostatic system of the young and adults. Side effects of antithrombotic agents in children; Potential advantages of low-molecular-weight heparin over for children; Thromboembolic and hemorrhagic complications of mechanical prosthetic heart valves with no antithrombotic therapy.
- Published
- 2001
- Full Text
- View/download PDF
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