Faculty of Medicine
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Item type:Publication, COVID-19-associated venous thromboembolism: risk of recurrence and major bleeding(Elsevier BV, 2023-10) ;Demelo-Rodriguez, Pablo ;Alonso-Beato, Rubén ;Jara-Palomares, Luis ;Galeano-Valle, FranciscoBura-Riviere, AlessandraComplications under anticoagulant treatment in patients with COVID-19-associated venous thromboembolism (VTE) have not been consistently reported. - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Inferior vena cava agenesis in patients with lower limb deep vein thrombosis in the RIETE registry. When and why to suspect(Elsevier BV, 2020-04-15) ;Tufano, Antonella ;López-Jiménez, Luciano ;Bikdeli, Behnood ;García-Bragado, FernandoMazzolai, LuciaLimited data exist about the clinical presentation and outcomes of patients with inferior vena cava agenesis (IVCA) who develop deep vein thrombosis (DVT). - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Systolic blood pressure and mortality in acute symptomatic pulmonary embolism(Elsevier, 2020) ;Quezada A, ;Jiménez D, ;Bikdeli B, ;Moores L,Porres-Aguilar M,Background: The optimal cutoff for systolic blood pressure (SBP) level to define high-risk pulmonary embolism (PE) remains to be defined. Methods: To evaluate the relationship between SBP levels on admission and mortality in patients with acute symptomatic PE, the current study included 39,257 consecutive patients with acute symptomatic PE from the RIETE registry between 2001 and 2018. Primary outcomes included all-cause and PE-specific 30-day mortality. Secondary outcomes included major bleeding and recurrent venous thromboembolism (VTE). Results: There was a linear inverse relationship between admission SBP and 30-day all-cause and PE-related mortality that persisted after multivariable adjustment. Patients in the lower SBP strata had higher rates of all-cause death (reference: SBP 110-129 mmHg) (adjusted odds ratio [OR] 2.9; 95% confidence interval [CI], 2.0-4.2 for SBP <70 mmHg; and OR 1.7; 95% CI, 1.4-2.1 for SBP 70-89 mmHg). The findings for 30-day PE-related mortality were similar (adjusted OR 4.4; 95% CI, 2.7-7.2 for SBP <70 mmHg; and OR 2.6; 95% CI, 1.9-3.4 for SBP 70-89 mmHg). Patients in the higher strata of SBP had significantly lower rates of 30-day all-cause mortality compared with the same reference group (adjusted OR 0.7; 95% CI, 0.5-0.9 for SBP 170-190 mmHg; and OR 0.6; 95% CI, 0.4-0.9 for SBP >190 mmHg). Consistent findings were also observed for 30-day PE-related death. Conclusions: In patients with acute symptomatic PE, a low SBP portends an increased risk of all-cause and PE-related mortality. The highest mortality was observed in patients with SBP <70 mmHg. - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Management and outcome of major bleeding in patients receiving vitamin K antagonists for venous thromboembolism(Elsevier BV, 2018-11) ;Moustafa, Farès ;Stehouwer, Alexander ;Kamphuisen, Pieter ;Sahuquillo, Joan CarlesSampériz, ÁngelBackground: The optimal management of major bleeding in patients receiving vitamin K antagonists (VKA) for venous thromboembolism (VTE) is unclear. Methods: We used the RIETE (Registro Informatizado Enfermedad TromboEmbólica) registry to assess the management and 30-day outcomes after major bleeding in patients receiving VKA for VTE. Results: From January 2013 to December 2017, 267 of 18,416 patients (1.4%) receiving long-term VKA for VTE had a major bleeding (in the gastrointestinal tract 78, intracranial 72, hematoma 50, genitourinary 20, other 47). Overall, 151 patients (57%) received blood transfusion; 110 (41%) vitamin K; 37 (14%) fresh frozen plasma; 29 (11%) pro-haemostatic agents and 20 (7.5%) a vena cava filter. During the first 30 days, 59 patients (22%) died (41 died of bleeding) and 13 (4.9%) had a thrombosis. On multivariable analysis, patients with intracranial bleeding (hazard ratio [HR]: 4.58; 95%CI: 2.40-8.72) and those with renal insufficiency at baseline (HR: 2.73; 95%CI: 1.45-5.15) had an increased mortality risk, whereas those receiving vitamin K had a lower risk (HR: 0.47; 0.24-0.92). On the other hand, patients receiving fresh frozen plasma were at increased risk for thrombotic events (HR: 4.22; 95%CI: 1.25-14.3). Conclusions: Major bleeding in VTE patients receiving VKA carries a high mortality rate. Intracranial bleeding and renal insufficiency increased the risk. Fresh frozen plasma seems to increase this risk for recurrent VTE.Background: The optimal management of major bleeding in patients receiving vitamin K antagonists (VKA) for venous thromboembolism (VTE) is unclear. Methods: We used the RIETE (Registro Informatizado Enfermedad TromboEmbólica) registry to assess the management and 30-day outcomes after major bleeding in patients receiving VKA for VTE. Results: From January 2013 to December 2017, 267 of 18,416 patients (1.4%) receiving long-term VKA for VTE had a major bleeding (in the gastrointestinal tract 78, intracranial 72, hematoma 50, genitourinary 20, other 47). Overall, 151 patients (57%) received blood transfusion; 110 (41%) vitamin K; 37 (14%) fresh frozen plasma; 29 (11%) pro-haemostatic agents and 20 (7.5%) a vena cava filter. During the first 30 days, 59 patients (22%) died (41 died of bleeding) and 13 (4.9%) had a thrombosis. On multivariable analysis, patients with intracranial bleeding (hazard ratio [HR]: 4.58; 95%CI: 2.40-8.72) and those with renal insufficiency at baseline (HR: 2.73; 95%CI: 1.45-5.15) had an increased mortality risk, whereas those receiving vitamin K had a lower risk (HR: 0.47; 0.24-0.92). On the other hand, patients receiving fresh frozen plasma were at increased risk for thrombotic events (HR: 4.22; 95%CI: 1.25-14.3). Conclusions: Major bleeding in VTE patients receiving VKA carries a high mortality rate. Intracranial bleeding and renal insufficiency increased the risk. Fresh frozen plasma seems to increase this risk for recurrent VTE. - Some of the metrics are blocked by yourconsent settings
Item type:Publication, 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. - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Development of a Risk Prediction Score for Occult Cancer in Patients With VTE(Elsevier, 2016) ;Jara-Palomares L, ;Otero R, ;Jimenez D, ;Carrier M,Tzoran I,Background: The benefits of a diagnostic workup for occult cancer in patients with VTE are controversial. Our aim was to provide and validate a risk score for occult cancer in patients with VTE. Methods: We designed a nested case-control study in a cohort of patients with VTE included in the RIETE (Registro Informatizado Enfermedad TromboEmbólica) registry from 2001 to 2014. Cases included cancer detected beyond the first 30 days and up to 24 months after VTE. Control subjects were defined as patients with VTE with no cancer in the same period. Results: Of 5,863 eligible patients, 444 (7.6%; 95% CI, 6.8%-8.2%) were diagnosed with occult cancer. On multivariable analysis, variables selected were male sex, age > 70 years, chronic lung disease, anemia, elevated platelet count, prior VTE, and recent surgery. We built a risk score assigning points to each variable. Internal validity was confirmed using bootstrap analysis. The proportion of patients with cancer who scored ≤ 2 points was 5.8% (241 of 4,150) and that proportion in those who scored ≥ 3 points was 12% (203 of 1,713). We also identified scores divided by sex and age subgroups. Conclusions: This is the first risk score that has identified patients with VTE who are at increased risk for occult cancer. Our score needs to be externally validated. - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Clinical outcomes during anticoagulant therapy in fragile patients with venous thromboembolism.(2017) ;Moustafa F ;Giorgi Pierfranceschi M ;Di Micco P ;Bucherini ELorenzo ABackground Subgroup analyses from randomized trials suggested favorable results for the direct oral anticoagulants in fragile patients with venous thromboembolism (VTE). The frequency and natural history of fragile patients with VTE have not been studied yet. Objectives To compare the clinical characteristics, treatment and outcomes during the first 3 months of anticoagulation in fragile vs non‐fragile patients with VTE. Methods Retrospective study using consecutive patients enrolled in the RIETE (Registro Informatizado Enfermedad TromboEmbolica) registry. Fragile patients were defined as those having age ≥75 years, creatinine clearance (CrCl) levels ≤50 mL/min, and/or body weight ≤50 kg. Results From January 2013 to October 2016, 15 079 patients were recruited. Of these, 6260 (42%) were fragile: 37% were aged ≥75 years, 20% had CrCl levels ≤50 mL/min, and 3.6% weighed ≤50 kg. During the first 3 months of anticoagulant therapy, fragile patients had a lower risk of VTE recurrences (0.78% vs 1.4%; adjusted odds ratio [OR]: 0.52; 95% confidence intervals [CI]: 0.37‐0.74) and a higher risk of major bleeding (2.6% vs 1.4%; adjusted OR: 1.41; 95% CI: 1.10‐1.80), gastrointestinal bleeding (0.86% vs 0.35%; adjusted OR: 1.84; 95% CI: 1.16‐2.92), haematoma (0.51% vs 0.07%; adjusted OR: 5.05; 95% CI: 2.05‐12.4), all‐cause death (9.2% vs 3.5%; adjusted OR: 2.02; 95% CI: 1.75‐2.33), or fatal PE (0.85% vs 0.35%; adjusted OR: 1.77; 95% CI: 1.10‐2.85) than the non‐fragile. Conclusions In real life, 42% of VTE patients were fragile. During anticoagulation, they had fewer VTE recurrences and more major bleeding events than the non‐fragile. - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Outcomes Associated With Inferior Vena Cava Filters Among Patients With Thromboembolic Recurrence During Anticoagulant Therapy.(Elsevier, 2016) ;Mellado M ;Pijoan JI ;Jiménez D ;Muriel AAujesky DObjectives: The aim of this study was to assess the effectiveness of inferior vena cava (IVC) filter use among patients who develop recurrent symptomatic venous thromboembolism (VTE) on anticoagulant therapy. Background: There is a lack of efficacy evidence of IVC filter therapy in patients with VTE recurrence on anticoagulant therapy. Methods: In this cohort study of patients with acute VTE identified from the RIETE (Registro Informatizado de la Enfermedad Tromboembólica) registry, the associations between IVC filter placement for VTE recurrence in the first 3 months of anticoagulant therapy and the outcomes of all-cause mortality, pulmonary embolism (PE)-related mortality, second recurrent VTE, and major bleeding rates through 30 days after diagnosis of recurrence were assessed. Results: Among 17 patients treated with filters and 49 matched patients treated without filters for VTE recurrence that presented as deep vein thrombosis, propensity score-matched groups showed no significant differences in death for filter insertion compared with no insertion (17.7% vs. 12.2%; p = 0.56). Among 48 patients treated with filters and 91 matched patients treated without filters for VTE recurrence that presented as PE, propensity score-matched groups showed a significant decrease in all-cause death for filter insertion compared with no insertion (2.1% vs. 25.3%; p = 0.02). The PE-related mortality rate was not significantly lower for filter insertion than no insertion (2.1% vs. 17.6%; p = 0.08), though the point estimates markedly differed. Conclusions: Among patients with VTE recurrence during the first 3 months of anticoagulant therapy, IVC filter insertion was not associated with a survival benefit in patients who recurred with deep vein thrombosis, although it was associated with a lower risk for all-cause death in patients who recurred with PE. - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Real-life treatment of venous thromboembolism with direct oral anticoagulants: The influence of recommended dosing and regimens(Thieme Medical Publishers, 2017) ;Trujillo-Santos J ;Di Micco P ;Dentali F ;Douketis JDíaz-Peromingo JAIn patients with venous thromboembolism (VTE), the influence on outcome of using direct oral anticoagulants (DOACs) at non-recommended doses or regimens (once vs twice daily) has not been investigated yet. We used the RIETE (Registro Informatizado Enfermedad TromboEmbólica) registry to compare the outcomes in patients with VTE receiving DOACs according to the recommendations of the product label versus in those receiving non-recommended doses and/or regimens. The major outcomes were the rate of VTE recurrences, major bleeding and death during the course of therapy. As of March 2016, 1635 VTE patients had received DOACs for initial therapy and 1725 for long-term therapy. For initial therapy, 287 of 1591 patients (18 %) on rivaroxaban and 22 of 44 (50 %) on apixaban did not receive the recommended therapy. For long-term therapy, 217 of 1611 patients (14 %) on rivaroxaban, 29 of 81 (36 %) on apixaban and 15 of 33 (46 %) on dabigatran did not receive the recommended therapy. During the course of therapy with DOACs, eight patients developed VTE recurrences, 14 had major bleeding and 13 died. Patients receiving DOACs at non-recommended doses and/or regimens experienced a higher rate of VTE recurrences (adjusted HR: 10.5; 95 %CI: 1.28-85.9) and a similar rate of major bleeding (adjusted HR: 1.04; 95 %CI: 0.36-3.03) or death (adjusted HR: 1.41; 95 %CI: 0.46-4.29) than those receiving the recommended doses and regimens. In our cohort, a non-negligible proportion of VTE patients received non-recommended doses and/or regimens of DOACs. This use may be associated with worse outcomes. - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Recurrence of venous thromboembolism in patients with recent gestational deep vein thrombosis or pulmonary embolism: Findings from the RIETE Registry(Elsevier, 2016) ;Barillari G ;Londero AP ;Brenner B ;Nauffal DMuñoz-Torrero JFIntroduction: The aim of this study was to investigate the recurrence rate of venous thromboembolism (VTE) and the prevalence of major bleeding or death in patients with previous VTE in pregnancy and puerperium. Risk factors for VTE recurrence were also assessed. Materials and methods: We evaluated a cohort of patients enrolled in the international, multicenter, prospective Registro Informatizado de la Enfermedad Trombo-Embólica (RIETE) registry with objectively confirmed VTE. Results: In the registry, 607 women were presenting with VTE that occurred during pregnancy or puerperium. The 2-year VTE recurrence rate was 3.3% (CI: 95 1.5-5.0%) and the recurrent VTE incidence rate was 2.28events/100 patients-year. Among the 16 cases of VTE recurrence 11 cases appeared during drug treatment while only five cases were diagnosed after therapy discontinuation. No significant difference was found in treatment duration among these two subgroups of VTE recurrence cases and women without recurrence. Furthermore, the use of thrombolytics and inferior vena cava filter in initial treatment was associated to an increased risk of VTE recurrence. Conclusions: The current study provides new insights on VTE recurrence rate in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) that occurred in pregnancy or postpartum period. These findings can contribute to risk assessment of thrombotic burden, thereby allowing for better decision making regarding antithrombotic management in this clinical setting.
