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PubMed2003

Association between inherited thrombophilias, antiphospholipid antibodies, and lipoprotein A levels and venous thromboembolism in pregnancy.

The objective of this study is to evaluate the association between venous thromboembolism (VTE) in pregnancy with thrombophilic factors. Thirty pregnant women with VTE were compared with 30 pregnant women matched by age and race without VTE and evaluated for risk factors and thrombophilia. Statistical analysis used two-tailed Fisher's exact test. VTE distribution was 30% in first trimester, 9% in 2nd trimester, 26% in 3rd trimester and 35% postpartum. Seventeen (57%) of VTE cases versus 2 (7%) of control cases had specific thrombophilia diagnosis ( p <0.001). The results were: Factor V Leiden mutation (27 vs. 3%) p = 0.026, MTHFR homozygous 677 mutation (10 vs. 44%) p = 0.017, prothrombin gene mutation (11 vs. 0%), protein C deficiency (7 vs. 0%), antiphospholipid antibodies (27 vs. 3%) p = 0.026, mean lipoprotein levels 49 versus 23 mg/dL, p = 0.008, mean homocysteine levels 7.8 versus 7.1 umol/L. An association is suggested between thromboembolic events in pregnancy and thrombophilia, especially Factor V Leiden gene mutation and elevated antiphospholipid antibodies. A new finding is the association of elevated lipoprotein A levels with thromboembolic events in pregnancy.

Adult↗
PubMed2003

Recurrent thromboembolism in cancer patients: incidence and risk factors.

In contrast with the paucity of data on the risk of a first episode of thrombosis in cancer patients, the frequency of recurrent thromboembolism in patients with malignancy has been extensively investigated, both during anticoagulation and after its cessation. Cancer patients are more likely to develop recurrent thromboembolism and major bleeding during anticoagulation than patients without malignancies. These events are more pronounced during the first weeks of treatment and increase with cancer severity. Since they are not associated with anticoagulant intensities outside the therapeutic range, possibilities for improvement using the current paradigms of anticoagulation seem limited and new treatment strategies should be developed. In this regard, the use of low-molecular-weight heparins for initial treatment and long-term anticoagulation in cancer patients with venous thrombosis seems promising. Furthermore, patients with active cancers exhibit a particularly high risk of recurrent venous thromboembolism after the cessation of anticoagulation. In view of the persisting high risk for recurrent thrombotic events in cancer patients, and the acceptable risk of bleeding, prolonged warfarin treatment should be considered in such patients for as long as the cancer is active.

Anticoagulants↗
PubMed2003

Arterial thromboembolism in the pediatric population.

The most common cause of arterial thromboembolism in the pediatric population is secondary to arterial catheterization. Non-catheter-related arterial thromboembolism is rare. The frequency of this complication has paralleled the advances in pediatric tertiary care that has lead to increasing numbers of children surviving life-threatening primary illnesses. Previously, these events were very rare and children were managed according to adult protocols. It is now known that the pathophysiology of thrombosis in children differs from that of adults and indeed is different for that of various age groups within the pediatric population, therefore requiring a unique diagnostic and therapeutic approach. This review highlights the available published data to support an evidence-based approach to the complication of arterial thromboembolism in the pediatric population, and underscores the urgent need for further randomized controlled trials.

Arterial Occlusive Diseases↗
PubMed1998

Effect of platelet inhibitors on thromboembolism after implantation of a Novacor N100--preliminary results.

BACKGROUND: Left-ventricular assist device implantation (LVAD) is still associated with thromboembolism as the optimal anticoagulation is still unclear. We report on the effects of adding platelet inhibitors to our anticoagulation regimen in our Novacor LVAD program. METHODS: Oral platelet aggregation inhibitors (aspirin 330 mg + dipyridamole 75 mg, three times per day) were added to the heparin/phenprocoumon treatment in 9 patients starting on postoperative day 3 to 7 (group A). Of the previous 41 patients, the last 20 patients served as a control group (group B), to reduce any learning curve effect. RESULTS: The mean interval of mechanical support between the two groups was comparable (group A vs B: 148 +/- 127 vs 104 +/- 61 days, n.s.). Accordingly, the cumulative support was much lower in group A (1051 days) as compared to group B (2091 days). In group B, 10 patients (50%) developed clinically evident thromboembolism. The number of events ranged from 1 to 10 (mean 1.4 +/- 2.3), with a total of 32. With addition of platelet inhibitors, the incidence of cerebral embolism dramatically dropped, as only one patient presented with transient ischemic attacks in group A (p < 0.05). Thoracic bleeding as defined by excessive drainage losses requiring redo thoracotomy did not increase (group A vs B: 22% vs 20%, n.s.). CONCLUSION: Addition of platelet inhibitors to heparin/phenprocoumon effectively prevents thromboembolism. However, platelet inhibitors should be postponed until sufficient hemostasis is achieved, since too early administration is associated with an increased risk of bleeding.

Anticoagulants↗
PubMed1997

APC resistance in childhood thromboembolism: diagnosis and clinical aspects.

Few studies of activated protein C resistance (APCR) and thromboembolism in childhood have been published. In the majority of childhood thromboses reported, the factor V Leiden mutation was associated with venous thromboses; however, one case report and three studies described arterial thromboembolism in infants and children due to the common mutation in the factor V gene. In one neonate purpura fulminans occurred, and heparin-induced thrombocytopenia type II was additionally documented. Two case reports and seven of nine studies reported associated clinical conditions together with inherited coagulation disorders. In three studies homozygous patients were mentioned. There are few studies describing the interaction between APCR and coagulation or the fibrinolytic system in symptomatic and nonsymptomatic infants. Compared with healthy brothers or sisters and a healthy age-matched control group, thrombin generation, D-dimer, PAI-1 activity, and t-PA antigen were found clearly elevated in children with APCR. In addition, infants and children with the Arg506-to-Gln mutation in the factor V gene showed significantly increased thrombomodulin concentrations along with normal protein C activities compared with relatives and healthy controls. No difference was recorded in these studies between heterozygous infants and children without vascular occlusion and patients who previously had suffered from thromboembolism. Until long-term data are available for the treatment of patients with APCR, such children should be treated in the same way as patients with deficiencies of protein C, protein S, or antithrombin.

Child↗
PubMed1996

Low-molecular-weight heparin (enoxaparin) as prophylaxis against venous thromboembolism after total hip replacement.

BACKGROUND: The risk of venous thromboembolism in patients undergoing total hip replacement is known to be high. However, the optimal duration of prophylaxis with anticoagulant agents after this procedure is unknown. We sought to determine whether one month of anticoagulant therapy with the low-molecular-weight heparin enoxaparin is more effective than enoxaparin therapy given only during the hospitalization for surgery. METHODS: Two hundred sixty-two patients undergoing total hip replacement received enoxaparin during their hospitalizations (average stay, 10 to 11 days). They were then randomly assigned to receive enoxaparin or placebo (131 patients each). Blinded outpatient therapy (or placebo) was continued long enough that the total treatment period, inpatient plus outpatient, was one month for each patient. Bilateral ascending phlebography was performed 19 to 23 days after discharge, with deep-vein thrombosis as the primary end point. Distal and proximal thrombosis, pulmonary embolism, and hemorrhage were also recorded, as were deaths. RESULTS: Venography was adequate in 116 patients in the placebo group and 117 in the enoxaparin group. We observed 43 episodes of deep-vein thrombosis and 2 episodes of pulmonary embolism in the placebo group, but only 21 episodes of deep-vein thrombosis and no episodes of pulmonary embolism in the enoxaparin group (incidence of thromboembolism, 39 percent and 18 percent, respectively; P<0.001). The difference in the incidence of proximal deep-vein thrombosis was also significant (24 percent and 7 percent in the placebo and enoxaparin groups, respectively; P<0.001). Six enoxaparin groups, respectively; P<0.001). Six patients in the enoxaparin group and one patient in the placebo group had hematomas at their injection sites. No patients died or had major complications. CONCLUSIONS: There were significantly fewer venous thromboembolic complications in patients undergoing elective hip replacement when prophylaxis with enoxaparin was given for a total of one month, rather than only during the hospitalization.

Adult↗
PubMed2001

Effects of a low-molecular-weight heparin on thrombus regression and recurrent thromboembolism in patients with deep-vein thrombosis.

BACKGROUND: Low-molecular-weight heparins are frequently used to treat venous thromboembolism, but optimal dosing regimens and clinical outcomes need further definition. METHODS: In this multicenter, open-label study with blinded adjudication of end points, we randomly assigned patients with acute deep-vein thrombosis to one of three treatment regimens: intravenous administration of unfractionated heparin; subcutaneous administration of a low-molecular-weight heparin, reviparin, twice a day for one week; or subcutaneous administration of reviparin once a day for four weeks. The primary end point was evidence of regression of the thrombus on venography on day 21; secondary end points were recurrent venous thromboembolism, major bleeding within 90 days after enrollment, and death. RESULTS: Of the patients receiving unfractionated heparin, 40.2 percent (129 of 321) had thrombus regression, as compared with 53.4 percent (175 of 328) of patients receiving reviparin twice daily and 53.5 percent (167 of 312) of the patients receiving reviparin once daily. With regard to thrombus regression, reviparin administered twice daily was significantly more effective than unfractionated heparin (relative likelihood of thrombus regression, 1.28; 97.5 percent confidence interval, 1.08 to 1.52), as was reviparin administered once daily (relative likelihood, 1.29; 97.5 percent confidence interval, 1.08 to 1.53). Mortality and the frequency of episodes of major bleeding were similar in the three groups. CONCLUSIONS: In acute deep-vein thrombosis, reviparin regimens are more effective than unfractionated heparin in reducing the size of the thrombus. Reviparin is also more effective than unfractionated heparin for the prevention of recurrent thromboembolism and equally safe.

Acute Disease↗
PubMed2001

Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after elective major knee surgery.

BACKGROUND: Despite thromboprophylaxis, major knee surgery carries a high risk of venous thromboembolism. Fondaparinux, the first of a new class of synthetic antithrombotic agents, may reduce this risk. METHODS: In a double-blind study, we randomly assigned 1049 consecutive patients undergoing elective major knee surgery to receive subcutaneous doses of either 2.5 mg of fondaparinux once daily or 30 mg of enoxaparin twice daily, with both treatments initiated postoperatively. The primary efficacy outcome was venous thromboembolism up to postoperative day 11, defined as deep-vein thrombosis detected by mandatory bilateral venography, documented symptomatic deep-vein thrombosis, or documented symptomatic pulmonary embolism. The primary safety outcome was major bleeding. RESULTS: The primary efficacy outcome was assessed in 724 patients. The fondaparinux group had a significantly lower incidence of venous thromboembolism by day 11 (12.5 percent [45 of 361 patients]) than the enoxaparin group (27.8 percent [101 of 363 patients]; reduction in risk, 55.2 percent; 95 percent confidence interval, 36.2 to 70.2; P<0.001). Major bleeding (including overt bleeding with a bleeding index of 2 or more) occurred more frequently in the fondaparinux group (P=0.006), but there were no significant differences between the two groups in the incidence of bleeding leading to death or reoperation or occurring in a critical organ. CONCLUSIONS: In patients undergoing elective major knee surgery, postoperative treatment with 2.5 mg of fondaparinux once daily was significantly more effective in preventing deep-vein thrombosis than 30 mg of enoxaparin twice daily.

Aged↗
PubMed1984

Thromboembolic complications in nephrotic syndrome. Coagulation abnormalities, renal vein thrombosis, and other conditions.

In patients with nephrotic syndrome, the presence of a hypercoagulable state is thought to give rise to a high incidence of thromboembolic phenomena. Renal vein thrombosis is a common complication in nephrotic patients, mainly in those with membranous nephropathy, and many other types of thromboembolic complications also occur. The mortality rate in nephrotic patients with thromboembolic complications may be significantly increased, with pulmonary emboli likely being the most common cause of death.

Antithrombins↗
PubMed2005

Implementation of clinical practice guidelines for prevention of thromboembolism in spinal cord injury.

BACKGROUND/OBJECTIVES: The purpose of this study was to determine whether publication of the "Prevention of Thromboembolism in Spinal Cord Injury" clinical practice guideline (CPG) changed patient management and whether adherence to CPG recommendations improved after a targeted implementation strategy. METHODS: Data were abstracted from medical records of 134 and 520 patients with acute and chronic spinal cord injury (SCI), respectively, from 6 Veterans Affairs medical centers over 3 time periods: prepublication (T1), preimplementation (T2), and postimplementation (T3) of the CPG. Targeted interventions were developed to address provider-perceived barriers to guideline adherence, based on findings from focus groups conducted at each site. The interventions incorporated two implementation strategies: standardized documentation templates/standing orders and social marketing/outreach visits. RESULTS: Use of the specified duration for pharmacologic prophylaxis increased from 60% to 65% to 75% of patients with acute SCI in T1, T2, and T3, respectively (P = 0.060 and 0.041 for T1 vs T2 and T2 vs T3, respectively). Rates of use for individual pharmacologic prophylaxis agents changed significantly over the course of the study, with use of low-molecular-weight heparin increasing from 7% in T1 to 42% in T3. Physical assessments for thrombosis on hospitalization days 1 and 30 improved between T2 and T3. Use of prophylaxis in chronically injured patients with new risk factors for thromboembolism increased from 16% to 31% to 34% during T1, T2, and T3 (P = 0.001 and 0.87, respectively). CONCLUSIONS: The CPG publication had only a modest effect on practice. Use of structured implementation further increased the adherence to some CPG recommendations for thromboembolism prophylaxis. Similar implementation strategies should be considered for CPG recommendations with low adherence and high potential for morbidity and mortality.

Adult↗
PubMed1998

The prothrombin gene G20210A variant in an unselected thromboembolic population. A Belgian prospective clinical study.

The presence of the 20210A allele of the prothrombin gene has recently been shown to be a risk factor of venous thromboembolism, probably mediated through increased prothrombin levels. The aim of the study was to determine the frequency of the prothrombin 20210A allele in 193 consecutive unselected patients with venous thromboembolism and 100 healthy controls and to analyze the clinical profile associated with this new inherited thrombophilic factor. In agreement with previous reports, we found a frequency of 7.3% of heterozygous carriers of the 20210A allele among patients and 1% among controls. We confirm that plasma prothrombin levels are more elevated in the individuals bearing the prothrombin 20210A allele compared with those who do not. We did not find any relationship between the presence of the prothrombin 20210A allele and either a family history of thromboembolism, the rate of recurrences or the age at disease onset. However, the co-inheritance in the same individual of both prothrombin 20210A allele and factor V Leiden was associated with a significantly lower age at disease onset suggesting a synergistic contribution of both abnormalities.

Adult↗
PubMed1977

Platelet factor 4 activity and thromboembolic episodes.

Platelet factor 4 activity was evaluated in 323 patients who had various diseases. High incidences (30% or more) of elevated levels of platelet factor 4 were found in patients with recent myocardial infarctions, recent episodes of thromboembolism, hepatic diseases, and low platelet counts. Three of the four patients who had prosthetic heart valves had markedly elevated platelet factor 4 activities. It appears that elevation of platelet factor 4 activity is associated with a high platelet turnover such as is seen in intravascular coagulation or thromboembolism. Determination of platelet factor 4 activity may be a valuable laboratory tool for the diagnosis of thromboembolism.

Age Factors↗
PubMed1984

Thromboembolic and haemorrhagic risk in mechanical and biological aortic prostheses.

Thromboembolism, valve thrombosis and haemorrhagic events have been compared in 356 Starr-Edwards (SE) 1260, 113 Björk-Shiley (BS), and 178 aortic bioprostheses operated upon between 1968 and 1982, and reviewed by the same group with less than 2% of patients lost of follow-up. Expressed in actuarial rate at 7 years the percentage of patients free of thromboembolism event is 87% for SE, 86% for BS, 94% for bioprostheses; the linearized rate is 2.9%/patient/year for SE, 2.2 for BS, 1.9 for bioprostheses (NS). Valve thrombosis was not observed in bioprostheses; 97.9% of patients with mechanical valves were free of valve thrombosis at 6.5 years. Haemorrhagic risk was lower with bioprostheses than with mechanical valves 0.2% patient/year vs 2.33 (P less than 0.005). The most important factor influencing thromboembolic and haemorrhagic risks is the quality of anticoagulant therapy. Other contributing factors are the date of the operation and associated mitral disease.

Actuarial Analysis↗
PubMed1984

Thromboembolism with low profile bioprosthesis.

Low profile bioprosthesis late follow-up indicates a low incidence of thromboembolism. For the entire series of 415 consecutively operated patients (rigid and flexible stents) the actuarial probability of freedom at 6 years is 90.3% (87.8% for MVR and 92.27% for AVR and 95.24% for MVR + AVR). The linearized incidence for MVR, is 2.5 +/- 0.62 per one hundred patients per year. For AVR this is 1.2 +/- 0.49 per one hundred patients per year. The probability of freedom of thromboembolism of the new flexible stent series (247 patients) at 48 months is 90.92% for MVR, 96.6% for AVR and 100% for MVR + AVR. Endocarditis for the entire series of patients (rigid/flexible stents) at 6 years is low: the linearized incidence for both MVR and AVR is 0.54 per one hundred patients per year. Tissues degeneration, after 5 years follow-up, in patients over 35 years old carrying LPB mounted on flexible stents was not observed. In the series of MVR patients, 17/209 presented thromboembolic complications. In the group of 17 patients, 88% had atrial fibrillation before surgery and 47% of the same group were on warfarin anticoagulation therapy when the embolic accident occurred. The indications for permanent anticoagulation therapy following bioprosthetic MVR in patients with chronic atrial fibrillation is still uncertain.

Actuarial Analysis↗
PubMed2001

APC resistance and third-generation oral contraceptives: Acquired resistance to activated protein C, oral contraceptives and the risk of thromboembolic disease.

Using a newly-developed technique, a severe acquired plasma resistance to activated protein C has been described in women using third-generation (rather than second-generation) oral contraceptives. The following items are discussed: (i) the technical parameters used to appreciate the effect of activated protein C induce a bias of interpretation, the mean intrinsic effect of activated protein C, in plasmas from women on second or third-generation oral contraceptives being strictly identical; (ii) there are no data available to show that this assay can indicate a thromboembolic risk in asymptomatic women on oral contraceptives; and (iii) this assay is a global and non-specific test, basically sensitive to the plasma concentrations of many coagulation factors which are increased or decreased by oestrogens and progestogens. For instance protein S, in which oral contraceptive-induced modifications account for the differential effect of oral contraceptives on Rosing's assay, but which modifications are not related to the thromboembolic risk of oral contraceptives. The androgenic potential of the progestogen may counteract the effect of oestrogens in the test. More generally, in such a complex situation in which there is a 'modification of the modification', there is no haemostasis-related test which provides a risk indicator for thrombosis. Based on testing of the plasma response to activated protein C, it is impossible to state that third-generation oral contraceptives induce a more important thromboembolic risk than oral contraceptives containing a more androgenic progestogen.

Activated Protein C Resistance↗
PubMed1993

Cardiac and thromboembolic morbidity among postmenopausal women with early-stage breast cancer in a randomized trial of adjuvant tamoxifen. The Stockholm Breast Cancer Study Group.

BACKGROUND: Tamoxifen, which binds to estrogen receptors, is widely used as adjuvant therapy after surgery for early-stage breast cancer. Our previous randomized trial of adjuvant tamoxifen therapy for breast cancer showed a significant decrease of new, contralateral breast cancers in patients who received tamoxifen. Tamoxifen may also influence risk factors for cardiac and thromboembolic disease (e.g., serum cholesterol and antithrombin III). PURPOSE: The purpose of this study was to assess morbidity from cardiac and thromboembolic disease among 2365 postmenopausal patients with early-stage breast cancer in the Stockholm randomized trial of adjuvant tamoxifen (40 mg daily for 2 or 5 years) versus no adjuvant endocrine therapy. Patients were entered in the study from November 1976 through December 1988. METHODS: In our retrospective study, the analysis of morbidity was based on data from a computerized, population-based register of hospital admissions and discharge diagnoses. Mortality data were obtained from the Swedish National Central Bureau of Statistics. In the Stockholm study, treatment with tamoxifen was initiated within 4-6 weeks of modified radical mastectomy or breast-conserving surgery including axillary lymph node dissection and postoperative radiation therapy to the breast. In that randomized trial, 755 patients at low risk of death from breast cancer received adjuvant tamoxifen only; 760 received no treatment. In addition, 628 high-risk patients were randomly assigned to receive adjuvant chemotherapy plus tamoxifen (173 patients) or postoperative radiotherapy plus tamoxifen (151) or, as a control, to receive chemotherapy (171) or postoperative radiation therapy (133), both without tamoxifen or other endocrine therapy. Median follow-up was 6 years. RESULTS: Tamoxifen therapy resulted in a statistically significant reduced incidence of hospital admissions due to cardiac disease. The relative hazard (tamoxifen for 2 or 5 years versus control) was 0.68 (95% confidence interval [CI] = 0.48-0.97; P = .03). In the randomized comparison of 5 versus 2 years of tamoxifen, there was a statistically significant difference favoring the longer treatment (relative hazard = 0.37; 95% CI = 0.15-0.92; P = .03). There was little difference between the tamoxifen and control groups in terms of admissions due to thromboembolic disease. CONCLUSIONS: These findings suggest that long-term adjuvant treatment with tamoxifen may result in substantial reduction of cardiac morbidity in patients with low risk of death from breast cancer as well as in women in chemopreventive studies who have high risk of developing breast cancer. IMPLICATIONS: Our results support continuation of ongoing trials of tamoxifen therapy in these two groups of subjects.

Aged↗
PubMed1991

Oral contraceptive estrogen dose and the risk of deep venous thromboembolic disease.

Despite the well-recognized association between oral contraceptives and deep venous thromboembolism, little is known about the risks associated with currently marketed formulations containing less than 50 micrograms of estrogen. To assess the venous thrombogenicity of low-estrogen oral contraceptives (those containing less than 50 micrograms of estrogen) relative to intermediate-dose (50 micrograms of estrogen) and high-dose (greater than 50 micrograms of estrogen) formulations, we conducted a cohort study of oral contraceptive users between the ages of 15 and 44 years in the Michigan Medicaid population. The period of the study was from 1980 through the third quarter of 1986. A total of 2,739,400 oral contraceptive prescriptions received by 234,218 women were analyzed. Using the low-estrogen cohort as the referent group, the age and calendar period adjusted relative risk of venous thromboembolism in users of intermediate-dose formulations was 1.5 (95% confidence interval (CI) 1.0-2.1, p = 0.04), and the relative risk in users of high-dose formulations was 1.7 (95% CI 0.9-3.0, p = 0.06). These data provide evidence that the dose-response relation between oral contraceptive estrogen and venous thromboembolism extends from 50 to 30 micrograms of estrogen, the dose range of currently marketed formulations.

Chemistry, Pharmaceutical↗
PubMed1998

Venous thromboembolism in the patient with acute traumatic brain injury: screening, diagnosis, prophylaxis, and treatment issues.

Venous thromboembolism is a life-threatening complication of traumatic brain injury. Consequently, knowledge of available screening, diagnostic, prophylactic, and treatment methods is critical to the management of the individual with traumatic brain injury. Venous thromboembolic risk varies among individuals, resulting in unique screening and prophylactic needs for each patient. In addition, anticoagulation, commonly employed for prophylaxis and treatment in other patient populations, may create an increased risk for intracranial hemorrhage when utilized following traumatic brain injury. The cost, sensitivity, specificity, efficacy, potential side effects, and alternatives for preventing, detecting, and treating venous thromboembolism are important considerations discussed in this article.

Acute Disease↗