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1.
Lancet ; 397(10291): 2253-2263, 2021 06 12.
Artigo em Inglês | MEDLINE | ID: covidwho-1253771

RESUMO

BACKGROUND: COVID-19 is associated with a prothrombotic state leading to adverse clinical outcomes. Whether therapeutic anticoagulation improves outcomes in patients hospitalised with COVID-19 is unknown. We aimed to compare the efficacy and safety of therapeutic versus prophylactic anticoagulation in this population. METHODS: We did a pragmatic, open-label (with blinded adjudication), multicentre, randomised, controlled trial, at 31 sites in Brazil. Patients (aged ≥18 years) hospitalised with COVID-19 and elevated D-dimer concentration, and who had COVID-19 symptoms for up to 14 days before randomisation, were randomly assigned (1:1) to receive either therapeutic or prophylactic anticoagulation. Therapeutic anticoagulation was in-hospital oral rivaroxaban (20 mg or 15 mg daily) for stable patients, or initial subcutaneous enoxaparin (1 mg/kg twice per day) or intravenous unfractionated heparin (to achieve a 0·3-0·7 IU/mL anti-Xa concentration) for clinically unstable patients, followed by rivaroxaban to day 30. Prophylactic anticoagulation was standard in-hospital enoxaparin or unfractionated heparin. The primary efficacy outcome was a hierarchical analysis of time to death, duration of hospitalisation, or duration of supplemental oxygen to day 30, analysed with the win ratio method (a ratio >1 reflects a better outcome in the therapeutic anticoagulation group) in the intention-to-treat population. The primary safety outcome was major or clinically relevant non-major bleeding through 30 days. This study is registered with ClinicalTrials.gov (NCT04394377) and is completed. FINDINGS: From June 24, 2020, to Feb 26, 2021, 3331 patients were screened and 615 were randomly allocated (311 [50%] to the therapeutic anticoagulation group and 304 [50%] to the prophylactic anticoagulation group). 576 (94%) were clinically stable and 39 (6%) clinically unstable. One patient, in the therapeutic group, was lost to follow-up because of withdrawal of consent and was not included in the primary analysis. The primary efficacy outcome was not different between patients assigned therapeutic or prophylactic anticoagulation, with 28 899 (34·8%) wins in the therapeutic group and 34 288 (41·3%) in the prophylactic group (win ratio 0·86 [95% CI 0·59-1·22], p=0·40). Consistent results were seen in clinically stable and clinically unstable patients. The primary safety outcome of major or clinically relevant non-major bleeding occurred in 26 (8%) patients assigned therapeutic anticoagulation and seven (2%) assigned prophylactic anticoagulation (relative risk 3·64 [95% CI 1·61-8·27], p=0·0010). Allergic reaction to the study medication occurred in two (1%) patients in the therapeutic anticoagulation group and three (1%) in the prophylactic anticoagulation group. INTERPRETATION: In patients hospitalised with COVID-19 and elevated D-dimer concentration, in-hospital therapeutic anticoagulation with rivaroxaban or enoxaparin followed by rivaroxaban to day 30 did not improve clinical outcomes and increased bleeding compared with prophylactic anticoagulation. Therefore, use of therapeutic-dose rivaroxaban, and other direct oral anticoagulants, should be avoided in these patients in the absence of an evidence-based indication for oral anticoagulation. FUNDING: Coalition COVID-19 Brazil, Bayer SA.


Assuntos
Anticoagulantes/uso terapêutico , COVID-19/sangue , COVID-19/tratamento farmacológico , Enoxaparina/uso terapêutico , Heparina/uso terapêutico , Rivaroxabana/efeitos adversos , Rivaroxabana/uso terapêutico , Adulto , Idoso , Coagulação Sanguínea/efeitos dos fármacos , Brasil/epidemiologia , Determinação de Ponto Final , Feminino , Produtos de Degradação da Fibrina e do Fibrinogênio , Hemorragia/induzido quimicamente , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Alta do Paciente , SARS-CoV-2 , Resultado do Tratamento
2.
Am J Case Rep ; 22: e932140, 2021 Jun 25.
Artigo em Inglês | MEDLINE | ID: mdl-34168105

RESUMO

BACKGROUND Left ventricular thrombus (LVT) is a complication of left ventricular dysfunction and myocardial infarction (MI) and is associated with systemic thromboembolism. Two-dimensional transthoracic echocardiography (TTE) is considered the first-line diagnostic tool for detection of LVT. Vitamin K antagonists (VKA) targeting an international normalized ratio (INR) from 2 to 3 are the only approved treatments by the Food and Drug Administration (FDA). New emerging observational data support the use of direct oral anticoagulants (DOACs) as an alternative therapeutic option; however, their safety and efficacy have not been assessed in a good-quality randomized controlled trial. CASE REPORT Here, we present a case of a 43-year-old man diagnosed with human immunodeficiency virus (HIV)-associated dilated cardiomyopathy complicated with an LVT. He was treated with rivaroxaban for 9 consecutive months with no interruption of therapy at any point in time; however, he presented to the emergency department with symptoms of decompensated heart failure. A follow-up TTE demonstrated a significant increase in the size of his LVT. This case questions the efficacy of using factor Xa inhibitor (rivaroxaban) as an alternative option for LVT treatment. CONCLUSIONS This case demonstrates a failure of rivaroxaban in treating LVT in a patient with HIV-associated dilated cardiomyopathy. Good-quality randomized clinical trials or prospective studies are required to establish the efficacy and safety of DOACs for LVT treatment as an alternative to VKA.


Assuntos
Rivaroxabana , Trombose , Adulto , Anticoagulantes/uso terapêutico , Inibidores do Fator Xa/uso terapêutico , Humanos , Masculino , Estudos Prospectivos , Rivaroxabana/uso terapêutico , Trombose/tratamento farmacológico
3.
BMC Infect Dis ; 21(1): 530, 2021 Jun 05.
Artigo em Inglês | MEDLINE | ID: mdl-34090366

RESUMO

BACKGROUND: Cytomegalovirus (CMV) is reported to have thrombogenic characteristics that activate factor X in vitro and stimulate the production of factor VIII and von Willebrand factor (vWF). Thrombosis associated with CMV infection is prevalent among immunocompromised patients and predominantly presents as a solitary large thrombus in the deep vein, pulmonary artery, splanchnic arteriovenous ducts, or other similar sites. Multiple thrombi, however, are rarely observed in such cases. Here, we report about an immunocompetent man with multiple microthrombi associated with CMV infection. CASE PRESENTATION: A 72-year-old Japanese man who complained of abdominal pain was hospitalized with multiple colonic stenosis. He was later diagnosed with CMV enterocolitis and treated with ganciclover from Day 27 post-admission. During hospitalization, the patient developed thrombi in his fingers. He was initially treated with anticoagulant therapy (rivaroxaban); however, the therapy was discontinued owing to a prolonged activated thromboplastin time and an elevated international normalized ratio of prothrombin time. Instead, vitamin K and fresh-frozen plasma were administered. Nevertheless, his coagulation profile remained abnormal. Eventually, he developed colonic perforation and had to undergo emergency surgery. An intraoperative specimen showed several microthrombi in the middle and small arteriovenous ducts of his small and large intestines. The patient's coagulopathy improved preoperatively, and his overall condition improved postoperatively. Since the activation of ADAMTS13 was reduced remarkably, the thrombotic tendency was determined to be a thrombotic microangiopathy-like condition owing to increased vWF. We could not attribute the coagulopathy to any other cause except CMV infection; therefore, we concluded that this was a case of multiple thrombosis associated with CMV. CONCLUSIONS: We present an extremely rare case of a patient with multiple thrombotic microangiopathy-like microthrombosis caused by CMV infection. Our findings suggest that CMV infection may be considered as a differential diagnosis for immunocompetent individuals who present with thrombosis of unspecified cause.


Assuntos
Infecções por Citomegalovirus/complicações , Enterocolite/tratamento farmacológico , Ganciclovir/uso terapêutico , Rivaroxabana/uso terapêutico , Trombose/diagnóstico , Proteína ADAMTS13/metabolismo , Idoso , Anticoagulantes/uso terapêutico , Antivirais/uso terapêutico , Citomegalovirus/efeitos dos fármacos , Citomegalovirus/isolamento & purificação , Infecções por Citomegalovirus/tratamento farmacológico , Enterocolite/complicações , Enterocolite/virologia , Humanos , Perfuração Intestinal/cirurgia , Masculino , Testes Sorológicos , Trombose/complicações
4.
Lancet ; 397(10291): 2253-2263, 2021 06 12.
Artigo em Inglês | MEDLINE | ID: mdl-34097856

RESUMO

BACKGROUND: COVID-19 is associated with a prothrombotic state leading to adverse clinical outcomes. Whether therapeutic anticoagulation improves outcomes in patients hospitalised with COVID-19 is unknown. We aimed to compare the efficacy and safety of therapeutic versus prophylactic anticoagulation in this population. METHODS: We did a pragmatic, open-label (with blinded adjudication), multicentre, randomised, controlled trial, at 31 sites in Brazil. Patients (aged ≥18 years) hospitalised with COVID-19 and elevated D-dimer concentration, and who had COVID-19 symptoms for up to 14 days before randomisation, were randomly assigned (1:1) to receive either therapeutic or prophylactic anticoagulation. Therapeutic anticoagulation was in-hospital oral rivaroxaban (20 mg or 15 mg daily) for stable patients, or initial subcutaneous enoxaparin (1 mg/kg twice per day) or intravenous unfractionated heparin (to achieve a 0·3-0·7 IU/mL anti-Xa concentration) for clinically unstable patients, followed by rivaroxaban to day 30. Prophylactic anticoagulation was standard in-hospital enoxaparin or unfractionated heparin. The primary efficacy outcome was a hierarchical analysis of time to death, duration of hospitalisation, or duration of supplemental oxygen to day 30, analysed with the win ratio method (a ratio >1 reflects a better outcome in the therapeutic anticoagulation group) in the intention-to-treat population. The primary safety outcome was major or clinically relevant non-major bleeding through 30 days. This study is registered with ClinicalTrials.gov (NCT04394377) and is completed. FINDINGS: From June 24, 2020, to Feb 26, 2021, 3331 patients were screened and 615 were randomly allocated (311 [50%] to the therapeutic anticoagulation group and 304 [50%] to the prophylactic anticoagulation group). 576 (94%) were clinically stable and 39 (6%) clinically unstable. One patient, in the therapeutic group, was lost to follow-up because of withdrawal of consent and was not included in the primary analysis. The primary efficacy outcome was not different between patients assigned therapeutic or prophylactic anticoagulation, with 28 899 (34·8%) wins in the therapeutic group and 34 288 (41·3%) in the prophylactic group (win ratio 0·86 [95% CI 0·59-1·22], p=0·40). Consistent results were seen in clinically stable and clinically unstable patients. The primary safety outcome of major or clinically relevant non-major bleeding occurred in 26 (8%) patients assigned therapeutic anticoagulation and seven (2%) assigned prophylactic anticoagulation (relative risk 3·64 [95% CI 1·61-8·27], p=0·0010). Allergic reaction to the study medication occurred in two (1%) patients in the therapeutic anticoagulation group and three (1%) in the prophylactic anticoagulation group. INTERPRETATION: In patients hospitalised with COVID-19 and elevated D-dimer concentration, in-hospital therapeutic anticoagulation with rivaroxaban or enoxaparin followed by rivaroxaban to day 30 did not improve clinical outcomes and increased bleeding compared with prophylactic anticoagulation. Therefore, use of therapeutic-dose rivaroxaban, and other direct oral anticoagulants, should be avoided in these patients in the absence of an evidence-based indication for oral anticoagulation. FUNDING: Coalition COVID-19 Brazil, Bayer SA.


Assuntos
Anticoagulantes/uso terapêutico , COVID-19/sangue , COVID-19/tratamento farmacológico , Enoxaparina/uso terapêutico , Heparina/uso terapêutico , Rivaroxabana/efeitos adversos , Rivaroxabana/uso terapêutico , Adulto , Idoso , Coagulação Sanguínea/efeitos dos fármacos , Brasil/epidemiologia , Determinação de Ponto Final , Feminino , Produtos de Degradação da Fibrina e do Fibrinogênio , Hemorragia/induzido quimicamente , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Alta do Paciente , SARS-CoV-2 , Resultado do Tratamento
5.
Angiol Sosud Khir ; 27(2): 169-175, 2021.
Artigo em Russo | MEDLINE | ID: mdl-34166358

RESUMO

Discussed in the article are the main problems related to surgical treatment of patients with peripheral artery disease, particularly taking into consideration that in the world there are from 160 to 202 million people suffering from this disease, with two thirds of such patients having signs of lesions of coronary or cerebral arteries. Vascular reconstructive interventions cannot completely eliminate the problem, since in the postoperative period there may develop cardiovascular complications related to both the limb involved as either acute or progressing chronic ischaemia and arteries of other localization (coronary, cerebral). The risk of serious cardiovascular complications in patients with a history of endured adverse ischaemic events on the part of limbs is severalfold higher. To solve these problems and decrease complications, salicylic acid is used as basic therapy. Attempts at replacing it by another drug or combined therapy with an alternative antiaggregant showed no advantages in increased risk of massive haemorrhage. On the other hand, a combination of salicylic acid with an anticoagulant at a low dose, i. e., rivaroxaban 2.5 mg twice daily as compared with acetylsalicylic acid monotherapy made it possible to significantly decrease the incidence of various cardiovascular complications in the form of myocardial infarction, stroke, adverse ischaemic events on the part of the extremity, limb amputation.


Assuntos
Doença Arterial Periférica , Inibidores da Agregação Plaquetária , Artérias , Quimioterapia Combinada , Humanos , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/tratamento farmacológico , Doença Arterial Periférica/cirurgia , Inibidores da Agregação Plaquetária/uso terapêutico , Rivaroxabana/uso terapêutico , Resultado do Tratamento
6.
Cochrane Database Syst Rev ; 5: CD003336, 2021 05 18.
Artigo em Inglês | MEDLINE | ID: mdl-34002371

RESUMO

BACKGROUND: People with chronic heart failure (HF) are at risk of thromboembolic events, including stroke, pulmonary embolism, and peripheral arterial embolism; coronary ischaemic events also contribute to the progression of HF. The use of long-term oral anticoagulation is established in certain populations, including people with HF and atrial fibrillation (AF), but there is wide variation in the indications and use of oral anticoagulation in the broader HF population. OBJECTIVES: To determine whether long-term oral anticoagulation reduces total deaths and stroke in people with heart failure in sinus rhythm. SEARCH METHODS: We updated the searches in CENTRAL, MEDLINE, and Embase in March 2020. We screened reference lists of papers and abstracts from national and international cardiovascular meetings to identify unpublished studies. We contacted relevant authors to obtain further data. We did not apply any language restrictions. SELECTION CRITERIA: Randomised controlled trials (RCT) comparing oral anticoagulants with placebo or no treatment in adults with HF, with treatment duration of at least one month. We made inclusion decisions in duplicate, and resolved any disagreements between review authors by discussion, or a third party. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion, and assessed the risks and benefits of antithrombotic therapy by calculating odds ratio (OR), accompanied by the 95% confidence intervals (CI). MAIN RESULTS: We identified three RCTs (5498 participants). One RCT compared warfarin, aspirin, and no antithrombotic therapy, the second compared warfarin with placebo in participants with idiopathic dilated cardiomyopathy, and the third compared rivaroxaban with placebo in participants with HF and coronary artery disease. We pooled data from the studies that compared warfarin with a placebo or no treatment. We are uncertain if there is an effect on all-cause death (OR 0.66, 95% CI 0.36 to 1.18; 2 studies, 324 participants; low-certainty evidence); warfarin may increase the risk of major bleeding events (OR 5.98, 95% CI 1.71 to 20.93, NNTH 17). 2 studies, 324 participants; low-certainty evidence). None of the studies reported stroke as an individual outcome. Rivaroxaban makes little to no difference to all-cause death compared with placebo (OR 0.99, 95% CI 0.87 to 1.13; 1 study, 5022 participants; high-certainty evidence). Rivaroxaban probably reduces the risk of stroke compared to placebo (OR 0.67, 95% CI 0.47 to 0.95; NNTB 101; 1 study, 5022 participants; moderate-certainty evidence), and probably increases the risk of major bleeding events (OR 1.65, 95% CI 1.17 to 2.33; NNTH 79; 1 study, 5008 participants; moderate-certainty evidence). AUTHORS' CONCLUSIONS: Based on the three RCTs, there is no evidence that oral anticoagulant therapy modifies mortality in people with HF in sinus rhythm. The evidence is uncertain if warfarin has any effect on all-cause death compared to placebo or no treatment, but it may increase the risk of major bleeding events. There is no evidence of a difference in the effect of rivaroxaban on all-cause death compared to placebo. It probably reduces the risk of stroke, but probably increases the risk of major bleedings. The available evidence does not support the routine use of anticoagulation in people with HF who remain in sinus rhythm.


Assuntos
Anticoagulantes/uso terapêutico , Cardiomiopatia Dilatada/complicações , Insuficiência Cardíaca/complicações , Tromboembolia/prevenção & controle , Administração Oral , Anticoagulantes/efeitos adversos , Aspirina/uso terapêutico , Doença Crônica , Insuficiência Cardíaca/mortalidade , Frequência Cardíaca , Hemorragia/induzido quimicamente , Humanos , Efeito Placebo , Placebos/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Rivaroxabana/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Tromboembolia/etiologia , Tromboembolia/mortalidade , Varfarina/efeitos adversos , Varfarina/uso terapêutico
7.
Kardiol Pol ; 79(6): 622-630, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34029374

RESUMO

Direct oral anticoagulants (DOACs), apixaban, dabigatran, edoxaban, and rivaroxaban, are widely used for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation as well as for prevention and treatment of venous thromboembolism. Although DOACs do not require routine laboratory monitoring of anticoagulant effect, there are special situations in which laboratory assessment may be warranted. Laboratory tests include quantitative assays, which measure plasma DOAC levels, and qualitative or semi-quantitative assays, which may be used to screen for the presence of clinically relevant DOAC levels. Indications for laboratory assessment include emergent indications (serious bleeding, urgent surgery, acute ischemic stroke with consideration of thrombolysis) and elective indications (extremes of bodyweight, renal hypo- or hyperfunction, liver disease, suspected drug-drug interactions, suspected gastrointestinal malabsorption). In general, quantitative assays that measure DOAC levels may be used for elective indications, whereas screening assays may be necessary for emergent indications if a quantitative assay with sufficiently rapid turnaround time is not available. Therapeutic ranges for DOACs have not been defined. In lieu of therapeutic ranges, data from pharmacokinetic studies may be used to determine whether a patient's plasma DOAC level falls within the expected range. If it does not, a change in therapy may be warranted. Depending on the clinical scenario, a change in therapy may involve adjustment of the DOAC dose, a change to a different DOAC, or a change to a different class of anticoagulant.


Assuntos
Fibrilação Atrial , Isquemia Encefálica , Acidente Vascular Cerebral , Administração Oral , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Dabigatrana/uso terapêutico , Humanos , Laboratórios , Piridonas/uso terapêutico , Rivaroxabana/uso terapêutico , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/prevenção & controle
9.
Am Heart J ; 238: 1-11, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33891907

RESUMO

BACKGROUND: Observational studies have suggested a higher risk of thrombotic events in patients with coronavirus disease 2019 (COVID-19). Moreover, elevated D-dimer levels have been identified as an important prognostic marker in COVID-19 directly associated with disease severity and progression. Prophylactic anticoagulation for hospitalized COVID-19 patients might not be enough to prevent thrombotic events; therefore, therapeutic anticoagulation regimens deserve clinical investigation. DESIGN: ACTION is an academic-led, pragmatic, multicenter, open-label, randomized, phase IV clinical trial that aims to enroll around 600 patients at 40 sites participating in the Coalition COVID-19 Brazil initiative. Eligible patients with a confirmed diagnosis of COVID-19 with symptoms up to 14 days and elevated D-dimer levels will be randomized to a strategy of full-dose anticoagulation for 30 days with rivaroxaban 20 mg once daily (or full-dose heparin if oral administration is not feasible) vs standard of care with any approved venous thromboembolism prophylaxis regimen during hospitalization. A confirmation of COVID-19 was mandatory for study entry, based on specific tests used in clinical practice (RT-PCR, antigen test, IgM test) collected before randomization, regardless of in the outpatient setting or not. Randomization will be stratified by clinical stability at presentation. The primary outcome is a hierarchical analysis of mortality, length of hospital stay, or duration of oxygen therapy at the end of 30 days. Secondary outcomes include the World Health Organization's 8-point ordinal scale at 30 days and the following efficacy outcomes: incidence of venous thromboembolism , acute myocardial infarction, stroke, systemic embolism, major adverse limb events, duration of oxygen therapy, disease progression, and biomarkers. The primary safety outcomes are major or clinically relevant non-major bleeding according to the International Society on Thrombosis and Haemostasis criteria. SUMMARY: The ACTION trial will evaluate whether in-hospital therapeutic anticoagulation with rivaroxaban for stable patients, or enoxaparin for unstable patients, followed by rivaroxaban through 30 days compared with standard prophylactic anticoagulation improves clinical outcomes in hospitalized patients with COVID-19 and elevated D-dimer levels.


Assuntos
Anticoagulantes/uso terapêutico , COVID-19/complicações , Enoxaparina/uso terapêutico , Rivaroxabana/uso terapêutico , Trombose/prevenção & controle , Administração Oral , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Brasil , COVID-19/sangue , COVID-19/mortalidade , Esquema de Medicação , Enoxaparina/administração & dosagem , Enoxaparina/efeitos adversos , Produtos de Degradação da Fibrina e do Fibrinogênio/análise , Hemorragia/induzido quimicamente , Hospitalização , Humanos , Oxigenoterapia , Rivaroxabana/administração & dosagem , Rivaroxabana/efeitos adversos , Trombose/etiologia , Fatores de Tempo
10.
Am Heart J ; 238: 1-11, 2021 08.
Artigo em Inglês | MEDLINE | ID: covidwho-1193194

RESUMO

BACKGROUND: Observational studies have suggested a higher risk of thrombotic events in patients with coronavirus disease 2019 (COVID-19). Moreover, elevated D-dimer levels have been identified as an important prognostic marker in COVID-19 directly associated with disease severity and progression. Prophylactic anticoagulation for hospitalized COVID-19 patients might not be enough to prevent thrombotic events; therefore, therapeutic anticoagulation regimens deserve clinical investigation. DESIGN: ACTION is an academic-led, pragmatic, multicenter, open-label, randomized, phase IV clinical trial that aims to enroll around 600 patients at 40 sites participating in the Coalition COVID-19 Brazil initiative. Eligible patients with a confirmed diagnosis of COVID-19 with symptoms up to 14 days and elevated D-dimer levels will be randomized to a strategy of full-dose anticoagulation for 30 days with rivaroxaban 20 mg once daily (or full-dose heparin if oral administration is not feasible) vs standard of care with any approved venous thromboembolism prophylaxis regimen during hospitalization. A confirmation of COVID-19 was mandatory for study entry, based on specific tests used in clinical practice (RT-PCR, antigen test, IgM test) collected before randomization, regardless of in the outpatient setting or not. Randomization will be stratified by clinical stability at presentation. The primary outcome is a hierarchical analysis of mortality, length of hospital stay, or duration of oxygen therapy at the end of 30 days. Secondary outcomes include the World Health Organization's 8-point ordinal scale at 30 days and the following efficacy outcomes: incidence of venous thromboembolism , acute myocardial infarction, stroke, systemic embolism, major adverse limb events, duration of oxygen therapy, disease progression, and biomarkers. The primary safety outcomes are major or clinically relevant non-major bleeding according to the International Society on Thrombosis and Haemostasis criteria. SUMMARY: The ACTION trial will evaluate whether in-hospital therapeutic anticoagulation with rivaroxaban for stable patients, or enoxaparin for unstable patients, followed by rivaroxaban through 30 days compared with standard prophylactic anticoagulation improves clinical outcomes in hospitalized patients with COVID-19 and elevated D-dimer levels.


Assuntos
Anticoagulantes/uso terapêutico , COVID-19/complicações , Enoxaparina/uso terapêutico , Rivaroxabana/uso terapêutico , Trombose/prevenção & controle , Administração Oral , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Brasil , COVID-19/sangue , COVID-19/mortalidade , Esquema de Medicação , Enoxaparina/administração & dosagem , Enoxaparina/efeitos adversos , Produtos de Degradação da Fibrina e do Fibrinogênio/análise , Hemorragia/induzido quimicamente , Hospitalização , Humanos , Oxigenoterapia , Rivaroxabana/administração & dosagem , Rivaroxabana/efeitos adversos , Trombose/etiologia , Fatores de Tempo
11.
Kardiologiia ; 61(3): 18-22, 2021 Mar 30.
Artigo em Russo | MEDLINE | ID: mdl-33849414

RESUMO

Aim        To evaluate the effectiveness of the decision-making module in selecting an oral anticoagulant for patients with atrial fibrillation.Material and methods        638 patients with atrial fibrillation aged 68.2±4.5 years were evaluated. The CHA2DS2-VASc, HAS-BLED, and 2MАСЕ scales, the creatinine clearance calculator, and the Morisky-Green questionnaire were used.Results   311 (48.75 %) patients had paroxysmal atrial fibrillation, 138 (21.6%) had persistent atrial fibrillation, 44 (22.7%) had long-standing persistent atrial fibrillation, and 145 (22.7 %) had permanent atrial fibrillation. Mean CHADS2­VASc scale score was 4.82; НAS-BLED scale score was 2.9; 2MACE score was 2.28; and compliance score was 3.52. 172 (26.9 %) patients were treated with rivaroxaban; 166 (26 %), with apixaban; 84 (13.2 %), with dabigatran; 210 (32.9 %), with warfarin; and 6 (1 %), with acetylsalicylic acid.Conclusion            The developed decision-making module is based on scientific justification of personalized selection of the oral anticoagulant and updates the knowledge on major issues of prescription.


Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Administração Oral , Idoso , Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Dabigatrana/uso terapêutico , Humanos , Pessoa de Meia-Idade , Piridonas/uso terapêutico , Rivaroxabana/uso terapêutico , Acidente Vascular Cerebral/tratamento farmacológico , Varfarina/uso terapêutico
12.
Kardiologiia ; 61(3): 87-95, 2021 Mar 30.
Artigo em Russo, Inglês | MEDLINE | ID: mdl-33849424

RESUMO

Multifocal arterial injury is common in patients with atherosclerotic cardiovascular diseases and is associated with increased risk of cardiovascular complications and death. Administration of more intensive antithrombotic therapy, particularly combinations of acetylsalicylic acid and a "vascular" dose of rivaroxaban, in patients with multifocal arterial injury is characterized by a beneficial ratio of efficiency and safety due to a pronounced decrease in the risk of cardiovascular complications. Detection of peripheral artery diseases in patients with ischemic heart disease and atherosclerotic cerebrovascular pathology makes it possible to improve the risk stratification, optimize the diagnostic tactics and clarify indications for more intensive antithrombotic therapy.


Assuntos
Fibrinolíticos , Doença Arterial Periférica , Aspirina/efeitos adversos , Quimioterapia Combinada , Fibrinolíticos/efeitos adversos , Humanos , Doença Arterial Periférica/complicações , Doença Arterial Periférica/tratamento farmacológico , Inibidores da Agregação Plaquetária/uso terapêutico , Rivaroxabana/uso terapêutico
13.
Medicine (Baltimore) ; 100(13): e25086, 2021 Apr 02.
Artigo em Inglês | MEDLINE | ID: mdl-33787591

RESUMO

ABSTRACT: Pulmonary embolism (PE) is a life-threatening disease, which accounts for the major type of venous thromboembolism. Currently, there is limited understanding and management for PE. Rivaroxaban is reported to treat patients with PE. However, there is still insufficient evidence on rivaroxaban for the treatment of Chinese patients with acute PE. Thus, this retrospective study investigated the benefits and safety of rivaroxaban for Chinese patients with acute PE.A total of 72 Chinese patient cases with acute PE were analyzed in this study. Of these, 36 cases who received rivaroxaban mono-therapy were assigned to the treatment group, while the remaining 36 cases who received standard therapy were assigned to the control group. The benefits were assessed by the duration of hospital stay, treatment satisfaction, and safety.After treatment, rivaroxaban mono-therapy showed better benefits in decreasing the duration of hospital stay (P < .01), increasing treatment satisfaction (P < .01), and reducing mild bleeding (P = .02) in Chinese patients with acute PE, than standard therapy.The results of this study indicated that rivaroxaban may provide more benefits than the standard therapy for Chinese patients with acute PE. Future studies are still needed to warrant the current results.


Assuntos
Inibidores do Fator Xa/uso terapêutico , Embolia Pulmonar/tratamento farmacológico , Rivaroxabana/uso terapêutico , Doença Aguda , China , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Estudos Retrospectivos , Resultado do Tratamento
14.
Am J Cardiol ; 148: 69-77, 2021 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-33667438

RESUMO

To address literature gaps on treatment with real-world evidence, this study compared effectiveness, safety, and cost outcomes in NVAF patients with coronary or peripheral artery disease (CAD, PAD) prescribed apixaban versus other oral anticoagulants. NVAF patients aged ≥65 years co-diagnosed with CAD/PAD initiating warfarin, apixaban, dabigatran, or rivaroxaban were selected from the US Medicare population (January 1, 2013 to September 30, 2015). Propensity score matching was used to match apixaban versus warfarin, dabigatran, and rivaroxaban cohorts. Cox models were used to evaluate the risk of stroke/systemic embolism (SE), major bleeding (MB), all-cause mortality, and a composite of stroke/myocardial infarction/all-cause mortality. Generalized linear and two-part models were used to compare stroke/SE, MB, and all-cause costs between cohorts. A total of 33,269 warfarin-apixaban, 9,335 dabigatran-apixaban, and 33,633 rivaroxaban-apixaban pairs were identified after matching. Compared with apixaban, stroke/SE risk was higher in warfarin (hazard ratio [HR]: 1.93; 95% confidence interval [CI]: 1.61 to 2.31), dabigatran (HR: 1.69; 95% CI: 1.18 to 2.43), and rivaroxaban (HR: 1.24; 95% CI: 1.01 to 1.51) patients. MB risk was higher in warfarin (HR: 1.67; 95% CI: 1.52 to 1.83), dabigatran (HR: 1.37; 95% CI: 1.13 to 1.68), and rivaroxaban (HR: 1.87; 95% CI: 1.71 to 2.05) patients vs apixaban. Stroke/SE- and MB-related medical costs per-patient per-month were higher in warfarin, dabigatran, and rivaroxaban patients versus apixaban. Total all-cause health care costs were higher in warfarin and rivaroxaban patients compared with apixaban patients. In conclusion, compared with apixaban, patients on dabigatran, rivaroxaban, or warfarin had a higher risk of stroke/SE, MB, and event-related costs.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Doença da Artéria Coronariana/complicações , Embolia/prevenção & controle , Custos de Cuidados de Saúde , Hemorragia/epidemiologia , Doença Arterial Periférica/complicações , Acidente Vascular Cerebral/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/complicações , Fibrilação Atrial/economia , Causas de Morte , Doença da Artéria Coronariana/economia , Dabigatrana/uso terapêutico , Embolia/economia , Embolia/etiologia , Feminino , Hemorragia/induzido quimicamente , Hemorragia/economia , Humanos , Masculino , Mortalidade , Infarto do Miocárdio/economia , Infarto do Miocárdio/epidemiologia , Doença Arterial Periférica/economia , Pontuação de Propensão , Modelos de Riscos Proporcionais , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Rivaroxabana/uso terapêutico , Acidente Vascular Cerebral/economia , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Estados Unidos/epidemiologia , Varfarina/uso terapêutico
15.
Vopr Virusol ; 66(1): 40-46, 2021 03 07.
Artigo em Russo | MEDLINE | ID: covidwho-1120830

RESUMO

INTRODUCTION: Analysis of the pathogenesis of coronavirus infection caused SARS-CoV-2 indicates a significant impact of hemorheological disorders on its course and outcomes. It is known that chronic cardiovascular diseases are associated with the risk of severe course and lethal outcomes both in COVID-19 and other infectious diseases. Therefore, in each case it is necessary to study the interaction and mutual influence of different components of the treatment program prescribed to such patients.The purpose of this work was to evaluate the effect of coagulation activity on the course of a novel coronavirus infection (COVID-19) and to justify the management of comorbid patients having been received novel oral anticoagulants (NOACs) in previously selected doses according to indications in concomitant somatic diseases. MATERIAL AND METHODS: Total 76 cases of confirmed coronavirus infection in patients who had been received initial therapy on an outpatient basis were analyzed. 26 patients who received NOACs (rivaroxaban, apixaban, dabigatran) made up the main group and 50 - the comparison (control) group in which patients had not been administered any drugs that affect blood clotting until the episode of COVID-19. All patients have been prescribed therapy following the Provisional guidelines «Prevention, diagnosis and treatment of coronavirus infection (COVID-19)¼ (https://static-0.minzdrav.gov.ru/system/attachments/attaches/). RESULTS AND DISCUSSION: The number of hospitalizations was significantly fewer in the group of patients who had been received NOACs (19 vs. 66% in the control group). No deaths or cases of severe respiratory and/or renal failure were observed in the main group, while adverse outcomes were noted in 14% of patients who had not been administered these drugs. CONCLUSION: Taking NOACs reduces the probability of severe course and adverse outcomes in the development of coronavirus infection caused by SARS-CoV-2, which indicates a significant contribution of coagulation mechanisms to the pathogenesis in COVID-19. There were no indications for drug replacement and correction of anticoagulant therapy regimens in patients who received adequate therapy with oral anticoagulants for treating a non-severe form of coronavirus infection in ambulatory patient settings.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , COVID-19/tratamento farmacológico , Doença das Coronárias/tratamento farmacológico , Coagulação Intravascular Disseminada/tratamento farmacológico , Hipertensão/tratamento farmacológico , Arteriosclerose Intracraniana/tratamento farmacológico , Acetilcisteína/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Antivirais/uso terapêutico , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/mortalidade , Fibrilação Atrial/virologia , Azitromicina/uso terapêutico , COVID-19/mortalidade , COVID-19/patologia , COVID-19/virologia , Estudos de Coortes , Comorbidade , Doença das Coronárias/diagnóstico , Doença das Coronárias/mortalidade , Doença das Coronárias/virologia , Dabigatrana/uso terapêutico , Coagulação Intravascular Disseminada/diagnóstico , Coagulação Intravascular Disseminada/mortalidade , Coagulação Intravascular Disseminada/virologia , Feminino , Humanos , Hipertensão/diagnóstico , Hipertensão/mortalidade , Hipertensão/virologia , Indóis/uso terapêutico , Interferon alfa-2/uso terapêutico , Arteriosclerose Intracraniana/diagnóstico , Arteriosclerose Intracraniana/mortalidade , Arteriosclerose Intracraniana/virologia , Masculino , Pessoa de Meia-Idade , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Rivaroxabana/uso terapêutico , SARS-CoV-2/efeitos dos fármacos , SARS-CoV-2/patogenicidade , Índice de Gravidade de Doença , Análise de Sobrevida
16.
Clin Drug Investig ; 41(5): 459-468, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33725323

RESUMO

BACKGROUND: Rivaroxaban is a selective inhibitor of coagulation factor Xa and its combination with aspirin showed better outcomes in the prevention of recurrent cardiovascular disease than aspirin alone. OBJECTIVE: This analysis aimed to economically compare the cost effectiveness of rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily) with aspirin alone in patients with coronary artery disease (CAD) or peripheral artery disease (PAD) and related subgroups. METHODS: The analysis simulates the perspective of the Italian National Healthcare Service and used a state-transition decision Markov model. Clinical efficacy data and health events risks were gathered from the COMPASS trial. Health outcomes and costs (in Euros) were evaluated over a lifetime horizon and were discounted at 3.5% per annum. Direct healthcare costs entered the analysis. Results were expressed in terms of incremental cost-effectiveness ratio (ICER), defined as cost per quality-adjusted life-year (QALY) gained. One-way deterministic and probabilistic sensitivity analyses were performed. RESULTS: For the CAD or PAD population, rivaroxaban plus aspirin was more effective and costly compared with aspirin alone. Incremental costs and efficacy produced an ICER of €16,522 per QALY gained. Analyses found similar trends for the PAD and CAD groups, with respective ICERs of €8003 and €18,599, while ICERs for the other groups were lower than €13,000 per QALY. Sensitivity analyses confirmed these findings. CONCLUSION: Compared with aspirin alone, rivaroxaban plus aspirin is cost effective in preventing recurrent cardiovascular events in all patients with CAD or PAD, from the Italian perspective. These results could help clinicians and decision makers to develop improved strategies for cardiovascular disease prevention.


Assuntos
Aspirina/administração & dosagem , Doença da Artéria Coronariana/tratamento farmacológico , Doença Arterial Periférica/tratamento farmacológico , Rivaroxabana/administração & dosagem , Idoso , Análise Custo-Benefício , Quimioterapia Combinada , Feminino , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Anos de Vida Ajustados por Qualidade de Vida , Rivaroxabana/uso terapêutico , Resultado do Tratamento
17.
Vopr Virusol ; 66(1): 40-46, 2021 03 07.
Artigo em Russo | MEDLINE | ID: mdl-33683064

RESUMO

INTRODUCTION: Analysis of the pathogenesis of coronavirus infection caused SARS-CoV-2 indicates a significant impact of hemorheological disorders on its course and outcomes. It is known that chronic cardiovascular diseases are associated with the risk of severe course and lethal outcomes both in COVID-19 and other infectious diseases. Therefore, in each case it is necessary to study the interaction and mutual influence of different components of the treatment program prescribed to such patients.The purpose of this work was to evaluate the effect of coagulation activity on the course of a novel coronavirus infection (COVID-19) and to justify the management of comorbid patients having been received novel oral anticoagulants (NOACs) in previously selected doses according to indications in concomitant somatic diseases. MATERIAL AND METHODS: Total 76 cases of confirmed coronavirus infection in patients who had been received initial therapy on an outpatient basis were analyzed. 26 patients who received NOACs (rivaroxaban, apixaban, dabigatran) made up the main group and 50 - the comparison (control) group in which patients had not been administered any drugs that affect blood clotting until the episode of COVID-19. All patients have been prescribed therapy following the Provisional guidelines «Prevention, diagnosis and treatment of coronavirus infection (COVID-19)¼ (https://static-0.minzdrav.gov.ru/system/attachments/attaches/). RESULTS AND DISCUSSION: The number of hospitalizations was significantly fewer in the group of patients who had been received NOACs (19 vs. 66% in the control group). No deaths or cases of severe respiratory and/or renal failure were observed in the main group, while adverse outcomes were noted in 14% of patients who had not been administered these drugs. CONCLUSION: Taking NOACs reduces the probability of severe course and adverse outcomes in the development of coronavirus infection caused by SARS-CoV-2, which indicates a significant contribution of coagulation mechanisms to the pathogenesis in COVID-19. There were no indications for drug replacement and correction of anticoagulant therapy regimens in patients who received adequate therapy with oral anticoagulants for treating a non-severe form of coronavirus infection in ambulatory patient settings.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , COVID-19/tratamento farmacológico , Doença das Coronárias/tratamento farmacológico , Coagulação Intravascular Disseminada/tratamento farmacológico , Hipertensão/tratamento farmacológico , Arteriosclerose Intracraniana/tratamento farmacológico , Acetilcisteína/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Antivirais/uso terapêutico , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/mortalidade , Fibrilação Atrial/virologia , Azitromicina/uso terapêutico , COVID-19/mortalidade , COVID-19/patologia , COVID-19/virologia , Estudos de Coortes , Comorbidade , Doença das Coronárias/diagnóstico , Doença das Coronárias/mortalidade , Doença das Coronárias/virologia , Dabigatrana/uso terapêutico , Coagulação Intravascular Disseminada/diagnóstico , Coagulação Intravascular Disseminada/mortalidade , Coagulação Intravascular Disseminada/virologia , Feminino , Humanos , Hipertensão/diagnóstico , Hipertensão/mortalidade , Hipertensão/virologia , Indóis/uso terapêutico , Interferon alfa-2/uso terapêutico , Arteriosclerose Intracraniana/diagnóstico , Arteriosclerose Intracraniana/mortalidade , Arteriosclerose Intracraniana/virologia , Masculino , Pessoa de Meia-Idade , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Rivaroxabana/uso terapêutico , SARS-CoV-2/efeitos dos fármacos , SARS-CoV-2/patogenicidade , Índice de Gravidade de Doença , Análise de Sobrevida
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