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2.
J Thromb Thrombolysis ; 47(3): 384-391, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30729376

RESUMO

Patients taking oral anticoagulants (OACs) currently represent one-third of all patients treated for epistaxis and an upward trend is expected. New direct oral anticoagulants (DOACs) have been on the market for approximately 10 years. DOACs are favoured over Vitamin K-Antagonists (VKAs) in the current guidelines. There are barely studies that investigate the impact of DOACs on patients with epistaxis. A retrospective study was performed analysing all patients who had stationary treatment for epistaxis from 01.01.2011 to 01.01.2018 in a tertiary care centre. In a total of 466 patients, 46.1% were on OACs. The main indication was atrial fibrillation (AF, 67.4%).The number of DOACs taken surpassed that of the VKAs during the past 2 years. The length of hospital stay was significantly longer in the phenprocoumon group (3 ± 0.2 days) in comparison to both the rivaroxaban (2.3 ± 0.1) and the apixaban (2.2 ± 0.1) groups (p = 0.005). Posterior epistaxis occurred more frequently in the phenprocoumon group (10.8%) than in the rivaroxaban (0%) and apixaban (0%) groups (p = 0.03). A correlation between CHA2DS2-VASc score (risk score for apoplexy in patients with AF, p = 0.01), HAS-BLED score (score for assessment of major bleeding in patients taking anticoagulants with AF, p = 0.006), and length of hospital stay (p = 0.002) with recurrence of epistaxis was found. Shorter hospital stays and exclusively anterior bleeding was noted in AF patients taking rivaroxaban and apixaban, whereas AF patients taking phenprocoumon stayed in hospital longer and had more posterior bleeding.


Assuntos
Fibrilação Atrial/tratamento farmacológico , Epistaxe/induzido quimicamente , Tempo de Internação , Idoso , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Femprocumona/efeitos adversos , Femprocumona/uso terapêutico , Pirazóis/efeitos adversos , Pirazóis/uso terapêutico , Piridonas/efeitos adversos , Piridonas/uso terapêutico , Estudos Retrospectivos , Medição de Risco/métodos , Rivaroxabana/efeitos adversos , Rivaroxabana/uso terapêutico
3.
Thromb Haemost ; 118(11): 1930-1939, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30357779

RESUMO

Patients with heart failure (HF) are frequently anti-coagulated with vitamin K-antagonists (VKAs). The use of long-acting VKA may be preferable for HF patients due to higher stability of plasma concentrations. However, evidence on phenprocoumon-based oral anti-coagulation (OAC) therapy in HF is scarce. The aim of this study was to assess the impact of the presence of HF on quality of phenprocoumon-based OAC and the subsequent clinical outcome. Quality of OAC therapy and the incidence of adverse events were analysed in a cohort of regular care (n = 2,011) from the multi-centre thrombEVAL study program (NCT01809015) stratified by the presence of HF. To assess the modifiability of outcome, results were compared with data from individuals receiving specialized care for anti-coagulation (n = 760). Overall, the sample comprised of 813 individuals with HF and 1,160 subjects without HF in the regular care cohort. Quality of OAC assessed by time in therapeutic range (TTR) was 66.1% (47.8%/82.8%) for patients with HF and 70.6% (52.1%/85.9%) for those without HF (p = 0.0046). Stratification for New York Heart Classification (NYHA)-class demonstrated a lower TTR with higher NYHA classes: TTRNYHA-I 69.6% (49.4%/85.6%), TTRNYHA-II 66.5% (50.1%/82.9%) and TTRNYHA-≥III 61.8% (43.1%/79.9%). This translated into a worse net clinical benefit outcome for HF (hazard ratio [HR] 1.63 [1.31/2.02]; p < 0.0001) and an increased risk of bleeding (HR 1.40 [1.04/1.89]; p = 0.028). Management in a specialized coagulation service resulted in an improvement of all, TTR (∆+12.5% points), anti-coagulation-specific and non-specific outcome of HF individuals. In conclusion, HF is an independent risk factor for low quality of OAC therapy translating into an increased risk for adverse events, which can be mitigated by specialized care.


Assuntos
Anticoagulantes/uso terapêutico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Insuficiência Cardíaca/tratamento farmacológico , Hemorragia/epidemiologia , Femprocumona/uso terapêutico , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Estudos de Coortes , Feminino , Alemanha/epidemiologia , Insuficiência Cardíaca/epidemiologia , Hemorragia/etiologia , Humanos , Incidência , Masculino , Femprocumona/efeitos adversos , Estudos Prospectivos , Risco , Resultado do Tratamento
4.
BMJ Open ; 8(9): e022690, 2018 09 10.
Artigo em Inglês | MEDLINE | ID: mdl-30206088

RESUMO

INTRODUCTION: Patients with end-stage kidney disease requiring maintenance haemodialysis treatment experience a dramatic cardiovascular morbidity and mortality. Due to the high atherosclerotic and arteriosclerotic burden and profound alterations in haemostasis, they frequently suffer and die from both thromboembolic and bleeding events. This is a particular concern in patients on haemodialysis with atrial fibrillation (AF). Controlled trials on the optimal anticoagulation in patients with AF on haemodialysis are not available. The randomised controlled phase IIIb AXADIA-AFNET 8 trial will evaluate the safety and efficacy of the factor Xa inhibitor apixaban in patients with AF requiring haemodialysis. METHODS AND ANALYSIS: A total of 222 patients will be randomised in an open-labelled, 1:1 design to receive either apixaban 2.5 mg twice daily or dose-adjusted vitamin K antagonist therapy (target international normalised ratio 2.0-3.0). All patients will be treated and followed up for a minimum of 6 months up to a maximum of 24 months. The primary outcome is major or clinically relevant, non-major bleedings or death of any cause. Secondary outcomes include stroke, cardiovascular death and other thromboembolic events, thus exploring the efficacy of apixaban. The first patient was randomised in June 2017. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethical Committee of the Landesaertzekammer, Westfalen-Lippe and the Medical Faculty of the University of Muenster, Muenster, Germany (reference number: 2016-598 f-A). Written informed consent will be obtained from all patients prior to study participation, including their consent for long-term follow-up. AXADIA-AFNET 8 is an investigator-initiated trial. Sponsor is AFNET, Muenster, Germany. Study findings will be disseminated to Bristol-Myers Squibb, Munich, Germany, and Pfizer, Berlin, Germany, to the participating centres, at research conferences and in peer-reviewed journals. TRIAL REGISTRATION NUMBERS: NCT02933697,Pre-results.


Assuntos
Fibrilação Atrial , Hemorragia/prevenção & controle , Femprocumona , Pirazóis , Piridonas , Diálise Renal/métodos , Insuficiência Renal Crônica , Tromboembolia/prevenção & controle , Adulto , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Feminino , Alemanha , Hemorragia/etiologia , Humanos , Masculino , Femprocumona/administração & dosagem , Femprocumona/efeitos adversos , Pirazóis/administração & dosagem , Pirazóis/efeitos adversos , Piridonas/administração & dosagem , Piridonas/efeitos adversos , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/terapia , Tromboembolia/etiologia
5.
Eur J Clin Pharmacol ; 74(10): 1317-1325, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29909576

RESUMO

PURPOSE: The pivotal trials for stroke prevention in non-valvular atrial fibrillation (NVAF) compared rivaroxaban, dabigatran, and apixaban with warfarin, as did most claims-based studies. Comparisons with phenprocoumon, the most frequently used vitamin K antagonist (VKA) in Germany, are scarce. METHODS: Risk of bleeding, ischemic stroke, and all-cause mortality in patients with NVAF were analyzed using data for 2010 to 2014 from a large German claims database. New users of oral anticoagulants from January 2012 to December 2013 were included and observed over 1 year. Baseline characteristics were adjusted using propensity score matching and logistic regression. Several sensitivity analyses were carried out. RESULTS: Fifty-nine thousand four hundred forty-nine rivaroxaban, 23,654 dabigatran, 4894 apixaban, and 87,997 matched phenprocoumon users were included. Adjusted hazard ratios (95% confidence intervals) compared with phenprocoumon were as follows: hospitalized bleedings: rivaroxaban 1.04 (0.97; 1.11), dabigatran 0.87 (0.77; 0.98), and apixaban 0.65 (0.50; 0.86); ischemic stroke: rivaroxaban 1.05 (0.94; 1.17), dabigatran 1.14 (0.96; 1.35), and apixaban 1.84 (1.20; 2.84); all-cause mortality: rivaroxaban 1.17 (1.11; 1.22), dabigatran 1.04 (0.95; 1.13), and apixaban 1.14 (0.97; 1.34). CONCLUSIONS: With rivaroxaban, no significant differences were observed compared to phenprocoumon with regard to hospitalized bleedings or ischemic strokes. Dabigatran was associated with fewer bleedings and a similar risk of ischemic strokes compared to phenprocoumon. Apixaban was also associated with fewer bleedings but was unexpectedly associated with more ischemic strokes, possibly reflecting selective prescribing. The association of rivaroxaban with higher all-cause mortality unrelated to bleedings or strokes has been described previously but remains to be explained.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Femprocumona/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Administração Oral , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/mortalidade , Isquemia Encefálica/epidemiologia , Isquemia Encefálica/prevenção & controle , Bases de Dados Factuais , Feminino , Seguimentos , Alemanha , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Femprocumona/efeitos adversos , Acidente Vascular Cerebral/epidemiologia , Vitamina K/antagonistas & inibidores , Adulto Jovem
7.
Clin Neurol Neurosurg ; 169: 116-120, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29655012

RESUMO

OBJECTIVES: The use of new anticoagulants potentially carries the risk of increased intracranial bleeding, but there is a lack of evidence. The aim of this study was to investigate whether the morbidity and mortality differs in head trauma patients depending on the type of anticoagulation. PATIENTS AND METHODS: A retrospective cohort study was conducted in 2009-2014. Based on sex, age, and Glasgow-Coma Scale (GCS), patients that received rivaroxaban were matched to two control groups, one that received no anticoagulant and another one that received phenprocoumon. The primary outcome was mortality. Among others, secondary outcome variables were the length of stay (LOS) at the hospital and presence of an intracranial injury. RESULTS: Sixty-nine patients (23 patients per group) were analyzed. The characteristics of patients did not differ significantly across groups. There were no significant differences between groups for the primary and secondary outcomes. Two patients died in the rivaroxaban group (one of them likely due to head trauma), while one patient died in the phenprocoumon group (likely not due to head trauma), and no patient died in the no anticoagulatoin group (p = 0.36). The LOS at the hospital was similar (5.0, 4.0, and 5.0 days; p = 0.94). An intracranial injury was observed in a similar number of patients in all groups (n = 11, n = 10, and n = 8; p = 0.75). CONCLUSION: Although limited in size, this study did not observe significant outcome differences in patients with traumatic head injuries, who received rivaroxaban, no anticoagulant or phenprocoumon. Although not significant, the only death likely due to head trauma in the study occurred in the rivaroxaban group. Larger studies are needed before clinical application of these findings.


Assuntos
Anticoagulantes/uso terapêutico , Lesões Encefálicas Traumáticas/tratamento farmacológico , Lesões Encefálicas Traumáticas/mortalidade , Inibidores do Fator Xa/uso terapêutico , Femprocumona/uso terapêutico , Rivaroxabana/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Lesões Encefálicas Traumáticas/diagnóstico , Estudos de Coortes , Inibidores do Fator Xa/efeitos adversos , Feminino , Humanos , Masculino , Morbidade , Mortalidade/tendências , Femprocumona/efeitos adversos , Estudos Retrospectivos , Rivaroxabana/efeitos adversos
8.
Neurocirugía (Soc. Luso-Esp. Neurocir.) ; 29(2): 86-92, mar.-abr. 2018. graf, tab
Artigo em Inglês | IBECS | ID: ibc-171433

RESUMO

Introduction: Chronic subdural hematoma (cSDH) is a common pathology encountered in neurosurgical practice, especially in elderly patients, who frequently require antithrombotic agents. The aim of this study was to investigate the influence of antithrombotic agents on recurrence rates and clinical outcomes in patients operated for cSDH. Methods: A cohort of patients operated for cSDH at one center during a 5 years period was analyzed retrospectively. Presenting symptoms, coagulation testing, history of antithrombotic agents and comorbidities were obtained from the patient charts. The standard neurosurgical procedure was a single burr hole under local anesthesia with insertion of a subdural drainage. Questionnaires and telephone interviews were used to assess the clinical outcome using the modified Rankin Scale (mRS). Good outcome was defined as mRS 0 to 3 and poor outcome as mRS 4 to 6. Results: 201 patients with cSDH underwent initial surgical treatment and were enrolled in the study. The median follow-up was 81 weeks. 41 patients (20.4%) were on antiplatelet drug and 43 (21.4%) were on phenprocoumon. A recurrent hematoma required surgery in 37 patients (18.4%). A poor outcome was seen in 36 patients (17.9%). Each of older age and administration of phenprocoumon at admission was an independent risk factor predictive of poor outcome, (p = 0.001 and p = 0.031, respectively)) Administration of antithrombotic agents had no impact on hematoma recurrence. Conclusion: Administration of phenprocoumon and older age might increase the risk of poor outcome in patients with cSDH. Neither the administration of phenprocoumon nor antiplatelet drug influenced the recurrence rate of subdural hematoma in our patient cohort


Introducción: El hematoma subdural crónico (HSC) es una enfermedad común en la práctica neuro-quirúgica, especialmente en pacientes mayores, quienes requieren con frecuencia agentes anti-trombóticos. El objetivo de este estudio fue investigar la influencia de los agentes anti-trombóticos en las tasas de recidiva y los resultados clínicos en los pacientes operados de HSC. Métodos: Se analizó retrospectivamente una cohorte de pacientes operados de HSC en un único centro, durante un periodo de 5 años. Se obtuvieron de las historias de los pacientes los síntomas de presentación, las pruebas de coagulación, el historial de agentes anti-trombóticos y las comorbilidades. El procedimiento quirúrgico estándar consistió en una trepanación bajo anestesia local, con inserción de un drenaje subdural. Se utilizaron cuestionarios y entrevistas telefónicas para valorar el resultado clínico mediante la Escala de Rankin modificada (mRS). El resultado favorable se definió como el valor de 0 a 3 de mRS, y el resultado desfavorable el valor de 4 a 6. Resultados: Doscientos uno pacientes con HSC fueron sometidos a tratamiento quirúrgico inicial, y fueron incluidos en el estudio. El seguimiento medio fue de 81 semanas. A 41 pacientes (20,4%) se les administró tratamiento anti-plaquetario y a 43 (21,4%) fenprocumón. El hematoma recurrente requirió cirugía en 37 pacientes (18,4%). Se observaron resultados desfavorables en 36 pacientes (17,9%). La avanzada edad y la administración de fenprocumón al ingreso resultaron factores predictivos independientes del resultado desfavorable (p = 0,001 y p = 0,031, respectivamente). La administración de agentes antitrombóticos no tuvo impacto sobre la recidiva del hematoma. Conclusión: La administración de fenprocumón y la edad avanzada pueden incrementar el riesgo de resultado desfavorable en los pacientes con HSC. Ni la administración de fenprocumón ni la de fármacos anti-plaquetarios influyeron en la tasa de hematomas subdurales en nuestra cohorte de pacientes


Assuntos
Humanos , Masculino , Feminino , Idoso , Hematoma Subdural Crônico/complicações , Hematoma Subdural Crônico/cirurgia , Fibrinolíticos/uso terapêutico , Recidiva , Hematoma Subdural Crônico/induzido quimicamente , Hematoma Subdural Crônico/diagnóstico por imagem , Fibrinolíticos/efeitos adversos , Femprocumona/efeitos adversos , Estudos Retrospectivos , Estudos de Coortes , Comorbidade , Inquéritos e Questionários , Análise Estatística , Razão de Chances
9.
BMJ Case Rep ; 20182018 Feb 12.
Artigo em Inglês | MEDLINE | ID: mdl-29440136

RESUMO

The cytochrome P450 is a superfamily of isoenzymes that are responsible for the metabolism of many drugs. Significant changes in pharmacokinetics and drug interactions may be due to induction of hepatic cytochrome P450 enzymes. Rifampicin is a common inducer of CYP3A4. We report a case of a 57-year-old woman who was suspected for endocarditis and therefore treated with rifampicin. Due to previous mechanical aortic valve replacement, she also received phenprocoumon for anticoagulation. Although continuing anticoagulant therapy, antibiotic coadministration led to normal international normalised ratio (INR) level. Fifteen days after the treatment with rifampicin ended, INR returned to therapeutic level.


Assuntos
Antibacterianos/uso terapêutico , Anticoagulantes/uso terapêutico , Insuficiência da Valva Aórtica/tratamento farmacológico , Endocardite/tratamento farmacológico , Implante de Prótese de Valva Cardíaca , Femprocumona/uso terapêutico , Rifampina/uso terapêutico , Antibacterianos/efeitos adversos , Anticoagulantes/efeitos adversos , Insuficiência da Valva Aórtica/cirurgia , Sistema Enzimático do Citocromo P-450 , Interações de Medicamentos , Feminino , Humanos , Coeficiente Internacional Normatizado , Pessoa de Meia-Idade , Femprocumona/efeitos adversos , Rifampina/efeitos adversos , Resultado do Tratamento , Vitamina K/antagonistas & inibidores
10.
Am J Cardiol ; 121(7): 879-887, 2018 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-29402419

RESUMO

Vitamin K antagonist (VKA) is a commonly prescribed anticoagulant with a narrow therapeutic window. Genetic polymorphisms account for high VKA dosage variability. Hence, we performed an updated meta-analysis of all randomized clinical trials (RCTs) comparing genotype-guided VKA versus standard dosing algorithms. We conducted a systematic search of electronic databases from inception to October 2017 for all RCTs. The primary outcome was the percentage of time in therapeutic range (TTR). Secondary outcomes were international normalized ratio >4, major and all bleeding events, thromboembolism, adverse and serious adverse events, and all-cause mortality. We calculated the weighted mean difference for the primary outcome and risk ratio (RR) for secondary outcomes using a random-effect model. We included 20 RCTs and analyzed a total of 5,980 adult patients. Our pooled analysis showed greater improvement in TTR for the genotype-guided group in comparison with the standard group (mean difference 3.41%, 95% confidence interval [CI] 0.71 to 6.10, p = 0.01). In addition, there were significant reductions in major and all bleeding events ((RR 0.35, 95% CI 0.20 to 0.63, p = 0.0004) and (RR 0.79, 95% CI 0.66 to 0.95, p = 0.01), respectively). However, there were no significant differences between the groups for international normalized ratio >4 (RR 0.89, 95% CI 0.80 to 1.00, p = 0.06), thromboembolism (RR 0.81, 95% CI 0.56 to 1.17, p = 0.25), serious adverse events (RR 0.79, 95% CI 0.61 to 1.03, p = 0.08), any adverse events (RR 0.94, 95% CI 0.88 to 1.01, p = 0.07), or all-cause mortality (RR 0.73, 95% CI 0.32 to 1.66, p = 0.46). In conclusion, genotype-guided VKA dosing can improve the TTR and reduce the risk for bleeding episodes, in comparison with standard dosing algorithms.


Assuntos
Anticoagulantes/administração & dosagem , Genótipo , Testes Farmacogenômicos , Variantes Farmacogenômicos , Vitamina K/antagonistas & inibidores , Acenocumarol/administração & dosagem , Acenocumarol/efeitos adversos , Anticoagulantes/efeitos adversos , Causas de Morte , Hemorragia/induzido quimicamente , Humanos , Coeficiente Internacional Normatizado , Mortalidade , Razão de Chances , Femprocumona/administração & dosagem , Femprocumona/efeitos adversos , Tromboembolia/epidemiologia , Varfarina/administração & dosagem , Varfarina/efeitos adversos
11.
Europace ; 20(4): 569-574, 2018 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-28460024

RESUMO

Aims: Several studies showed reduced stroke severity in patients with atrial fibrillation (AF) if the international normalized ratio (INR) was ≥ 2 at stroke onset. There are no respective data for non-vitamin K-dependent oral anticoagulants (NOACs). The aim of this study was to compare the impact of NOAC or phenprocoumon intake on stroke severity. Methods and results: In this single-centre observational study, 3669 patients with acute ischaemic stroke were retrospectively analysed regarding AF status and medication immediately before admission. Using multivariable regression, we analysed the association of pre-admission anticoagulation with severe stroke (National Institutes of Health Stroke Scale score ≥ 11) on admission and poor outcome at discharge (modified Rankin scale score > 2). Before the index stroke, 655 patients had known AF and a CHA2DS2-VASc score ≥ 2. While 325 (49.6%) patients were anticoagulated, 159 (24.3%) were prescribed a NOAC and 75 (11.5%) phenprocoumon patients had an INR ≥ 2 on admission. Compared with AF patients without medical stroke prevention, an INR ≥ 2 [OR 0.23 (95% CI 0.10-0.53)] or NOAC intake [OR 0.48 (95% CI 0.27-0.86)] were associated with a lower probability of severe stroke after adjustment for confounders, while an INR < 2 [OR 0.62 (95% CI 0.33-1.16)] was not. Adjusted odds ratios for poor functional outcome at hospital discharge were 0.47 (95% CI 0.27-0.84) for NOAC patients, 0.33 (95% CI 0.17-0.65) for INR ≥ 2 and 0.61 (95% CI 0.32-1.16) for INR < 2. Conclusion: NOAC intake before stroke did reduce the probability of severe stroke on hospital admission and poor functional outcome at hospital discharge as similarly demonstrated for phenprocoumon patients with an INR ≥ 2 on admission.


Assuntos
Anticoagulantes/administração & dosagem , Fibrilação Atrial/tratamento farmacológico , Isquemia Encefálica/prevenção & controle , Femprocumona/administração & dosagem , Acidente Vascular Cerebral/prevenção & controle , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/etiologia , Feminino , Hospitalização , Humanos , Coeficiente Internacional Normatizado , Masculino , Femprocumona/efeitos adversos , Fatores de Proteção , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/etiologia , Fatores de Tempo , Resultado do Tratamento
12.
Clin Otolaryngol ; 43(1): 103-108, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-28510336

RESUMO

OBJECTIVES: Treatment of epistaxis in patients on anticoagulants is challenging and associated with higher admission rates and longer hospital stays compared with patients without anticoagulation. However, there is little information about epistaxis in patients taking new direct oral anticoagulants such as rivaroxaban compared with patients on traditional vitamin K antagonists such as phenprocoumon. DESIGN: Retrospective cohort study. SETTING: The study was conducted at the emergency department of the University Hospital Inselspital, Bern, Switzerland. PARTICIPANTS: All admissions to the emergency department of the University Hospital Inselspital, Bern, Switzerland from 1st July 2012 to 30th June 2016 with non-traumatic epistaxis on anticoagulant therapy with phenprocoumon or rivaroxaban were included. MAIN OUTCOME MEASURES: We compared clinical outcome parameters (admission rates, length of hospital stay and mortality) for both anticoagulant groups. RESULTS: We included 440 patients with epistaxis, 123 (28%) on rivaroxaban and 317 (72%) on phenprocoumon. Fewer hospital admissions and shorter hospital stays were found in patients under rivaroxaban (12 (10.4%) vs 57 (18.0%) patients, P=.033; 0.7±2.2 vs 1.5±3.7 days, P=.011) compared with phenprocoumon. Anterior epistaxis was more common in the rivaroxaban group in contrast to posterior epistaxis in patients on phenprocoumon (74 (60.2%) vs 139 (43.8%) patients, P=.002; 7 (5.7%) vs 39 (12.3%) patients, P=.042). CONCLUSIONS: Our data suggests that epistaxis on direct oral anticoagulation with rivaroxaban is associated with shorter hospital stays and fewer hospital admissions than epistaxis on vitamin K antagonist phenprocoumon.


Assuntos
Epistaxe/induzido quimicamente , Tempo de Internação/tendências , Admissão do Paciente/tendências , Femprocumona/efeitos adversos , Medição de Risco , Rivaroxabana/efeitos adversos , Idoso , Anticoagulantes/efeitos adversos , Epistaxe/epidemiologia , Inibidores do Fator Xa/efeitos adversos , Feminino , Seguimentos , Humanos , Incidência , Masculino , Estudos Retrospectivos , Suíça/epidemiologia
13.
Ophthalmologe ; 115(7): 573-578, 2018 Jul.
Artigo em Alemão | MEDLINE | ID: mdl-28597205

RESUMO

BACKGROUND: To determine and compare the frequency of intraocular hemorrhage in patients who underwent oral anticoagulation with apixaban or phenprocoumon. METHODS: A retrospective analysis of patients under oral anticoagulant medication (apixaban or phenprocoumon) seen between January 2015 and June 2015 at the department of ophthalmology, University of Muenster Medical Center was performed. Vitreal or retinal hemorrhage in addition to clinical information including age, gender, best corrected visual acuity, concomitant diseases, concomitant medication and therapy were obtained. Bleeding frequency in both groups was compared using Fisher's exact test. RESULTS: A total of 172 patients were included with a mean age = 74.0 ± 10.6 years, 57.0% (n = 98) male and 43.0% (n = 74) female. In the phenprocoumon group 147 patients (3.4%, n = 5) developed a retinal or vitreal hemorrhage. In the apxiban group 25 patients (36%, n = 9) developed a retinal or vitreal hemorrhage. There was a significant correlation between the group and bleeding risk (p < 0.001). CONCLUSION: There was a significant correlation between medication (apixaban vs. phenprocoumon) and bleeding risk in this study population. Further studies with more patients especially in patients with a high risk of hemorhage, age-related macular degeneration (AMD) and proliferative diabetic retinopathy are needed.


Assuntos
Anticoagulantes/efeitos adversos , Femprocumona/efeitos adversos , Pirazóis/efeitos adversos , Piridonas/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
14.
J Neurol Neurosurg Psychiatry ; 89(3): 263-270, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29030422

RESUMO

INTRODUCTION: The characteristics and natural history of acute non-vitamin K antagonists oral anticoagulants (NOAC)-associated intracerebral haemorrhage (ICH) are largely unknown. We performed a comprehensive systematic review and meta-analysis to compare baseline ICH volume, haematoma expansion and clinical outcomes between NOAC-ICH versus vitamin K antagonists-ICH (VKA-ICH). METHODS: We searched PubMed and conference abstracts for observational studies comparing baseline characteristics and outcomes in patients with NOAC-ICH versus VKA-ICH using an appropriate keyword/MeSH term search strategy. Data were extracted following PRISMA and MOOSE guidelines. The main outcome measures were mortality and unfavourable functional outcome (modified Rankin Score: 4-6) at discharge and at 3 months, as well as ICH volumes and haematoma expansion rates in the two groups. Random-effects models with DerSimonian-Laird weights were used for pooled estimates calculation. RESULTS: Twelve studies including 393 NOAC-ICH and 3482 VKA-ICH were pooled in meta-analysis. There was no difference in mean ICH-volume between the two groups (standard mean difference: -0.24; 95% CI -0.52 to 0.04, p=0.093). The rates of haematoma expansion were comparable in NOAC-ICH versus VKA-ICH (OR: 0.76; 95% CI 0.49 to 1.19, p=0.236). We did not find any difference between patients with NOAC-ICH versus VKA-ICH in all-cause mortality at discharge (OR: 0.66; 95% CI 0.42 to 1.05, p=0.077) and unfavourable functional outcome at discharge (OR: 0.77; 95% CI 0.41 to 1.44, p=0.413). The 3-month outcome was also comparable between the two ICH groups. Moderate-to-substantial statistical heterogeneity was noted. CONCLUSION: Our results confirm that ICH volume, haematoma expansion, mortality and functional outcome appear to be similar for NOAC-ICH versus VKA-ICH. Large prospective cohorts and updated meta-analyses are needed to provide more precise estimates.


Assuntos
Anticoagulantes/efeitos adversos , Hemorragia Cerebral/induzido quimicamente , Hematoma/induzido quimicamente , Antitrombinas/efeitos adversos , Hemorragia Cerebral/mortalidade , Hemorragia Cerebral/fisiopatologia , Dabigatrana/efeitos adversos , Inibidores do Fator Xa/efeitos adversos , Hematoma/mortalidade , Hematoma/fisiopatologia , Humanos , Mortalidade , Razão de Chances , Femprocumona/efeitos adversos , Pirazóis/efeitos adversos , Piridinas/efeitos adversos , Piridonas/efeitos adversos , Rivaroxabana/efeitos adversos , Índice de Gravidade de Doença , Tiazóis/efeitos adversos , Vitamina K/antagonistas & inibidores , Varfarina/efeitos adversos
15.
Neurocirugia (Astur) ; 29(2): 86-92, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29122534

RESUMO

INTRODUCTION: Chronic subdural hematoma (cSDH) is a common pathology encountered in neurosurgical practice, especially in elderly patients, who frequently require antithrombotic agents. The aim of this study was to investigate the influence of antithrombotic agents on recurrence rates and clinical outcomes in patients operated for cSDH. METHODS: A cohort of patients operated for cSDH at one center during a 5 years period was analyzed retrospectively. Presenting symptoms, coagulation testing, history of antithrombotic agents and comorbidities were obtained from the patient charts. The standard neurosurgical procedure was a single burr hole under local anesthesia with insertion of a subdural drainage. Questionnaires and telephone interviews were used to assess the clinical outcome using the modified Rankin Scale (mRS). Good outcome was defined as mRS 0 to 3 and poor outcome as mRS 4 to 6. RESULTS: 201 patients with cSDH underwent initial surgical treatment and were enrolled in the study. The median follow-up was 81 weeks. 41 patients (20.4%) were on antiplatelet drug and 43 (21.4%) were on phenprocoumon. A recurrent hematoma required surgery in 37 patients (18.4%). A poor outcome was seen in 36 patients (17.9%). Each of older age and administration of phenprocoumon at admission was an independent risk factor predictive of poor outcome, (p=0.001 and p=0.031, respectively)) Administration of antithrombotic agents had no impact on hematoma recurrence. CONCLUSION: Administration of phenprocoumon and older age might increase the risk of poor outcome in patients with cSDH. Neither the administration of phenprocoumon nor antiplatelet drug influenced the recurrence rate of subdural hematoma in our patient cohort.


Assuntos
Anticoagulantes/efeitos adversos , Drenagem , Fibrinolíticos/efeitos adversos , Hematoma Subdural Crônico/cirurgia , Inibidores da Agregação de Plaquetas/efeitos adversos , Trepanação , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Dano Encefálico Crônico/etiologia , Comorbidade , Feminino , Fibrinolíticos/uso terapêutico , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Femprocumona/efeitos adversos , Femprocumona/uso terapêutico , Inibidores da Agregação de Plaquetas/uso terapêutico , Complicações Pós-Operatórias/epidemiologia , Recidiva , Reoperação , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Resultado do Tratamento
16.
J Thromb Haemost ; 16(1): 116-124, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29108090

RESUMO

Essentials The knowledge of quality and safety of acenocoumarol and phenprocoumon use in children is limited. We used data from a multicenter retrospective follow-up study in children in the Netherlands. The quality of anticoagulation control in the first month of use was low, but improved thereafter. No thromboembolic events occurred, however bleeding events occurred in 1-3 out of 10 patients. SUMMARY: Background The use of vitamin-K antagonists in pediatric patients is rare and information on the quality and safety of treatment with acenocoumarol and phenprocoumon is limited. Objectives To assess the quality, safety and effectiveness during the first year of acenocoumarol and phenprocoumon treatment in pediatric patients in the Netherlands. Methods The Children Anticoagulation and Pharmacogenetics Study (CAPS) was designed as a multicenter retrospective follow-up study. Patients who used acenocoumarol or phenprocoumon at an age of ≤ 18 years, were selected from four pediatric hospitals and one anticoagulation clinic in the Netherlands. The quality of treatment was assessed by calculating the percentage of time in therapeutic INR range (TTR) for the first month and for every 3 months of use during the first year of treatment. Effectiveness and safety were assessed by the number of thromboembolic and bleeding events. Results In total, 213 patients participated, of whom 187 (155 acenocoumarol; 32 phenprocoumon) were included in this analysis. The mean TTR was 47.0% and 51.4% in the first month of use for acenocoumarol and phenprocoumon, respectively. After the first 3 months the mean TTR for both VKAs was above 64%. In 14.6% (acenocoumarol) and 31.3% (phenprocoumon) of the patients a bleeding event occurred during the first year of treatment; no thromboembolic events were reported. Conclusions The quality of anticoagulation treatment was low during the first month of use and leaves room for improvement. After the first month it increased to an acceptable level. However, bleeding events occurred frequently during the first year.


Assuntos
Acenocumarol/administração & dosagem , Anticoagulantes/administração & dosagem , Coagulação Sanguínea/efeitos dos fármacos , Femprocumona/administração & dosagem , Tromboembolia/tratamento farmacológico , Acenocumarol/efeitos adversos , Administração Oral , Adolescente , Fatores Etários , Anticoagulantes/efeitos adversos , Criança , Pré-Escolar , Monitoramento de Medicamentos/métodos , Feminino , Fidelidade a Diretrizes/normas , Hemorragia/induzido quimicamente , Humanos , Lactente , Coeficiente Internacional Normatizado , Masculino , Países Baixos , Femprocumona/efeitos adversos , Guias de Prática Clínica como Assunto/normas , Padrões de Prática Médica/normas , Indicadores de Qualidade em Assistência à Saúde/normas , Estudos Retrospectivos , Tromboembolia/sangue , Tromboembolia/diagnóstico , Fatores de Tempo , Resultado do Tratamento
17.
Int J Cardiol ; 248: 201-207, 2017 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-28688719

RESUMO

INTRODUCTION: The aim of this observational study was to compare the postprocedural incidence of bleeding and thromboembolic complications associated with novel oral anticoagulants (NOACs) with that of interrupted and continuous phenprocoumon after pulmonary vein isolation (PVI) using a purse-string suture (PSS) closure of the puncture site. METHODS AND RESULTS: Consecutive patients who had undergone PVI via cryoballoon ablation were divided into the following groups: (1) interrupted phenprocoumon with heparin bridging (n=101), (2) continuous phenprocoumon targeting an internationally normalized ratio>2 (n=70), and (3) NOACs without bridging that were restarted 2-4h after the procedure (n=185). Protamine was not administered after venous closure with PSS at the end of the procedure. The total complication rate was significantly lower in group 3 than in groups 1 and 2 (1.62% vs. 6.93% vs. 7.14%, p=0.04). The hospital costs were lower and the hospital stay length was significantly shorter (4484±3742 vs. 6082±4044 Euro vs. 4908±2925, p=0.03; 1.94±1.67 vs. 2.70±1.80 vs. 2.19±1.30days, p<0.01). No thromboembolic event occurred. Vascular complications were the most common complications noted (80%). The occurrence of any complication led to a significantly longer hospital stay (5 vs. 2days, p<0.01) and higher costs (10,052±6241 Euro vs. 4747±3447, p<0.01). The vascular complication rate after PSS was independent of intraprocedural heparin dosage and activated clotting time. CONCLUSIONS: NOACs have a lower complication rate and appear to be safer in this setting than phenprocoumon. The hospital costs and hospital stay length after PVI was significantly reduced in patients treated with NOACs compared with phenprocoumon.


Assuntos
Anticoagulantes/administração & dosagem , Criocirurgia/métodos , Femprocumona/administração & dosagem , Veias Pulmonares/cirurgia , Técnicas de Sutura , Administração Oral , Idoso , Anticoagulantes/efeitos adversos , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos , Estudos de Coortes , Criocirurgia/efeitos adversos , Feminino , Seguimentos , Hematoma/induzido quimicamente , Hematoma/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Femprocumona/efeitos adversos , Complicações Pós-Operatórias/induzido quimicamente , Complicações Pós-Operatórias/etiologia , Técnicas de Sutura/efeitos adversos , Tromboembolia/induzido quimicamente , Tromboembolia/etiologia , Resultado do Tratamento
18.
J Thromb Haemost ; 15(5): 868-875, 2017 05.
Artigo em Inglês | MEDLINE | ID: mdl-28296129

RESUMO

Essentials It is unknown if hemophilia patients with atrial fibrillation need anticoagulation. Endogenous thrombin potentials (ETP) in hemophilia patients and patients on coumarins were compared. Severe hemophilia patients had comparable ETP to therapeutic international normalized ratio (INR). In non-severe hemophilia, 33% had higher ETP than therapeutic INR and may need anticoagulation. Click to hear Dr Negrier's perspective on global assays for assessing coagulation SUMMARY: Background It is unknown whether patients with hemophilia A with atrial fibrillation require treatment with vitamin K antagonists (VKAs) to the same extent as the normal population. Objective To compare hemostatic potential in hemophilia patients and patients on VKAs using thrombin generation (TG). Methods In this cross-sectional study, TG, initiated with 1pM tissue factor, was measured in 133 patients with severe (FVIII < 1%, n = 15) and non-severe (FVIII 1-50%, n = 118) hemophilia A, 97 patients on a VKA with an international normalized ratio (INR) ≥ 1.5 and healthy controls. Endogenous thrombin potential (ETP) (nm*min) was compared according to FVIII level (< 1%, 1-19% and 20-50%) with healthy controls and patients with sub-therapeutic INR (1.5-1.9) and therapeutic INR (≥ 2.0). Medians and interquartile ranges (IQRs) were calculated. Results Compared with healthy controls (898 [IQR 803-1004]), both hemophilia patients and patients on VKAs had lower median ETPs at 304 (196-449) and 176 (100-250), respectively. ETP was quite similar in severe hemophilia patients (185 [116-307]) and patients with a therapeutic INR (156 [90-225]). Compared with patients with therapeutic INR, ETP in patients with FVIII 1-19% and patients with FVIII 20-50% was higher at 296 (203-430) and 397 (219-632), respectively. All patients with therapeutic INR had an ETP < 400. Considering this threshold, 93% of severe hemophilia patients, 70% of patients with FVIII 1-19% and 52% of patients with FVIII 20-50% had an ETP < 400. Conclusion In severe hemophilia patients, TG was comparable to that in patients with a therapeutic INR. In one-third of non-severe hemophilia patients, TG was higher. These results suggest that anticoagulation therapy should be considered in a substantial proportion of non-severe hemophilia patients.


Assuntos
Acenocumarol/administração & dosagem , Anticoagulantes/administração & dosagem , Fibrilação Atrial/tratamento farmacológico , Coagulação Sanguínea/efeitos dos fármacos , Hemofilia A/sangue , Hemostasia/efeitos dos fármacos , Femprocumona/administração & dosagem , Trombina/metabolismo , Vitamina K/antagonistas & inibidores , Acenocumarol/efeitos adversos , Adolescente , Adulto , Idoso , Anticoagulantes/efeitos adversos , Fibrilação Atrial/sangue , Fibrilação Atrial/diagnóstico , Estudos de Casos e Controles , Estudos Transversais , Monitoramento de Medicamentos/métodos , Feminino , Hemofilia A/diagnóstico , Humanos , Coeficiente Internacional Normatizado , Cinética , Masculino , Pessoa de Meia-Idade , Femprocumona/efeitos adversos , Índice de Gravidade de Doença , Adulto Jovem
19.
Clin Res Cardiol ; 106(8): 618-628, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28293797

RESUMO

BACKGROUND: Non-vitamin K antagonist oral anticoagulants (NOACs) are at least as effective and safe as vitamin K antagonists (VKAs) for stroke prevention in atrial fibrillation (AF). All pivotal trials have compared NOACs to warfarin. However, other VKAs are commonly used, for instance phenprocoumon. PATIENTS AND METHODS: A retrospective cohort study using a German claims database assessed the comparative risks of bleeding leading to hospitalization during therapy with NOACs and phenprocoumon in AF patients. Endpoints consisted of major bleeding, gastrointestinal bleeding, and any bleeding. Data were collected from January 1, 2013 to March 31, 2015. Patients newly initiated on dabigatran, apixaban, rivaroxaban, or phenprocoumon were included. Hazard Ratios for bleeding events were derived from Cox proportional hazard models, adjusting for differences in baseline characteristics. Propensity score matching was performed as a sensitivity analysis. RESULTS: A total of 35,013 patients were identified, including 3138 on dabigatran, 3633 on apixaban, 12,063 on rivaroxaban, and 16,179 on phenprocoumon. Patients prescribed apixaban or phenprocoumon were older compared to those on dabigatran or rivaroxaban and had a higher CHA2DS2-VASc score. After adjusting for baseline confounders, apixaban was associated with lower risks of major bleeding (HR 0.68, 95% CI 0.51-0.90, p = 0.008), gastrointestinal bleeding (HR 0.53, 95% CI 0.39-0.72, p < 0.001), and any bleeding (HR 0.80, 95% CI 0.70-0.92, p = 0.002) compared to phenprocoumon. There were no significant differences in bleeding risk between dabigatran and phenprocoumon. Rivaroxaban was associated with more gastrointestinal bleeding (HR 1.39, 95% CI 1.21-1.60, p < 0.001) and any bleeding (HR 1.19, 95% CI 1.10-1.28, p < 0.001). Sensitivity analysis using propensity score matching confirmed these observations. CONCLUSIONS: Apixaban therapy is associated with a significantly reduced risk of bleeding compared to phenprocoumon. Bleeding risk with dabigatran was similar to that of phenprocoumon but bleeding risk with rivaroxaban was higher.


Assuntos
Fibrilação Atrial/complicações , Hemorragia/induzido quimicamente , Femprocumona/efeitos adversos , Vigilância de Produtos Comercializados/métodos , Acidente Vascular Cerebral/prevenção & controle , Administração Oral , Idoso , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Fibrilação Atrial/tratamento farmacológico , Feminino , Seguimentos , Alemanha/epidemiologia , Hemorragia/epidemiologia , Humanos , Incidência , Masculino , Femprocumona/administração & dosagem , Estudos Retrospectivos , Acidente Vascular Cerebral/etiologia
20.
Thromb Haemost ; 117(5): 870-879, 2017 05 03.
Artigo em Inglês | MEDLINE | ID: mdl-28229160

RESUMO

The aim of this observational cohort study was to specify the risk of the vitamin K antagonist (VKA) phenprocoumon during first trimester of pregnancy, in particular to estimate the risk of birth defects and spontaneous fetal loss. Four hundred eight pregnancies with phenprocoumon exposure were compared to 1,642 pregnancies neither exposed to VKA nor to other major teratogens or fetotoxicants. There was no typical warfarin embryopathy in our exposed cohort. However, the overall rate of major birth defects was significantly increased (7.4 % vs 2.3 %; adjusted odds ratio [ORadj] 2.14; 95 % confidence interval [CI] 1.4-3.4). With early cessation until five completed gestational weeks the birth defect risk was similar to the comparison cohort (2.4 % vs 2.3 %; ORadj 1.07; 95 % CI 0.2-3.6). With treatment duration exceeding seven gestational weeks the rate of major birth defects increased up to five-fold (10.8 % vs 2.3 %; ORadj 5.18; 95 % CI 2.0-11.6). The overall risk of spontaneous abortion (SAB) was 38.0 % vs 17.5 % in the comparison cohort (adjusted hazard ratio [HRadj] 2.9; 95 % CI 2.2-3.9). The treatment duration had a significant effect on the hazard of SAB (HRadj 1.12; 95 % CI 1.01-1.25 per each additional exposure week). Phenprocoumon and other VKA carry an embryotoxic risk. This risk seems to be time-dependent with a steep risk increase for birth defects and also for fetal loss after week 5. If maternal disease permits, VKA therapy should be switched to safer alternatives such as heparins immediately after early recognition of pregnancy.


Assuntos
Anormalidades Induzidas por Medicamentos/etiologia , Aborto Espontâneo/induzido quimicamente , Anticoagulantes/administração & dosagem , Coagulação Sanguínea/efeitos dos fármacos , Femprocumona/administração & dosagem , Vitamina K/antagonistas & inibidores , Anormalidades Induzidas por Medicamentos/diagnóstico , Aborto Espontâneo/diagnóstico , Aborto Terapêutico , Adulto , Anticoagulantes/efeitos adversos , Peso ao Nascer , Esquema de Medicação , Substituição de Medicamentos , Feminino , Humanos , Recém-Nascido , Modelos Logísticos , Razão de Chances , Femprocumona/efeitos adversos , Gravidez , Primeiro Trimestre da Gravidez/sangue , Nascimento Prematuro/induzido quimicamente , Modelos de Riscos Proporcionais , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
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