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Lancet Haematol ; 6(7): e359-e365, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31133411


BACKGROUND: Because studies of direct oral anticoagulants in patients with venous thromboembolism and non-valvular atrial fibrillation have had minimal representation of morbidly obese patients (ie, body-mass index [BMI] ≥40 kg/m2), their efficacy and safety in this population are unclear. We investigated whether apixaban and rivaroxaban are as effective and safe as warfarin in morbidly obese patients. METHODS: We did a single-centre, retrospective analysis of chart data for all adult patients aged at least 18 years at Montefiore Medical Center (Bronx, NY, USA) with a BMI of at least 40 kg/m2 who were prescribed apixaban, rivaroxaban, or warfarin for either venous thromboembolism or atrial fibrillation between March 1, 2013, and March 1, 2017. Patients who had both venous thromboembolism and atrial fibrillation were excluded, as were patients with indications other than atrial fibrillation and venous thromboembolism. Outcomes of recurrent venous thromboembolism, stroke, and bleeding were measured from the first prescription date to the earliest of a thrombotic event, medication discontinuation, death, or end of study on June 30, 2017. Analyses were stratified by anticoagulation indication and adjusted for comorbidities, CHA2DS2-VASc score, and age where appropriate. Outcome rates were compared using Pearson's χ2 or Fisher's exact test. Time-to-event analyses accounting for length of follow-up were used to compare risks of outcomes. FINDINGS: We obtained data for 795 patients: 150 prescribed apixaban, 326 rivaroxaban, and 319 warfarin. In 366 patients prescribed an anticoagulant for venous thromboembolism, the incidence of recurrent venous thromboembolism was similar between the apixaban, rivaroxaban, and warfarin cohorts (1/47 [2·1%, 95% CI 0·0-6·3], 3/152 [2·0%, 0·0-4·2], and 2/167 [1·2%, 0·0-2·9], respectively; p=0·74). Incidence of major bleeding in this patient group was also similar between the treatment cohorts (1/47 patients on apixaban [2·1%, 95% CI 0·0-6·3], 2/152 on rivaroxaban [1·3%, 0·0-3·1], and 4/167 on warfarin [2·4%, 0·1-4·7]; p=0·77). In 429 patients prescribed an anticoagulant for atrial fibrillation, incidence of stroke was similar between the treatment cohorts (1/103 patients on apixaban [1·0%, 95% CI 0·0-2·9], 4/174 on rivaroxaban [2·3%, 0·1-4·5], and 2/152 on warfarin [1·3%, 0·0-3·1], p=0·71). In this patient group, major bleeding occurred in 3/103 patients on apixaban (2·9%, 95% CI 0·0-6·2), 5/174 on rivaroxaban (2·9%, 0·4-5·4), and 12/152 on warfarin (7·9%, 3·6-12·2); p=0·063. Time-to-event analyses showed that risk of all outcomes in patients with venous thromboembolism, and stroke and composite bleeding in patients with atrial fibrillation, were similar between the anticoagulant cohorts. INTERPRETATION: Our retrospective study provides further evidence of similar efficacy and safety between the direct oral anticoagulants apixaban and rivaroxaban, and warfarin in morbidly obese patients with atrial fibrillation and venous thromboembolism. These data, if confirmed in prospective studies, might enable patients with a BMI of at least 40 kg/m2 to benefit from more convenient, and possibly safer, anticoagulants. FUNDING: None.

Anticoagulantes/uso terapêutico , Inibidores do Fator Xa/uso terapêutico , Obesidade Mórbida/tratamento farmacológico , Varfarina/uso terapêutico , Adulto , Idoso , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Índice de Massa Corporal , Inibidores do Fator Xa/efeitos adversos , Feminino , Hemorragia/epidemiologia , Hemorragia/etiologia , Humanos , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Obesidade Mórbida/patologia , Modelos de Riscos Proporcionais , Pirazóis/efeitos adversos , Pirazóis/uso terapêutico , Piridonas/efeitos adversos , Piridonas/uso terapêutico , Recidiva , Estudos Retrospectivos , Rivaroxabana/efeitos adversos , Rivaroxabana/uso terapêutico , Tromboembolia Venosa/complicações , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/epidemiologia , Varfarina/efeitos adversos
J Thromb Thrombolysis ; 42(4): 545-51, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27383828


In patients with cancer and myeloproliferative disorders, leukocytosis has been associated with an increased venous thromboembolic (VTE) risk. Our goal was to determine whether persistent neutrophilia (PN), not associated with known causes such as malignancies, infections or steroids, is independently associated with VTE. All adult patients with >3 outpatient complete blood counts (CBCs) within 3 years were included. PN was defined as having an absolute neutrophil count >95 % (>2SD) of the population (≥7.8 × 10(9)/L) on at least three CBCs, at least 2 months apart. Separate analyses for neutrophil counts ≥9 × 10(9)/L and ≥10 × 10(9)/L were also performed. Blood counts from inpatients were excluded. Primary outcome was diagnosis of VTE, as determined by ICD-9 codes. Odds ratios were adjusted for diabetes, smoking, obesity, gender, and age. Charlson score was utilized as a morbidity measure. Data on 43,538 outpatients were collected. Although there was no association of VTE with neutrophil counts ≥7.8 × 10(9)/L, patients with ≥9.0 × 10(9)/L neutrophils were twice as likely to be diagnosed with VTE compared to those with normal neutrophil counts (OR 2.0, 95 % CI 1.3, 3.1; p = 0.003). Patients with neutrophil counts ≥10.0 × 10(9)/L were at an even higher risk (OR 2.3, 95 % CI 1.2, 4.8; p = 0.019). Charlson scores significantly modified this risk when incorporated into analysis. Elevated neutrophil counts are associated with an increased risk of venous thrombosis even when they are not due to cancer, infection or steroids. In patients with significant comorbidities, neutrophilia may be a marker of VTE risk.

Neutropenia/sangue , Tromboembolia Venosa/sangue , Trombose Venosa/sangue , Adulto , Biomarcadores/sangue , Feminino , Humanos , Contagem de Leucócitos , Masculino , Neutropenia/etiologia , Fatores de Risco , Tromboembolia Venosa/complicações , Trombose Venosa/complicações
J Gen Intern Med ; 31(2): 182-187, 2016 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-26209179


BACKGROUND: Low molecular weight heparins (LMWHs) have been cautiously used in patients with chronic kidney disease (CKD) due to fear of accumulation. Dalteparin, however, has shown minimal tendency to accumulate in patients with CKD and may be safe to use in this patient population. OBJECTIVE: We compared the incidence of clinically significant bleeding in patients with CKD receiving therapeutic doses of dalteparin to that of patients with CKD receiving therapeutic doses of UFH. DESIGN: This was a retrospective cohort study. SUBJECTS: Inpatients with CKD (GFR < 60 ml/min) who were treated with therapeutic dalteparin or UFH were included in the study MAIN MEASURES: Primary outcome was major bleeding within 10 days of anticoagulation, identified by ICD-9 code and confirmed by chart review. Demographic characteristics, laboratory values, comorbidities, prior bleeding history and inpatient medications were extracted for each admission from the electronic medical record. Logistic regression models were created to examine the association between choice of anticoagulant and bleeding rates, after adjustment for demographic and clinical characteristics. KEY RESULTS: Dalteparin-treated patients were significantly less likely to experience a major bleed than patients treated with UFH (1.14 % vs. 3.49 %, p < 0.001). The reduced likelihood of bleeding associated with dalteparin treatment remained significant after adjustment for patient characteristics (HR 0.39, 95 % CI: 0.21-0.70, p < 0.0001). A stratified analysis for subgroups with GFR< 30 mL/min and with GFR between 30 and 60 mL/min showed that dalteparin was still associated with lower odds of bleeding compared to treatment with unfractionated heparin, but the difference was nonsignificant for GFR< 30 (HR 0.35, 95 % CI: 0.11-1.15), even after adjustment (OR 0.37, 95 % CI: 0.11-1.22). CONCLUSION: In patients with CKD, treatment with therapeutic dose dalteparin was associated with lower rates of bleeding than treatment with unfractionated heparin. For patients with severe CKD (GFR< 30), dalteparin was shown to be at least as safe as unfractionated heparin.

Anticoagulantes/efeitos adversos , Dalteparina/efeitos adversos , Hemorragia/induzido quimicamente , Heparina/efeitos adversos , Insuficiência Renal Crônica/complicações , Idoso , Idoso de 80 Anos ou mais , Feminino , Taxa de Filtração Glomerular , Hemorragia/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Insuficiência Renal Crônica/fisiopatologia , Estudos Retrospectivos