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PubMed2001

Setting a standard for venous thromboembolism prophylaxis.

Trials of the new antithrombotic agent fondaparinux sodium in patients undergoing orthopedic surgery are discussed. Phase II studies conducted in more than 900 hip-replacement and 400 knee-replacement patients demonstrated significant dose-dependent reductions in the frequency of venous thromboembolism. Phase III trials evaluated the efficacy and safety of fondaparinux sodium 2.5 mg s.c. once daily starting six hours after surgery compared with enoxaparin for prevention of venous thromboembolism (VTE). Four multicenter, randomized, comparative, double-blind Phase III trials were conducted: two in total hip replacement patients (Ephesus and Pentathlon 2000), one in knee surgery patients (PentaMaks), and one in hip fracture surgery patients (Penthifra). All four studies followed the same design template, and the comparator was one of two regimens of enoxaparin approved for this indication. Enoxaparin sodium 30 mg s.c. every 12 hours starting postoperatively was used in Pentathlon 2000 and PentaMaks, and enoxaparin sodium 40 mg s.c. once daily starting preoperatively was used in Ephesus and Penthifra. The primary efficacy endpoint was the occurrence of VTE up to day 11, as determined by venography or confirmation of symptoms. The main safety outcome was occurrence of major bleeding. In total, 7344 patients were randomized and efficacy was evaluated in 5385 (73.3%). Risk of VTE was reduced by 50% in patients receiving fondaparinux compared with those receiving enoxaparin. Safety profiles for clinically relevant bleeding were similar between the two drugs. Fondaparinux sodium, a novel antithrombotic agent, is effective for the prevention of VTE, with a favorable safety profile, in patients undergoing major orthopedic surgery.

Anticoagulants↗
PubMed1991

Hypercoagulable state and thromboembolism following warfarin withdrawal in post-myocardial-infarction patients.

Nine out of 47 (19%) patients on chronic anticoagulation with warfarin, as secondary prophylaxis after myocardial infarction, initially treated with streptokinase, had thromboembolic complications within 4 weeks after sudden (7/25) or gradual (2/22:NS) warfarin withdrawal. The biochemical effects of warfarin withdrawal were repeatedly studied in 20 of the patients during the first 14 days following drug cessation. During the first 4 days, the levels of coagulation factors VII and IX increased more rapidly than proteins C and S. Thus, a gap was created between the factors provoking and inhibiting the coagulation process. Furthermore, plasma concentrations of fibrinopeptide A (FPA) increased, reflecting activation of the coagulation system. These laboratory findings suggest that withdrawal of warfarin creates a transient hypercoagulable state, imposing a risk of thromboembolic events in patients given anticoagulant treatment as secondary prophylaxis following myocardial infarction.

Adult↗
PubMed1984

Plasma beta-thromboglobulin in patients with valvular heart disease with or without valve replacement: relationship with thromboembolic accidents.

Plasma beta-thromboglobulin (BTG) was measured in 132 patients with valvular heart disease: 43 were studied before, 89 after surgery (78 mechanical valves and 11 bioprostheses). In this group of 89 selected patients, a history of thromboembolism was present in 53 (5 of them had bioprosthesis). Some abnormalities have been observed in patients with valvular heart disease as compared with controls: decreased platelet count and retention on glass column, and increased BTG. There is no statistically significant difference in BTG level between patients with (m +/- SD: 62.4 +/- 42.0 ng ml-1), or without (59.5 +/- 41.0 ng ml-1) a prosthesis; in the small series of 11 patients with a bioprosthesis, BTG was slightly lower than in other patients (44.5 +/- 14.1 ng ml-1), but still higher than in controls (26.8 +/- 13.3 ng ml-1). In the patients with a history of thromboembolism, BTG was significantly higher (66.7 +/- 47.9 ng ml-1 than in patients without this complication (49.9 +/- 21.0 ng ml-1). Thus, BTG evaluation may have some value in valvular heart disease but, at present, it should be confined to systematic research including prospective studies.

Adult↗
PubMed2004

The prevention of venous thromboembolism in older adults: guidelines.

The rationale for thromboprophylaxis is based on the high prevalence of venous thromboembolism (VTE), a disorder involving deep vein thrombosis (DVT) and pulmonary embolism (PE), among hospitalized patients, the clinically silent nature of VTE in most patients, and the morbidity, cost, and potential mortality associated with unprevented thromboembolism. Both DVT and PE cause few specific symptoms, and the clinical diagnosis is unreliable. Since the first clinical manifestation of VTE may be fatal PE, it is inappropriate to wait for symptoms before treatment. Unrecognized and untreated DVT may also cause the postphlebitic syndrome and predispose patients to subsequent episodes of recurrent VTE. Routine screening for VTE has also not been shown to reduce the incidence of symptomatic VTE or fatal PE. Use of effective methods of prophylaxis is more cost effective and is safer than selective, intensive screening for VTE. This article reviews current recommendations for the prevention of VTE as they apply to older adults. The recommendations discussed are based on the Sixth American College of Chest Physicians Consensus Conference on Antithrombotic Therapy reported in Chest. 2001;119:132S-175S.

Age Factors↗
PubMed2005

Prevention of perioperative venous thromboembolism and coronary events: differential responsiveness to an intervention program to improve guidelines adherence.

INTRODUCTION: Prevention of venous thromboembolism and coronary events (with beta-blockers) during and after surgery is at the top of a list of safety practices for hospitalized patients, recommended by the Agency for Health Care Research and Quality (AHRQ). We wished to determine and improve adherence to clinical guidelines for these topics in our institution. PATIENTS, MATERIAL, AND METHODS: A prospective survey was conducted over several weeks on operated patients in a 1200-beds medical center (a teaching, community and referral hospital in Jerusalem, Israel). Eligibility for and actual administration of prophylactic treatment with anticoagulant and beta-blockers were determined. Following an intervention program, which included staff meetings, development of local protocols, and academic detailing by a nurse, the survey was repeated. RESULTS: In general, adherence to recommended anticoagulation prophylaxis was low, found in only 29% [95% confidence interval (CI) = 23-36] of eligible patients. After the intervention, adequate anticoagulation increased to 50% (95% CI = 40-59) of eligible patients (P < 0.001). Initiation of beta-blockers in preventing perioperative cardiac events was very low (0%, 95% CI = 0-5%) and did not increase after intervention. CONCLUSIONS: Adherence to guidelines for prevention of surgical complications was found to be low in our institution. A multifaceted intervention significantly increased use of prophylaxis for venous thromboembolism but not for coronary events. This differential response suggests that the success of a quality improvement project strongly depends on topic content and its phase of acceptance.

Adrenergic beta-Antagonists↗
PubMed1978

Oral contraceptives, smoking, and other factors in relation to risk of venous thromboembolic disease.

Analysis of data from the Walnut Creek Contraceptive Drug Study showed a significant increase in risk of venous thromboembolic disease in the absence of surgery, trauma, malignancy, pregnancy, and the puerperium for women with a previous history of thromboembolism, hypertension, diabetes, varicose veins, gallbladder disease, and cigarette smoking. Education, marital status, parity, use of noncontraceptive estrogens, and obesity were not associated with an increase in risk of the disease. When only cases of the disease in the absence of all known predisposing causes (idiopathic cases) were analyzed, both oral contraceptive use and smoking remained as independent risk factors; there was no evidence of a positive interaction between them.

Adult↗
PubMed1995

Randomized comparison of aspirin and phenprocoumon for prevention of right-sided thromboembolic complications associated with transvenous defibrillation leads.

Death due to pulmonary embolism caused by thrombosis formation along a pacing wire has been reported in patients with antibradycardia pacemakers. The purpose of this prospective and randomized study was to evaluate the effects of prophylactically assigned aspirin (100 mg per day) or phenprocoumon (a coumarin derivative) on the incidence of right-sided thromboembolic complications associated with transvenous defibrillation leads. Multiplane transoesophageal echocardiography and pulmonary scintigraphy were performed in 62 consecutive patients immediately and 6 +/- 2 months after transvenous defibrillator implantation. Aspirin or phenprocoumon was administered to the patients in a randomized and parallel manner. By means of multiplane transoesophageal echocardiography and pulmonary scintigraphy no thromboembolic events were observed immediately after transvenous defibrillator implantation. After 6 +/- 2 months, however, multiplane transoesophageal echocardiography disclosed thrombi on the transvenous leads in 13 of 62 patients (21%) despite antithrombotic therapy. At the same time, pulmonary scintigraphy did not reveal any defects compatible with pulmonary embolism. Although thrombi occurred in only four patients treated with phenprocoumon, but in nine patients receiving aspirin, this difference was statistically insignificant. Other variables associated with the occurrence of thrombosis formation were not identified. One fatal intracranial haemorrhage occurred in the phenprocoumon group.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1996

Aorto-subclavian thromboembolism: a rare complication associated with moderate ovarian hyperstimulation syndrome.

The case of an arterial aorto-subclavian thromboembolism associated with a moderate ovarian hyperstimulation syndrome (OHSS) and following ovulation induction for in-vitro fertilization in a young woman is reported. Because of the lack of response to systemic thrombolysis, a left postero-lateral thoracotomy was performed on day 8 after embryo transfer. A fibrinocruoric embolus situated at the junction of the left subclavian artery from the aorta was removed through a left subclavian arteriotomy. The distal axillary embolus was removed by a retrograde balloon catheter embolectomy. A moderate OHSS was observed. The ovarian stimulation and OHSS-related risks of thromboembolism are discussed. We conclude that, in the absence of risk factors, counselling about possible complications resulting from stimulation must be emphasized.

Adult↗
PubMed2003

Comparison of the incidence rates of thromboembolic events reported for patients prescribed rofecoxib and meloxicam in general practice in England using prescription-event monitoring (PEM) data.

BACKGROUND: Rofecoxib and meloxicam are classified as cyclo-oxygenase (COX)-2 selective inhibitors. The Drug Safety Research Unit (DSRU) monitored the post-marketing safety of these drugs in England using the non-interventional observational cohort technique of prescription-event monitoring (PEM). OBJECTIVES: To compare the incidence rates of selected thromboembolic (TE)(cardiovascular, cerebrovascular and peripheral venous thrombotic) events reported for patients prescribed rofecoxib and meloxicam in general practice. METHODS: Patients were identified from dispensed prescriptions written by general practitioners (GPs) for meloxicam (December 1996 to March 1997) and rofecoxib (July to November 1999). Simple questionnaires requesting details of events recorded during/after treatment, indication and potential risk factors (including age, sex and NSAIDs prescribed within 3 months of treatment) were posted to prescribing GPs approximately 9 months after the first prescription for each patient. Incidence rates of the first event within each TE group were calculated; crude and age- and sex-adjusted rate ratios (RR) obtained using regression modelling. RESULTS: During the 9 months after starting treatment, 21 (0.14%) and 19 (0.10%) patients were reported to have cardiovascular TE events, and 74 (0.48%) and 52 (0.27%) cerebrovascular TE events, and 6 (0.05%) and 20 (0.10%) were reported to have peripheral venous thrombotic events for rofecoxib and meloxicam, respectively. Regarding time to first event, there was a persistent divergence between the two drugs from the start of treatment for both the cerebrovascular TE event group (log rank test P = 0.0063) and the peripheral venous thrombotic event group (log rank test P = 0.0264). Indication and use of a NSAID within 3 months prior to starting treatment had no statistically significant effect on the relative risk estimates of the event groups and was excluded from subsequent analyses. Adjusting for the two identified risk factors of age (age2) and sex, for rofecoxib the adjusted cerebrovascular TE event group rate was higher than for meloxicam [RR 1.68 (95% CI 1.15, 2.46)]; lower than meloxicam for the peripheral venous thrombotic event group [RR 0.29 (95% CI 0.11, 0.78)], and not different for the cardiovascular TE event group [RR 1.38 (95% CI 0.71, 2.67)]. CONCLUSIONS: This study reports a relative increase in the rate of cerebrovascular TE events and a relative reduction in peripheral venous thrombotic events in users of rofecoxib compared with meloxicam. There was no difference in the rate of cardiovascular thromboembolic events. The incidence of these three groups of events reported in each of these two drug cohorts was low (less than 0.5%), therefore the relevance of our findings needs to be taken into consideration with other clinical and pharmacoepidemiological studies.

Adult↗
PubMed2005

Autoantibody to CD40 ligand in systemic lupus erythematosus: association with thrombocytopenia but not thromboembolism.

OBJECTIVES: To examine the prevalence, clinical associations and pathogenic roles of autoantibodies to CD40 ligand (CD40L) in patients with systemic lupus erythematosus (SLE). METHODS: Plasma anti-CD40L antibodies from 125 patients with SLE, 24 with primary antiphospholipid syndrome (APS) and 90 with idiopathic thrombocytopenic purpura (ITP) and from 62 healthy individuals were measured with an enzyme-linked immunosorbent assay (ELISA). HeLa cells transfected with human CD40L cDNA (HeLa/CD40L) were used to confirm the presence of anti-CD40L autoantibodies. The effect of anti-CD40L antibodies on the CD40L-CD40 interaction was evaluated by observing CD40L-induced IkappaB activation in CD40-expressing fibroblasts. RESULTS: Anti-CD40L autoantibody was detected in seven (6%) SLE, three (13%) primary APS and 11 (12%) ITP patients, but in no healthy controls. Antibody binding in an ELISA was competitively inhibited by membrane components of HeLa/CD40L. Anti-CD40L antibody-positive IgG specifically bound the surface of living HeLa/CD40L, as shown by flow cytometry. The frequency of thrombocytopenia was significantly higher in SLE patients with the anti-CD40L antibody than in those without (100 vs 14%; P<0.00001), whereas there was no association between the anti-CD40L antibody and thrombosis. Binding of the anti-CD40L antibodies in patients' plasma to CD40L was competitively inhibited by a series of mouse anti-CD40L monoclonal antibodies. Anti-CD40L antibody-positive IgG failed to inhibit CD40L-induced IkappaB activation. CONCLUSIONS: Anti-CD40L autoantibody is associated with thrombocytopenia but not thromboembolism. Our findings are potentially useful in understanding the complex roles of CD40L in the pathophysiology of thrombosis and haemostasis as well as the thromboembolic complications that occur during treatment with anti-CD40L humanized antibody.

Adult↗
PubMed2002

Two patients with arterial thromboembolism among 311 patients with adenocarcinoma of the pancreas.

PURPOSE: To examine the prevalence and characteristics of arterial thromboembolism in patients with adenocarcinoma of the pancreas. METHODS: Retrospective review of charts of all patients with cancer of the pancreas diagnosed and followed at a regional teaching hospital over a decade. RESULTS: In total, 320 patients were diagnosed and 311 were available for evaluation. Two patients with arterial thromboembolism were identified (0.65%) and studied. Both had extensive metastatic disease on diagnosis and, soon after, developed an acute arterial occlusion of the iliac and femoral arteries, with no identifiable embolic source (case 1) or acute intestinal infarction due to mesenteric and multiple other embolic arterial occlusions associated with nonbacterial thrombotic endocarditis (NBTE) of the mitral valve (case 2). Both cases had laboratory evidence of disseminated intravascular coagulation and succumbed to their illnesses within a very short time. CONCLUSION: Arterial occlusion in pancreatic cancer is a rare preterminal event that may be caused by cardiogenic emboli from NBTE or to thrombosis in situ. The pathogenesis is briefly reviewed.

Adenocarcinoma↗
PubMed2003

Metastatic carcinoma presenting with concomitant eosinophilia and thromboembolism.

A case of a 58-year-old female patient who presented with significant blood eosinophilia and thromboembolic events is described. The patient was eventually diagnosed as suffering from a disseminated malignancy of gastrointestinal origin. Immunohistochemical studies of the tumor are presented. These studies show that tumor cells produce interleukin-3 and -5 and granulocyte macrophage-colony stimulating factor. These cytokines are known to support differentiation, proliferation, and survival of eosinophils. Their secretion is the probable explanation for the appearance of high blood eosinophilia in this patient. To the best of our knowledge, combined blood eosinophilia and thromboembolism as presenting manifestations of a solid tumor have never been reported.

Carcinoma↗
PubMed1975

A comparative analysis of warfarin and low-dose heparin as thromboembolism prophylaxis in total hip replacement patinets.

Warfarin, low-dose heparin, or a combination of low-dose heparin and hydrocortisone was administered to 300 patients undergoing total hip replacement. The lowest incidence of thromboembolic (5 per cent) was attained with Warfarin. Further investigation into the method of administration of low-dose heparin is necessary before it can be used effectively as thromboembolism prophylaxis in total hip replacement patients. The addition of hydrocortisone was not found useful.

Arthroplasty↗
PubMed1980

Prophylaxis of venous thromboembolism: analysis of cost effectiveness.

The rapidly expanding literature regarding prevention of venous thromboembolism is confusing and contradictory, but, when analysed in the aggregate, the collective experience permits a judgment about the relative efficacy of different prophylactic regimens in specific patient populations, who vary in the risk factors predisposing them to thromboembolism. The dollar cost of the several approaches to prevention and their consequences should also be a matter of concern. Efficacy and dollar cost together determine cost effectiveness, which provides a practical guide to selection of the prophylactic approach appropriate to an individual patient.

Aspirin↗
PubMed1992

Factor XII clotting activity and antigen levels in patients with thromboembolic disease.

Individuals with severe factor XII (FXII) deficiency may be prone to thromboembolic disease and this thrombophilic state may be due to insufficient contact activation dependent fibrinolysis. According to our previous study (Thromb Haemostas 1991; 65: 117-121), however, heterozygous FXII deficiency is not a strong prethrombotic risk factor, only one out of 45 obligatory or possible heterozygotes having sustained a thrombotic event. In the present study, FXII clotting activity (FXII:C) and antigen concentration (FXII:AG) were measured in 200 patients having suffered from idiopathic thromboembolism and compared with the values in 200 healthy controls. Mean FXII levels were not significantly different in thrombophilic patients and controls, and subnormal FXII values were not more frequently encountered in patients than in controls. Specific FXII activity, i.e. the ratio of FXII:C to FXII:AG, showed considerable variation in each of the two groups, but patients and controls had a similar distribution of specific FXII activity. Variations in specific FXII activity were not explained by differences in beta 2-glycoprotein I levels. In conclusion, heterozygous FXII deficiency is not a strong prethrombotic risk factor and subnormal FXII values are not more common in thrombophilic patients than in healthy individuals.

Adolescent↗
PubMedDate not supplied

Hematologic abnormalities and thromboembolic complications in calves implanted with pneumatic artificial hearts. Long-term studies and autopsy findings.

The purpose of this study was to assess hematologic abnormalities and thromboembolic complications related to long-term use of the pneumatic artificial heart (PAH). Laboratory data and autopsy findings were analyzed from 24 calves that survived 70-353 (150 +/- 82) days after implantation of a PAH. Compared with baseline levels, the hemoglobin was significantly lower, and the plasma hemoglobin and serum LDH significantly higher, throughout the follow-up period. The platelet count decreased during the first 10-30 weeks, but returned to preoperative levels by week 35. Platelet survival in 4 calves in stable condition was normal, and the leukocyte count and absolute neutrophil count were within normal limits. At autopsy, thrombotic complications and organ infarction were noted in 13 calves, and major septic complications were documented in 10 animals. The authors' observations indicate that thromboembolism and infection are major complications of long-term use of the PAH.

Animals↗
PubMedDate not supplied

Pathophysiologic role of contact activation in bleeding followed by thromboembolic complications after implantation of a ventricular assist device.

The time period after implantation of a ventricular assist device in patients with end-stage heart disease is complicated by hemorrhage in the early postoperative period and by thromboembolism in the later course. To investigate the pathophysiologic role of contact activation in 12 bridging patients (10 patients with a paracorporeal Berlin Heart [Berlin Heart GmbH, Berlin, Germany], 2 patients with an intracorporeal Novacor system [Novacor N100; Baxter, Oakland, CA]), hemostatic parameters were determined until heart transplantation or at least up to the 51st postoperative day. The following were observed: 1) In the early postoperative period, until day 15, levels of contact factors XI, XII, and prekallikrein were below normal, whereas levels of plasmin-a2-antiplasmin (PAP) complexes were elevated. Thrombin-antithrombin III (TAT) complexes, as well as platelet factor 4 and beta-thromboglobulin, significantly increased immediately after surgery. 2) In the later postoperative period, starting with the third postoperative week, an increase of factors XI, XII, and prekallikrein was observed. PAP and TAT complexes, as well as platelet factor 4 and beta-thromboglobulin, remained elevated. It is concluded that, in the early postoperative period, hemostasis is influenced mainly by an activation of the intrinsic contact system dependent fibrinolytic system with consumption of contact factors and increased levels of PAP complexes, whereas later system dependent fibrinolysis becomes less important, leading to a shift of the balance toward coagulation, with sustained prothrombin and platelet activation. This is in accord with the observed clinical complications (e.g., early postoperative bleeding, and thromboembolic events later on).

Adult↗