Prediction of Venous Thromboembolism in Patients With Cancer by Measuring Thrombin Generation: Results From the Vienna Cancer and Thrombosis Study

2011 ◽  
Vol 29 (15) ◽  
pp. 2099-2103 ◽  
Author(s):  
Cihan Ay ◽  
Daniela Dunkler ◽  
Ralph Simanek ◽  
Johannes Thaler ◽  
Silvia Koder ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Thrombin Generation ◽  
Multivariable Analysis ◽  
Rank Test ◽  
Cumulative Probability ◽  
Total Study Population ◽  
Patients With Cancer ◽  
Increased Risk ◽  
Progression Of Disease ◽  
Tumor Types

Purpose Patients with cancer are at increased risk of venous thromboembolism (VTE). Laboratory tests measuring the overall thrombophilic tendency might be useful to assess VTE risk. The aim of this study was to investigate thrombin generation, a key process in hemostasis, as predictor of cancer-associated VTE. Patients and Methods The Vienna Cancer and Thrombosis Study (CATS) is a prospective observational cohort study of patients with newly diagnosed cancer or progression of disease after remission. The study end point is occurrence of objectively confirmed symptomatic or fatal VTE within a follow-up period of 2 years. Thrombin generation was measured with a commercially available assay. Results One thousand thirty-three patients with malignancies of the breast (n = 151), lung (n = 148), upper (n = 44) and lower gastrointestinal tract (n = 125), pancreas (n = 67), kidney (n = 34), prostate (n = 122), and brain (n = 134) or lymphoma (n = 126), multiple myeloma (n = 26), and other tumor types (n = 56) were observed for a median observation period of 517 days. VTE occurred in 77 patients (7.5%). Patients with elevated peak thrombin (defined as values ≥ 611 nM thrombin, representing the 75th percentile of the total study population) had an increased risk of VTE with a hazard ratio of 2.1 (95% CI, 1.3 to 3.3, P = .002) in multivariable analysis including age, sex, surgery, chemotherapy, and radiotherapy. The cumulative probability of developing VTE after 6 months was significantly higher in patients with elevated peak thrombin than in those with lower peak thrombin (11% v 4%; log-rank test: P = .002). Conclusion Measurement of thrombin generation may help identify patients with cancer at high risk of VTE.

D-Dimer and Prothrombin Fragment 1 + 2 Predict Venous Thromboembolism in Patients With Cancer: Results From the Vienna Cancer and Thrombosis Study

2009 ◽  
Vol 27 (25) ◽  
pp. 4124-4129 ◽  
Author(s):  
Cihan Ay ◽  
Rainer Vormittag ◽  
Daniela Dunkler ◽  
Ralph Simanek ◽  
Alexandru-Laurentiu Chiriac ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Multivariable Analysis ◽  
High Grade Glioma ◽  
Cumulative Probability ◽  
Total Study Population ◽  
Prothrombin Fragment ◽  
Patients With Cancer ◽  
Progression Of Disease ◽  
Tumor Types ◽  
D Dimer

Purpose Venous thromboembolism (VTE) is a well-recognized complication of cancer. Laboratory parameters might be useful to assess the VTE risk in patients with cancer. The aim of this study was to investigate D-dimer and prothrombin fragment 1 + 2 (F 1 + 2), which reflect activation of blood coagulation and fibrinolysis, for prediction of cancer-associated VTE. Patients and Methods In a prospective, observational, cohort study of 821 patients with newly diagnosed cancer or progression of disease who did not recently receive chemotherapy, radiotherapy, or surgery were enrolled and followed for a median of 501 days (interquartile range, 255 to 731 days). The malignancies in these patients were as follows: breast (n = 132), lung (n = 119), stomach (n = 35), lower gastrointestinal tract (n = 106), pancreas (n = 46), kidney (n = 22), and prostate (n = 101) cancers; high-grade glioma (n = 102); malignant lymphoma (n = 94); multiple myeloma (n = 17); and other tumor types (n = 47). The study end point was occurrence of objectively confirmed symptomatic or fatal VTE. Results VTE occurred in 62 patients (7.6%). The cutoff level for elevated D-dimer and elevated F 1 + 2 was set at the 75th percentile of the total study population. In multivariable analysis that included elevated D-dimer, elevated F 1 + 2, age, sex, surgery, chemotherapy, and radiotherapy, the hazard ratios (HRs) of VTE in patients with elevated D-dimer (HR, 1.8; 95% CI, 1.0 to 3.2; P = .048) and elevated F 1 + 2 (HR, 2.0; 95% CI, 1.2 to 3.6; P = .015) were statistically significantly increased. The cumulative probability of developing VTE after 6 months was highest in patients with both elevated D-dimer and elevated F 1 + 2 (15.2%) compared with patients with nonelevated D-dimer and nonelevated F 1 + 2 (5.0%; P < .001). Conclusion High D-dimer and F 1 + 2 levels independently predict occurrence of VTE in patients with cancer.

Predictive Value of D-Dimer Levels for Venous Thromboembolism in Cancer Patients: Results from the Vienna Cancer and Thrombosis Study (CATS)

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3824-3824
Author(s):  
Cihan Ay ◽  
Rainer Vormittag ◽  
Daniela Dunkler ◽  
Ralph Simanek ◽  
Alexandru-Laurentiu Chiriac ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Predictive Value ◽  
Significant Risk ◽  
Cumulative Probability ◽  
Total Study Population ◽  
Cox Regression Analysis ◽  
Increased Risk ◽  
Diagnosis Of Cancer ◽  
D Dimer

Abstract Venous thromboembolism (VTE) is a frequent complication of cancer, which represents a major cause of morbidity and mortality in cancer patients. Laboratory parameters with a predictive value for VTE could help to assign a patient to a high or low risk group. D-Dimer is a global indicator of coagulation activation and fibrinolysis and is frequently elevated in cancer patients, even without thrombosis. The measurement of D-dimer levels is a widely applied test in the diagnostic work-up of patients with suspected VTE. Prospective observational studies have shown that D-dimer levels have a predictive value for the risk of recurrence in non-cancer patients after the discontinuation of oral anticoagulant treatment. Whether testing for D-Dimer at diagnosis of cancer would be useful for prediction of cancer-associated thrombosis, is not elucidated because up to now appropriately designed prospective studies have not yet been carried out. Therefore, we have assessed D-Dimer levels in cancer patients as risk predictor for VTE and provide a report from the ongoing prospective observational CATS, which was initiated in October 2003. Patients with newly diagnosed cancer or progression of disease that had neither chemotherapy within the last three months, nor radiotherapy nor surgery within the last two weeks were recruited and followed prospectively. Occurrence of VTE and information on the patients’ anti-cancer-treatment within the follow up period were recorded. Observation ended with occurrence of VTE, death or after 2 years. VTE has always been confirmed by imaging. D-Dimer levels were measured with a D-Dimer latex agglutination assay. Kaplan Meier and Cox regression analysis were applied for statistical calculation. Data on 821 patients with cancer (370 women/451 men, median age [IQR]: 62 [53–68] yrs) were available for analyses. Patients were followed for a median observation time of 454 days. Main tumour entities were malignancies of the breast (n=132), lung (n=119), upper (n=35) and lower gastrointestinal tract (n=106), pancreas (n=46), kidney (n=22) and prostate (n=101). Furthermore, 102 patients had high-grade glioma, 94 lymphomas, 17 multiple myeloma and 47 other tumour types. During the observation period VTE occurred in 62 patients (24 female/38 male, median age [IQR]: 60 [50–66] yrs). Elevated levels of D-Dimer (cut-off level 1.44 μg/ml, representing the 75th percentile of the total study population) [hazard ratio (HR): 2.4, 95% CI 1.4–4.0], surgery [HR: 2.3, 95% CI 1.0–5.3] and radiotherapy [HR: 2.3, 95% CI 1.2–4.4] were statistically significant risk factors for VTE in multivariate analysis including D-Dimer, age, sex, surgery, chemotherapy and radiotherapy. The cumulative probability of developing VTE after 6 months was 11.2 % in patients with D-Dimer levels above and 4.2 % in those below the 75th percentile (p=0.003). In conclusion, cancer patients with elevated D-Dimer levels have an approximately 3-fold increased risk for future occurrence of VTE. High levels of D-Dimer independently predict VTE in these patients and D-Dimer measurement at diagnosis of cancer would help identify patients at increased risk for VTE.

High Plasma Levels of Soluble P-Selectin Are Predictive for Venous Thromboembolism in Cancer Patients - Results from the Vienna Cancer and Thrombosis Study (CATS).

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 701-701
Author(s):  
Cihan Ay ◽  
Ralph Simanek ◽  
Rainer Vormittag ◽  
Daniela Dunkler ◽  
Guelay Alguel ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Plasma Levels ◽  
High Plasma ◽  
Cumulative Probability ◽  
Total Study Population ◽  
Cox Regression Analysis ◽  
Increased Risk ◽  
Soluble P ◽  
Observation Period

Abstract Cancer patients are at high risk for venous thromboembolism (VTE), which represents an additional burden and a frequent cause of increased mortality. Laboratory parameters with a predictive value for VTE could help to assign a patient to a high or low risk group. In recent studies the cell adhesion molecule P-selectin was identified to be a strong risk factor for VTE. However, the role of soluble P-selectin (sP-selectin) in cancer-associated VTE is not known because up to now clinical data are not available. Therefore, we assessed sP-selectin plasma levels in cancer patients as a risk predictor for VTE and provide a report from the ongoing prospective observational CATS. Patients with newly diagnosed cancer or progression of disease who had no chemotherapy within the last three months were enrolled from October 2003 to October 2006 and followed prospectively via phone and mail. Occurrence of VTE and information on the patientś anti-cancer-treatment within the follow up period were recorded. VTE has always been confirmed by imaging. sP-selectin levels were measured with a highly sensitive ELISA. Kaplan Meier and Cox regression analysis were applied for statistical calculation. We included 687 patients (319 female/368 male, median age [IQR]: 62 [54–68] yrs) with malignant disease and followed them for a median observation period of 415 days. Main tumour entities were malignancies of the breast (n=125), lung (n=86), upper (n=30) and lower gastrointestinal tract (n=100), pancreas (n=42), kidney (n=19) and prostate (n=72). Furthermore, 80 patients had high-grade glioma, 73 lymphomas, 18 multiple myeloma and 42 other tumour types. Distant metastases were found in 268 patients at the time of recruitment. During the observation period VTE occurred in 45 patients (21 female/24 male, median age [IQR]: 62 [48–66] yrs). Elevated plasma levels of sP-selectin (cut-off level 53.1 ng/mL representing the 75th percentile of the total study population, 173 patients) [hazard ratio (HR): 2.5, 95% CI 1.4 – 4.6], surgery [HR: 3.9, 95% CI 1.8 – 8.5] and radiotherapy [HR: 3.2, 95% CI 1.6 – 6.4] were statistically significant risk factors for VTE in multivariable analysis including sP-selectin, age, sex, surgery, chemotherapy and radiotherapy. The cumulative probability of VTE after 6 months was 11.9% in patients with sP-selectin plasma levels above and 3.7% in those below the 75th percentile. In conclusion, high plasma levels of sP-selectin independently predict VTE in cancer patients. Measurement of sP-selectin at diagnosis of cancer would help to identify patients at increased risk for VTE.

High plasma levels of soluble P-selectin are predictive of venous thromboembolism in cancer patients: results from the Vienna Cancer and Thrombosis Study (CATS)

Blood ◽  
2008 ◽  
Vol 112 (7) ◽  
pp. 2703-2708 ◽  
Author(s):  
Cihan Ay ◽  
Ralph Simanek ◽  
Rainer Vormittag ◽  
Daniela Dunkler ◽  
Guelay Alguel ◽  
...  
Keyword(s):  
Risk Factor ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Plasma Levels ◽  
Multivariable Analysis ◽  
Significant Risk ◽  
Significant Risk Factor ◽  
Cumulative Probability ◽  
Increased Risk ◽  
Soluble P

Abstract Cancer patients are at high risk for venous thromboembolism (VTE). Laboratory parameters with a predictive value for VTE could help stratify patients into high- or low-risk groups. The cell adhesion molecule P-selectin was recently identified as risk factor for VTE. To investigate soluble P-selectin (sP-selectin) in cancer patients as risk predictor for VTE, we performed a prospective cohort study of 687 cancer patients and followed them for a median (IQR) of 415 (221-722) days. Main tumor entities were malignancies of the breast (n = 125), lung (n = 86), gastrointestinal tract (n = 130), pancreas (n = 42), kidney (n = 19), prostate (n = 72), and brain (n = 80); 91 had hematologic malignancies; 42 had other tumors. VTE occurred in 44 (6.4%) patients. In multivariable analysis, elevated sP-selectin (cutoff level, 53.1 ng/mL, 75th percentile of study population) was a statistically significant risk factor for VTE after adjustment for age, sex, surgery, chemotherapy, and radiotherapy (hazard ratio = 2.6, 95% confidence interval, 1.4-4.9, P = .003). The cumulative probability of VTE after 6 months was 11.9% in patients with sP-selectin above and 3.7% in those below the 75th percentile (P = .002). High sP-selectin plasma levels independently predict VTE in cancer patients. Measurement of sP-selectin at diagnosis of cancer could help identify patients at increased risk for VTE.

Tumor Grade Is Associated With Venous Thromboembolism in Patients With Cancer: Results From the Vienna Cancer and Thrombosis Study

2012 ◽  
Vol 30 (31) ◽  
pp. 3870-3875 ◽  
Author(s):  
Jonas Ahlbrecht ◽  
Boris Dickmann ◽  
Cihan Ay ◽  
Daniela Dunkler ◽  
Johannes Thaler ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Cox Regression ◽  
Tumor Grade ◽  
Individual Risk ◽  
Rank Test ◽  
Cumulative Probability ◽  
Low Grade ◽  
High Grade ◽  
Cox Regression Analysis ◽  
Patients With Cancer

Purpose Patients with cancer are at risk of venous thromboembolism (VTE). Tumor-related factors could help estimate patients' individual risk for VTE. Currently, only scarce information on the association between tumor grade and VTE is available. We thus evaluated the role of tumor grade and its association with VTE. Patients and Methods The Vienna Cancer and Thrombosis Study is a prospective, observational cohort study including patients with newly diagnosed cancer or progression of disease after remission. Study end point is the occurrence of symptomatic VTE. Results Seven hundred forty-seven patients with solid tumors received follow-up for a median of 526 days. VTE occurred in 52 patients (7.0%). At study inclusion, 468 patients had low-grade tumors (G1 and G2) and 279 had high-grade tumors (G3 and G4). In multivariable Cox regression analysis including tumor grade, tumor histology, tumor sites, stage, sex, and age, patients with high-grade tumors had a significantly higher risk of VTE compared with those with low-grade tumors (hazard ratio, 2.0; 95% CI, 1.1 to 3.5; P = .015). The cumulative probability of developing VTE after 6 months was higher in patients with high-grade tumors than in those with low-grade tumors (8.2% v 4.0%; log-rank test P = .037). Patients with high-grade tumors had higher D-dimer levels (P = .008) and leukocyte counts (P < .001), and lower hemoglobin levels (P = .008). Conclusion The tumor grade may help identify patients with cancer who are at high risk of VTE. The association of tumor grade with recently identified biomarkers indicates a link between tumor differentiation and pathogenesis of cancer-associated VTE.

Diagnosis and Initial Treatment of Venous Thromboembolism in Patients With Cancer

2009 ◽  
Vol 27 (29) ◽  
pp. 4889-4894 ◽  
Author(s):  
Michael B. Streiff
Keyword(s):  
Venous Thromboembolism ◽  
Initial Treatment ◽  
Vena Cava ◽  
Initial Therapy ◽  
Primary Objective ◽  
Thrombotic Disease ◽  
Venous Stenting ◽  
Patients With Cancer ◽  
Vena Cava Filters ◽  
Increased Risk

Purpose Venous thromboembolism (VTE) is a common complication of cancer and its therapy. The purpose of this article is to review the diagnosis and initial treatment of VTE in the patient with cancer. Methods I conducted a survey of the English-language literature on topics relevant to the diagnosis and initial treatment of VTE in patients with cancer. Results Patients with cancer are at increased risk for VTE because of the presence of multiple risk factors for thrombotic disease. The most common signs and symptoms of VTE as well as the utility of clinical prediction rules and D-dimer testing in the diagnosis of VTE in the patient with cancer are reviewed. Duplex ultrasound and computer tomography angiography are the primary objective diagnostic modalities for VTE. Low molecular weight heparin is the preferred initial therapy for VTE. Until further data emerge, thrombolysis and vena cava filters should be reserved for patients in whom anticoagulation is insufficient or contraindicated. Outpatient management is feasible for carefully selected patients with cancer with deep vein thrombosis (DVT) and low-risk pulmonary embolism. Anticoagulation is the preferred initial therapy for cancer patients with central venous catheter–associated DVT, calf DVT, and unsuspected VTE. Conclusion Optimal initial management of VTE in patients with cancer entails maintaining a high index of suspicion for thrombotic disease, confirming diagnostic suspicions with objective testing and evidence-based use of anticoagulation, and adjunctive therapeutic modalities (thrombolysis, vena cava interruption, venous stenting). Further investigation of initial diagnostic and treatment strategies for VTE focusing on patients with cancer are warranted.

scholarly journals Prevention of venous thromboembolism in cancer patients: current approaches and opportunities for improvement

2011 ◽  
pp. 191-204
Author(s):  
Alpesh N. Amin ◽  
Steven B. Deitelzweig
Keyword(s):  
At Risk ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Assessment Model ◽  
Major Surgery ◽  
Medical Illness ◽  
Patients With Cancer ◽  
Increased Risk ◽  
National Quality ◽  
American Society

Venous thromboembolism (VTE), a common complication in patients with cancer, is associated with increased risk of morbidity, mortality, and recurrent VTE. Risk factors for VTE in cancer patients include the type and stage of cancer, comorbidities, age, major surgery, and active chemotherapy. Evidence-based guidelines for thromboprophylaxis in cancer patients have been published: the National Comprehensive Cancer Network and American Society for Clinical Oncology guidelines recommend thromboprophylaxis for hospitalized cancer patients, while the American College of Chest Physician guidelines recommend thromboprophylaxis for surgical patients with cancer and bedridden cancer patients with an acute medical illness. Guidelines do not generally recommend routine thromboprophylaxis in ambulatory patients during chemotherapy, but there is evidence that some of these patients are at risk of VTE; some may be at higher risk while on active chemotherapy. Approaches are needed to identify those patients most likely to benefit from thromboprophylaxis, and, to this end, a risk assessment model has been developed and validated. Despite the benefits, many at-risk patients do not receive any thromboprophylaxis, or receive prophylaxis that is not compliant with guideline recommendations. Quality improvement initiatives have been developed by the Centers for Medicare and Medicaid Services, National Quality Forum, and Joint Commission to encourage closure of the gap between guideline recommendations and clinical practice for prevention, diagnosis, and treatment of VTE in hospitalized patients. Health-care institutions and providers need to take seriously the burden of VTE, improve prophylaxis rates in patients with cancer, and address the need for prophylaxis across the patient continuum.

scholarly journals Prevention of venous thromboembolism in cancer patients: current approaches and opportunities for improvement

2011 ◽  
Vol 5 (3) ◽  
pp. 191
Author(s):  
Alpesh N. Amin ◽  
Steven B. Deitelzweig
Keyword(s):  
At Risk ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Assessment Model ◽  
Major Surgery ◽  
Medical Illness ◽  
Patients With Cancer ◽  
Increased Risk ◽  
National Quality ◽  
American Society

Venous thromboembolism (VTE), a common complication in patients with cancer, is associated with increased risk of morbidity, mortality, and recurrent VTE. Risk factors for VTE in cancer patients include the type and stage of cancer, comorbidities, age, major surgery, and active chemotherapy. Evidence-based guidelines for thromboprophylaxis in cancer patients have been published: the National Comprehensive Cancer Network and American Society for Clinical Oncology guidelines recommend thromboprophylaxis for hospitalized cancer patients, while the American College of Chest Physician guidelines recommend thromboprophylaxis for surgical patients with cancer and bedridden cancer patients with an acute medical illness. Guidelines do not generally recommend routine thromboprophylaxis in ambulatory patients during chemotherapy, but there is evidence that some of these patients are at risk of VTE; some may be at higher risk while on active chemotherapy. Approaches are needed to identify those patients most likely to benefit from thromboprophylaxis, and, to this end, a risk assessment model has been developed and validated. Despite the benefits, many at-risk patients do not receive any thromboprophylaxis, or receive prophylaxis that is not compliant with guideline recommendations. Quality improvement initiatives have been developed by the Centers for Medicare and Medicaid Services, National Quality Forum, and Joint Commission to encourage closure of the gap between guideline recommendations and clinical practice for prevention, diagnosis, and treatment of VTE in hospitalized patients. Health-care institutions and providers need to take seriously the burden of VTE, improve prophylaxis rates in patients with cancer, and address the need for prophylaxis across the patient continuum.

scholarly journals Preventing Venous Thromboembolism in Ambulatory Patients with Cancer: A Narrative Review

Cancers ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 612 ◽  
Author(s):  
Anne Rossel ◽  
Helia Robert-Ebadi ◽  
Christophe Marti
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Absolute Risk ◽  
Narrative Review ◽  
Relative Reduction ◽  
Number Needed To Treat ◽  
Chemotherapeutic Regimen ◽  
Patients With Cancer ◽  
Increased Risk ◽  
Risk Of Cancer

Venous thromboembolism (VTE) is frequent among patients with cancer. Ambulatory cancer patients starting chemotherapy have a 5% to 10% risk of cancer associated thrombosis (CAT) within the first year after cancer diagnosis. This risk may vary according to patient characteristics, cancer location, cancer stage, or the type of chemotherapeutic regimen. Landmark studies evaluating thrombophrophylaxis with low molecular weight heparin (LMWH) for ambulatory cancer patients have shown a relative reduction in the rate of symptomatic VTE of about one half. However, the absolute risk reduction is modest among unselected patients given a rather low risk of events resulting in a number needed to treat (NNT) of 40 to 50. Moreover, this modest benefit is mitigated by a trend towards an increased risk of bleeding, and the economic and patient burden due to daily injections of LMWH. For these reasons, routine thromboprophylaxis is not recommended by expert societies. Advances in VTE risk stratification among cancer patients, and growing evidence regarding efficacy and safety of direct oral anticoagulants (DOACs) for the treatment and prevention of CAT have led to reconsider the paradigms of this risk–benefit assessment. This narrative review aims to summarize the recent evidence provided by randomized trials comparing DOACs to placebo in ambulatory cancer patients and its impact on expert recommendations and clinical practice.

scholarly journals Outcomes beyond the Third Month of Anticoagulation in Patients Aged >75 Years with a First Episode of Unprovoked Venous Thromboembolism

TH Open ◽  
2018 ◽  
Vol 02 (04) ◽  
pp. e428-e436 ◽  
Author(s):  
Amaia Iñurrieta ◽  
José Pedrajas ◽  
Manuel Núñez ◽  
Luciano López-Jiménez ◽  
Alba Velo-García ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Multivariable Analysis ◽  
First Episode ◽  
Vein Thrombosis ◽  
The Third ◽  
Fatal Bleeding ◽  
Increased Risk ◽  
Deep Vein

Background The ideal duration of anticoagulant therapy in elderly patients with unprovoked venous thromboembolism (VTE) has not been consistently evaluated. Methods We used the RIETE (Registro Informatizado Enfermedad TromboEmbólica) registry to compare the rate and severity of pulmonary embolism (PE) recurrences versus major bleeding beyond the third month of anticoagulation in patients >75 years with a first episode of unprovoked VTE. Results As of September 2017, 7,830 patients were recruited: 5,058 (65%) presented with PE and 2,772 with proximal deep vein thrombosis (DVT). During anticoagulant therapy beyond the third month (median, 113 days), 44 patients developed PE recurrences, 36 developed DVT recurrences, 101 had major bleeding, and 241 died (3 died of recurrent PE and 19 of bleeding). The rate of major bleeding was twofold higher than the rate of PE recurrences (2.05 [95% confidence interval, CI: 1.68–2.48] vs. 0.90 [95% CI: 0.66–1.19] events per 100 patient-years) and the rate of fatal bleeding exceeded the rate of fatal PE events (0.38 [95% CI: 0.24–0.58] vs. 0.06 [95% CI: 0.02–0.16] deaths per 100 patient-years). On multivariable analysis, patients who had bled during the first 3 months (hazard ratio [HR]: 4.32; 95% CI: 1.58–11.8) or with anemia at baseline (HR: 1.87; 95% CI: 1.24–2.81) were at increased risk for bleeding beyond the third month. Patients initially presenting with PE were at increased risk for PE recurrences (HR: 3.60; 95% CI: 1.28–10.1). Conclusion Prolonging anticoagulation beyond the third month was associated with more bleeds than PE recurrences. Prior bleeding, anemia, and initial VTE presentation may help decide when to stop therapy.

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