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PubMed2001

Effective risk stratification of surgical and nonsurgical patients for venous thromboembolic disease.

Effective and safe methods of preventing venous thromboembolism (VTE) are now widely available, but a significant proportion of patients develop VTE either because thromboprophylaxis has not been used or because the intensity of thromboprophylaxis is not matched to the level of risk. Thromboembolic risk varies widely according to the clinical setting and presence of underlying risk factors, but VTE may not be suspected even in high-risk patients. Clinical risk factors for VTE include recent surgery, cancer, stroke, previous VTE, immobilization, and advanced age. Recent attention has focused on the role of inherited and acquired molecular factors in determining overall thromboembolic risk. These factors include the classic thrombophilias-deficiencies of antithrombin III, protein C, and protein S-and several newly described molecular risk factors: factor V Leiden, the prothrombin 20210A gene mutation, and hyperhomocysteinemia. Based on emerging knowledge of risk factors, several risk assessment models (RAMs) have been devised that stratify patients according to overall VTE risk, allowing thromboprophylaxis to be tailored appropriately. Compared with older risk assessment formulas, current RAMs are simpler and include specific recommendations for thromboprophylaxis based on the available scientific evidence. Consensus documents on VTE prevention classify patients into low-, moderate-, and high-risk categories. More recently, a new risk group, very high risk, has been described. Very-high-risk patients are especially prone to thromboembolic complications and need intensive and in some cases prolonged thromboprophylaxis.

Humans↗
PubMed1980

Oral contraceptives and thromboembolic disease: effects of lowering oestrogen content.

The introduction of low-oestrogen oral contraceptives in Sweden and the concomitant disappearance of high-dose preparations did not result in a lowering of the mortality of fertile women from thromboembolic disease. Morbidity due to thromboembolism seems to have fallen, and the number of thromboembolic incidents reported to the Swedish Adverse Drug Reaction Committee decreased dramatically. The decrease was due exclusively to a reduction in venous thromboembolic disease: the frequency of arterial complications (cerebral and coronary) remained constant.

Adolescent↗
PubMed1985

Thromboembolic complications and haemostatic changes in cyclosporin-treated cadaveric kidney allograft recipients.

The incidence of thromboembolic complications was compared retrospectively in 90 cadaveric kidney allograft recipients treated with cyclosporin and low-dose steroids and the same number of cadaveric kidney allograft recipients treated with azathioprine, antilymphocyte globulin, and high-dose steroids. In the cyclosporin group, 17 thromboembolic complications occurred in 13 patients: 10 pulmonary emboli, 1 renal vein thrombosis, 3 deep vein thromboses, and 3 haemorrhoidal thromboses. In the azathioprine group, the only thromboembolic complication was 1 episode of superficial thrombophlebitis. Haemostatic tests in cyclosporin-treated and azathioprine-treated patients and normal subjects (10 in each group) showed increased concentrations of factor VIII C, fibrinogen, antithrombin III, and protein C in the cyclosporin-treated patients. Adenosine-5'-diphosphate-induced platelet aggregation was also significantly enhanced in the cyclosporin group. The effect of cyclosporin on haemostasis may predispose to thromboembolic complications.

Azathioprine↗
PubMed1989

Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation. The Copenhagen AFASAK study.

From November, 1985, to June, 1988, 1007 outpatients with chronic non-rheumatic atrial fibrillation (AF) entered a randomised trial; 335 received anticoagulation with warfarin openly, and in a double-blind study 336 received aspirin 75 mg once daily and 336 placebo. Each patient was followed up for 2 years or until termination of the trial. The primary endpoint was a thromboembolic complication (stroke, transient cerebral ischaemic attack, or embolic complications to the viscera and extremities). The secondary endpoint was death. The incidence of thromboembolic complications and vascular mortality were significantly lower in the warfarin group than in the aspirin and placebo groups, which did not differ significantly. 5 patients on warfarin had thromboembolic complications compared with 20 patients on aspirin and 21 on placebo. 21 patients on warfarin were withdrawn because of non-fatal bleeding complications compared with 2 on aspirin and none on placebo. Thus, anticoagulation therapy with warfarin can be recommended to prevent thromboembolic complications in patients with chronic non-rheumatic AF.

Adult↗
PubMed2001

[Risk factors and incidence of venous thromboembolic disease in internal medicine: prospective descriptive study on 947 hospitalized patients].

PURPOSE: The thromboembolic risk is difficult to evaluate in medical inpatients because of the multiplicity of risk factors. The lack of scientific data leads to a certain empiricism in selection of patients who need a preventive treatment. METHODS: All patients hospitalised in an internal medicine department were included during 34 months. The pathogenic mechanism of risk factors (venous stasis or hypercoagulability) was analysed as well as their progress (transient or permanent risk factors) and their pathogenic weight (major risk factor or not). Three levels of embolic risk (high, intermediate, low) were identified. A preventive treatment was initiated only for patients at high or intermediate risk. A clinical screening for thromboembolic events was performed daily. Therefore, we have excluded patients who needed a hypocoagulant treatment. RESULTS: Nine hundred and forty-seven patients were included. Age (over 60) was the most frequent permanent risk factor (70%). Bed rest was the most frequent transient risk factor responsible for venous stasis. Fifty percent of patients had a transient and permanent risk factor and needed a preventive treatment according to our selection criteria. The incidence of thromboembolic events was 0.4% in the high-risk treated group and 0.2% in the low-risk non-treated group. CONCLUSIONS: Venous stasis factors are the more frequent risk factor in internal medicine, perhaps because of the increasing number of geriatric patients. The incidence of thromboembolic disease is low in high-risk inpatients when a preventive treatment is performed.

Aged↗
PubMed1999

Dalteparin in emergency patients to prevent admission prior to investigation for venous thromboembolism.

A 15-month prospective cohort study of emergency department (ED) patients with suspected venous thromboembolism was conducted to assess the role of low molecular weight heparin (dalteparin) in an emergency setting in suspected venous thromboembolism prior to diagnostic confirmation. Patients were given a therapeutic dose of dalteparin and were discharged home; they then returned the next day for diagnostic testing. All patients were followed for 3 months. Of 128 patients, 44 had positive test results and 84 had negative test results. Four patients required admission for other reasons. Seventeen had continuing symptoms after initial negative testing; 10 returned to the ED and 9 had repeat Doppler ultrasound, all of which remained negative. None of the 84 negative patients were diagnosed with venous thromboembolism subsequent to an initial negative test. There were no serious adverse effects. This study suggests that treatment with low molecular weight heparin pending outpatient investigation for suspected venous thromboembolism in emergency patients is safe and effective. This could lead to substantial cost savings in the management of this problem. Further study is warranted.

Adolescent↗
PubMed2004

Pancreatic cancer and thromboembolic disease.

Thromboembolic disease is a common complication of pancreatic cancer and is causally associated with the generation of an intrinsic hypercoagulable state. Pancreatic-cancer cells activate platelets and express several procoagulant factors, including tissue factor and thrombin. The activation of coagulation is not simply an epiphenomenon, but might also be related to enhanced tumour growth and angiogenesis. Clinical manifestations of thromboembolic disease in pancreatic cancer include deep venous thrombosis, pulmonary embolism, disseminated intravascular coagulation, portal vein thrombosis, and arterial thromboembolism. Reported incidences of disease range from 17% to 57%. Treatment options include warfarin and low-molecular-weight heparins. Studies over the past decade suggest that long-term use of these heparins in both primary and secondary prevention of venous thromboembolic disease improves outcomes in comparison with warfarin. Further research is needed to understand better the morbidity and mortality associated with this disease in pancreatic cancer and to optimise strategies of prevention and treatment.

Anticoagulants↗
PubMed1998

Tamoxifen and risk of idiopathic venous thromboembolism.

AIMS: To evaluate a possible positive association between tamoxifen treatment and the risk of developing idiopathic venous thromboembolism (VTE) in women with breast cancer in the absence of clinical risk factors for venous thromboembolism other than breast cancer itself. METHODS: Using information from the large UK-based General Practice Research Database, we identified, within a cohort of more than 10000 women with breast cancer, all women who developed a first-time diagnosis of deep vein thrombosis or pulmonary embolism of uncertain cause between January 1, 1991 and December 31, 1996. In a case-control analysis, we compared their tamoxifen exposure experience prior to the thromboembolic event with that of a randomly selected group of control women with breast cancer who were matched to cases on age, year of the breast cancer diagnosis and calendar time. RESULTS: We identified 25 cases of idiopathic VTE and 172 controls, all of whom had breast cancer, but were otherwise free from other risk factors for VTE. Past tamoxifen exposure was not materially associated with an elevated risk of developing VTE, and we therefore combined never and past users as reference group. The relative risk estimate of VTE for current tamoxifen exposure, as compared with never and past use combined, was 7.1 (95% CI 1.5-33), adjusted for body mass index, smoking status and hysterectomy status. High body mass index was an independent predictor of VTE itself. CONCLUSIONS: Our study provides evidence that current use of tamoxifen increases the risk of idiopathic venous thromboembolism.

Adolescent↗
PubMed1996

Resistance to activated protein C (APCR) in children with venous or arterial thromboembolism.

Resistance to activated protein C (APCR), in the majority of cases due to the point mutation Arg 506 Gln of the factor V gene, has emerged as the most important hereditary cause of venous thromboembolism. Using an activated thromboplastin time (aPTT) based method in the presence of APC together with a DNA technique based on the polymerase chain reaction, we investigated 37 children with venous (V: n=19) or arterial (A: n=18) thromboembolism and 196 age-matched healthy controls for the presence of this mutation. In the control group 10 children were detected to be heterozygous for the factor V Leiden mutation, indicating a prevalence of 5.1%. 10/19 children (52%) with venous thrombosis and 7/18 (38%) patients with arterial thromboembolism showed the common factor V gene mutation. Additional inherited coagulation disorders were found in 1/10 (V:10%) and 2/7 (A:28%) APC-resistant patients. Inherited coagulation disorders without APCR were diagnosed in 3/9 (V: 33%) and 2/11 (A:18%) children. Furthermore, we diagnosed exogenous risk factors in 6/10 (V: 60%) and 2/7 (A: 28%) children with thrombosis and APCR. These data are evidence that APCR combined with exogenous reasons may play an important role in the early manifestation of thromboembolism during infancy and childhood.

Adolescent↗
PubMed2000

Venous thromboembolism and hypercoagulability in splenectomized patients with thalassaemia intermedia.

Thromboembolic phenomena have been described in patients with thalassaemia intermedia and major, although there are relatively few epidemiological data on the overall frequency of these complications. To obtain more insight into the risk and mechanism of venous thromboembolism in thalassaemia, the aims of this study were: (i) to establish retrospectively the prevalence of thromboembolic events in a large group of adults with thalassaemia intermedia and major during a follow up period of 10 years; (ii) to measure in subgroups of these patients sensitive markers of activation of coagulation and fibrinolysis enzymes; and (iii) to look for possible procoagulant mechanisms. A high prevalence of thromboembolic events was found, particularly in splenectomized patients with thalassaemia intermedia (29%). These patients had high plasma levels of markers of coagulation and fibrinolysis activation. Furthermore, thalassaemic red cells and erythroid precursors from splenectomized patients with thalassaemia intermedia had an enhanced capacity to generate thrombin. To evaluate the role of splenectomy per se on procoagulant activity, we evaluated the capacity to form thrombin in healthy individuals who had been splenectomized for trauma. They produced the same amount of thrombin as non-splenectomized controls. In conclusion, the results of this study show the existence of a hypercoagulable state in splenectomized patients with thalassaemia intermedia and that their red and erythroid cells are capable of acting as activated platelets in thrombin generation.

Adult↗
PubMed1997

Prevalence of activated protein C resistance and analysis of clinical profile in thromboembolic patients. A Belgian prospective study.

OBJECTIVES: To assess the prevalence of activated protein C resistance (APC-R) among healthy subjects and thromboembolic patients and to determine the clinical characteristics associated with APC-R. DESIGN: A prospective study. SETTING: One academic medical centre. SUBJECTS: 91 health controls and 126 thromboembolic patients. MEASUREMENTS: Patients and control were genotyped for the factor V Leiden (VaQ506) mutation. The anticoagulant response of the patient's plasma to activated protein C was also determined. RESULTS: The frequency of APC-R was 3.3% among healthy control subjects and 22% among thrombotic patients of whom 18% were heterozygous and 4% were homozygous. The mean age at the first thrombotic event and the severity of thrombotic disease including the proportion of proximal deep vein thrombosis and the frequency of lung embolism were identical among APC-R positive and negative patients. A family history of thromboembolic disease was elicited more frequently in APC-R positive than in APC-R negative patients (57% vs. 22%, P < 0.001). The recurrence rate was higher for APCR-R positive patients (57% vs. 34%, P < 0.05). The percentage of cases with a factor predisposing to thrombosis was very similar in APC-R positive (57%) and negative (68%) patients. CONCLUSIONS: A familial history of thromboembolic disease and recurrences are significantly more frequent among APC-R positive than APC-R negative patients.

Adolescent↗
PubMed2002

Bleeding and thromboembolic risks of internal cardioversion for persistent atrial fibrillation.

Although internal cardioversion is an effective method for converting AF the thromboembolic risk and bleeding complication of this procedure remains unclear. Retrospective analysis of the thromboembolic events and bleeding complications was performed in 114 consecutive patients (mean age 63 +/- 10 years, 91 men) who underwent internal cardioversion for persistent AF (mean AF duration 31 +/- 42 months). All patients received therapeutic warfarin for 3 weeks prior to the procedure, which was then replaced by periprocedural heparin therapy during internal cardioversion. The mean INR value before the internal cardioversion was 1.3 +/- 0.2. A total of 992 R wave synchronized shocks were delivered (mean 8.7 shocks/patients) without ventricular proarrhythmia. Successful internal cardioversion of AF was achieved in 100 (88%) patients. Two (2%) patients developed major bleeding complications with pericardial effusion after the procedure. Both of them subsided with conservative treatment. Minor bleeding with wound hematoma occurred in 8 (7%) of 114 after the procedure. Overall, there was no significant difference in the risk of procedure related complication between the use of heparin infusion and subcutaneous LMWH injection (6/78 [13%] vs 3/36 [8%], P = 0.9). No thromboembolic event was observed after 4 weeks of follow-up. In conclusion, the risk of thromboembolism after discontinuation of anticoagulation before the procedure is low in patients with persistent AF underwent internal cardioversion. However, the use of periprocedural heparin therapy was associated with an increase risk of procedure related bleeding complications.

Anticoagulants↗
PubMed2003

Efficacy and safety of bemiparin compared with enoxaparin in the prevention of venous thromboembolism after total knee arthroplasty: a randomized, double-blind clinical trial.

In this randomized, multicenter, controlled, double-blind, sequential trial, 381 patients undergoing primary total knee replacement were randomly assigned to receive subcutaneous injections of either 3500 IU anti-factor Xa of bemiparin sodium, first dose 6 h after surgery, or 40 mg of enoxaparin, first dose 12 h before surgery, followed by daily doses for 10 +/- 2 days, for the prophylaxis of venous thromboembolism. The primary efficacy endpoint was venous thromboembolism up to postoperative day 10 +/- 2, defined as deep vein thrombosis detected by mandatory bilateral venography, documented symptomatic deep vein thrombosis and/or documented symptomatic pulmonary embolism. The primary safety endpoint was major bleeding. Eighty-seven percent of all randomized patients (333 of 381 patients) were evaluable for efficacy. The incidence of venous thromboembolism was 32.1% (53 of 165 patients) in the bemiparin group and 36.9% (62 of 168 patients) in the enoxaparin group. The absolute risk difference was 4.8% in favor of bemiparin [95% confidence interval (CI), -15.1% to 5.6%; non-inferiority P-value: 0.02; superiority P-value: 0.36]. The incidence of proximal deep vein thrombosis was 1.8% (three of 165 patients) in the bemiparin group and 4.2% (seven of 168 patients) in the enoxaparin group. Major bleeding occurred in six patients (three in each group). There were no deaths during the study. This trial shows that bemiparin started postoperatively is as effective and safe as enoxaparin started preoperatively in the prevention of venous thromboembolism in patients undergoing total knee replacement.

Aged↗
PubMedDate not supplied

[Thromboembolic complications related to the use of bone cement in hip arthroplasty--pathogenesis and prophylaxis].

INTRODUCTION: Cemented total hip arthroplasty (THA) has to be considered a high-risk procedure with respect to cardiovascular complications. The insertion of cement and prosthesis may lead to intravasation of fat and bone marrow into the circulation. METHODS: This article represents a review on the relevant literature about thromboembolic complications associated with the use of bone cement in THA. RESULTS/DISCUSSION: The method of canal preparation and lavage is of paramount importance to reduce the potential embolic load. Additionally, thorough cleaning of the intramedullary cavity (using jet lavage) improves the cement penetration into the bone and increases the shear strength of the bone-cement interface. Modern cementing techniques include the use of high pulsatile lavage, a cement restrictor and cement pressurization. With the application of these techniques a sufficient drainage of the medullary canal should be guaranteed to minimise the risk for thromboembolic complications. During the insertion of cementless implants the intravasation of embolic material seems to be less, but it is likewise possible to have a thromboembolic complication during cementless THA. However, it is not justified as a consequence to use the thromboembolic risk as the main indication for implant choice, in particular as the overall risk of a serious fatal complication is low.

Arthroplasty, Replacement, Hip↗
PubMed2003

Prediction, prevention, and treatment of venous thromboembolic disease in pregnancy.

Pregnancy is recognized as an independent risk factor for venous thromboembolism leading to thromboembolic events, particularly in women with prior venous thrombosis, family history of thrombosis, or additional thrombophilic risk factors. To reduce the incidence of venous thromboembolism in pregnancy and improve outcomes, an individual risk stratification on the basis of probability of thrombosis as a rationale for an individual risk-adapted prophylaxis is required. In women without prior thrombosis, the presence of a heterozygous factor V Leiden or heterozygous G20210A mutation in the prothrombin gene is associated with a pregnancy-associated thrombotic risk of approximately 1 in 400. Thus, in pregnant carriers of either one of these mutations the risk of venous thromboembolism is low. For this reason, routine thrombophilia screening of all pregnant women is not recommended. However, a combination of the two genetic risk factors can increase the risk to a modest level (risk 1 in 25). In women with a single episode of prior thrombosis associated with a transient risk factor (such as surgery or trauma) and no additional genetic risk factor, the probability of a pregnancy-associated thrombosis also appears to be low. In contrast, in women with a prior idiopathic venous thrombosis who carry an additional hereditary risk factor or who have a positive family history of thrombosis, a high risk (> 10%) can be expected, supporting the indication for active antepartum and postpartum heparin prophylaxis. In many cases, the absolute magnitude of risk is unknown or estimated, and recommendations are often empiric.

Female↗
PubMed1998

Enoxaparin plus compression stockings compared with compression stockings alone in the prevention of venous thromboembolism after elective neurosurgery.

BACKGROUND: Compression stockings are recommended for prophylaxis against venous thromboembolism in patients undergoing neurosurgery, but anticoagulant agents have not gained wide acceptance because of concern about intracranial bleeding. METHODS: In a multicenter, randomized, double-blind trial, we assessed the efficacy and safety of enoxaparin in conjunction with the use of compression stockings in the prevention of venous thromboembolism in patients undergoing elective neurosurgery. Enoxaparin (40 mg once daily) or placebo was given subcutaneously for not less than seven days beginning within 24 hours after the completion of surgery. The primary end point was symptomatic, objectively confirmed venous thromboembolism or deep-vein thrombosis assessed by bilateral venography, which was performed in all patients on day 8+/-1. Bleeding side effects were carefully assessed. RESULTS: Among the 307 patients assigned to treatment groups, 129 of the 154 patients receiving placebo (84 percent) and 130 of the 153 patients receiving enoxaparin (85 percent) had venographic studies adequate for analysis. An additional patient in the placebo group died before venography of autopsy-confirmed pulmonary embolism. In this analysis, 42 patients given placebo (32 percent) and 22 patients given enoxaparin (17 percent) had deep-vein thrombosis (relative risk in the enoxaparin group, 0.52; 95 percent confidence interval, 0.33 to 0.82; P=0.004). The rates of proximal deep-vein thrombosis were 13 percent in patients receiving placebo and 5 percent in patients receiving enoxaparin (relative risk in the enoxaparin group, 0.41; 95 percent confidence interval, 0.17 to 0.95; P=0.04). Two patients in the placebo group died of autopsy-confirmed pulmonary embolism on days 9 and 16. Major bleeding occurred in four patients receiving placebo (intracranial bleeding in all four) and four patients (intracranial bleeding in three) receiving enoxaparin (3 percent of each group). CONCLUSIONS: Enoxaparin combined with compression stockings is more effective than compression stockings alone for the prevention of venous thromboembolism after elective neurosurgery and does not cause excessive bleeding.

Adult↗
PubMed2002

Duration of prophylaxis against venous thromboembolism with enoxaparin after surgery for cancer.

BACKGROUND: Abdominal surgery for cancer carries a high risk of venous thromboembolism, but the optimal duration of postoperative thromboprophylaxis is unknown. METHODS: We conducted a double-blind, multicenter trial in which patients undergoing planned curative open surgery for abdominal or pelvic cancer received enoxaparin (40 mg subcutaneously) daily for 6 to 10 days and were then randomly assigned to receive either enoxaparin or placebo for another 21 days. Bilateral venography was performed between days 25 and 31, or sooner if symptoms of venous thromboembolism occurred. The primary end point with respect to efficacy was the incidence of venous thromboembolism between days 25 and 31. The primary safety end point was bleeding during the three-week period after randomization. The patients were followed for three months. RESULTS: The intention-to-treat analysis of efficacy included 332 patients. The rates of venous thromboembolism at the end of the double-blind phase were 12.0 percent in the placebo group and 4.8 percent in the enoxaparin group (P=0.02). This difference persisted at three months (13.8 percent vs. 5.5 percent, P=0.01). Three patients in the enoxaparin group and six in the placebo group died within three months after surgery. There were no significant differences in the rates of bleeding or other complications during the double-blind or follow-up periods. CONCLUSIONS: Enoxaparin prophylaxis for four weeks after surgery for abdominal or pelvic cancer is safe and significantly reduces the incidence of venographically demonstrated thrombosis, as compared with enoxaparin prophylaxis for one week.

Abdominal Neoplasms↗
PubMed2003

Secondary prevention of venous thromboembolism with the oral direct thrombin inhibitor ximelagatran.

BACKGROUND: For many patients with venous thromboembolism, secondary prevention with vitamin K antagonists is not extended beyond six months, since the risk of recurrence may be outweighed by the risk of major bleeding. METHODS: In a double-blind, multicenter trial, we randomly assigned 1233 patients with venous thromboembolism who had undergone six months of anticoagulant therapy to extended secondary prevention with the oral direct thrombin inhibitor ximelagatran (24 mg) or placebo, taken twice daily, for 18 months without monitoring of coagulation. At base line, bilateral ultrasonography of the legs and perfusion lung scanning were performed. RESULTS: Data from 612 patients in the ximelagatran group and 611 in the placebo group were analyzed. The occurrence of the primary end point, symptomatic recurrent venous thromboembolism, was confirmed in 12 patients assigned to ximelagatran and 71 patients assigned to placebo (hazard ratio, 0.16; 95 percent confidence interval, 0.09 to 0.30; P<0.001). Death from any cause occurred in 6 patients in the ximelagatran group and 7 patients in the placebo group, and bleeding occurred in 134 patients and 111 patients, respectively (hazard ratio, 1.19; 95 percent confidence interval, 0.93 to 1.53; P=0.17). The incidence of major hemorrhage was low (six events in the ximelagatran group and five in the placebo group), and none of these hemorrhages were fatal. The cumulative risk of a transient elevation of the alanine aminotransferase level to more than three times the upper limit of normal was 6.4 percent in the ximelagatran group, as compared with 1.2 percent in the placebo group (P<0.001). CONCLUSIONS: Oral ximelagatran was superior to placebo for the extended prevention of venous thromboembolism. There was no significant increase in the frequency of bleeding complications, but there was an increase in the number of patients with a transient elevation in the alanine aminotransferase level.

Administration, Oral↗