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PubMed2001

Low-molecular-weight heparin versus warfarin for secondary prophylaxis of venous thromboembolism: a cost-effectiveness analysis.

PURPOSE: To compare the cost effectiveness of low-molecular-weight heparin with that of oral anticoagulants in preventing recurrences after an episode of venous thromboembolism. METHODS: A decision tree was used to assess the cost and the expected quality-adjusted years of life (QALY) after treatment with either low-molecular-weight heparin or warfarin, based on pooled data from six published trials. Preferences were elicited with a modified time trade-off method in a sample of patients attending an anticoagulation clinic. RESULTS: Compared with warfarin, low-molecular-weight heparin significantly decreased the rate of minor bleeding (odds ratio [OR] = 0.24; 95% confidence interval [CI]: 0.14 to 0.43) but not recurrent deep vein thromboses (OR = 0.77; 95% CI: 0.43 to 1.35). Patients' preference for warfarin (0.988, on a 0 to 1 scale) was lower than that for low-molecular-weight heparin (0.992), but the difference was not statistically significant. A Monte Carlo analysis estimated that low-molecular-weight heparin saved an average of 13 quality-adjusted days compared with warfarin, at a cost of $6,583 per QALY (95% CI: $5,525 to $7,625) based on costs in Italy and $28,231 per QALY (95% CI: $20,872 to $36,773) based on costs in the United States. When we included rebound recurrences after interruption of therapy, which were more common with low-molecular-weight heparin, treatment with low-molecular-weight heparin cost $53,166 per QALY in Italy and $177,166 per QALY in the United States. CONCLUSIONS: Low-molecular-weight heparin might be a cost-effective drug for secondary prophylaxis of venous thromboembolism, especially in patients at high risk of recurrence and where the drug's cost is lower. The apparent increase in recurrence after interruption of therapy needs to be investigated more thoroughly before low-molecular-weight heparin can be recommended routinely.

Administration, Oral↗
PubMed2001

Thromboembolic complications after electrical cardioversion in patients with atrial flutter.

PURPOSE: To determine the incidence of thromboembolic complications after cardioversion in patients with atrial flutter. SUBJECTS AND METHODS: We reviewed 615 electrical cardioversions performed electively in 493 patients with atrial flutter. Embolic complications were evaluated during the 30 days after cardioversion. Follow-up data were obtained by follow-up visits and by contacting the treating physician. RESULTS: Anticoagulants had been administered in 415 cardioversions (67%). Cardioversion was successful in 570 procedures (93%). Three embolic events (in 3 patients) occurred in the 30 days after 550 successful cardioversions with completed follow-up (0.6% of successful procedures; 95% confidence interval, 0.1% to 1.6%). Two of the 3 patients had not been anticoagulated, whereas the third patient had subtherapeutic oral anticoagulation. No embolic event occurred in procedures performed with adequate anticoagulation. The incidence of embolism in patients regardless of subtherapeutic anticoagulation was 1% (3 of 303 successful cardioversions). CONCLUSIONS: We observed a low (0.6%) incidence of postcardioversion thromboembolic complications in patients with atrial flutter. Embolic events did not occur in patients with adequate anticoagulation.

Administration, Oral↗
PubMed1986

Use of the Greenfield filter for thromboembolic disease in pregnancy.

Recent technical advances in surgical intervention for thromboembolic disease have made the Greenfield filter a safe and effective treatment when heparin is contraindicated or recurrent emboli develop. One successful use of Greenfield filter placement in pregnancy has been reported. We report six additional cases. Maternal morbidity was negligible, and fetal outcomes were good. The use of the Greenfield filter as an adjunctive therapy for treatment of severe thromboembolic disease in pregnancy appears to be safe and should be considered in appropriate candidates.

Adult↗
PubMed1999

Risk of venous thromboembolism with third-generation oral contraceptives: A review.

Recent data indicate that users of third-generation oral contraceptives, those containing the new progestins desogestrel, gestodene, and norgestimate, have 2 to 3 times the risk of venous thromboembolism faced by users of second-generation oral contraceptives. The risk of development of deep vein thrombosis was also found to be 2 to 5 times greater with a low-estrogen, desogestrel-containing oral contraceptive than with second-generation monophasic and triphasic preparations. Investigators point to an acquired resistance to the anticoagulation effects of activated protein C, the most common cause of hereditary thrombophilia, as a possible mechanism. The American College of Obstetrics and Gynecology's Committee on Gynecologic Practice reconfirms the increased risk of venous thromboembolism associated with third-generation progestins versus other progestins. Because the third-generation oral contraceptives may have benefit for some patients, however, it defers to the individual clinician's and patient's judgment regarding the use of a desogestrel-containing formulation (the only third-generation progestin available in the United States).

Clinical Trials as Topic↗
PubMed1998

Arterial thromboembolic events in patients with the factor V Leiden mutation.

BACKGROUND: The factor V Leiden mutation affects 6% of the United States population and is known to be associated with venous thrombosis. We identify, herein, 30 individuals with the Leiden mutation and known arterial thromboembolic events. METHODS: The factor V mutation was assessed using polymerase chain reaction. RESULTS: In the 16 patients sustaining a cerebrovascular accident, the mean age was 44.1 and 11 (69%) were younger than 50. Similarly, the 13 patients presenting with an acute myocardial infarction were relatively young with a mean age of 45.5, and 9 (65%) patients presented at less than 50 years of age. Radiographic information was available for 19 patients in this study. No significant arterial atherosclerotic disease was demonstrated in 18 (95%) of these patients. CONCLUSIONS: This study demonstrates an association between the factor V Leiden mutation and the development of unexplained arterial thromboembolic events, especially in younger patients without existing atherosclerotic disease.

Adolescent↗
PubMed1997

Contraceptive knowledge and attitudes of Austrian adolescents after mass media reports linking third-generation oral contraceptives with an increased risk of venous thromboembolism.

We performed a representative survey to determine the level of knowledge of 1,010 Austrian adolescents aged 14 to 24 years about selected facts relating to the recent massive news coverage of the increase in the risk of venous thromboembolism in users of third-generation oral contraceptives and to assess the contraceptive behavior of this population. The overall use rate of oral contraceptives and condoms had increased significantly between 1991 and 1996. Sixty-six percent of the adolescents surveyed stated not having heard or read any media reports on oral contraceptives. Only 8% of those who had knew that most reports focused on the pill as a possible cause of venous thromboembolism, whereas the majority of respondents indicated that the media conveyed doubts regarding the health safety of oral contraceptives in general. Nearly half of adolescents were unable to define what a thrombosis was. Thus, although the mass media play an important role in transmitting medical information, the dissemination of practical, accurate advice on the risks of a drug and competent patient counseling is reserved for the health care professionals.

Adolescent↗
PubMed1998

Newer oral contraceptives and the risk of venous thromboembolism.

Research on the relationship between venous thromboembolism and the progestagen content of combined oral contraceptives has pointed to an increase in risk associated with products containing desogestrel and gestodene. Although many biases must have been at play in these nonexperimental studies, the errors that have been suggested and examined are not of a sufficient magnitude to account for the observed results. The most plausible explanation of the available data is that combined oral contraceptives containing desogestrel and gestodene carry a very small risk of venous thromboembolism, which exceeds the even smaller risk carried by products containing levonorgestrel. The position of norgestimate is uncertain.

Contraceptives, Oral, Combined↗
PubMed1998

Normalized activated protein C ratio itself not associated with increased risk of venous thromboembolism.

Recently, discussions focused on the question whether acquired activated (APC) resistance is a clue to the observed association between venous thromboembolism (VTE) risk and oral contraceptive (OC) use, especially with the so-called third-generation OC. The objective of our study was to check the validity of acquired APC resistance regarding VTE risk in a case-control study. Sixty-seven women with confirmed VTE diagnosis (n = 67) were consecutively ascertained in primary health care settings, interviewed and blood samples taken (at the earliest 6 months after VTE). Cases were age-matched to 290 population controls. Acquired APC resistance was measured as normalized APC ratio (APCRN). The effect of APC on tissue factor initiated thrombin generation was measured in plasma using alpha 2-macroglobulin attached thrombin activity as an endpoint. Higher risk (odds) ratio with 95% CI) of VTE for carriers of heterozygote Factor V Leiden mutation was confirmed [OR = 2.72 (CI:1.51-4.92)]. However, there is no association between VTE and the level of APCRN OR 0.65 (CI:0.35-1.22). We conclude that acquired APC resistance, measured with a tissue factor initiated test, is unlikely to have a direct association to the clinical outcome of venous thromboembolism.

Adolescent↗
PubMed1978

Relationships of mesenteric thromboembolism, oral feeding, and necrotizing enterocolitis.

Mesenteric blood vessels were examined in postmortem specimens of 30 selected infants. The infants had had necrotizing enterocolitis (16 cases) or other lesions (14 cases). Mesenteric thromboemboli were observed in 12 of the infants with necrotizing enterocolitis (P less than 0.001). Umbilical vessel catheters were apparently responsible for the emboli. Multiple instances of thrombosis and thromboembolism were detected in other organs. Ninety-four percent of infants with necrotizing enterocolitis were orally fed (P less than 0.001). Mesenteric thromboemboli were more frequent in infants who were fed via the digestive route while an umbilical arterial catheter was in place. Mesenteric thromboembolism in these infants was postulated to have been attributable to increased postprandial blood flow in the mesenteric vessels.

Catheterization↗
PubMed1998

Prevalence of the factor V leiden mutation in children and neonates with thromboembolic disease.

OBJECTIVE: Resistance to activated protein C (APC) has been identified as a risk factor for thrombotic disease in adults. In over 90% of cases, the basis for the APC resistance is a mutation in the coagulation factor V gene (factor V Leiden) that renders the protein more resistant to inactivation by APC. We sought to determine the prevalence of the factor V Leiden (FVL) mutation in neonates and children who had experienced an arterial or venous thromboembolic event. STUDY DESIGN: We retrospectively analyzed the clinical records of 33 neonates and 52 children with thromboembolic disease. Screening for the FVL mutation was performed by DNA analysis, allowing for identification of patients as normal, heterozygous, or homozygous. RESULTS: Of the 85 patients studied, 12 (14.1%) were heterozygous for FVL; none were homozygous. Of the 47 patients who had arterial central nervous system events, 8 (17%) were positive for the FVL mutation, including 6 of 22 (27%) neonates. Of those patients who had a venous thrombosis, 4 of 32 (12.5%) were FVL positive. None of the 85 patients had protein C deficiency, 3.5% had protein S deficiency, 1.2% had antithrombin III deficiency, and 16.5% had anti-phospholipid antibodies. CONCLUSION: These data suggest that the FVL mutation plays a role in the development of arterial and venous thrombotic events in neonates and children.

Adolescent↗
PubMed1984

Diagnosis and treatment of recurrent venous thromboembolism.

The diagnosis of recurrent venous thromboembolism includes an evaluation of the patient for inherited or acquired disorders, associated with an increased risk of thromboembolism. Treatment depends, in part, on the underlying disease and, in part, on an adequate understanding of the principles of anticoagulant therapy.

Anticoagulants↗
PubMed1997

Enoxaparin, a low-molecular-weight heparin suppresses prothrombin activation more effectively than unfractionated heparin in patients treated for venous thromboembolism.

Although unfractionated heparin (UFH) is standard therapy for venous thromboembolism, there is a clinical failure rate of up to 10%. Newer treatment strategies include low-molecular-weight heparins (LMWH). As part of an international study comparing the efficacy and safety of enoxaparin, a LMWH versus UFH in patients with venous thromboembolism, we studied the effects of enoxaparin and UFH on the plasma concentrations of two activation peptides, fragment 1 + 2 (F1 + 2), and thrombin-antithrombin III (TAT) complexes. We hypothesized that enoxaparin would be more effective in suppressing activation of coagulation. Intravenous heparin was given by bolus injection followed by infusion. There were 2 enoxaparin treatment groups (1 mg/kg s.c., bid and 1.5 mg/kg s.c. daily). Plasma samples were obtained from 11 patients in the enoxaparin group and 6 patients in the heparin group prior to and at 6 hour intervals after initiating therapy. Clinical characteristics of the enoxaparin and UFH patient groups were similar. TAT concentrations were not statistically different between groups at any treatment interval. However, plasma F1 + 2 concentrations differed significantly (p < 0.05); concentrations in the enoxaparin group were consistently lower over time than in the UFH group. These results suggest that this LMWH is more effective in suppressing ongoing thrombosis in vivo than UFH in patients with venous thrombosis.

Adult↗
PubMed1998

Thromboembolic complications several days after a single-dose administration of aspirin.

The antithrombotic properties of acetyl salicylic acid (ASA) used at current doses are largely demonstrated. However, our previous study showed unexpected thrombotic potencies associated with the use of this drug. In this study we investigate the effect of aspirin on an experimental thrombosis induced by laser beams, according to its in vivo plasma concentration. Experiments were done on nine groups of seven Wistar male rats. The groups are defined by the delay between aspirin administration time and the laser-induced thrombosis time. Results from this study showed an enhancement of thromboembolic complications when thrombosis was induced 8 or 10 days after aspirin administration; the number of emboli and the duration of embolization are increased, compared to the control group. The prothrombotic properties of ASA demonstrated in this study, might limit its therapeutic benefit and might explain thromboembolic complications observed in some ASA-treated patients. These results also suggest a biological monitoring several days after aspirin administration to patients.

Administration, Cutaneous↗
PubMed2002

Ximelagatran and melagatran compared with dalteparin for prevention of venous thromboembolism after total hip or knee replacement: the METHRO II randomised trial.

BACKGROUND: Heparins substantially reduce the risk of thromboembolic complications after total hip or knee replacement. However, they can be given only by injection and have several other drawbacks. We did a multicentre, randomised, double-blind study to examine the dose-response relation of subcutaneous melagatran, a direct thrombin inhibitor, followed by oral ximelagatran as thromboprophylaxis after total hip or knee replacement. We aimed to compare the efficacy and safety with that of dalteparin. METHODS: Of 1900 patients, 1495 were assigned to four dose categories of subcutaneous melagatran from just before surgery (1.00 mg, 1.50 mg, 2.25 mg, or 3.00 mg twice daily) followed from the day after surgery by oral ximelagatran (8 mg, 12 mg, 18 mg, or 24 mg twice daily). 381 patients were assigned subcutaneous dalteparin 5000 IU once daily, from the evening before surgery. Bilateral venography was done at 7-10 days, and clinically suspected venous thromboembolism (VTE) was confirmed radiologically. The primary endpoint was the rate of deep-vein thrombosis and pulmonary embolism (PE). Analyses were by intention to treat. FINDINGS: 1876 patients underwent total replacement of hip (n=1270) or knee (n=606); evaluable venograms were obtained in 1473 (79%). Four patients without evaluable venograms had PE. Overall, a significant dose-dependent decrease in VTE was seen with melagatran/ximelagatran (lowest to highest group: 111 [37.8%], 70 [24.1%], 71 [23.7%], and 43 [15.1%]; p=0.0001); there were also significant relations for both total hip and total knee replacement individually. The frequency of VTE was significantly lower with the highest dose of melagatran/ximelagatran than with dalteparin (15.1% vs 28.2%, p<0.0001). There were no reoperations due to bleeding and no critical organ bleeding. Excessive surgical bleeding was uncommon but more frequent in the highest dose group. INTERPRETATION: This sequential therapy was effective and safe in patients undergoing major joint replacement surgery. The findings should be confirmed in a large phase III trial.

Adult↗
PubMed1980

Prevention of venous thromboembolism. A survey of methods used by orthopaedic and general surgeons.

752 orthopaedic and 663 general surgeions were sent a questionnaire asking how they attempted to prevent venous thromboembolism; the survey concerned prophylaxis offered routinely to elderly patients with hip fractures, to patients undergoing elective hip replacement arthroplasty, and to patients undergoing major abdominal and thoracic operations. The response rate was more than 70%. The results suggest that the provision of prophylaxis against venous thromboembolism is inversely related to the frequency with which it occurs--e.g., the proportions of surgeons offering no routine prophylaxis or ambulation and physiotherapy only was 72% for hip fractures, 52% for hip replacement, and 38% for general surgery.

Early Ambulation↗
PubMed1989

Rates of thromboembolism with three different mechanical heart valve prostheses: randomised study.

In 434 operations for valvular heart disease, patients were randomised to receive Björk-Shiley, Edwards-Duromedics, or Medtronic-Hall mechanical prostheses. At a median follow-up time of 37.5 months there were no differences in hazard of death or non-embolic events. In the first six postoperative months the incidence of thromboembolism was about the same for the three valves. Subsequently, however, the incidence of thromboembolism for the Edwards-Duromedics valve was 3.9 times higher than for the Björk-Shiley valve, and for the Medtronic-Hall valve 2.6 times higher than for the Björk-Shiley valve.

Adult↗
PubMed1989

The Canadian American Ticlopidine Study (CATS) in thromboembolic stroke.

The Canadian American Ticlopidine Study (CATS) is a randomised, double-blind, placebo-controlled trial to assess the effect of ticlopidine (250 mg twice daily) in reducing the rate of subsequent occurrence of stroke, myocardial infarction, or vascular death in patients who have had a recent thromboembolic stroke. Twenty-five centres entered 1072 patients into the study between 1 week and 4 months after their qualifying stroke. The patients were treated and followed for up to 3 years (mean 24 months). In the efficacy analysis, the event rate per year for stroke, myocardial infarction or vascular death, considered together, was 15.3% in the placebo group and 10.8% in the ticlopidine group, representing a relative risk reduction with ticlopidine of 30.2% (95% confidence interval 7.5-48.3%; p = 0.006). Ticlopidine was beneficial for both men and women (relative risk reductions 28.1%, p = 0.037, and 34.2%, p = 0.045, respectively). Analysis by intention-to-treat gave a smaller estimate of risk reduction (23.3%, p = 0.020) for stroke, myocardial infarction, or vascular death. Adverse experiences associated with ticlopidine included neutropenia (severe in about 1% of cases) and skin rash and diarrhoea (severe in 2% of cases each); all were reversible. This study provides evidence of a beneficial effect of ticlopidine in both men and women with a recent thromboembolic stroke.

Aged↗