Faculty of Medicine

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    Uterine bleeding during anticoagulation in women with venous thromboembolism.
    (Elsevier, 2017)
    Moustafa F,
    ;
    Fernández S,
    ;
    Fernández-Capitán C,
    ;
    Nieto JA,
    ;
    Pedrajas JM,
    Background: Women presenting with uterine bleeding during the course of anticoagulant therapy for venous thromboembolism (VTE) present a difficult therapeutic dilemma due to the absence of evidence-based recommendations. Methods: We used the RIETE (Registro Informatizado Enfermedad TromboEmbólica) database to assess the clinical characteristics of women presenting with uterine bleeding during anticoagulation for VTE, its frequency, time course, management and 30-day outcomes. Results: As of October 2016, 31,951 women with VTE were recruited in RIETE. During the course of anticoagulant therapy, 53 (0.17%) developed major uterine bleeding, 118 (0.37%) non-major uterine bleeding and 948 (2.97%) had major bleeding in other sites. Median time elapsed from VTE to bleeding was: 32, 71 and 22 days, respectively. Mean age was: 56±17, 52±20 and 75±14 years, respectively. Women with major uterine bleeding more likely had cancer (51%), anemia (72%), raised platelet count (19%) or recent major bleeding (11%) at VTE presentation than those in the other subgroups. During the first 30 days after bleeding, 17%, 1.7% and 31% of women died, respectively. Of 11 women with uterine bleeding who died, 9 (82%) had cancer, two (18%) died of bleeding and one (9.1%) died of pulmonary embolism after discontinuing anticoagulation. Conclusions: Uterine bleeding during the course of anticoagulation for VTE is not uncommon and mostly affects young women. Those with cancer, anaemia, raised platelet count or recent bleeding at baseline are at an increased risk for uterine bleeding during anticoagulation.
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    Outcome of Patients with Venous Thromboembolism and Factor V Leiden or Prothrombin 20210 Carrier Mutations During the Course of Anticoagulation.
    (Elsevier, 2017)
    Tzoran I
    ;
    Papadakis M
    ;
    Brenner B
    ;
    Fidalgo Á
    ;
    Rivas A
    Background: Individuals with factor V Leiden or prothrombin G20210A mutations are at a higher risk to develop venous thromboembolism. However, the influence of these polymorphisms on patient outcome during anticoagulant therapy has not been consistently explored. Methods: We used the Registro Informatizado de Enfermedad TromboEmbólica database to compare rates of venous thromboembolism recurrence and bleeding events occurring during the anticoagulation course in factor V Leiden carriers, prothrombin mutation carriers, and noncarriers. Results: Between March 2001 and December 2015, 10,139 patients underwent thrombophilia testing. Of these, 1384 were factor V Leiden carriers, 1115 were prothrombin mutation carriers, and 7640 were noncarriers. During the anticoagulation course, 160 patients developed recurrent deep vein thrombosis and 94 patients developed pulmonary embolism (16 died); 154 patients had major bleeding (10 died), and 291 patients had nonmajor bleeding. On multivariable analysis, factor V Leiden carriers had a similar rate of venous thromboembolism recurrence (adjusted hazard ratio [HR], 1.16; 95% confidence interval [CI], 0.82-1.64), half the rate of major bleeding (adjusted HR, 0.50; 95% CI, 0.25-0.99) and a nonsignificantly lower rate of nonmajor bleeding (adjusted HR, 0.66; 95% CI, 0.43-1.01) than noncarriers. Prothrombin mutation carriers and noncarriers had a comparable rate of venous thromboembolism recurrence (adjusted HR, 1.00; 95% CI, 0.68-1.48), major bleeding (adjusted HR, 0.75; 95% CI, 0.42-1.34), and nonmajor bleeding events (adjusted HR, 1.10; 95% CI, 0.77-1.57). Conclusions: During the anticoagulation course, factor V Leiden carriers had a similar risk for venous thromboembolism recurrence and half the risk for major bleeding compared with noncarriers. This finding may contribute to decision-making regarding anticoagulation duration in selected factor V Leiden carriers with venous thromboembolism.
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    The Clinical Course of Venous Thromboembolism May Differ According to Cancer Site.
    (Elsevier, 2016)
    Mahé I
    ;
    Chidiac J
    ;
    Bertoletti L
    ;
    Font C
    ;
    Trujillo-Santos J
    Background: We hypothesized that the clinical course of venous thromboembolism in patients with active cancer may differ according to the specificities of primary tumor site. Aim and methods: We used data from RIETE (international registry of patients with venous thromboembolism) to compare the clinical venous thromboembolism-related outcomes during the course of anticoagulation in patients with one of the 4 more frequent cancers (breast, prostate, colorectal, or lung cancer). Results: As of September 2014, 3947 cancer patients were recruited, of whom 938 had breast, 629 prostate, 1189 colorectal, and 1191 lung cancer. Overall, 55% had metastatic disease (42%, 36%, 53%, and 72%, respectively). During the course of anticoagulant therapy (mean duration, 139 days), the rate of thromboembolic recurrences was similar to the rate of major bleeding in patients with breast (5.6 [95% confidence interval (CI), 3.8-8.1] vs 4.1 [95% CI, 2.7-5.9] events per 100 patient-years) or colorectal cancer (10 [95% CI, 7.6-13] vs 12 [95% CI, 9.4-15] per 100 patient-years). In contrast, in patients with prostate cancer, the rate of venous thromboembolic recurrences was half the rate of major bleeding (6.9 [95% CI, 4.4-10] vs 13 [95% CI, 9.2-17] events per 100 patient-years), whereas in those with lung cancer, the rate of thromboembolic recurrences was twofold higher than the rate of major bleeding (27 [95% CI, 22-23] vs 11 [95% CI, 8.6-15] per 100 patient-years). Conclusions: Significant differences in the clinical profile of venous thromboembolic-related outcomes were observed according to the site of cancer. These findings suggest the development of cancer-specific anticoagulant strategies as an area for further research.
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    Venous thromboembolism in patients with glioblastoma multiforme: Findings of the RIETE registry
    (Elsevier, 2015)
    Portillo J
    ;
    de la Rocha VI
    ;
    Font L
    ;
    Braester A
    ;
    Madridano O
    Background: There is uncertainty about the optimal therapy of venous thromboembolism (VTE) in patients with glioblastoma multiforme (GBM). Methods: We used the RIETE (Registro Informatizado Enfermedad TromboEmbólica) database to compare the rate of VTE recurrences and major bleeding during the course of anticoagulation in patients with GBM, other cancers and in patients without cancer. Results: As of September 2014, 53,546 patients have been recruited in RIETE. Of these, 72 (0.13%) had GBM and 11,811 (22%) had other cancers. Most patients in all 3 subgroups received initial therapy with low-molecular-weight heparin (LMWH), but those with GBM received slightly lower doses than those with other cancers or without cancer. Then, most patients with GBM continued on LMWH for long-term therapy, at similar doses than those in the other subgroups. During the course of anticoagulation (mean, 202 days), 3 patients with GBM presented VTE recurrences (10.9 per 100 patient-years; 95% CI: 2.76-29.5) and 4 suffered major bleeding (one intracranial) (14.5 bleeds per 100 patient-years; 95%CI: 4.60-34.9). Compared with patients with other cancers, those with GBM had a similar rate of VTE recurrences and major bleeds, but had a higher rate of extracranial hematoma (p<0.05). Compared with VTE patients without cancer, those with GBM had a higher rate of PE recurrences (p<0.01) and major bleeding (p<0.001), particularly extracranial hematoma (p<0.001). Conclusions: Patients with GBM and VTE had a similar rate of VTE recurrences or major bleeds during the course of anticoagulant therapy than those with other cancers.