Fatal bleeding in patients receiving anticoagulant therapy for venous thromboembolism: findings from the RIETE registry

Nieto, José Antonio; Solano, Rosario; Ruiz-Ribó, María Dolores; Ruíz-Giménez, Nuria; Prandoni, Paolo; Kearon, Clive; Monreal, M.

doi:10.1111/j.1538-7836.2010.03852.x

Cited by 177 publications

(133 citation statements)

References 18 publications

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“…Our data confirm that the use of anticoagulant therapy carries a higher risk to bleed than to recur in the elderly and in the renally impaired, as previously reported 14, 21, 22, 23, 24, 25. During initial therapy with LMWH, fragile patients weighing ≤50 kg received slightly higher (non‐significantly) mean daily doses per body weight of LMWH compared with non‐fragile patients.…”

Section: Discussionsupporting

confidence: 88%

Clinical outcomes during anticoagulant therapy in fragile patients with venous thromboembolism

Moustafa

Giorgi‐Pierfranceschi²,

Micco

et al. 2017

Research and Practice in Thrombosis and Haemostasis

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Essentials Recent randomized trials suggested fewer bleeding events in fragile patients with VTE receiving DOACs.The frequency, clinical characteristics and outcome of these patients have not been reported in real life.Fragile patients with VTE had a higher risk for major bleeding or death and a lower risk for recurrences than non‐fragile. BackgroundSubgroup 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.ObjectivesTo compare the clinical characteristics, treatment and outcomes during the first 3 months of anticoagulation in fragile vs non‐fragile patients with VTE.MethodsRetrospective 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.ResultsFrom 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.ConclusionsIn real life, 42% of VTE patients were fragile. During anticoagulation, they had fewer VTE recurrences and more major bleeding events than the non‐fragile.

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Section: Discussionsupporting

confidence: 88%

Clinical outcomes during anticoagulant therapy in fragile patients with venous thromboembolism

Moustafa

Giorgi‐Pierfranceschi²,

Micco

et al. 2017

Research and Practice in Thrombosis and Haemostasis

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“…Guidelines generally suggest a minimum of 3 months, a length of treatment that is associated with a lower risk of VTE recurrence than shorter durations [46], or long term if the initial event was idiopathic or if risk factors persist (table 4) [2,12,46,[50][51][52][53]. Patients with CTEPH should remain on lifelong anticoagulation [54].…”

Section: Long-term Prevention Of Recurrent Vte After An Initial Pementioning

confidence: 99%

“…Judging the benefit of continued anticoagulation in elderly patients, those with severe renal impairment, patients with cancer or those who are immobilised is particularly challenging because these factors increase the risks of both recurrent VTE and serious anticoagulant-related bleeding [12,51,52]. Of note, a population-based case-control study showed that patients with cancer receiving chemotherapy have an approximately six-fold increase in the adjusted (for location at VTE onset) risk ratio for VTE compared with healthy controls [55].…”

Section: Long-term Prevention Of Recurrent Vte After An Initial Pementioning

confidence: 99%

Developments in the management and treatment of pulmonary embolism

Limbrey

Howard

2015

Eur Respir Rev

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Pulmonary embolism (PE) is a serious and costly disease for patients and healthcare systems. Guidelines emphasise the importance of differentiating between patients who are at high risk of mortality (those with shock and/or hypotension), who may be candidates for thrombolytic therapy or surgery, and those with less severe presentations. Recent clinical studies and guidelines have focused particularly on risk stratification of intermediate-risk patients. Although the use of thrombolysis has been investigated in these patients, anticoagulation remains the standard treatment approach. Individual risk stratification directs initial treatment. Rates of recurrence differ between subgroups of patients with PE; therefore, a review of provoking factors, along with the risks of morbidity and bleeding, guides the duration of ongoing anticoagulation. The direct oral anticoagulants have shown similar efficacy and, in some cases, reduced major bleeding compared with standard approaches for acute treatment. They also offer the potential to reduce the burden on patients and outpatient services in the post-hospital phase. Rivaroxaban, dabigatran and apixaban have been shown to reduce the risk of recurrent venous thromboembolism versus placebo, when given for >12 months. Patients receiving direct oral anticoagulants do not require regular coagulation monitoring, but follow-up, ideally in a specialist PE clinic in consultation with primary care providers, is recommended. @ERSpublications Direct oral anticoagulants have the potential to improve management of patients with pulmonary embolism http://ow.ly/NV7K6

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“…Fatal major bleeding occurs in 0.2% of patients within 3 months after PE, with a nonfatal major bleeding rate of 2.0% [9,10]. Before outpatient treatment in low-risk PE patients can be accepted as standard patient care, comparable safety to inpatient care has to be proven [11].…”

Section: Introductionmentioning

confidence: 99%

Outpatientversusinpatient treatment in patients with pulmonary embolism: a meta-analysis

Zondag¹,

Kooiman²,

Klok³

et al. 2012

Eur Respir J

156

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Our aim was to study the safety of outpatient treatment in low risk patients with acute pulmonary embolism compared with inpatient treatment, the current clinical standard.We searched Medline, Web of Science, Cochrane and EMBASE databases and included studies on outpatient treatment of pulmonary embolism. The outcomes were 3-month recurrent venous thromboembolism, major bleeding and all-cause mortality. We identified 13 studies (1657 patients) with outpatients (discharge ,24 h), three studies (256 patients) with early discharge patients (discharged within 72 h) and five studies (383 patients) with inpatients. The pooled incidence of recurrent venous thromboembolism was 1.7% (95% CI 0.92-3.1%) in outpatients, 1.1% (0.22-5.4%) in patients discharged early and 1.2% (0.16-8.1%) in inpatients. The pooled incidence of major bleeding was 0.97% (0.58-1.6%) in outpatients, 0.78% (0.16-3.7%) in early discharge patients and 1.0% (0.39-2.8%) in inpatients. The pooled incidence of mortality was 1.9% (0.79-4.6%) in outpatients, 2.3% (1.1-5.1%) in early discharge patients and 0.74% (0.04-11%) in inpatients.Incidences of recurrent venous thromboembolism, major bleeding and, after correction for malignancies, mortality were comparable between outpatients, patients discharged early and inpatients. We conclude that home treatment or early discharge of selected low-risk patients with pulmonary embolism is as safe as inpatient treatment. @ERSpublications Home treatment or early discharge of selected low-risk patients with pulmonary embolism is as safe as inpatient treatment

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Fatal bleeding in patients receiving anticoagulant therapy for venous thromboembolism: findings from the RIETE registry

Cited by 177 publications

References 18 publications

Clinical outcomes during anticoagulant therapy in fragile patients with venous thromboembolism

Clinical outcomes during anticoagulant therapy in fragile patients with venous thromboembolism

Developments in the management and treatment of pulmonary embolism

Outpatientversusinpatient treatment in patients with pulmonary embolism: a meta-analysis

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