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PubMed2003

Comparison of ximelagatran with warfarin for the prevention of venous thromboembolism after total knee replacement.

BACKGROUND: In a previous study of the prevention of venous thromboembolism after total knee replacement, the efficacy of ximelagatran, an oral direct thrombin inhibitor that does not require monitoring of coagulation or dose adjustment, was found to be similar to that of warfarin at a dose of 24 mg of ximelagatran twice daily. The purpose of the present study was to determine whether a higher dose of ximelagatran is superior to warfarin. METHODS: This randomized, double-blind trial compared a regimen of 7 to 12 days of oral ximelagatran, at a dose of 24 or 36 mg twice daily, starting the morning after surgery, with warfarin therapy started the evening of the day of surgery. The composite end point of venous thromboembolism and death from all causes and the incidence of bleeding were the primary outcome measures. RESULTS: Among the 1851 patients in the efficacy analysis, oral ximelagatran at a dose of 36 mg twice daily was superior to warfarin with respect to the primary composite end point of venous thromboembolism and death from all causes (20.3 percent vs. 27.6 percent; P=0.003). There were no significant differences between these two groups with respect to major bleeding (incidence, 0.8 percent and 0.7 percent, respectively), perioperative indicators of bleeding, wound characteristics, or the composite secondary end point of proximal deep-vein thrombosis, pulmonary embolism, and death (2.7 percent vs. 4.1 percent; P=0.17). CONCLUSIONS: The efficacy of oral ximelagatran, administered starting the morning after total knee replacement, was superior to that of warfarin for prevention of venous thromboembolism. Rates of hemorrhagic complications with the two drugs were similar.

Administration, Oral↗
PubMed2003

Randomized comparison of enoxaparin with unfractionated heparin for the prevention of venous thromboembolism in medical patients with heart failure or severe respiratory disease.

BACKGROUND: We compared the efficacy and safety of the low-molecular weight heparin enoxaparin with unfractionated heparin (UFH) for the prevention of venous thromboembolic disease in patients with heart failure or severe respiratory disease. METHODS: This was a multicenter, controlled, randomized, open study in which patients received either enoxaparin (40 mg once daily) or UFH (5000 IU 3 times daily) for 10 +/- 2 days in 64 medical departments in Germany. Patients were stratified and enrolled according to their underlying disease: severe respiratory disease or heart failure. The primary efficacy parameter was a thromboembolic event up to 1 day after the treatment period. RESULTS: Of the 665 patients enrolled, 451 patients were able to be evaluated in the primary efficacy analysis. The incidence of thromboembolic events was 8.4% with enoxaparin and 10.4% with UFH. Enoxaparin was at least as effective as UFH, with a 1-sided equivalence region of -4% (90% CI -2.5-6.5, P =.015). Enoxaparin was associated with fewer deaths, less bleeding, and significantly fewer adverse events (45.8% vs 53.8%, P =.044). CONCLUSIONS: Enoxaparin is at least as effective as UFH in the prevention of thromboembolic events in patients with heart failure or severe respiratory disease. Its beneficial safety profile and once-daily administration is advantageous for inpatient and outpatient use.

Aged↗
PubMed2001

Heparin antibodies and thromboembolism in heparin-coated and noncoated ventricular assist devices.

OBJECTIVE: Coating of ventricular assist devices (VADs) with heparin improves the biocompatibility and may reduce the need for systemic anticoagulation. However, heparins are associated with the risk of formation of heparin/platelet factor 4 antibodies (HPF4/A) and the development of heparin-associated thromboemboli. We analyzed the occurrence of HPF4/A and thromboembolism in patients with heparin-coated and noncoated VADs. METHODS: One hundred patients were enrolled in the investigation. Fifty-seven received a heparin-coated (group 1) and 43 a noncoated (group 2) VAD. HPF4/A testing was performed before and 2 and 12 weeks after implantation by the heparin platelet factor 4 enzyme-linked immunosorbent assay. RESULTS: There was no significant difference in the occurrence of HPF4/A in the 2 groups (P =.102). Before the operation, 21 of the patients in group 1 had positive test responses and 25 in group 2. No patient had HPF4/A after termination of systemic heparinization. In group 1 there was no significant difference in the incidence of recurrent pump thromboses in patients who had positive test responses for HPF4/A (n = 11) when compared with those who had negative test responses (n = 9, P =.89). Twenty-one patients had HPF/A but no thromboembolism. However, all 22 patients who had thromboembolism had HPF4/A. CONCLUSIONS: Heparin coating of the VAD surface does not enhance the occurrence of HPF4/A-associated immunologic or thrombogenic reactions. However, the presence of these antibodies is strongly associated with an increased risk of thromboembolism in patients with a VAD.

Adolescent↗
PubMed2006

Natural history of thromboembolism in AL amyloidosis.

To determine the natural history of thromboembolism in patients with biopsy-proven AL amyloidosis, medical records of 2,132 patients evaluated at Mayo Clinic between 1975 and 2000 were reviewed. Forty patients (21 male) were found to have objectively documented thromboembolism. The median age was 65 years. Four patients had a monoclonal gammopathy of undetermined significance, 20 had an unspecified plasma cell proliferative disorder, 11 had multiple myeloma, and 1 had Waldenström macroglobulinemia. Twelve patients had cardiac amyloid, and 20 had renal amyloid. Neither the extent of the amyloid nor the type of monoclonal protein was predictive of the development of thromboembolic events. Thromboembolism preceded the diagnosis of AL amyloidosis in 11 patients, occurred at the time of diagnosis or within 1 month after diagnosis in 11 patients, and occurred 1 month or more after diagnosis in 18 patients. Twenty-nine patients (73%) had venous thrombosis and 11 (28%) had arterial thrombosis. Eight patients (20%) died within 1 month after the thrombotic event, and 18 (45%) died within 1 year. The development of thrombosis in patients with AL amyloidosis appears to predict significant mortality within the first month and year after the event.

Aged↗
PubMed2000

Are factor V Leiden carriers who use oral contraceptives at extreme risk for venous thromboembolism?

BACKGROUND: Major concern was raised by an earlier study regarding oral contraceptive use in women with the factor V Leiden mutation. A more than 30-fold increase in relative risk for venous thromboembolism was reported; for homozygotes, the relative risk was as much as 100-fold or more. OBJECTIVE: To replicate the reported risk estimates with a new population-based case-control study. METHODS: Eighty women with a diagnosis of venous thromboembolism were consecutively identified and compared with population-based controls (n = 406). Factor V Leiden mutation was identified by genotype analysis. The evaluation was performed with conditional logistic regression (matched for 5-year age group). RESULTS: Matched, adjusted odds ratios (OR) for idiopathic venous thromboembolism in women without and with the factor V Leiden mutation who used oral contraceptives were 4.1 (95% confidence interval (CI) 2.1-7.8) and 10.2 (95% CI 1.2-88.4), respectively. The adjusted OR for factor V Leiden carriers was 2.0 (95% CI 1.0-4.4). The OR for women with the factor V Leiden mutation and oral contraceptive use versus no factor V Leiden mutation and no oral contraceptive use was 10.2 (95% CI 3.8-27.6). CONCLUSION: The results confirm the increased relative risk of idiopathic venous thromboembolism for users of oral contraceptives and factor V Leiden carriers. However, we suspect that the true risk for women who are factor V Leiden carriers may be increased two- to four-fold rather than seven-fold or more, and that the risk for the combination of factor V Leiden and oral contraceptive use may be increased in the order often- to 15-fold rather than over 30-fold.

Adolescent↗
PubMed1984

Mitral valve replacement with St Jude Medical prosthesis. Incidence of thromboembolic events in 349 patients.

This study reports incidence of thromboembolic episodes in a series of 349 patients where the St. Jude Medical (SJM) valve was implanted in the mitral position (252 isolated mitral, 91 mitral and aortic, 4 triple valve and 2 mitral and tricuspid valve replacements). The mean follow up was 28 months (range 6 to 57 months) which represents 784 patient-years. Overall operative mortality was 15 patients (4.3%). There were no valve-related deaths. Late post-operative prosthetic thrombosis occurred in 3 poorly anticoagulated patients (0.4% patient-years). A further 4 patients had a thromboembolic episode (0.5% patient-years). The overall frequency of thromboembolic episodes was 0.9 events per 100 patient-years. Per- and post-operative anticoagulation methods are described. The frequency of thromboembolism was studied with respect to the performance of SJM valve analyzed by echocardiography regardless the positioning of the prosthesis in the mitral ring. Our experience indicates that the SJM valve offers an excellent alternative in the choice of mechanical valve.

Anticoagulants↗
PubMed2003

Thromboembolism after ovarian stimulation: successful management of a woman with superior sagittal sinus thrombosis after IVF and embryo transfer: case report.

The current literature was reviewed in order to analyse the clinical manifestations, progression and management, and pregnancy outcome of thromboembolism in infertile patients undergoing ovarian stimulation. The first case of superior sagittal sinus thrombosis following IVF that was successfully managed with intracranial thrombectomy is also reported. This retrospective cohort study comprised 65 women who experienced thromboembolism after ovarian stimulation (64 from other published studies and the present case report). Thrombosis attack occurred at a mean (+/-SD) of 25.5 +/- 20.1 days after oocyte retrieval. The onset timing in the intracranial thrombosis group (10.2 +/- 4.6 days) was less (P < 0.05) than in those experiencing thromboembolism at other sites. Ovarian hyperstimulation syndrome (OHSS), haemoconcentration and high serum estradiol level were noted in 79, 62 and 54% of women respectively. Forty-eight of 55 patients (87%) who received anticoagulation recovered without sequelae. Among patients willing to continue pregnancy, 32% succeeded in term delivery with all healthy babies, and 23% were ongoing pregnancies. In conclusion, ovarian stimulation cycles accompanying high serum estradiol levels, haemoconcentration or OHSS are at potential risk of thromboembolism. Dose-adjusted heparinization is recommended as the first-line treatment of choice, while intravascular thrombolysis or operative thrombectomy is an aggressive but effective treatment. Continuation of pregnancy is considered safe, without any increased risk of fetal congenital anomalies.

Adult↗
PubMed1998

Hormone replacement therapy and the risk of hospitalization for venous thromboembolism: a population-based study in southern Europe.

The authors evaluated the risk of venous thromboembolism associated with hormone replacement therapy in a cohort of 265,431 women aged 45-79 years who did not have major risk factors for venous thromboembolism. Through review of hospital charts, 171 cases were confirmed (pulmonary embolism = 77; deep venous thrombosis = 94). Ten thousand controls were randomly sampled. The risk of venous thromboembolism among nonusers of hormone replacement therapy was 1.3 per 10,000 women per year. Current users of hormone replacement therapy had 2.3 times higher risk of venous thromboembolism (95 percent confidence interval 1.0-5.3) compared with nonusers. The increased risk was restricted to the first year of treatment.

Administration, Cutaneous↗
PubMed2003

Severe venous thromboembolism in a young man with Klinefelter's syndrome and heterozygosis for both G20210A prothrombin and factor V Leiden mutations.

Klinefelter's syndrome is the most common cause of primary testicular failure, resulting in impairment of both spermatogenesis and testosterone production. It is a chromosomal disorder characterized by small, firm testes, azoospermia, gynecomastia, varying degrees of eunuchoidism and testosterone deficiency with elevated gonadotropin plasma levels. In Klinefelter's syndrome there is an increase of certain systemic diseases including venous thromboembolism. An increased thromboembolic risk in hypogonadic men has been explained with hypofibrinolysis due to androgen deficiency. Only two cases have been reported about the association between Klinefelter's syndrome and well-known congenital or acquired thrombophilias. We report the case of a 39-year-old patient with Klinefelter's syndrome who underwent severe deep venous thrombosis with pulmonary embolism, in the absence of any circumstantial triggering event. Further examinations also showed a double heterozygosis for G20210A prothrombin and factor V Leiden mutations. This case suggests that the increased thromboembolic risk, reported in Klinefelter's syndrome, can be worsened by the co-existence of one or more well-known thrombophilic conditions, as shown by the relatively young age of the patient. More studies are needed to clearly understand the pathogenesis of venous thromboembolism in males affected by Klinefelter's syndrome.

Adult↗
PubMed1995

Use of thrombolytics for the treatment of thromboembolic disease during pregnancy.

The incidence of thromboembolic disease is increased during pregnancy. Prevention and treatment of thromboembolic disease can have a significant impact on the morbidity and mortality of pregnant women. Anticoagulation with heparin is the treatment of choice; however, in some instances this is inadequate or contraindicated. In the nonpregnant patient, alternative therapies have included surgical intervention or fibrinolytic agents. Traditionally, thrombolytic therapy has been considered a relative contraindication during pregnancy due to the maternal and fetal risk of hemorrhagic complications. Hence, no controlled trials of agents such as streptokinase, urokinase, or tissue plasminogen activator for the treatment of thromboembolic events during pregnancy, have been performed, or are currently feasible. Since 1961, 36 reports have been published describing the use of thrombolytic agents during pregnancy. In a review of the world's literature, 172 pregnant women affected with thromboembolic conditions were treated with thrombolytic medications. A maternal mortality rate of 1.2 percent was observed. Approximately 10 pregnancy losses were noted (5.8 percent). Hemorrhagic complications were reported in 8.1 percent of patients. We summarize the published literature on the use of thrombolytic agents during pregnancy and discuss the treatment success and reported complications.

Adult↗
PubMed2003

The role of low-molecular-weight heparins in the prevention and treatment of venous thromboembolism in cancer patients.

Accumulating evidence suggests that low-molecular-weight heparins are the drug of choice for the prevention and treatment of venous thromboembolism in patients with cancer. For prophylaxis in the surgical setting, once-daily subcutaneous injections of low-molecular-weight heparin are as effective and safe as multiple doses of unfractionated heparin. Extending prophylaxis with low-molecular-weight heparins beyond hospitalization was recently found to reduce safely the risk of postoperative thrombosis after abdominal surgery for cancer. For the long-term treatment of deep vein thrombosis and in select patients with pulmonary embolism, recently completed clinical trials have shown that secondary prophylaxis with low-molecular-weight heparin is feasible and more effective than oral anticoagulant therapy in preventing recurrent venous thromboembolism in cancer patients. There is also evidence that low-molecular-weight heparins are effective in cancer patients who develop recurrent thrombosis while on warfarin therapy. Lastly, the potential antineoplastic effects of low-molecular-weight heparins make these agents an attractive option in patients with cancer. Although the management of cancer patients with venous thromboembolism remains challenging, low-molecular-weight heparins have simplified and improved the prevention and treatment of venous thromboembolism in these high-risk patients.

Anticoagulants↗
PubMed2004

Interleukin-6 and antiphospholipid antibodies in women with contraceptive-related thromboembolic disease.

OBJECTIVE: The aim of this study was to explore the possible (joint) contributing role of interleukin-6 (IL-6) and antiphospholipid antibodies to the occurrence of the venous thromboembolism in women using oral contraceptives. METHODS: Interleukin-6 and antiphospholipid antibodies (anti-beta2-glycoprotein I antibody-immunoglobulin M [IgM], G [IgG], and A [IgA]; anticardiolipin-IgM and IgG; antiphosphatidylserine-IgM and IgG) were measured in 30 women (median age 41, range 28-49 years) in the stable period (on average 3.5 years) after first venous thromboembolism. Sixteen patients used oral contraceptives during the episode of venous thromboembolism (oral contraceptives group), whereas 14 patients did not (non-oral contraceptives group). Thirty-seven age-matched, healthy women served as controls RESULTS: Compared with controls, the oral contraceptives group had elevated IL-6 (median interquartile range 2.3 [1.1-4.3] versus 1.4 [0-2.0] pg/mL, P <.05). The oral contraceptives group had elevated anti-beta2-glycoprotein I antibody-IgM in comparison with both the non-oral contraceptives group (median interquartile range 47.5 [2.0-77.0] versus 29.50 [11.00-45.50] OD(450), P <.06) and controls (47.5 [2.0-77.0] versus 17.5 [3.5-30.0] OD(450), P <.001). Interleukin-6 level in the non-oral contraceptives group was related to obesity, whereas such a relation was not found in the oral contraceptives group, suggesting the presence of another factor (oral contraceptive use), which stimulates IL-6 production. Of particular interest is our finding that elevated IL-6 levels correlated significantly positively with elevated anti-beta2-glycoprotein I antibody-IgG in patients who were users of oral contraceptives (but not overweight, n = 10) (r = 0.56, P <.05) CONCLUSION: The results suggest a new hypothesis that, in susceptible women, use of oral contraceptives induces production of IL-6, which stimulates production of anti-beta2-glycoprotein I. Thus, the prothrombotic profile is aggravated and could facilitate occurrence of venous thromboembolism. This remains to be elucidated in further studies.

Adult↗
PubMed2006

The Mark Coventry Award: Prevention of readmission for venous thromboembolism after total knee arthroplasty.

Venous thromboembolism is the most common reason for readmission after total knee arthroplasty. Prospective contrast venography was conducted from 1984 to 2003 in 1321 patients undergoing total knee arthroplasty. Patients with deep venous thrombosis or pulmonary embolism were treated with warfarin; those with negative venograms received no further anticoagulation. From 1984 to 1992, patients not completing venography were discharged without warfarin; since 1993 patients without venography received warfarin for 6 weeks. Readmission for deep venous thrombosis, pulmonary embolism, or bleeding was tracked for 6 months. Venography was completed in 810 patients; 343 (42.3%) had deep venous thrombosis. Readmission for venous thromboembolism occurred in 0.6% of patients after total knee compared with 1.62% after total hip arthroplasty. Following total knee arthroplasty, patients discharged on warfarin (target INR 2.0) had a 0.21% readmission rate compared with 1.05% for patients with negative venograms discharged without further anticoagulation. One patient suffered a fatal pulmonary embolism after negative venography and no outpatient prophylaxis. Secondary prophylaxis with extended warfarin therapy reduced venous thromboembolism-related readmission. Surveillance venograms were a poor predictor of ultimate thromboembolism risk and need for extended anticoagulation therapy. We therefore recommend extended warfarin prophylaxis for all patients after hospital discharge following total knee arthroplasty.

Arthroplasty, Replacement, Knee↗
PubMed2006

Thromboembolic disease after total hip arthroplasty: who is at risk?

The strong activation of the clotting cascade that occurs during total hip arthroplasty places patients at increased risk for venous thromboembolism. The risk is higher in those patients with the following predisposing factors, listed in approximate order of importance: hip fracture; malignancy, particularly if associated with chemotherapy; antiphospholipid syndrome; immobility; history of venous thromboemholism; administration of tamoxifen; raloxifene; oral contraceptives or estrogen; morbid obesity; stroke; atherosclerosis; and an American Society of Anesthesiologists physical status classification of 3 or greater. The following risk factors are weak or controversial: advanced age; diabetes mellitus; congestive heart disease; atrial fibrillation; varicose veins; and smoking. However, 50% of patients who develop thromboembolism after total hip arthroplasty have no clinical predisposing factors. In a matched, controlled study, we defined the major genetic predispositions that increase the risk of venous thromboembolism after total hip arthroplasty: deficiency of antithrombin III (< 75%) and protein C (< 70%), and prothrombin gene mutation. Preoperative genetic screening in conjunction with the recognized clinical risk factors can help categorize postoperative venous thromboembolism risk and differentiate patients who can be protected with milder and safer prophylaxis (eg, aspirin, intermittent pneumatic compression) compared with those at higher risk who need to be anticoagulated.

Arthroplasty, Replacement, Hip↗
PubMed2005

Protein S type III deficiency is no risk factor for venous and arterial thromboembolism in 168 thrombophilic families: a retrospective study.

Free protein S rather than total protein S levels are currently measured to detect inherited protein S deficiency. Because type III (free protein S) deficiency is still not established as risk factor for thrombosis, we assessed the absolute risk of venous and arterial thromboembolism in a family cohort study. Annual incidences in first-degree relatives with and without protein S deficiency type III were compared. Probands had experienced thrombosis and had either the prothrombin G20210A mutation, increased factor VIII:C levels or hyperhomocysteinemia. Relatives were tested for these thrombophilic disorders and factor V Leiden. Levels of antithrombin, protein C, total and free protein S, and factor XI:C were additionally measured. Of 500 relatives enrolled, 105 were excluded from analysis because they could not be classified, due to acquired conditions. Protein S deficiency type III was demonstrated in 60/395 remaining relatives (15%). Other thrombophilic defects were equally distributed among deficient and non-deficient relatives. Annual incidences of venous thromboembolism were 0.28 per 100 person-years [95% confidence interval (CI), 0.09-0.66] in deficient relatives versus 0.20 per 100 person-years (95% CI, 0.12-0.30) in non-deficient relatives [hazard ratio, 1.4 (95% CI, 0.4-4.0)]. For arterial thromboembolism these values were 0.16 per 100 person-years (95% CI, 0.03-0.46) versus 0.10 per 100 person-years (95% CI, 0.05-0.19) [hazard ratio, 1.5 (95% CI, 0.3-6.0)]. These results suggest that protein S deficiency type III is not associated with an increased risk of either venous or arterial thromboembolism.

Adolescent↗
PubMed2004

Low-molecular-weight heparin for the prevention and treatment of venous thromboembolism in pregnancy.

PURPOSE OF REVIEW: Low-molecular-weight heparins (LMWHs) have largely replaced unfractionated heparins for both prophylaxis and treatment of venous thromboembolism in nonpregnant patients. However, until recently, evidence in pregnant women was lacking, despite the increasing use of LMWHs during pregnancy in clinical practice. This review covers recent literature on the use of LMWHs in relation to pregnancy. RECENT FINDINGS: The main areas covered in this review are the use of LMWHs in both prophylaxis and treatment of venous thromboembolism in pregnancy. The review also considers issues relating to monitoring of LMWHs in pregnancy, and safety from both a maternal and a fetal perspective. SUMMARY: The available evidence demonstrates that LMWHs are of at least equivalent efficacy but have a better safety profile compared with unfractionated heparins in both prophylaxis and treatment of maternal venous thromboembolism, and are more convenient to administer. There is no consensus with respect to whether these agents require monitoring during pregnancy other than periodic checking of the platelet count. The clinical implication from the available evidence is that LMWHs should now be regarded as the anticoagulant agents of choice for both prophylaxis and treatment of maternal venous thromboembolism.

Factor Xa↗
PubMed2004

Cytomegalovirus-associated venous thromboembolism in renal transplant recipients: a report of 7 cases.

Renal-transplant recipients have a higher prevalence of thromboembolic events compared with the general population. This elevated risk has been attributed to immunosuppressive drugs as well as metabolic and immunologic factors. Cytomegalovirus (CMV) infection, a frequent complication of transplantation, is known to modify endothelial phenotype from anticoagulant into procoagulant. There are few reports addressing the association of venous thromboembolism with CMV infection in immunocompetent patients. Some authors have also reported cases of arterial thrombosis in transplant recipients presenting CMV infection. However, the association of venous thromboembolic events with CMV infection has not yet been discussed in these patients. We present seven cases of simultaneous acute CMV infection and venous thromboembolism in renal-transplant recipients and suggest a potential causative effect.

Adult↗
PubMed2004

Low intensity warfarin: is it clinically useful in venous thromboembolism management?

Therapy for a first episode of venous thromboembolism (VTE) typically includes a vitamin K antagonist, such as warfarin, for 3-6 months at an international normalized ratio (INR) of 2-3. After the cessation of warfarin therapy, unprovoked VTE is associated with a recurrence rate of 5-15% per year. Prolonging initial therapy does not reduce the recurrence risk once warfarin is discontinued and is not routinely recommended for such patients. The Prevention of Recurrent Venous Thromboembolism (PREVENT) and Extended Low-Intensity Anticoagulation for Thromboembolism (ELATE) trials were undertaken to evaluate the efficacy and safety of low-intensity warfarin (INR 5-2) in this population. While both trials demonstrated that low-intensity warfarin offers substantial protection against recurrent VTE, only the ELATE trial included a standard intensity arm; this arm showed a significantly lower recurrence rate and a major bleed rate that, surprisingly, was similar to the low-intensity arm. There still remains no consensus that long-term warfarin at an INR of 2-3 should be recommended for all patients who sustain a first unprovoked venous thromboembolic event, which largely stems from our current inability to reliably identify those patients most likely to develop recurrences. Given that an individualized approach is required in deciding the duration of anticoagulation, it is the author's belief that low-intensity warfarin, which the PREVENT trial demonstrated could be monitored every other month, is a useful option for some patients with a first episode of VTE.

Anticoagulants↗