Hospital volume and outcomes for acute pulmonary embolism: multinational population based cohort study

Jiménez, David; Bikdeli, Behnood; Quezada, Andrés; Muriel, Alfonso; Lobo, José Luís; Miguel‐Díez, Javier de; Jara‐Palomares, Luis; Ruiz-Artacho, Pedro; Yusen, Roger D.; Monreal, Manuel

doi:10.1136/bmj.l4416

Cited by 47 publications

(36 citation statements)

References 24 publications

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“…A number of variables, identified by several articles, including age, cancer, history of bleeding, anemia, thrombocytopenia, renal insufficiency, intensity and duration of anticoagulant therapy or use of concomitant drugs, have been associated with a worse outcome in patients with VTE. 1,2 However, the role of platelet count in the outcome in patients treated for VTE is still matter of discussion.…”

Section: The Risk Of Bleeding During Anticoagulationmentioning

confidence: 99%

<p>Platelet Count and Bleeding in Patients Receiving Anticoagulant Therapy for Venous Thromboembolism: Lesson from the RIETE Registry</p>

Micco¹,

Monreal²

2020

JBM

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Major bleeding is one of the most dangerous complications for patients undergoing anticoagulant treatment for VTE. Several clinical scores have been planned to identify patients at higher risk of bleeding, and most of them take into consideration the number of platelets in particular if lower than normal. Here we report the clinical experience made with the RIETE registry concerning anticoagulant treatment in the presence of different values of platelets and their related risk of bleeding.

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Section: The Risk Of Bleeding During Anticoagulationmentioning

confidence: 99%

<p>Platelet Count and Bleeding in Patients Receiving Anticoagulant Therapy for Venous Thromboembolism: Lesson from the RIETE Registry</p>

Micco¹,

Monreal²

2020

JBM

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“…We observed a continuous decrease in IHM from 2001 to 2018, a finding consistent with the decreasing trend reported by Barco et al when they analyzed vital registration data from the WHO Mortality Database (2000–2015) [ 8 ]. Among potential explanations are the temporal changes in pharmacological and interventional treatments for PE [ 9 ] and more effective referral to high-volume centers [ 38 ].…”

Section: Discussionmentioning

confidence: 99%

Changing Trends in Hospital Admissions for Pulmonary Embolism in Spain from 2001 to 2018

Miguel‐Díez

Albaladejo-Vicente

López‐de‐Andrés

et al. 2020

JCM

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(1) Background: The aims of this study were to examine trends in the incidence, clinical characteristics, and in-hospital outcomes of patients hospitalized with pulmonary embolism in Spain and to identify factors associated with in-hospital mortality (IHM). (2) Methods: We included all patients who were hospitalized for pulmonary embolism between 2001 and 2018. Data were collected from the Spanish National Hospital Discharge Database. (3) Results: We identified 241,821 hospitalizations for pulmonary embolism during the study period. The incidence of pulmonary embolism increased from 20.49 cases per 100,000 inhabitants in the period 2001–2002 to 35.9 cases in the period 2017–2018 (p < 0.001). After controlling for possible confounders, there was a significant increase in the incidence over the study period (adjusted incidence rate ratio 1.53, 95% Confidence Interval I 1.51–1.56). The median length of hospital stay was 11 days in the period 2001–2002, decreasing to seven days in the period 2017–2018 (p < 0.001). For the total time period, the crude IHM rate was 9.51%. After multivariable adjustment, IHM decreased significantly over time. The IHM was significantly higher in women, in patients suffering from more comorbidities, and in those with a massive pulmonary embolism. (4) Conclusions: Our results revealed an increase in the incidence of pulmonary embolism hospitalizations from 2001 to 2018 in Spain, with older patients being the most affected.

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“…12,13 In the current study, we used the data from the Registro Informatizado Enfermedad TromboEmbólica (RIETE), a prospective multinational registry of patients with objectively confirmed VTE (ClinicalTrials.gov identifier: NCT02832245), to assess the efficacy and safety of edoxaban for long-term therapy of VTE in real-life clinical practice. 14,15 According to the product label, the recommended dose of edoxaban for long-term therapy is 60 mg daily, but this dose should be reduced to 30 mg daily in patients with creatinine clearance (CrCl) levels 15-50 mL/minute, body weight ≤ 60 kg, or concomitant use of P-glycoprotein inhibitors, because they are perceived as being at increased risk for bleeding. Thus, we compared the rate of the composite of VTE recurrences or major bleeding during the course of edoxaban therapy in patients receiving recommended vs. non-recommended doses of edoxaban.…”

Section: Study Highlightsmentioning

confidence: 99%

Edoxaban for the Long‐Term Therapy of Venous Thromboembolism: Should the Criteria for Dose Reduction be Revised?

Camporese

Simioni

Micco

et al. 2020

Clinical Translational Sci

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Edoxaban is used for venous thromboembolism (VTE) treatment. Real-life data are lacking about its use in long-term therapy. We aimed to assess the efficacy and the safety of edoxaban for long-term VTE treatment in a real-life setting. Patients with VTE included in the Registro Informatizado Enfermedad TromboEmbólica (RIETE) registry, receiving edoxaban 60 or 30 mg daily were prospectively followed up to validate the benefit of using different dosages. The main outcome was the composite of VTE recurrences or major bleeding in patients with or without criteria for dose reduction. Multivariable analysis to identify predictors for the composite outcome was performed. From October 2015 to November 2019, 562 patients received edoxaban for long-term therapy. Most (94%) of the 416 patients not meeting criteria for dose reduction received 60 mg daily, and 92 patients meeting criteria (63%) received 30 mg daily. During treatment, two patients developed recurrent VTE, six had major bleeding and nine died (2 from fatal bleeding). Among patients not meeting criteria for dose reduction, those receiving 30 mg daily had a higher rate of the composite event (hazard ratio (HR) 8.37; 95% confidence interval (CI) 1.12-42.4) and a significant higher mortality rate (HR 31.1; 95% CI 4.63-262) than those receiving 60 mg. Among patients meeting criteria for dose reduction, those receiving 60 mg daily had no events, and a nonsignificantly higher mortality rate (HR 5.04; 95% CI 0.54-133) than those receiving 30 mg daily. In conclusion, edoxaban seems to be effective and safe for long-term VTE treatment in real life. Criteria for dose reduction should be reformulated. Current guidelines of antithrombotic therapy, 1,2 based on the evidence from randomized trials, 3-7 recommend the use of direct oral anticoagulants (DOACs) as initial and long-term therapy in patients with venous thromboembolism (VTE). However, the pivotal trials where their indication was based applied strict exclusion criteria, aimed to exclude patients with a presumed high risk of bleeding. The International Regulatory Authorities encourage the pharmaceutical companies to develop postauthorization safety studies that should start shortly after the approval of the

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Hospital volume and outcomes for acute pulmonary embolism: multinational population based cohort study

Cited by 47 publications

References 24 publications

<p>Platelet Count and Bleeding in Patients Receiving Anticoagulant Therapy for Venous Thromboembolism: Lesson from the RIETE Registry</p>

<p>Platelet Count and Bleeding in Patients Receiving Anticoagulant Therapy for Venous Thromboembolism: Lesson from the RIETE Registry</p>

Changing Trends in Hospital Admissions for Pulmonary Embolism in Spain from 2001 to 2018

Edoxaban for the Long‐Term Therapy of Venous Thromboembolism: Should the Criteria for Dose Reduction be Revised?

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