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1.
BMJ Open ; 11(10): e045530, 2021 10 25.
Artigo em Inglês | MEDLINE | ID: mdl-34697109

RESUMO

INTRODUCTION: Inferior vena cava (IVC) filters are commonly used in patients with venous thromboembolism to prevent fatal pulmonary embolism, but the thrombosis risk increases after filter placement. Warfarin is a widely anticoagulant, but long-term monitoring and dose adjustments are required. Anticoagulation with rivaroxaban is more straightforward as it dose not require laboratory monitoring. This study compares the efficacy and safety of rivaroxaban and warfarin as an in anticoagulation therapy for patients with IVC filter placement. METHODS AND ANALYSIS: This is a multicentre, randomised controlled trial. In total, 200 patients with deep vein thrombosis (DVT) with IVC filter implantation from 10 hospitals will be recruited. The patients will be randomised to the experimental group (rivaroxaban) or the control group (nadroparin overlapped with warfarin). The primary outcomes include death of any cause, pulmonary embolism (PE)-related death, bleeding and recurrent PE/DVT. The secondary outcomes include the percentage of other vascular events, IVC filter retrieval failure and net clinical benefits. This study aims to provide reliable, verification for the efficacy and safety of rivaroxaban antithrombotic therapy after IVC filter placement. ETHICS AND DISSEMINATION: The study was approved by the Human Research Ethics Committee of the Second Affiliated Hospital of Zhejiang University School of Medicine (approval number: (2019) 295). The results will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals TRIAL REGISTRATION NUMBER: NCT04066764.


Assuntos
Embolia Pulmonar , Filtros de Veia Cava , Anticoagulantes/efeitos adversos , Contraindicações , Humanos , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Embolia Pulmonar/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , Rivaroxabana/efeitos adversos , Resultado do Tratamento
2.
Isr Med Assoc J ; 23(9): 595-600, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34472236

RESUMO

BACKGROUND: Limited data exist regarding the safety of ultrasound-guided femoral nerve blockade (US-FNB) in patients with hip fractures treated with anti-Xa direct oral anticoagulants (DOAC). OBJECTIVES: To compare the safety outcomes of US-FNB to conventional analgesia in patients with hip fractures treated with anti-Xa DOAC. METHODS: This observational exploratory prospective study included 69 patients who presented to our emergency department (ED) in 3 years with hip fracture and who were treated with apixaban or rivaroxaban. Patients received either a US-FNB (n=19) or conventional analgesics (n=50) based on their preference and, and the presence of a trained ED physician qualified in performing US-FNB. Patients were observed for major bleeding events during and 30 days after hospitalization. The degree of preoperative pain and opioid use were also observed. RESULTS: We found no significant difference in the number of major bleeding events between groups (47.4% vs. 54.0%, P = 0.84). Degree of pain measured 3 and 12 hours after presentation was found to be lower in the US-FNB group (median visual analog scale of pain improvement from baseline of -5 vs. -3 (P = 0.002) and -5 vs.-4 (P = 0.023), respectively. Opioid administration pre-surgery was found to be more than three times more common in the conventional analgesia group (26.3% vs.80%, P < 0.0001). CONCLUSIONS: Regarding patients treated with Anti-Xa DOAC, US-FNB was not associated with an increase in major bleeding events compared to conventional analgesia, although it was an effective means of pain alleviation. Larger scale randomized controlled trials are required to determine long-term safety and efficacy.


Assuntos
Inibidores do Fator Xa/administração & dosagem , Fraturas do Quadril/cirurgia , Bloqueio Nervoso/métodos , Dor Pós-Operatória/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Analgésicos/administração & dosagem , Analgésicos Opioides/administração & dosagem , Estudos de Coortes , Serviço Hospitalar de Emergência , Inibidores do Fator Xa/efeitos adversos , Feminino , Nervo Femoral/diagnóstico por imagem , Hemorragia/epidemiologia , Hemorragia/etiologia , Humanos , Masculino , Bloqueio Nervoso/efeitos adversos , Medição da Dor , Projetos Piloto , Estudos Prospectivos , Pirazóis/administração & dosagem , Pirazóis/efeitos adversos , Piridonas/administração & dosagem , Piridonas/efeitos adversos , Rivaroxabana/administração & dosagem , Rivaroxabana/efeitos adversos , Ultrassonografia de Intervenção
3.
J Int Med Res ; 49(9): 3000605211047712, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34586928

RESUMO

Although direct-acting oral anticoagulants (DOACs) decrease the bleeding risk compared with vitamin K antagonists (VKAs), DOACs might cause spontaneous hemothorax in very elderly patients, even at a very low dose. Interactions between drugs might increase the risk of bleeding. In this article, we report a case of a 95-year-old man who developed spontaneous hemothorax while taking rivaroxaban 2.5 mg twice daily, 3 days after concomitant use of itraconazole. Rivaroxaban was discontinued, and thoracentesis was performed to drain grossly bloody pleural effusion. To our knowledge, this is the first case report of spontaneous hemothorax that might have been caused by concomitant low-dose rivaroxaban and azole anti-fungal agents. This case highlights the potential risk of spontaneous hemothorax in very elderly patients while taking rivaroxaban and azole anti-fungal agents simultaneously. Special attention should be paid to interactions between drugs that might increase the risk of bleeding. Drugs that have competing metabolic pathways should be avoided. Closer monitoring, including testing for anti-Xa and additional reassessment, should be considered in high-risk patients.


Assuntos
Fibrilação Atrial , Rivaroxabana , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Inibidores do Fator Xa/efeitos adversos , Hemorragia , Hemotórax/tratamento farmacológico , Humanos , Itraconazol/uso terapêutico , Masculino , Rivaroxabana/efeitos adversos
4.
Am Heart J ; 242: 115-122, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34480880

RESUMO

BACKGROUND: The devastating Coronavirus disease (COVID-19) pandemic is associated with a high prothrombotic state. It is unclear if the coagulation abnormalities occur because of the direct effect of SARS-CoV-2 or indirectly by the cytokine storm and endothelial damage or by a combination of mechanisms. There is a clear indication of in-hospital pharmacological thromboprophylaxis for every patient with COVID-19 after bleed risk assessment. However, there is much debate regarding the best dosage regimen, and there is no consensus on the role of extended thromboprophylaxis. DESIGN: This study aims to evaluate the safety and efficacy of rivaroxaban 10 mg once daily for 35 ± 4 days versus no intervention after hospital discharge in COVID-19 patients who were at increased risk for VTE and have received standard parenteral VTE prophylaxis during hospitalization. The composite efficacy endpoint is a combination of symptomatic VTE, VTE-related death, VTE detected by bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35 ± 4 posthospital discharge and symptomatic arterial thromboembolism (myocardial infarction, nonhemorrhagic stroke, major adverse limb events, and cardiovascular death) up to day 35 ± 4 posthospital discharge. The key safety outcome is the incidence of major bleeding according to ISTH criteria. SUMMARY: The MICHELLE trial is expected to provide high-quality evidence around the role of extended thromboprophylaxis in COVID-19 and will help guide medical decisions in clinical practice.1.


Assuntos
COVID-19/complicações , Inibidores do Fator Xa/administração & dosagem , Rivaroxabana/administração & dosagem , Trombose/prevenção & controle , Adulto , Brasil , Esquema de Medicação , Inibidores do Fator Xa/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Estudos Prospectivos , Embolia Pulmonar/etiologia , Embolia Pulmonar/prevenção & controle , Rivaroxabana/efeitos adversos , Tromboembolia/etiologia , Tromboembolia/prevenção & controle , Trombose/etiologia , Trombose Venosa/etiologia , Trombose Venosa/prevenção & controle
6.
Rev Cardiovasc Med ; 22(3): 1019-1027, 2021 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-34565103

RESUMO

The populations included in the randomized controlled clinical trials and observational studies were different. The effectiveness and safety of rivaroxaban for stroke prevention in patients with atrial fibrillation (AF) varied among studies. This study aimed to estimate the real-world outcomes of rivaroxaban in patients with AF accurately. A discrete event simulation (DES) was used to predict the counterfactual results of the ROCKET AF study. The hypothetical cohorts of patients were generated using Monte Carlo simulation according to the baseline covariate distributions that matched the marginal distribution of covariates reported in the ROCKET AF and three observational studies. The DES model structure was constructed based on a priori knowledge about disease progression and possible outcomes of patients with AF. The DES model accurately replicated the overall results of the ROCKET AF study. Both predicted stroke/systematic embolism (SE) and major bleeding rates were lower in the three observational studies than in the simulated ROCKET AF study. The risk difference of stroke/SE and major bleeding was not significant among the predicted outcomes of the three observational studies. Although some differences existed in the absolute rates of stroke/SE and major bleeding between observed and simulated studies, the results confirmed that rivaroxaban was noninferior to warfarin for the prevention of stroke/systematic embolism with no significance in the risk of major bleeding in large AF populations, which was similar to the results of ROCKET AF.


Assuntos
Fibrilação Atrial , Simulação por Computador , Embolia , Acidente Vascular Cerebral , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Inibidores do Fator Xa/efeitos adversos , Humanos , Método de Monte Carlo , Estudos Observacionais como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Rivaroxabana/efeitos adversos , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento , Varfarina
7.
Cardiovasc Ther ; 2021: 8561350, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34497668

RESUMO

Background: The guidelines on antithrombotic treatment in patients with symptomatic peripheral artery disease (PAD) undergoing peripheral revascularization of the lower extremities were developed based on heterogeneous trials, assessing various dose regimens and recruiting patients who were subjected to different revascularization procedures. Objective: To compare efficacy and safety of treatments used in patients with PAD undergoing peripheral revascularization accounting for between-trial heterogeneity and large dispersion of the quality of evidence. Methods: A systematic literature review of randomised controlled trials (RCTs) recruiting adult patients with PAD receiving antithrombotics was conducted until January 2020. Hazard ratios (HR) were pooled using Bayesian network meta-analysis. The estimated between-treatment effects were presented as HR together with 95% credible intervals. The base case analysis included studies recruiting patients following recent peripheral revascularization, who received treatment regimens administered within the recommended therapeutic window, while a sensitivity scenario included all identified trials. Results: Thirteen RCTs were identified (8 RCTs enrolled patients following peripheral revascularization and 5 RCTs regardless of the previous revascularization). Five trials, recruiting an overall of 8349 patients, were considered for the base case analysis. Of those, 6564 patients were recruited in the VOYAGER PAD trial comparing rivaroxaban plus aspirin (RIV plus ASA) versus ASA. RIV plus ASA was associated with a lower risk of repeated peripheral revascularization versus ASA monotherapy (HR = 0.88 [0.79, 0.99]), however having a trend towards an increased rate of major bleeding (HR = 1.43 [0.98, 2.11]). There was no evidence for differences between RIV plus ASA and dual antiplatelet therapy and vitamin K antagonists plus ASA. Similar results were observed in sensitivity analyses. Conclusions: RIV plus ASA is associated with reduced risk of revascularization compared with ASA monotherapy, but the evidence for other comparators, in particular antiplatelet regimens, was insufficient to guide treatment decisions and highlights the challenge in establishing the magnitude of comparative efficacy using existing RCTs.


Assuntos
Doença Arterial Periférica , Rivaroxabana , Adulto , Aspirina , Humanos , Metanálise em Rede , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/tratamento farmacológico , Inibidores da Agregação Plaquetária/efeitos adversos , Rivaroxabana/efeitos adversos
8.
Ann Palliat Med ; 10(7): 8082-8093, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34353093

RESUMO

BACKGROUND: To evaluate the efficacy and safety of Xa inhibitors in patients with heart failure (HF) and coronary artery disease (CAD) or peripheral artery disease (PAD). METHODS: A systematic electronic literature search was performed using the PubMed, Web of Science, EMBASE, and Cochrane Library databases from inception to June 26, 2019. A total of four randomized controlled trials involving 14,694 patients were included in this meta-analysis. RESULTS: The meta-analysis showed that there was no statistical difference between the Xa inhibitor and control group regarding the primary efficacy outcome [rivaroxaban 2.5 mg group: relative risk (RR) 0.82, 95% CI: 0.66-1.01, P=0.06; rivaroxaban 5 mg group: RR 0.86, 95% CI: 0.73-1.02, P=0.08]. The risk of the primary safety outcome was significantly increased among patients who received Xa inhibitors compared with the control group (rivaroxaban 2.5 mg group: RR 1.55, 95% CI: 1.21-1.98, P=0.0006; rivaroxaban 5 mg group: RR 1.66, 95% CI: 1.30-2.12, P<0.0001). There was no significant difference in the risk of cardiovascular death between the Xa inhibitor and control group (rivaroxaban 2.5 mg group: RR 0.79, 95% CI: 0.54-1.14, P=0.21; rivaroxaban 5 mg group: RR 0.89, 95% CI: 0.73-1.08, P=0.24). The risk of myocardial infarction (MI) in the rivaroxaban 5 mg group was significantly lower than that of the control group (RR 0.83, 95% CI: 0.69-0.99, P=0.04). However, the risk of MI in the rivaroxaban 2.5 mg group was similar to that of the control group (RR 0.85, 95% CI: 0.71-1.01, P=0.07). DISCUSSION: Xa inhibitors were associated with a higher risk of major adverse cardiovascular events and bleeding among HF and CAD or PAD patients. Therefore, Xa inhibitors should be used cautiously in patients with HF and CAD or PAD.


Assuntos
Insuficiência Cardíaca , Doença Arterial Periférica , Inibidores do Fator Xa/efeitos adversos , Insuficiência Cardíaca/tratamento farmacológico , Humanos , Doença Arterial Periférica/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto , Rivaroxabana/efeitos adversos
10.
Cardiovasc Revasc Med ; 30: 26-32, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34420589

RESUMO

BACKGROUND: The use of warfarin in patients with atrial fibrillation (AF) and end-stage renal disease (ESRD) has been implicated with efficacy and safety concerns. Evidence on the role of direct oral anticoagulants (DOACs) in this population is limited. METHODS: Electronic databases were searched and articles comparing the safety and efficacy of warfarin with apixaban or rivaroxaban were identified. Pooled hazard ratios (HR) were computed using a random-effects model. RESULTS: A total of eight articles consisting of 30,806 patients; (rivaroxaban 2196, apixaban 2745 and warfarin 25,865) were identified. The pooled HR for major bleeding events favored apixaban over warfarin (0.53, 95% confidence interval (CI) 0.33-0.84, p = 0.008). Apixaban was similar to warfarin in terms of clinically relevant non-major bleeding (HR 1.08, 95% CI 0.64-1.84, p = 0.77) and stroke events (HR 1.09, 95% CI 0.85, 1.39, p = 0.99). There was no significant difference in the risk of major bleeding events (HR 0.95, 95% CI 0.50-1.81, p = 0.88) and stroke between rivaroxaban (HR 1.39, 95% CI, 0.59-3.29, p = 0.09) and warfarin. The combined results of major bleeding in the apixaban group were not affected by the sensitivity analysis. CONCLUSIONS: Apixaban may have a lower risk of major bleeding and comparable risk of stroke when compared with warfarin in AF patients with ESRD.


Assuntos
Anticoagulantes , Fibrilação Atrial , Falência Renal Crônica , Administração Oral , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Humanos , Falência Renal Crônica/complicações , Falência Renal Crônica/diagnóstico , Falência Renal Crônica/tratamento farmacológico , Pirazóis/efeitos adversos , Piridonas/efeitos adversos , Rivaroxabana/efeitos adversos , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Varfarina/efeitos adversos
11.
Eur Heart J ; 42(39): 4040-4048, 2021 10 14.
Artigo em Inglês | MEDLINE | ID: mdl-34430972

RESUMO

AIMS: In this secondary analysis of the VOYAGER trial, rivaroxaban 2.5 mg twice/day plus aspirin 100 mg/day was assessed in older adults. Advanced age is associated with elevated bleeding risk and unfavourable net benefit for dual antiplatelet therapy in chronic coronary artery disease. The risk-benefit of low-dose rivaroxaban in patients ≥75 years with peripheral artery disease (PAD) after lower extremity revascularization (LER) has not been described. METHODS AND RESULTS: The primary endpoint was a composite of acute limb ischaemia, major amputation, myocardial infarction, ischaemic stroke, or cardiovascular death. The principal safety outcome was thrombolysis in myocardial infarction (TIMI) major bleeding analysed by the pre-specified age cut-off of 75 years. Of 6564 patients randomized, 1330 (20%) were >75 years. Absolute 3-year Kaplan-Meier cumulative incidence rates for primary efficacy (23.4% vs. 19.0%) and safety (3.5% vs. 1.5%) endpoints were higher in elderly vs. non-elderly patients. Efficacy of rivaroxaban (P-interaction 0.83) and safety (P-interaction 0.38) was consistent irrespective of age. The combination of intracranial and fatal bleeding was not increased in patients >75 years (2 rivaroxaban vs. 8 placebo). Overall, benefits (absolute risk reduction 3.8%, number needed to treat 26 for the primary endpoint) exceeded risks (absolute risk increase 0.81%, number needed to harm 123 for TIMI major bleeding). CONCLUSION: Patients ≥75 years with PAD are at both heightened ischaemic and bleeding risk after LER. No excess harm with respect to major, intracranial or fatal bleeding was seen in older patients yet numerically greater absolute benefits were observed. This suggests that low-dose rivaroxaban combined with aspirin should be considered in PAD after LER regardless of age.


Assuntos
Isquemia Encefálica , Doença Arterial Periférica , Acidente Vascular Cerebral , Idoso , Aspirina/efeitos adversos , Quimioterapia Combinada , Inibidores do Fator Xa/efeitos adversos , Humanos , Doença Arterial Periférica/complicações , Doença Arterial Periférica/tratamento farmacológico , Doença Arterial Periférica/cirurgia , Inibidores da Agregação Plaquetária/efeitos adversos , Rivaroxabana/efeitos adversos , Acidente Vascular Cerebral/tratamento farmacológico
12.
Ann Biol Clin (Paris) ; 79(4): 315-324, 2021 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-34405808

RESUMO

Since direct oral anticoagulants have been marketed, the management of major bleeding in emergency departments has become more challenging. In 2013 and 2016, the Working Group in Perioperative Haemostasis made several proposals for this. The objective of the present study was to evaluate conformity with these proposals in daily clinical practice. We performed a retrospective single-center cohort study addressing the management of major bleeding in patients treated by direct oral anticoagulant in an emergency department. Patients were included between January 1, 2015 and November 30, 2017. Among 3,365 patients admitted to the emergency department for bleeding, a total of 191 were treated by direct oral anticoagulant and 55 (28.8%) with major bleeding were included in the present study. The majority of patients received rivaroxaban (n = 44, 80.0%) and were treated for atrial fibrillation (n = 47, 85.0%). Bleeding concerned gastrointestinal (n = 30, 54.6%) and (n = 14, 25.5%) intracranial location. Twenty-one patients (38.2%) were treated by prothrombin complex concentrate, and 31 patients (56.4%) were transfused. Intervention for hemostatic control was performed for 30 patients (54.6%). Thirty-three patients (60.0%) presented a deviation from protocol. There is no significant difference for mortality at 3 months according to whether or not there was a deviation from protocol. Nearly two-thirds of patients with major bleeding associated with direct oral anticoagulant administration had protocol deviation, but there was no effect on mortality.


Assuntos
Anticoagulantes , Hemorragia , Administração Oral , Anticoagulantes/efeitos adversos , Estudos de Coortes , Serviço Hospitalar de Emergência , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Hemorragia/terapia , Humanos , Estudos Retrospectivos , Rivaroxabana/efeitos adversos
14.
Kardiologiia ; 61(6): 52-58, 2021 Jul 01.
Artigo em Russo, Inglês | MEDLINE | ID: mdl-34311688

RESUMO

Aim      To evaluate outcomes in patients with acute coronary syndrome and atrial fibrillation who receive rivaroxaban and the patients' compliance with the antithrombotic therapy.Material and methods  The study was performed from October 2017 through December 2019 and included 129 patients. Events between the discharge from the hospital and 12 months of follow-up were recorded. The primary endpoint was development of major, minor or requiring medical attention bleeding according to the TIMI scale. The secondary endpoint was a combination of recurrent myocardial infarction, nonfatal acute ischemic cerebrovascular disease, nonfatal systemic embolism, stent thrombosis, and cardiovascular mortality.Results 32 (24.8%) patients early terminated the antiplatelet treatment and 22 (17.1%) patients terminated the rivaroxaban treatment. 26 (20.2 %) patients had hemorrhagic complications. The highest incidence of hemorrhage was observed within the first 2 months after the discharge. None of the bleedings was fatal. Composite endpoint events were observed in 24 (18.6 %) patients, including 14 (10.9 %) who died from cardiovascular causes.Conclusion      The compliance with the antiplatelet therapy was insufficient. The incidence of hemorrhagic complications was relatively high; minor and requiring medical attention hemorrhages mostly contributed to the structure of these complications. The observed incidence of recurrent ischemic events associated with a high mortality presents a more serious problem compared to hemorrhagic complications of the combination antiplatelet therapy and warrants a more aggressive tactics of the antiplatelet treatment in high-risk patients.


Assuntos
Síndrome Coronariana Aguda , Fibrilação Atrial , Síndrome Coronariana Aguda/tratamento farmacológico , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Quimioterapia Combinada , Inibidores do Fator Xa/efeitos adversos , Humanos , Inibidores da Agregação Plaquetária/uso terapêutico , Rivaroxabana/efeitos adversos
15.
Kardiologiia ; 61(6): 79-87, 2021 Jul 01.
Artigo em Russo | MEDLINE | ID: mdl-34311691

RESUMO

Senile patients with atrial fibrillation (AF) are at a higher risk of thromboembolism and hemorrhage than younger patients. Three direct oral anticoagulants (DOAC), apixaban, dabigatran, and rivaroxaban, are registered in the Russian Federation and are extensively used for prevention of stroke in patients with AF. The DOAC treatment of older patients requires considering peculiarities of these patients, clinical situation and properties of individual drugs to achieve the balance of efficiency and safety and a comprehensive protection. According to studies of real clinical practice DOAC may have advantages over warfarin (reduced risk of fractures, diabetes mellitus, and dementia). Compliance with and constancy of the DOAC treatment are important for its efficiency, particularly in senile age. Results of clinical trials and real clinical practice studies have confirmed that rivaroxaban may provide a comprehensive protection for a senile patient with AF due to favorable indexes of efficiency and safety, beneficial effect on the risk of coronary events and impairment оf renal function, whereas once a day dosing of rivaroxaban improves the compliance with this treatment and its constancy.


Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Administração Oral , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Dabigatrana/uso terapêutico , Humanos , Piridonas/efeitos adversos , Gestão de Riscos , Rivaroxabana/efeitos adversos , Federação Russa , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle
16.
J Am Coll Cardiol ; 78(1): 14-23, 2021 07 06.
Artigo em Inglês | MEDLINE | ID: mdl-34210409

RESUMO

BACKGROUND: The combination of 2.5 mg rivaroxaban twice daily and 100 mg aspirin once daily compared with 100 mg aspirin once daily reduces major adverse cardiovascular (CV) events in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). OBJECTIVES: The aim of this work was to report the effects of the combination on overall and cause-specific mortality. METHODS: The COMPASS trial enrolled 27,395 patients of whom 18,278 were randomized to the combination (n = 9,152) or aspirin alone (n = 9,126). Deaths were adjudicated by a committee blinded to treatment allocation. Previously identified high-risk baseline features were polyvascular disease, chronic kidney disease, mild or moderate heart failure, and diabetes. RESULTS: During a median of 23 months of follow-up (maximum 47 months), 313 patients (3.4%) allocated to the combination and 378 patients (4.1%) allocated to aspirin alone died (hazard ratio [HR]: 0.82; 95% confidence interval [CI]: 0.71-0.96; P = 0.01). Compared with aspirin, the combination reduced CV death (160 [1.7%] vs 203 [2.2%]; HR: 0.78; 95% CI: 0.64-0.96; P = 0.02) but not non-CV death. There were fewer deaths following MI, stroke, and CV procedures, as well as fewer sudden cardiac, other, and unknown causes of CV deaths and coronary heart disease deaths. Patients with 0, 1, 2, and 3 or 4 high-risk features at baseline had 4.2, 4.8, 25.0, and 53.9 fewer deaths, respectively, per 1000 patients treated for 30 months. CONCLUSIONS: The combination of rivaroxaban and aspirin compared with aspirin reduced overall and CV mortality with consistent reductions in cause specific CV mortality in patients with chronic CAD or PAD. The absolute mortality benefits are greater with increasing baseline risk. (Cardiovascular Outcomes for People Using Anticoagulant Strategies [COMPASS]; NCT01776424).


Assuntos
Aspirina , Doença da Artéria Coronariana , Doença Arterial Periférica , Rivaroxabana , Idoso , Aspirina/administração & dosagem , Aspirina/efeitos adversos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/tratamento farmacológico , Doença da Artéria Coronariana/mortalidade , Diabetes Mellitus/epidemiologia , Quimioterapia Combinada , Inibidores do Fator Xa/administração & dosagem , Inibidores do Fator Xa/efeitos adversos , Feminino , Insuficiência Cardíaca/epidemiologia , Humanos , Masculino , Avaliação de Resultados em Cuidados de Saúde , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/tratamento farmacológico , Doença Arterial Periférica/mortalidade , Inibidores da Agregação Plaquetária/administração & dosagem , Inibidores da Agregação Plaquetária/efeitos adversos , Medição de Risco , Fatores de Risco , Rivaroxabana/administração & dosagem , Rivaroxabana/efeitos adversos , Índice de Gravidade de Doença
18.
Pan Afr Med J ; 38: 333, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34285756

RESUMO

We reported an anaphylactic reaction following ingestion of rivaroxaban in a 48-years-old male, who was recently discharged from the hospital as a case of deep vein thrombosis. At home, the patient developed a diffuse itchy skin rash, shortness of breath, and vomiting 30 minutes after rivaroxaban ingestion. Emergency Medical Service found that the patient had severe dyspnea, low blood pressure, and decreased blood oxygen saturation. The patient was given oxygen, intramuscular epinephrine, intravenous hydrocortisone, diphenhydramine, salbutamol nebulizer, and was immediately transferred to the emergency department of Hamad General Hospital. Subcutaneous enoxaparin was initiated, while hydrocortisone and salbutamol nebulizer continued. On the next day, his vital signs had stabilized, and intravenous hydrocortisone was switched to prednisolone tablets, and salbutamol nebulizer was switched to budesonide/salmeterol inhaler, whereas enoxaparin was overlapped with warfarin. After achieving the target international normalized ratio (INR), enoxaparin was discontinued and the patient was discharged with significant clinical and laboratory improvement.


Assuntos
Anafilaxia/induzido quimicamente , Inibidores do Fator Xa/efeitos adversos , Rivaroxabana/efeitos adversos , Anafilaxia/terapia , Anticoagulantes/administração & dosagem , Broncodilatadores/administração & dosagem , Inibidores do Fator Xa/administração & dosagem , Glucocorticoides/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Rivaroxabana/administração & dosagem , Trombose Venosa/tratamento farmacológico
19.
Thromb Res ; 204: 126-133, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34198049

RESUMO

INTRODUCTION: Venous thromboembolism (VTE) management increasingly involves anticoagulation with direct oral anticoagulants (DOACs). Few studies have used competing-risks analyses to ascertain the mortality-adjusted hemorrhage and recurrent VTE (rVTE) risk of individual DOACs. Furthermore, hemorrhage risk factors in patients treated with apixaban remain underexplored. MATERIALS AND METHODS: Patients diagnosed with VTE receiving anticoagulation were identified from the Optum Clinformatics Data Mart (2003-2019). Study endpoints included readmissions for intracranial hemorrhage (ICH), non-intracranial hemorrhage (non-ICH hemorrhage), and rVTE. Coarsened exact matching was used to balance baseline clinical characteristics. Complication incidence was evaluated using a competing-risks framework. We additionally modeled hemorrhage risk in apixaban-treated patients. RESULTS: Overall, 225,559 patients were included, of whom 34,201 received apixaban and 46,007 received rivaroxaban. Compared to rivaroxaban, apixaban was associated with decreased non-ICH hemorrhage (sHR = 0.560, 95%CI = 0.423-0.741), but not ICH, and rVTE (sHR = 0.802, 95%CI = 0.651-0.988) risk. This was primarily in emergent readmissions (sHR[emergent hemorrhage] = 0.515, 95%CI = 0.372-0.711; sHR[emergent rVTE] = 0.636, 95%CI = 0.488-0.830). Contributors to emergent hemorrhage in apixaban-treated patients include older age (sHR = 1.025, 95%CI = 1.011-1.039), female sex (sHR = 1.662, 95%CI = 1.252-2.207), prior prescription antiplatelet therapy (sHR = 1.591, 95%CI = 1.130-2.241), and complicated hypertension (sHR = 1.936, 95%CI = 1.134-3.307). Patients anticipated to be "high-risk" experienced elevated ICH (sHR = 3.396, 95%CI = 1.375-8.388) and non-ICH hemorrhage (sHR = 3.683, 95%CI = 2.957-4.588) incidence. CONCLUSIONS: In patients with VTE receiving anticoagulation, apixaban was associated with reduced non-ICH hemorrhage and rVTE risk, compared to rivaroxaban. Risk reduction was restricted to emergent readmissions. We present a risk-stratification approach to predict hemorrhage in patients receiving apixaban, potentially guiding future clinical decision-making.


Assuntos
Tromboembolia Venosa , Administração Oral , Idoso , Anticoagulantes/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Hemorragia/tratamento farmacológico , Humanos , Piridonas/efeitos adversos , Rivaroxabana/efeitos adversos , Tromboembolia Venosa/tratamento farmacológico
20.
RMD Open ; 7(2)2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-34253684

RESUMO

BACKGROUND: Despite vitamin K antagonists (VKA) being the gold standard in the prevention of thromboembolic events in antiphospholipid syndrome (APS), non-vitamin K antagonists oral anticoagulants/direct oral anticoagulants (DOACs) have been used off-label. OBJECTIVE: We aimed to perform a systematic review comparing DOACs to VKA regarding prevention of thromboembolic events, occurrence of bleeding events and mortality in patients with APS. METHODS: An electronic database search was performed through MEDLINE, CENTRAL and Web of Science. After data extraction, we pooled the results using risk ratio (RR) and 95% CI. Heterogeneity was assessed using the I². The outcomes considered were all thromboembolic events as primary, and major bleeding, all bleeding events and mortality as secondary. Evidence confidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation methodology. RESULTS: We included 7 studies and a total of 835 patients for analyses. Thromboembolic events were significantly increased in DOACs arm, compared with VKA-RR 1.69, 95% CI 1.09 to 2.62, I²-24%, n=719, 6 studies. In studies using exclusively rivaroxaban, which was the most representative drug in all included studies, the thromboembolic risk was increased threefold (RR 3.36, 95% CI 1.53 to 7.37). The risks of major bleeding, all bleeding events and mortality were not significantly different from control arm. The grade of certainty of our results is very low. CONCLUSIONS: Current evidence suggests DOACs use, particularly rivaroxaban, among patients with APS, is less effective than VKA since it is associated with 69% increased risk of thromboembolic events. TRIAL REGISTRATION NUMBER: CRD42020216178.


Assuntos
Síndrome Antifosfolipídica , Anticoagulantes/efeitos adversos , Síndrome Antifosfolipídica/complicações , Síndrome Antifosfolipídica/tratamento farmacológico , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Rivaroxabana/efeitos adversos , Vitamina K
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