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PubMedDate not supplied

Coagulolysis assay in the detection of deep vein thrombosis in the orthopedic patient. A preliminary report.

The recently developed coagulolysis assay was utilized in conjuction with fibrinogen uptake scanning to monitor 91 of 111 consecutive orthopedic patients scheduled for hip surgery or total knee replacement. Sixteen patients had abnormal coagulolysis assays and positive scans. Venography was performed in 15 of these patients, and deep vein thrombosis was documented in 12. Five patients developed pulmonary emboli, including one with negative venogram. Thus, over 80% of the patients in which both the coagulolysis assay and the fibrinogen scan were abnormal had additional documentation of deep vein thrombosis. In 41 patients, the coagulolysis assay was negative. Venograms were not routinely performed in this group. However, 3 patients developed pulmonary emboli indicating that deep vein thrombosis developed in this group. Only one patient had a normal coagulolysis with a positive fibrinogen scan. Venography documented a deep vein thrombosis. Thirty-three patients who had normal coagulolysis assays and negative fibrinogen scans also had no evidence of deep vein thrombosis or pulmonary embolism. The coagulolysis assay appears to be a safe, noninvasive study for the detection of deep vein thrombosis. There was only a one per cent false-negative incidence.

Blood Coagulation Tests↗
PubMed1984

[Efficacy and value of fibrinolytic agents in chronic proximal venous thrombosis of the lower limbs].

Forty patients (mean age = 56 +/- 17 years) hospitalized for proximal venous thrombosis of the lower limbs of over 7 days duration were treated with fibrinolytic drugs: streptokinase (SK) 28 cases, urokinase (UK) 12 cases. The efficacy of fibrinolytic therapy was assessed by phlebography before and 4.5 +/- 2 days after onset of treatment. A phlebographic score based on Marder's method was used to quantify the thrombosis. The repermeabilisation of venous branches was also noted. The results show an overall efficacy of fibrinolytic drugs: total lysis was observed in 6 patients and partial thrombolysis in 18 patients. The overall reduction of the phlebographic score was -2.8 +/- 3.9, and the rate of repermeabilisation of the femoral veins was over 50%. Streptokinase seemed to be the most effective drug. Better results were obtained when the thrombosis was treated early and was proximally situated, but good results were also observed in cases of total thrombosis with a floating thrombus. Effective fibrinolysis was observed in thromboses of up to 3 months duration. There was no correlation between biological efficacy and clinical symptoms. In conclusion, fibrinolytic drugs are partially effective in semi-recent or chronic venous thrombosis and their usefulness should not be overlooked, especially in cases of persistent thrombosis of the femoral veins.

Adult↗
PubMed1984

Deep-vein thrombosis following total knee replacement. An analysis of six hundred and thirty-eight arthroplasties.

For this study on the incidence and prevention of deep-vein thrombosis, we examined the data on 517 patients with 638 total knee replacements. All of the patients had postoperative venograms and 475 had postoperative perfusion lung scans. We collected data on known risk factors, tourniquet time, knee deformity, postoperative rehabilitation, and methods of prophylaxis, and performed extensive statistical evaluation. Forty-nine patients inadvertently did not receive prophylaxis, and in forty-one (84 per cent) of them ipsilateral deep-vein thrombosis developed. The incidence of ipsilateral thrombosis was 57 per cent in the 468 patients who did receive some form of prophylaxis. Ipsilateral thrombosis in the popliteal veins or thigh was seen in 11 per cent of the patients with unilateral total knee replacement, and contralateral thrombosis was noted in 3 per cent. Bilateral total knee replacement was associated with a 58 per cent incidence of ipsilateral deep-vein thrombosis in the calf and a 14 per cent incidence in the thigh. Pulmonary embolism was diagnosed clinically in nine patients (1.7 per cent), but was suggested on perfusion lung scans in thirty-nine patients (7 per cent). Twelve patients (2.3 per cent) received formal anticoagulant therapy. In no patient was the pulmonary embolism fatal. No specific high-risk population was identified. While no one prophylactic regimen was proved to be more effective than another in our series, we think that prophylactic measures should be part of the management of patients undergoing total knee replacement.

Adult↗
PubMed1981

Relationship of hypothyroidism to diabetes mellitus, renal amyloidosis, and thrombosis in purebred beagles.

Review of 484 records for colony Beagles revealed an association between hypothyroidism and diabetes mellitus. The average time between first notation of hypothyroidism and later development of diabetes mellitus was 2.8 years. An association was also made with hypothyroidism, renal amyloidosis, and thrombosis. Hypothyroidism was significantly related to thrombosis, thrombosis was significantly related to renal amyloidosis, but hypothyroidism and renal amyloidosis were not significantly related. Of 62 hypothyroid dogs, 11 were diabetic and 7 others had thrombosis. Six hypothyroid dogs had renal amyloidosis, 4 of which had thrombosis. One dog had renal amyloidosis and thrombosis in the absence of hypothyroidism. There does not appear to be an association with any of the lesions and previous low-dose, whole-body gamma, or sham irradiation.

Amyloidosis↗
PubMed1995

Urokinase therapy in neonates with catheter related central venous thrombosis.

The results of fibrinolytic therapy with urokinase were evaluated in 26 neonates with catheter related central venous thrombosis. Complete thrombolysis could be achieved in 13 patients (50%), partial thrombolysis in 3 patients (12%). No effect was seen in 10 patients (38%). Therapy success was influenced by age, size and location of the thrombus. Coincidence of infection occurred in 16 patients (62%). Mild hemorrhagic complications were seen in 2 patients (8%), no other significant side effects were observed. Nine patients with residual thrombosis were treated with oral anticoagulants following urokinase resulting in resolution of the thrombus in 6 patients within 3 months (67%). The incidence of asymptomatic recurrent thrombosis was high (28%). Urokinase might be an effective and safe treatment for central venous thrombosis in neonates. Prophylactic antibiotic therapy during the infusion of urokinase and long-term treatment with oral anticoagulants after thrombosis are advisable. Early detection of thrombosis might enhance the success rate of fibrinolytic therapy. Therefore, we strongly recommend routine echocardiographic screening of central venous catheters.

Case-Control Studies↗
PubMed1994

Collaborative overview of randomised trials of antiplatelet therapy--III: Reduction in venous thrombosis and pulmonary embolism by antiplatelet prophylaxis among surgical and medical patients. Antiplatelet Trialists' Collaboration.

OBJECTIVE: To determine the efficacy of antiplatelet therapy as prophylaxis against deep venous thrombosis or pulmonary embolism in surgical and high risk medical patients. DESIGN: Overviews of all randomised trials of antiplatelet therapy that could have been available by March 1990 and in which deep venous thrombosis was assessed systematically. SETTING: 53 trials (total 8400 patients) of an average of two weeks of antiplatelet therapy versus control in general or orthopaedic surgery; nine trials (600 patients) of antiplatelet therapy versus control in other types of immobility; 18 trials (1000 patients) of one antiplatelet regimen versus another. RESULTS: Overall, a few weeks of antiplatelet therapy produced a highly significant (2P < 0.00001) reduction in deep venous thrombosis. 25% of patients allocated antiplatelet therapy versus 34% of appropriately adjusted controls had deep venous thrombosis detected by systematic fibrinogen scanning or venography, representing prevention in about 90 patients per 1000 allocated antiplatelet therapy. There was an even greater proportional reduction in pulmonary embolism: such emboli were detected among 47 (1.0%) antiplatelet allocated patients versus an adjusted control total of 129 (2.7%), representing prevention among about 17 patients per 1000 treated (2P < 0.00001). In analyses confined to surgical trials, the proportional reductions were similar and separately significant for nonfatal pulmonary embolism (0.7% antiplatelet therapy v 1.8% control; 2P < 0.00001) and for deaths attributed to pulmonary embolism (0.2% v 0.9%; 2P = 0.0001). There was a slight but non-significant excess of deaths from other causes (1.0% v 0.7%), which made the difference in total mortality nonsignificant, though still favourable (1.2% v 1.5%). Information on adding antiplatelet therapy to heparin was limited but, at least for pulmonary embolism, suggested more protection from the combination than from heparin alone. The proportional reduction in the odds of suffering a deep venous thrombosis was roughly the same in patients having general surgery, traumatic orthopaedic surgery, and elective orthopaedic surgery (and in medical patients who were at increased risk of thromboembolism). For pulmonary embolism the numbers affected were smaller, but again the reductions were highly significant both in general surgery (16 (0.5%) v 58 (1.7%) pulmonary emboli; 2P < 0.0001) and in orthopaedic surgery (28 (2.7%) v 63 (6.1%) pulmonary emboli; 2P < 0.0002). CONCLUSION: It had previously been supposed that antiplatelet therapy did not influence venous thromboembolism, and many surgeons and physicians do not use it routinely for thromboprophylaxis, even for patients who are at substantial risk of deep venous thrombosis or pulmonary embolism. These results indicate that antiplatelet therapy--either alone or, for greater effect, in addition to other proved forms of thromboprophylaxis (such as subcutaneous heparin)--should be considered.

Blood Loss, Surgical↗
PubMed1993

Prophylactic agents for venous thrombosis in elective hip surgery. Meta-analysis of studies using venographic assessment.

BACKGROUND: We determined the relative efficacy of various agents or combinations of agents in the prophylaxis of deep venous thrombosis after elective hip arthroplasty. METHODS: Peer-reviewed, English-language, human studies articles from 1975 through 1991 were obtained through a MEDLINE database search. Additional references were obtained from bibliographies. Articles that compared the effect of two or more prophylactic agents or placebo in preventing deep venous thrombosis as assessed by venography were selected for further review. Only studies of elective hip surgery in which all patients had venographic screening for thrombosis were included. Twenty-three of 101 studies met these criteria. Data were abstracted by one of us. Methodologic criteria and outcome data from each study were recorded and analyzed. RESULTS: There was significant heterogeneity in the deep venous thrombosis rate among studies. Although the rates were lowest for low-molecular-weight heparin with or without the use of stockings, adjusted-dose heparin, and warfarin, many agents had similar low rates. There was less heterogeneity when the relative risk was used as a summary statistic for studies in which two agents were compared. With pairwise comparisons, low-molecular-weight heparin performed better than every agent with which it was compared. Other agents performed well but were not consistently better. CONCLUSIONS: Multiple agents or combinations are effective prophylaxis for deep venous thrombosis, but none decreases the rate to zero. There was overlap in the 95% confidence intervals for the probability of deep venous thrombosis for various agents and especially for the probabilities for proximal thrombi. Many agents have not been compared directly with each other, but low-molecular-weight heparin consistently performed well.

Anticoagulants↗
PubMed1993

Etiology, incidence, and prevention of deep vein thrombosis in acute spinal cord injury.

This article provides a critical review of the literature on the etiology, incidence, and prevention of deep-vein thrombosis in acute spinal cord injured patients. Stasis and hypercoagulability are the two major factors contributing to the development of thrombosis in this patient population. This has been supported by studies that demonstrate an impaired venous return from the lower extremities and abnormal coagulation factors, which predispose to thrombogenesis. The incidence of deep vein thrombosis secondary to the above etiologies varies from 49% to 100% in the first 12 weeks with the first 2 weeks having the highest rate following acute injury. This high rate of complication has led to numerous studies to identify the most effective regimens of prophylaxis. Studies using noninvasive testing and venography in acute spinal cord injury have supported two approaches for preventing deep-vein thrombosis. Single agent pharmacologic therapy with adjusted dose heparin is effective but does carry some risk of bleeding. Combination therapy with external pneumatic compression sleeves plus either aspirin/dipyridamole or low-dose heparin and electrical stimulation plus low-dose heparin have significantly reduced the incidence of deep vein thrombosis. The duration of prophylaxis with the above modalities has varied between 8 and 12 weeks following acute injury. Further large scale studies are required in this high-risk population to better delineate the incidence of deep vein thrombosis and pulmonary embolism, to identify the best modalities, and to define the duration of treatment for the prevention of these complications.(ABSTRACT TRUNCATED AT 250 WORDS)

Acute Disease↗
PubMed1993

125I-fibrinogen leg scanning: reassessment of its role for the diagnosis of venous thrombosis in post-operative patients.

OBJECTIVE: To determine the reasons why 125I-fibrinogen leg scanning, a screening test which was reported to be very sensitive for the detection of post-operative thrombosis, has shown poor sensitivity in contemporary studies. STUDY IDENTIFICATION: English-language reports were identified through a Medline computer search (1965-1991), Current Contents, and an extensive manual search of the bibliographies in identified articles. STUDY SELECTION: Studies in orthopaedic or general surgical patients were reviewed that compared 125I-fibrinogen leg scanning with venography in all patients (accuracy studies) or in patients in whom 125I-fibrinogen leg scanning became positive (positive predictive value studies). DATA EXTRACTION: A systematic appraisal of study design and specific descriptive information concerning the selection of patients. RESULTS OF DATA SYNTHESIS: Six of the 15 studies which compared 125I-fibrinogen leg scanning with venography were level 1 studies (potential for bias minimized) and nine were classified as level 2 studies (potential for bias not minimized). In orthopaedic surgical patients, the pooled sensitivity of leg scanning for isolated calf vein thrombosis, for all venous thrombosis, and the pooled specificity were 55%, 45%, and 92% for the level 1 studies, respectively. These indices were 88%, 82%, and 79%, respectively for the level 2 studies (P < 0.001). Only two (level 2) studies were found that evaluated the accuracy of leg scanning for venous thrombosis in general surgical patients. CONCLUSION: We conclude that leg scanning is an insensitive method for the screening of post-operative venous thrombosis in orthopaedic patients. Our findings call into question the validity of the many studies (including meta-analyses) evaluating prophylactic agents for venous thrombosis which used leg scanning as the only test for the assessment of efficacy.

Fibrinogen↗
PubMed1995

[Pulmonary embolism and the level of thrombosis. A prospective study of 155 patients].

This study was designed to assess the risk of associated pulmonary embolism according to the level of deep venous thrombosis. From March 1992 to March 1994, 328 patients were referred to medical units for suspected deep venous thrombosis, with recent clinical signs, less than a week. Each patient underwent contrast venography and/or duplex ultrasounds of lower extremities, ventilation and perfusion lung scan within 48 hours and angiography in case of low or intermediate pulmonary embolism probability. Diagnosis of deep venous thrombosis was confirmed in 155 patients; location was distal in 41, proximal in 114; an associated pulmonary embolism was found in 66 patients (10 with distal, 56 with proximal deep venous thrombosis); odds ratio was 2.99 (95% Cl: 1.2-3.13). Significantly higher risk of associated pulmonary embolism when deep venous thrombosis involves proximal veins is confirmed, but as many as 10 out of 41 patients with distal thrombosis also had an associated embolism. Management of both distal and proximal deep venous thromboses appears identical.

Aged↗
PubMed1995

New molecular insights into the genetics of thrombophilia. Resistance to activated protein C caused by Arg506 to Gln mutation in factor V as a pathogenic risk factor for venous thrombosis.

Genetic risk factors are important in the pathogenesis of venous thrombosis, as demonstrated by the familial clustering of the disease. However, well defined genetic defects were until recently found in less than 10% of the thrombosis patients. In 1993, inherited resistance to activated protein C (APC) was reported as a novel pathogenetic risk factor for thrombosis. It is found in 20-60% of patients with venous thrombosis. APC-resistance is in more than 90% of the cases caused by a single point mutation in the gene for factor V (G to A transition at nucleotide position 1691), which predicts replacement of Arg(R)506 in the APC-cleavage site with a Gln(Q). After activation, mutated factor V, FV:Q506, is less efficiently degraded by APC than normal factor V, which results in increased thrombin generation and a hypercoagulable state. The FV:Q506 mutation is highly prevalent in the general population (5-10%). Heterozygosity for FV:Q506 is associated with a 5-10-fold increased risk of thrombosis, whereas homozygous cases have 50-100-fold increased risk of thrombosis.

Enzyme Activation↗
PubMed1996

Comparison of two warfarin regimens in the prevention of venous thrombosis following total knee replacement.

A prospective, randomized trial was conducted to compare the effectiveness and safety of warfarin given in two regimens in prevention of venous thrombosis after total knee replacement. Adult patients scheduled for primary or revision total knee replacement were randomly assigned to receive either a "two-step" warfarin regimen beginning 10-14 days pre-operatively or, alternatively, to begin warfarin the night before surgery. Post-operatively, the dose was adjusted in both groups to achieve a target International Normalized Ratio (INR) of 2.2 and prophylaxis was continued until venography on post-operative days five through nine. Bleeding was assessed by surgical blood loss, transfusion requirements, changes in hematocrit, and clinically identified bleeding complications. The occurrence of deep vein thrombosis was nearly the same in the two treatment groups, 39% in patients randomized to the two-step regimen as compared to 38% in those beginning the night before surgery. The occurrence of proximal vein thrombosis was also similar, 5% versus 7% (p = NS). Patients in the two-step group received 1.33 +/- 1.26 transfusions compared to 0.95 +/- 1.22 in the night before group (p < 0.05) and also had a lower nadir post-operative hematocrit of 26.7 +/- 3.1 as compared to 28.5 +/- 3.2 (p < 0.0001). Major bleeding complications were associated with excessively prolonged INRs and occurred in five patients in the two-step group and two in the night before group. Patients in both groups who developed thrombosis had a significantly lower INR on post-operative days two and three compared to those without thrombosis. We conclude that a prophylactic warfarin regimen for prevention of deep vein thrombosis after total knee replacement beginning the night before surgery is more convenient and may be associated with less bleeding than a regimen beginning warfarin 10-14 days pre-operatively. Careful control of anticoagulant intensity is needed to achieve maximum effectiveness and avoidance of bleeding complications.

Adult↗
PubMed1996

[Hemostatic status in subjects with deep venous thrombosis].

The authors report a study on the hemostatic status of a group of patients with deep venous thrombosis in order to highlight the possible pathogenetic responsibility of blood coagulative disorders in the genesis of thrombosis. The group consisted of 27 patients (14 males, 13 females, mean age 48 +/- 4 years) with deep venous thrombosis of the lower limbs (clinical symptoms were primary in 21 cases, secondary in 6 cases) diagnosed on the basis of clinical data and ultrasonographic instrumental findings. Fourteen normal subjects were also examined as a control group (12 males, 2 females, mean age 28 +/- 5 years). Venous blood was collected on fasting from patients and controls to examine the following parameters: fibrinogen (F), factor VII (F VII), antithrombin III (AT III), protein C (PC), protein S (PS) using coagulometric methods (IL), and tissue plasminogen activator (tPA), plasminogen activator inhibitor (PAI-1), fibrinopeptide A (FPA), betathromboglobulin (BTG) and dimer-D (D-D) using ELISA methods (Boehringer). Patients with deep venous thrombosis showed a significant increase in F, FVII, tPA and D-D levels compared to controls, whereas a significant reduction was observed in PAI-1. Nonsignificant variations were found for AT III, PC, PS and BTG. In the light of these results the authors affirm that: high fibrinogen and factor VII levels are highly prognostic for thrombosis in patients with deep venous thrombosis; the importance of the lack of inhibitory factors (AT III, PC, PS) is confined to individual genetically predisposed cases; there is an efficacious hyperfibrinolytic reactive response to the presence of thrombus (increase in tPA and D-D, reduction of PAI-1).

Blood Coagulation↗
PubMed1997

The use of D-dimer testing and impedance plethysmographic examination in patients with clinical indications of deep vein thrombosis.

OBJECTIVE: To prospectively test the hypothesis that a diagnosis of deep vein thrombosis can be excluded in outpatients who present with clinical indications of deep vein thrombosis and whose results of D-dimer testing and impedance plethysmographic examination on the day of presentation are normal. DESIGN: Prospective cohort study. SETTING: Four university-affiliated hospitals. METHODS: Three hundred ninety-eight consecutive patients with clinical indications of deep vein thrombosis were included in the final analysis. All patients underwent an assessment of pretest probability, bedside D-dimer testing, and impedance plethysmographic examination. In most patients, if the results of D-dimer testing and impedance plethysmographic examination were negative for deep vein thrombosis, anticoagulants were withheld and patients were followed up for 3 months. If the results of one or both tests were abnormal, an examination using venous compression ultrasonography or phlebography was performed. RESULTS: In the majority of patients (69%), the results of D-dimer testing and impedance plethysmographic examination were normal. This combination had a negative predictive value of 98.5% (95% confidence interval, 96.3-99.6) for deep vein thrombosis. CONCLUSION: The results of the D-dimer assay and impedance plethysmographic examination on the day of presentation can be used to treat the majority of outpatients who present with clinical indications of deep vein thrombosis without further testing.

Adult↗
PubMed1997

Relationship of anti beta2-glycoprotein I and anti prothrombin antibodies to thrombosis and pregnancy loss in patients with antiphospholipid antibodies.

The lupus anticoagulant (LA) and anticardiolipin antibodies (aCL) are clinically relevant because of their association with thrombosis and pregnancy loss. The group of antiphospholipid antibodies (aPL) includes antibodies primarily directed against various phospholipid-binding proteins, mainly beta2-glycoprotein I (beta2GPI) and prothrombin. Some studies suggest that there is an association between the presence of anti beta2GPI antibodies (alphabeta2GPI) of IgG isotype and thrombosis. Therefore, aPL defined according to the plasma protein to which they are directed appear to be more appropriate for the evaluation of their clinical importance. Using home-made ELISAs we evaluated the presence of alphabeta2GPI and antiprothrombin antibodies (anti-II) of both isotypes (IgG and IgM) in a group of 233 patients with LA and/or aCL. Forty-four women had a history of pregnancy loss, 45 patients had a history of venous thrombosis (VT) and 32 of arterial thrombosis (AT). Patients from the autoimmune group (systemic lupus erythematosus and antiphospholipid syndrome) had a higher prevalence of alphabeta2GPI and/or anti-II than those from the miscellaneous group. In the univariate analysis, a significant association was shown between the presence of alphabeta2GPI-IgG (OR 3.2; 95% CI 1.5-6.6) and previous VT, but not AT. Anti-II were related to VT but the multivariate analysis showed that alphabeta2GPI-IgG are the only independent risk factor for VT (OR 3.0; 95% CI 1.3-6.2). The presence of alphabeta2GPI-IgM correlates well with a history of pregnancy loss (OR 2.6; 95% CI 1.1-6.1). The coagulation tests profile showed that the clotting assays were more prolonged in patients having aCL, alphabeta2GPI or anti-II. But a higher prevalence of abnormal results was only found for the dilute Russell viper venom time in patients with VT, as compared to those without thrombosis (94.4% vs. 58.7%, p <0.02). The measurement of alphabeta2GPI of both isotypes could help to identify aPL-positive patients with a higher risk for thrombosis and pregnancy loss, although this association should be confirmed by prospective studies.

Abortion, Spontaneous↗
PubMed1997

[Pulmonary embolism and unusual deep venous thrombosis. Report of two cases].

Contrast venography is the gold standard for the diagnosis of deep vein thrombosis in the lower limb extremities, but it fails to visualize deep veins like deep femoral vein and internal iliac vein. The internal iliac can be examined with duplex scanning if the technique and the examination conditions are correct. As reported in these two cases, thrombosis of these deep veins may lead to pulmonary embolism. The first case is a young female with venous thromboembolic disease in whom internal iliac vein thrombosis was documented only at the second examination. In the second case, deep femoral vein thrombosis appeared early in a comatose young male. This thrombosis may be classified as proximal muscular vein thrombosis. These two cases emphasize the importance of a duplex scanning examination performed with rigorous technique, whose the main limitation being examination conditions.

Adult↗
PubMedDate not supplied

[Deep venous thrombosis and neoplastic pathology: our experience in emergencies].

Deep vein thrombosis incidence is 1/1000 per year; it is associated with many risk factors which is considered as "thrombophilic states". Its pathogenesis is complex, caused by alterations of hemostasis system. Many studies have established the relation between cancer and subsequent venous thromboembolism, confirming the relationship of neoplastic cell interaction with coagulation system. Forty-seven patients admitted to the hospital from 1987 to 1996 with symptomatic clinically proved deep vein thrombosis were included in a retrospective study. Routine examination at the time of diagnosis of deep vein thrombosis revealed an occult cancer in 8 out of 47 patients; 9 out of 47 patients were admitted in hospital with vein thrombosis and known cancer. The aim of this study is to suggest the best, first treatment of vein thromboembolism in emergency to avoid the dangerous pulmonary embolism complication. The patients affected with deep vein thrombosis and cancer were elderly (over 70 years old, in mean); the neoplasia was of digestive system (8/17) in advanced metastatic stage there was cancer familiarity in 7 out of 47 patients. The high risk of pulmonary embolism associated to deep vein thrombosis suggests the importance of early starting the anticoagulant therapy and placing caval filter.

Adolescent↗
PubMed1999

A reduced sensitivity for activated protein C in the absence of factor V Leiden increases the risk of venous thrombosis.

Activated protein C (APC) resistance caused by the factor V Leiden mutation is associated with an increased risk of venous thrombosis. We investigated whether a reduced response to APC, not due to the factor V point mutation, is also a risk factor for venous thrombosis. For this analysis, we used the Leiden Thrombophilia Study (LETS), a case-control study for venous thrombosis including 474 patients with a first deep-vein thrombosis and 474 age- and sex-matched controls. All carriers of the factor V Leiden mutation were excluded. A dose-response relationship was observed between the sensitivity for APC and the risk of thrombosis: the lower the normalized APC sensitivity ratio, the higher the associated risk. The risk for the lowest quartile of normalized APC-SR (<0.92), which included 16.5% of the healthy controls, compared with the highest quartile (normalized APC-SR > 1.05) was greater than fourfold increased (OR = 4.4; 95% confidence interval, 2.9 to 6.6). We adjusted for VIII:C levels, which appeared to affect our APC resistance test. The adjusted (age, sex, FVIII:C) odds ratio for the lowest quartile was 2.5 (95% confidence interval, 1.5 to 4.2). So, after adjustment for factor VIII levels, a reduced response to APC remained a risk factor. Our results show that a reduced sensitivity for APC, not caused by the factor V Leiden mutation, is a risk factor for venous thrombosis.

Activated Protein C Resistance↗