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1.
Circulation ; 147(25): 1891-1901, 2023 06 20.
Artigo em Inglês | MEDLINE | ID: mdl-37154020

RESUMO

BACKGROUND: COVID-19 (coronavirus disease 2019) is associated with heightened risks of venous and arterial thrombosis and hospitalization due to respiratory failure. To assess whether prophylactic anticoagulation can safely reduce the frequency of venous and arterial thrombosis, hospitalization, and death in nonhospitalized patients with symptomatic COVID-19 and at least one thrombosis risk factor, we conducted the PREVENT-HD double-blind, placebo-controlled randomized trial (A Study of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic COVID-19] Infection). METHODS: PREVENT-HD was conducted between August 2020 and April 2022 at 14 US integrated health care delivery networks. A virtual trial design used remote informed consent and clinical monitoring and facilitated data collection through electronic health record integration with a cloud-based research platform. Nonhospitalized patients with symptomatic COVID-19 and at least one thrombosis risk factor were enrolled and randomly assigned to either 10 mg of oral rivaroxaban or placebo daily for 35 days. The primary efficacy outcome was time to first occurrence of a composite of symptomatic venous thromboembolism, myocardial infarction, ischemic stroke, acute limb ischemia, non-central nervous system systemic arterial embolism, hospitalization, or death through day 35. The principal safety end point was International Society on Thrombosis and Hemostasis critical-site or fatal bleeding. The last study visit was on day 49. RESULTS: The study was terminated prematurely because of enrollment challenges and a lower-than-expected blinded pooled event rate. A total of 1284 patients underwent randomization with complete accrual of primary events through May 2022. No patients were lost to follow-up. The primary efficacy outcome occurred in 22 of 641 in the rivaroxaban group and 19 of 643 in the placebo group (3.4% versus 3.0%; hazard ratio, 1.16 [95% CI, 0.63-2.15]; P=0.63). No patient in either group experienced critical-site or fatal bleeding. One patient receiving rivaroxaban had a major bleed. CONCLUSIONS: The study was terminated prematurely after enrollment of 32% of planned accrual because of recruitment challenges and lower-than-expected event rate. Rivaroxaban prescribed for 35 days in nonhospitalized patients with symptomatic COVID-19 at risk for thrombosis did not appear to reduce a composite end point of venous and arterial thrombotic events, hospitalization, and death. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04508023.


Assuntos
COVID-19 , Trombose , Humanos , Rivaroxabana/efeitos adversos , Pacientes Ambulatoriais , Trombose/epidemiologia , Trombose/prevenção & controle , Hemorragia/induzido quimicamente , Hemorragia/tratamento farmacológico , Hospitalização , Anticoagulantes/efeitos adversos
2.
JAMA ; 332(10): 825-834, 2024 09 10.
Artigo em Inglês | MEDLINE | ID: mdl-39133476

RESUMO

Importance: Direct oral anticoagulants (DOACs), comprising apixaban, rivaroxaban, edoxaban, and dabigatran, are commonly used medications to treat patients with atrial fibrillation and venous thromboembolism. Decisions about how to manage DOACs in patients undergoing a surgical or nonsurgical procedure are important to decrease the risks of bleeding and thromboembolism. Observations: For elective surgical or nonsurgical procedures, a standardized approach to perioperative DOAC management involves classifying the risk of procedure-related bleeding as minimal (eg, minor dental or skin procedures), low to moderate (eg, cholecystectomy, inguinal hernia repair), or high risk (eg, major cancer or joint replacement procedures). For patients undergoing minimal bleeding risk procedures, DOACs may be continued, or if there is concern about excessive bleeding, DOACs may be discontinued on the day of the procedure. Patients undergoing a low to moderate bleeding risk procedure should typically discontinue DOACs 1 day before the operation and restart DOACs 1 day after. Patients undergoing a high bleeding risk procedure should stop DOACs 2 days prior to the operation and restart DOACs 2 days after. With this perioperative DOAC management strategy, rates of thromboembolism (0.2%-0.4%) and major bleeding (1%-2%) are low and delays or cancellations of surgical and nonsurgical procedures are infrequent. Patients taking DOACs who need emergent (<6 hours after presentation) or urgent surgical procedures (6-24 hours after presentation) experience bleeding rates up to 23% and thromboembolism as high as 11%. Laboratory testing to measure preoperative DOAC levels may be useful to determine whether patients should receive a DOAC reversal agent (eg, prothrombin complex concentrates, idarucizumab, or andexanet-α) prior to an emergent or urgent procedure. Conclusions and Relevance: When patients who are taking a DOAC require an elective surgical or nonsurgical procedure, standardized management protocols can be applied that do not require testing DOAC levels or heparin bridging. When patients taking a DOAC require an emergent, urgent, or semiurgent surgical procedure, anticoagulant reversal agents may be appropriate when DOAC levels are elevated or not available.


Assuntos
Anticoagulantes , Reversão da Anticoagulação , Perda Sanguínea Cirúrgica , Assistência Perioperatória , Hemorragia Pós-Operatória , Humanos , Administração Oral , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Anticoagulantes/sangue , Fibrilação Atrial/tratamento farmacológico , Assistência Perioperatória/métodos , Piridinas/administração & dosagem , Piridinas/efeitos adversos , Piridinas/sangue , Rivaroxabana/administração & dosagem , Rivaroxabana/efeitos adversos , Rivaroxabana/sangue , Tromboembolia Venosa/tratamento farmacológico , Dabigatrana/administração & dosagem , Dabigatrana/efeitos adversos , Dabigatrana/sangue , Tiazóis/administração & dosagem , Tiazóis/efeitos adversos , Tiazóis/sangue , Perda Sanguínea Cirúrgica/prevenção & controle , Hemorragia Pós-Operatória/induzido quimicamente , Hemorragia Pós-Operatória/epidemiologia , Hemorragia Pós-Operatória/prevenção & controle , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Reversão da Anticoagulação/métodos
3.
Circulation ; 145(19): 1471-1479, 2022 05 10.
Artigo em Inglês | MEDLINE | ID: mdl-35389229

RESUMO

BACKGROUND: Extended thromboprophylaxis has not been widely implemented in acutely ill medical patients because of bleeding concerns. The MAGELLAN (Multicenter, Randomized, Parallel Group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin) and MARINER (Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk) trials evaluated whether rivaroxaban compared with enoxaparin or placebo could prevent venous thromboembolism without increased bleeding. We hypothesized that patients with major bleeding but not those with nonmajor clinically relevant bleeding would be at an increased risk of all-cause mortality (ACM). METHODS: We evaluated all bleeding events in patients taking at least 1 dose of study drug and their association with ACM in 4 mutually exclusive groups: (1) no bleeding, or first event was (2) nonmajor clinically relevant bleeding, (3) major bleeding, or (4) trivial bleeding. Using a Cox proportional hazards model adjusted for differences in baseline characteristics associated with ACM, we assessed the risk of ACM after such events. RESULTS: Compared with patients with no bleeding, the risk of ACM for patients with nonmajor clinically relevant bleeding was not increased in MARINER (hazard ratio, 0.43; P=0.235) but was increased in MAGELLAN (hazard ratio, 1.74; P=0.021). Major bleeding was associated with a higher incidence of ACM in both studies, whereas trivial bleeding was not associated with ACM in either study. CONCLUSIONS: Patients with major bleeding had an increased risk of ACM, whereas nonmajor clinically relevant bleeding was not consistently associated with an increased risk of death. These results inform the risk-benefit calculus of extended thromboprophylaxis in medically ill patients. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: MAGELLAN, NCT00571649. URL: https://www. CLINICALTRIALS: gov; Unique identifier: MARINER, NCT02111564.


Assuntos
Rivaroxabana , Tromboembolia Venosa , Assistência ao Convalescente , Anticoagulantes/efeitos adversos , Enoxaparina/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/complicações , Humanos , Alta do Paciente , Rivaroxabana/efeitos adversos , Tromboembolia Venosa/epidemiologia
4.
Lancet ; 399(10319): 50-59, 2022 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-34921756

RESUMO

BACKGROUND: Patients hospitalised with COVID-19 are at risk for thrombotic events after discharge; the role of extended thromboprophylaxis in this population is unknown. METHODS: In this open-label, multicentre, randomised trial conducted at 14 centres in Brazil, patients hospitalised with COVID-19 at increased risk for venous thromboembolism (International Medical Prevention Registry on Venous Thromboembolism [IMPROVE] venous thromboembolism [VTE] score of ≥4 or 2-3 with a D-dimer >500 ng/mL) were randomly assigned (1:1) to receive, at hospital discharge, rivaroxaban 10 mg/day or no anticoagulation for 35 days. The primary efficacy outcome in an intention-to-treat analysis was a composite of symptomatic or fatal venous thromboembolism, asymptomatic venous thromboembolism on bilateral lower-limb venous ultrasound and CT pulmonary angiogram, symptomatic arterial thromboembolism, and cardiovascular death at day 35. Adjudication was blinded. The primary safety outcome was major bleeding. The primary and safety analyses were carried out in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT04662684. FINDINGS: From Oct 8, 2020, to June 29, 2021, 997 patients were screened. Of these patients, 677 did not meet eligibility criteria; the remaining 320 patients were enrolled and randomly assigned to receive rivaroxaban (n=160 [50%]) or no anticoagulation (n=160 [50%]). All patients received thromboprophylaxis with standard doses of heparin during hospitalisation. 165 (52%) patients were in the intensive care unit while hospitalised. 197 (62%) patients had an IMPROVE score of 2-3 and elevated D-dimer levels and 121 (38%) had a score of 4 or more. Two patients (one in each group) were lost to follow-up due to withdrawal of consent and not included in the intention-to-treat primary analysis. The primary efficacy outcome occurred in five (3%) of 159 patients assigned to rivaroxaban and 15 (9%) of 159 patients assigned to no anticoagulation (relative risk 0·33, 95% CI 0·12-0·90; p=0·0293). No major bleeding occurred in either study group. Allergic reactions occurred in two (1%) patients in the rivaroxaban group. INTERPRETATION: In patients at high risk discharged after hospitalisation due to COVID-19, thromboprophylaxis with rivaroxaban 10 mg/day for 35 days improved clinical outcomes compared with no extended thromboprophylaxis. FUNDING: Bayer.


Assuntos
Assistência ao Convalescente , Coagulação Sanguínea/efeitos dos fármacos , COVID-19/complicações , Inibidores do Fator Xa/farmacologia , Inibidores do Fator Xa/uso terapêutico , Rivaroxabana/farmacologia , Rivaroxabana/uso terapêutico , Tromboembolia Venosa/prevenção & controle , Adulto , Idoso , Feminino , Heparina/administração & dosagem , Heparina/uso terapêutico , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Alta do Paciente , Resultado do Tratamento , Tratamento Farmacológico da COVID-19
5.
Am J Gastroenterol ; 118(5): 812-819, 2023 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-36434811

RESUMO

INTRODUCTION: The periprocedural management of patients with atrial fibrillation (AF) using a direct oral anticoagulant (DOAC) undergoing elective gastrointestinal (GI) endoscopic procedure remains uncertain. We investigated the safety of a standardized periprocedural DOAC management strategy. METHODS: The Periprocedural Anticoagulation Use for Surgery Evaluation cohort study enrolled adult patients receiving a DOAC (apixaban, rivaroxaban, or dabigatran) for AF scheduled for an elective procedure or surgery. This analysis addresses patients undergoing digestive endoscopy. Standardized periprocedural management consisted of DOAC interruption 1 day preendoscopy with resumption 1 day after procedure at low-moderate risk of bleeding or 2 days in case of a high bleeding risk. Thirty-day outcomes included GI bleeding, thromboembolic events, and mortality. RESULTS: Of 556 patients on a DOAC (mean [SD] age of 72.5 [8.6] years; 37.4% female; mean CHADS 2 score 1.7 [1.0]), 8.6% were also on American Society of Anesthesiology (ASA) and 0.7% on clopidogrel. Most of the patients underwent colonoscopies (63.3%) or gastroscopies (14.0%), with 18.9% having both on the same procedural day. The mean total duration of DOAC interruption was 3.9 ± 1.6 days. Four patients experienced an arterial thromboembolic event (0.7%, 0.3%-1.8%) within 24.2 ± 5.9 days of DOAC interruption. GI bleeding events occurred in 2.5% (1.4%-4.2%) within 11.1 ± 8.1 days (range: 0.6; 25.5 days) of endoscopy, with major GI bleeding in 0.9% (0.4%-2.1%). Three patients died (0.5%; 0.2%-1.6%) 15.6-22.3 days after the endoscopy. DISCUSSION: After a contemporary standardized periprocedural management strategy, patients with AF undergoing DOAC therapy interruption for elective digestive endoscopy experienced low rates of arterial thromboembolism and major bleeding.


Assuntos
Fibrilação Atrial , Adulto , Humanos , Feminino , Criança , Masculino , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Anticoagulantes/uso terapêutico , Estudos de Coortes , Rivaroxabana/uso terapêutico , Dabigatrana/uso terapêutico , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/tratamento farmacológico , Endoscopia Gastrointestinal , Administração Oral
6.
Blood ; 137(20): 2838-2847, 2021 05 20.
Artigo em Inglês | MEDLINE | ID: mdl-33824972

RESUMO

Thromboembolic events, including venous thromboembolism (VTE) and arterial thromboembolism (ATE), and mortality from subclinical thrombotic events occur frequently in coronavirus disease 2019 (COVID-19) inpatients. Whether the risk extends postdischarge has been controversial. Our prospective registry included consecutive patients with COVID-19 hospitalized within our multihospital system from 1 March to 31 May 2020. We captured demographics, comorbidities, laboratory parameters, medications, postdischarge thromboprophylaxis, and 90-day outcomes. Data from electronic health records, health informatics exchange, radiology database, and telephonic follow-up were merged. Primary outcome was a composite of adjudicated VTE, ATE, and all-cause mortality (ACM). Principal safety outcome was major bleeding (MB). Among 4906 patients (53.7% male), mean age was 61.7 years. Comorbidities included hypertension (38.6%), diabetes (25.1%), obesity (18.9%), and cancer history (13.1%). Postdischarge thromboprophylaxis was prescribed in 13.2%. VTE rate was 1.55%; ATE, 1.71%; ΑCM, 4.83%; and MB, 1.73%. Composite primary outcome rate was 7.13% and significantly associated with advanced age (odds ratio [OR], 3.66; 95% CI, 2.84-4.71), prior VTE (OR, 2.99; 95% CI, 2.00-4.47), intensive care unit (ICU) stay (OR, 2.22; 95% CI, 1.78-2.93), chronic kidney disease (CKD; OR, 2.10; 95% CI, 1.47-3.0), peripheral arterial disease (OR, 2.04; 95% CI, 1.10-3.80), carotid occlusive disease (OR, 2.02; 95% CI, 1.30-3.14), IMPROVE-DD VTE score ≥4 (OR, 1.51; 95% CI, 1.06-2.14), and coronary artery disease (OR, 1.50; 95% CI, 1.04-2.17). Postdischarge anticoagulation was significantly associated with reduction in primary outcome (OR, 0.54; 95% CI, 0.47-0.81). Postdischarge VTE, ATE, and ACM occurred frequently after COVID-19 hospitalization. Advanced age, cardiovascular risk factors, CKD, IMPROVE-DD VTE score ≥4, and ICU stay increased risk. Postdischarge anticoagulation reduced risk by 46%.


Assuntos
COVID-19/complicações , Tromboembolia/epidemiologia , Tromboembolia/etiologia , Idoso , Anticoagulantes/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Alta do Paciente , Sistema de Registros , Fatores de Risco , SARS-CoV-2 , Tromboembolia/prevenção & controle
7.
Blood ; 135(20): 1788-1810, 2020 05 14.
Artigo em Inglês | MEDLINE | ID: mdl-32092132

RESUMO

There may be many predictors of venous thromboembolism (VTE) and bleeding in hospitalized medical patients, but until now, systematic reviews and assessments of the certainty of the evidence have not been published. We conducted a systematic review to identify prognostic factors for VTE and bleeding in hospitalized medical patients and searched Medline and EMBASE from inception through May 2018. We considered studies that identified potential prognostic factors for VTE and bleeding in hospitalized adult medical patients. Reviewers extracted data in duplicate and independently and assessed the certainty of the evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach. Of 69 410 citations, we included 17 studies in our analysis: 14 that reported on VTE, and 3 that reported on bleeding. For VTE, moderate-certainty evidence showed a probable association with older age; elevated C-reactive protein (CRP), D-dimer, and fibrinogen levels; tachycardia; thrombocytosis; leukocytosis; fever; leg edema; lower Barthel Index (BI) score; immobility; paresis; previous history of VTE; thrombophilia; malignancy; critical illness; and infections. For bleeding, moderate-certainty evidence showed a probable association with older age, sex, anemia, obesity, low hemoglobin, gastroduodenal ulcers, rehospitalization, critical illness, thrombocytopenia, blood dyscrasias, hepatic disease, renal failure, antithrombotic medication, and presence of a central venous catheter. Elevated CRP, a lower BI, a history of malignancy, and elevated heart rate are not included in most VTE risk assessment models. This study informs risk prediction in the management of hospitalized medical patients for VTE and bleeding; it also informs guidelines for VTE prevention and future research.


Assuntos
Hemorragia/diagnóstico , Hospitalização , Tromboembolia Venosa/diagnóstico , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Feminino , Hemorragia/epidemiologia , Hemorragia/etiologia , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Fatores de Risco , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/etiologia
8.
JAMA ; 327(2): 129-137, 2022 01 11.
Artigo em Inglês | MEDLINE | ID: mdl-35015038

RESUMO

Importance: Among patients younger than 21 years of age, the optimal duration of anticoagulant therapy for venous thromboembolism is unknown. Objective: To test the hypothesis that a 6-week duration of anticoagulant therapy for provoked venous thromboembolism is noninferior to a conventional 3-month therapy duration in patients younger than 21 years of age. Design, Setting, and Participants: Randomized clinical trial involving 417 patients younger than 21 years of age with acute, provoked venous thromboembolism enrolled at 42 centers in 5 countries from 2008-2021. The main exclusions were severe anticoagulant deficiencies or prior venous thromboembolism. Patients without persistent antiphospholipid antibodies and whose thrombi were resolved or not completely occlusive upon repeat imaging at 6 weeks after diagnosis underwent randomization. The final visit for the primary end points occurred in January 2021. Interventions: Total duration for anticoagulant therapy of 6 weeks (n = 207) vs 3 months (n = 210) for provoked venous thromboembolism. Main Outcomes and Measures: The primary efficacy and safety end points were centrally adjudicated symptomatic recurrent venous thromboembolism and clinically relevant bleeding events within 1 year blinded to treatment group. The primary analysis was noninferiority in the per-protocol population. The noninferiority boundary incorporated a bivariate trade-off that included an absolute increase of 0% in symptomatic recurrent venous thromboembolism with an absolute risk reduction of 4% in clinically relevant bleeding events (1 of 3 points on the bivariate noninferiority boundary curve). Results: Among 417 randomized patients, 297 (median age, 8.3 [range, 0.04-20.9] years; 49% female) met criteria for the primary per-protocol population analysis. The Kaplan-Meier estimate for the 1-year cumulative incidence of the primary efficacy outcome was 0.66% (95% CI, 0%-1.95%) in the 6-week anticoagulant therapy group and 0.70% (95% CI, 0%-2.07%) in the 3-month anticoagulant therapy group, and for the primary safety outcome, the incidence was 0.65% (95% CI, 0%-1.91%) and 0.70% (95% CI, 0%-2.06%). Based on absolute risk differences in recurrent venous thromboembolism and clinically relevant bleeding events between groups, noninferiority was demonstrated. Adverse events occurred in 26% of patients in the 6-week anticoagulant therapy group and in 32% of patients in the 3-month anticoagulant therapy group; the most common adverse event was fever (1.9% and 3.4%, respectively). Conclusions and Relevance: Among patients younger than 21 years of age with provoked venous thromboembolism, anticoagulant therapy for 6 weeks compared with 3 months met noninferiority criteria based on the trade-off between recurrent venous thromboembolism risk and bleeding risk. Trial Registration: ClinicalTrials.gov Identifier: NCT00687882.


Assuntos
Anticoagulantes/administração & dosagem , Hemorragia/induzido quimicamente , Tromboembolia Venosa/tratamento farmacológico , Adolescente , Fatores Etários , Anticoagulantes/efeitos adversos , Criança , Pré-Escolar , Esquema de Medicação , Feminino , Seguimentos , Humanos , Incidência , Lactente , Recém-Nascido , Estimativa de Kaplan-Meier , Masculino , Recidiva , Terapêutica , Fatores de Tempo , Tromboembolia Venosa/etiologia , Adulto Jovem
9.
N Engl J Med ; 379(12): 1118-1127, 2018 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-30145946

RESUMO

BACKGROUND: Patients who are hospitalized for medical illness remain at risk for venous thromboembolism after discharge, but the role of extended thromboprophylaxis in the treatment of such patients is a subject of controversy. METHODS: In this randomized, double-blind trial, medically ill patients who were at increased risk for venous thromboembolism on the basis of a modified International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) score of 4 or higher (scores range from 0 to 10, with higher scores indicating a higher risk of venous thromboembolism) or a score of 2 or 3 plus a plasma d-dimer level of more than twice the upper limit of the normal range (defined according to local laboratory criteria) were assigned at hospital discharge to either once-daily rivaroxaban at a dose of 10 mg (with the dose adjusted for renal insufficiency) or placebo for 45 days. The primary efficacy outcome was a composite of symptomatic venous thromboembolism or death due to venous thromboembolism. The principal safety outcome was major bleeding. RESULTS: Of the 12,024 patients who underwent randomization, 12,019 were included in the intention-to-treat analysis. The primary efficacy outcome occurred in 50 of 6007 patients (0.83%) who were given rivaroxaban and in 66 of 6012 patients (1.10%) who were given placebo (hazard ratio, 0.76; 95% confidence interval [CI], 0.52 to 1.09; P=0.14). The prespecified secondary outcome of symptomatic nonfatal venous thromboembolism occurred in 0.18% of patients in the rivaroxaban group and 0.42% of patients in the placebo group (hazard ratio, 0.44; 95% CI, 0.22 to 0.89). Major bleeding occurred in 17 of 5982 patients (0.28%) in the rivaroxaban group and in 9 of 5980 patients (0.15%) in the placebo group (hazard ratio, 1.88; 95% CI, 0.84 to 4.23). CONCLUSIONS: Rivaroxaban, given to medical patients for 45 days after hospital discharge, was not associated with a significantly lower risk of symptomatic venous thromboembolism and death due to venous thromboembolism than placebo. The incidence of major bleeding was low. (Funded by Janssen Research and Development; MARINER ClinicalTrials.gov number, NCT02111564 .).


Assuntos
Inibidores do Fator Xa/uso terapêutico , Hospitalização , Rivaroxabana/uso terapêutico , Tromboembolia Venosa/prevenção & controle , Assistência ao Convalescente , Idoso , Método Duplo-Cego , Esquema de Medicação , Inibidores do Fator Xa/administração & dosagem , Inibidores do Fator Xa/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Alta do Paciente , Rivaroxabana/administração & dosagem , Rivaroxabana/efeitos adversos , Resultado do Tratamento , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/mortalidade , Trombose Venosa/prevenção & controle
10.
Am Heart J ; 235: 12-23, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33577800

RESUMO

BACKGROUND: COVID-19 is associated with both venous and arterial thrombotic complications. While prophylactic anticoagulation is now widely recommended for hospitalized patients with COVID-19, the effectiveness and safety of thromboprophylaxis in outpatients with COVID-19 has not been established. STUDY DESIGN: PREVENT-HD is a double-blind, placebo-controlled, pragmatic, event-driven phase 3 trial to evaluate the efficacy and safety of rivaroxaban in symptomatic outpatients with laboratory-confirmed COVID-19 at risk for thrombotic events, hospitalization, and death. Several challenges posed by the pandemic have necessitated innovative approaches to clinical trial design, start-up, and conduct. Participants are randomized in a 1:1 ratio, stratified by time from COVID-19 confirmation, to either rivaroxaban 10 mg once daily or placebo for 35 days. The primary efficacy end point is a composite of symptomatic venous thromboembolism, myocardial infarction, ischemic stroke, acute limb ischemia, non-central nervous system systemic embolization, all-cause hospitalization, and all-cause mortality. The primary safety end point is fatal and critical site bleeding according to the International Society on Thrombosis and Haemostasis definition. Enrollment began in August 2020 and is expected to enroll approximately 4,000 participants to yield the required number of end point events. CONCLUSIONS: PREVENT-HD is a pragmatic trial evaluating the efficacy and safety of the direct oral anticoagulant rivaroxaban in the outpatient setting to reduce major venous and arterial thrombotic events, hospitalization, and mortality associated with COVID-19.


Assuntos
COVID-19/complicações , Inibidores do Fator Xa/uso terapêutico , Hospitalização , Pacientes Ambulatoriais , Rivaroxabana/uso terapêutico , Trombose/prevenção & controle , Adulto , COVID-19/mortalidade , Causas de Morte , Método Duplo-Cego , Extremidades/irrigação sanguínea , Inibidores do Fator Xa/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Hemorragia/mortalidade , Mortalidade Hospitalar , Humanos , Isquemia/etiologia , AVC Isquêmico/etiologia , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Placebos/uso terapêutico , Rivaroxabana/efeitos adversos , Trombose/mortalidade , Tromboembolia Venosa/mortalidade , Tromboembolia Venosa/prevenção & controle
11.
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
12.
Semin Respir Crit Care Med ; 42(2): 308-315, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33548931

RESUMO

Venous thromboembolism (VTE) is the leading preventable cause of death in hospitalized patients and data consistently show that acutely ill medical patients remain at increased risk for VTE-related morbidity and mortality in the post-hospital discharge period. Prescribing extended thromboprophylaxis for up to 45 days following an acute hospitalization in key patient subgroups that include more than one-quarter of hospitalized medically-ill patients represents a paradigm shift in the way hospital-based physicians think about VTE prevention. Advances in the field of primary thromboprophylaxis in acutely-ill medical patients using validated VTE and bleeding risk assessment models have established key patient subgroups at high risk of VTE and low risk of bleeding that may benefit from both in-hospital and extended thromboprophylaxis. The direct oral anticoagulants betrixaban and rivaroxaban are now U.S. Food and Drug Administration-approved for in-hospital and extended thromboprophylaxis in medically ill patients and provide net clinical benefit in these key subgroups. Coronavirus disease-2019 may predispose patients to VTE due to excessive inflammation, platelet activation, endothelial dysfunction, and hemostasis. The optimum preventive strategy for these patients requires further investigation. This article aims to review the latest concepts in predicting and preventing VTE and discuss the new era of extended thromboprophylaxis in hospitalized medically ill patients.


Assuntos
Anticoagulantes/uso terapêutico , COVID-19/terapia , Duração da Terapia , Hospitalização , Embolia Pulmonar/prevenção & controle , Tromboembolia Venosa/prevenção & controle , Trombose Venosa/prevenção & controle , Benzamidas/uso terapêutico , COVID-19/sangue , COVID-19/complicações , Cuidados Críticos , Sistemas de Apoio a Decisões Clínicas , Humanos , Informática Médica , Alta do Paciente , Embolia Pulmonar/etiologia , Piridinas/uso terapêutico , Medição de Risco , Rivaroxabana/uso terapêutico , SARS-CoV-2 , Tromboembolia Venosa/etiologia , Trombose Venosa/etiologia
13.
J Thromb Thrombolysis ; 51(1): 12-16, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32564180

RESUMO

External validation is a prerequisite in order for a prediction model to be introduced into clinical practice. Nonetheless, methodologically intact external validation studies are a scarce finding. Utilization of big datasets can help overcome several causes of methodological failure. However, transparent reporting is needed to standardize the methods, assess the risk of bias and synthesize multiple validation studies in order to infer model generalizability. We describe the methodological challenges faced when using multiple big datasets to perform the first retrospective external validation study of the Prospective Comparison of Methods for thromboembolic risk assessment with clinical Perceptions and AwareneSS in real life patients-Cancer Associated Thrombosis (COMPASS-CAT) Risk Assessment Model for predicting venous thromboembolism in patients with cancer. The challenges included choosing the starting point, defining time sensitive variables that serve both as risk factors and outcome variables and using non-research oriented databases to form validated definitions from administrative codes. We also present the structured plan we used so as to overcome those obstacles and reduce bias with the target of producing an external validation study that successfully complies with prediction model reporting guidelines.


Assuntos
Big Data , Neoplasias/complicações , Medição de Risco/métodos , Trombose/etiologia , Bases de Dados Factuais , Humanos , Estudos Retrospectivos , Fatores de Risco , Tromboembolia/etiologia
14.
J Thromb Thrombolysis ; 51(4): 897-901, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33665766

RESUMO

Venous thromboembolism (VTE) has emerged as an important issue in patients with COVID-19. The purpose of this study is to identify the incidence of VTE and mortality in COVID-19 patients initially presenting to a large health system. Our retrospective study included adult patients (excluding patients presenting with obstetric/gynecologic conditions) across a multihospital health system in the New York Metropolitan Region from March 1-April 27, 2020. VTE and mortality rates within 8 h of assessment were described. In 10,871 adults with COVID-19, 118 patients (1.09%) were diagnosed with symptomatic VTE (101 pulmonary embolism, 17 deep vein thrombosis events) and 28 patients (0.26%) died during initial assessment. Among these 146 patients, 64.4% were males, 56.8% were 60 years or older, 15.1% had a BMI > 35, and 11.6% were admitted to the intensive care unit. Comorbidities included hypertension (46.6%), diabetes (24.7%), hyperlipidemia (14.4%), chronic lung disease (12.3%), coronary artery disease (11.0%), and prior VTE (7.5%). Key medications included corticosteroids (22.6%), statins (21.2%), antiplatelets (20.6%), and anticoagulants (20.6%). Highest D-Dimer was greater than six times the upper limit of normal in 51.4%. Statin and antiplatelet use were associated with decreased VTE or mortality (each p < 0.01). In COVID-19 patients who initially presented to a large multihospital health system, the overall symptomatic VTE and mortality rate was over 1.0%. Statin and antiplatelet use were associated with decreased VTE or mortality. The potential benefits of antithrombotics in high risk COVID-19 patients during the pre-hospitalization period deserves study.


Assuntos
COVID-19/complicações , Embolia Pulmonar , Trombose Venosa , COVID-19/epidemiologia , COVID-19/fisiopatologia , COVID-19/terapia , Feminino , Produtos de Degradação da Fibrina e do Fibrinogênio/análise , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Incidência , Unidades de Terapia Intensiva/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Mortalidade , New York/epidemiologia , Avaliação de Processos e Resultados em Cuidados de Saúde , Inibidores da Agregação Plaquetária/uso terapêutico , Fatores de Proteção , Embolia Pulmonar/sangue , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/etiologia , Embolia Pulmonar/mortalidade , Estudos Retrospectivos , Fatores de Risco , SARS-CoV-2/isolamento & purificação , Trombose Venosa/sangue , Trombose Venosa/diagnóstico , Trombose Venosa/etiologia , Trombose Venosa/mortalidade
15.
J Thromb Thrombolysis ; 52(4): 1032-1035, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34146235

RESUMO

There is a need to discriminate which COVID-19 inpatients are at higher risk for venous thromboembolism (VTE) to inform prophylaxis strategies. The IMPROVE-DD VTE risk assessment model (RAM) has previously demonstrated good discrimination in non-COVID populations. We aimed to externally validate the IMPROVE-DD VTE RAM in medical patients hospitalized with COVID-19. This retrospective cohort study evaluated the IMPROVE-DD VTE RAM in adult patients with COVID-19 admitted to one of thirteen Northwell Health hospitals in the New York metropolitan area between March 1, 2020 and April 27, 2020. VTE was defined as new-onset symptomatic deep venous thrombosis or pulmonary embolism. To assess the predictive value of the RAM, the receiver operating characteristic (ROC) curve was plotted and the area under the curve (AUC) was calculated. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated. Of 9407 patients who met study criteria, 274 patients developed VTE with a prevalence of 2.91%. The VTE rate was 0.41% for IMPROVE-DD score 0-1 (low risk), 1.21% for score 2-3 (moderate risk), and 5.30% for score ≥ 4 (high risk). Approximately 45.7% of patients were classified as high VTE risk, 33.3% moderate risk, and 21.0% low risk. Discrimination of low versus moderate-high VTE risk demonstrated sensitivity 0.971, specificity 0.215, PPV 0.036, and NPV 0.996. ROC AUC was 0.703. In this external validation study, the IMPROVE-DD VTE RAM demonstrated very good discrimination to identify hospitalized COVID-19 patients at low, moderate, and high VTE risk.


Assuntos
COVID-19 , Medição de Risco , Tromboembolia Venosa , COVID-19/complicações , Humanos , Pacientes Internados , Cidade de Nova Iorque , Estudos Retrospectivos , Fatores de Risco , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/epidemiologia
16.
Oncologist ; 25(7): e1083-e1090, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32017293

RESUMO

BACKGROUND: Current risk assessment models (RAMs) for prediction of venous thromboembolism (VTE) risk in the outpatient cancer population have shown poor predictive value in many of the most common cancers. The Comparison of Methods for Thromboembolic Risk Assessment with Clinical Perceptions and AwareneSS in Real Life Patients-Cancer Associated Thrombosis (COMPASS-CAT) RAM was derived in this patient population and predicted patients at high risk for VTE even after initiation of chemotherapy. We sought to externally validate this RAM. MATERIALS AND METHODS: Patients aged ≥18 years who presented to a tertiary care center between January 1, 2014, and December 31, 2016, with invasive breast, ovarian, lung, or colorectal cancers were included. The COMPASS-CAT RAM was applied using our health system's tumor registry and variables that were identified by International Statistical Classification of Diseases and Related Health Problems-9 and -10 codes of the electronic health record and independent chart review. The primary endpoint at 6-month study follow-up was documented VTE. RESULTS: A total of 3,814 patients were included. Documented VTE at 6-month follow-up occurred in 5.85% of patients. Patients stratified into low/intermediate- and high-risk groups had VTE rates of 2.27% and 6.31%, respectively. The sensitivity, specificity, and negative and positive predictive value of the RAM were 95%, 12%, 97.73%, and 6.31%, respectively. Diagnostic accuracy via receiver operating characteristic curve was calculated at 0.62 of the area under the curve. CONCLUSION: In this large retrospective external validation study of the COMPASS-CAT RAM for VTE in patients with cancer undergoing active treatment, model discrimination was moderate and calibration was poor. The model had good negative predictive value. Further prospective validation studies-especially within 6 months of cancer diagnosis-are needed before the model can be implemented into routine clinical practice for primary thromboprophylaxis of high-VTE-risk patients with cancer with solid tumors. IMPLICATIONS FOR PRACTICE: This study provides further guidance for researchers and clinicians in determining clinical and laboratory risk factors associated with development of venous thromboembolism among the ambulatory population of patients being treated for lung, breast, colorectal, or ovarian cancer. It validates the COMPASS-CAT risk model that was developed in this cancer population and suggests that further prospective validation of the model, with more focus on patients within 6 months of their index cancer diagnosis, would likely enhance the accuracy and usefulness of this model as a clinical prediction tool.


Assuntos
Neoplasias , Tromboembolia Venosa , Adolescente , Adulto , Anticoagulantes , Humanos , Neoplasias/complicações , Neoplasias/epidemiologia , Pacientes Ambulatoriais , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/etiologia
17.
Semin Thromb Hemost ; 46(1): 26-31, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31830765

RESUMO

Interruption of chronic anticoagulation due to the bleeding risk associated with an elective procedure may also lead to an elevated risk of thromboembolism. Periprocedural bridging with either unfractionated heparin or low-molecular weight heparin had been the mainstay of therapy for many patients receiving chronic warfarin treatment based on an estimation of a patient's thromboembolic risk. However, recent results from cohort studies and placebo-controlled randomized trials in the periprocedural use of heparin bridging for warfarin-treated patients reveal a consistent two- to three-fold increase in the risk of major bleeding and no benefit in terms of a reduction in the risk of stroke and systemic embolism. The most recent antithrombotic guidance statements suggest that the majority of patients on chronic warfarin, except those at high risk of thromboembolism, may safely interrupt and resume warfarin without heparin bridging in elective periprocedural settings. In addition, data from the use of heparin bridging in patients on direct oral anticoagulants during temporary interruption for an elective procedure also reveal harm and no benefits of this approach. A strategy that considers the pharmacokinetic properties of the direct oral anticoagulants, the bleeding risk of each procedure, and patient renal function would safely obviate the need for heparin bridging. In this review, the authors summarize the major studies of heparin bridging for patients on chronic oral anticoagulants that may lead to a change in practice in periprocedural antithrombotic management and define an evidence-based heparin bridging protocol for those patient groups who may be the candidates for this approach.


Assuntos
Administração Oral , Anticoagulantes/uso terapêutico , Perda Sanguínea Cirúrgica/prevenção & controle , Procedimentos Cirúrgicos Eletivos , Heparina de Baixo Peso Molecular/uso terapêutico , Assistência Perioperatória , Tromboembolia/prevenção & controle , Varfarina/uso terapêutico , Anticoagulantes/efeitos adversos , Heparina de Baixo Peso Molecular/efeitos adversos , Humanos , Testes de Função Renal , Fatores de Risco , Varfarina/efeitos adversos
18.
Ann Emerg Med ; 76(4): 470-485, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-31732375

RESUMO

Bleeding is the most common complication of anticoagulant use. The evaluation and management of the bleeding patient is a core competency of emergency medicine. As the prevalence of patients receiving anticoagulant agents and variety of anticoagulants with different mechanisms of action, pharmacokinetics, indications, and corresponding reversal agents increase, physicians and other clinicians working in the emergency department require a current and nuanced understanding of how best to assess, treat, and reverse anticoagulated patients. In this project, we convened an expert panel to create a consensus decision tree and framework for assessment of the bleeding patient receiving an anticoagulant, as well as use of anticoagulant reversal or coagulation factor replacement, and to address controversies and gaps relevant to this topic. To support decision tree interpretation, the panel also reached agreement on key definitions of life-threatening bleeding, bleeding at a critical site, and emergency surgery or urgent invasive procedure. To reach consensus recommendations, we used a structured literature review and a modified Delphi technique by an expert panel of academic and community physicians with training in emergency medicine, cardiology, hematology, internal medicine/thrombology, pharmacology, toxicology, transfusion medicine and hemostasis, neurology, and surgery, and by other key stakeholder groups.


Assuntos
Anticoagulantes/administração & dosagem , Antagonismo de Drogas , Anticoagulantes/uso terapêutico , Consenso , Serviço Hospitalar de Emergência/organização & administração , Serviço Hospitalar de Emergência/estatística & dados numéricos , Prova Pericial , Hemorragia/tratamento farmacológico , Humanos
19.
J Thromb Thrombolysis ; 49(2): 316-320, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31898275

RESUMO

Anticoagulation Management Services (AMS) are known to improve warfarin management in the outpatient setting. The guideline recommendations are well established and indicate that patients who receive a Vitamin K antagonist (VKA) should be under the care of an experienced and specialized anticoagulation clinic (Lip et al. in Chest 154(5):1121-1201, 2018). Warfarin, a VKA, is considered a high risk medication and one of the most common causes of adverse events with poor patient outcomes. Anticoagulation care is assessed by measuring the percent of Time in Therapeutic Range (TTR) in patients receiving a VKA. Evidence shows that a 10% improvement in TTR has been associated with a 10% reduction in adverse event rates. Optimal management over usual medical care should prevent 7 myocardial infarctions, strokes, major bleeds, or deaths per 100 patients/year (Bussey et al. in Pharmacotherapy 9(4):214-219, 1989). Telehealth or telemedicine can be defined as the use of electronic information along with telecommunication technologies to provide medical services to individuals that are in remote locations from each other (Perednia in JAMA 273(6):483-488, 1995; Gray et al in J Thromb Thrombolysis 2019(48):690-693, 2019). This technology allows a provider located at a distant site to use two-way audio visual electronic communication to deliver clinical health care services to a patient who is located at an originating site (Kristian et al. Int J Technol Assess Health Care 28(1):44-51, 2012; Testa and Zimmermann in Telemedicine for managing patients on oral anticoagulant, 2011; Telehealth Services in CMS Manual System Pub 100-04 medicare claims processing, 2019). The goals of the Telehealth Anticoagulation Management Service are to: (1) increase patient satisfaction (2) reduce turnaround time for results by providing the INR (International Normal Ratio) results in real time (3) increase patient compliance to INR testing and (4) improve system wide anticoagulation care by increasing cTTR (center Time in Therapeutic Range) metrics to high quality metrics of 65% and above. The overarching goal of our health system Telehealth program was to develop a collaborative care telemedicine INR model in collaboration with core laboratories (Patient Service Centers or PSCs) in order to improve patient quality metrics on warfarin. In this model, the Tele-ACTS Center (Telehealth Anticoagulation and Clinical Thrombosis Service) team was able to provide distant care for the outpatient population on warfarin maintenance therapy using a virtual telemedicine INR model located in a distant location to the PSC. Using this model, we were able to improve center-based TTR by 45.73%.


Assuntos
Anticoagulantes/administração & dosagem , Coagulação Sanguínea/efeitos dos fármacos , Telemedicina/métodos , Varfarina/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Fibrilação Atrial/sangue , Fibrilação Atrial/tratamento farmacológico , Coagulação Sanguínea/fisiologia , Feminino , Hemorragia/sangue , Hemorragia/induzido quimicamente , Humanos , Coeficiente Internacional Normatizado/métodos , Coeficiente Internacional Normatizado/normas , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Telemedicina/normas , Tromboembolia/sangue , Tromboembolia/tratamento farmacológico , Varfarina/efeitos adversos
20.
Circulation ; 138(14): 1402-1411, 2018 10 02.
Artigo em Inglês | MEDLINE | ID: mdl-29794081

RESUMO

BACKGROUND: Direct oral anticoagulants (DOACs) are surpassing warfarin as the anticoagulant of choice for stroke prevention in nonvalvular atrial fibrillation. DOAC outcomes in elective periprocedural settings have not been well elucidated and remain a source of concern for clinicians. The aim of this meta-analysis was to evaluate the periprocedural safety and efficacy of DOACs versus warfarin in patients with nonvalvular atrial fibrillation. METHODS: We reviewed the literature for data from phase III randomized controlled trials comparing DOACs with warfarin in the periprocedural period among patients with nonvalvular atrial fibrillation. Substudies from 4 trials (RE-LY [Randomized Evaluation of Long-Term Anticoagulation Therapy], ROCKET AF [Rivaroxaban Once Daily Oral Direct Factor Xa Inhibitor Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation], ARISTOTLE [Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation], and ENGAGE-AF [Effective Anticoagulation With Factor xA Next Generation in Atrial Fibrillation]) were included in the meta-analysis. DOACs as a group and warfarin were compared in terms of the 30-day pooled risk for stroke/systemic embolism, major bleeding, and death, according to whether the study drug was interrupted or not periprocedurally. The overall relative risk (RR) was estimated with a random-effects model. The I2 test was used to assess heterogeneity in RR among the studies. RESULTS: In the uninterrupted anticoagulant strategy, there were no differences in the rates of stroke/systemic embolism (pooled risk, 0.6% [29 events/4519 procedures] versus 1.1% [31/2971]; RR, 0.70; 95% confidence interval [CI], 0.41-1.18) and death (1.4% versus 1.8%; RR, 0.77; 95% CI, 0.53-1.12) between DOACs and warfarin and significantly fewer major bleeding events (2.0% versus 3.3%; RR, 0.62; 95% CI, 0.47-0.82) with DOACs compared to warfarin. Under an interrupted strategy, there was no significant difference between DOACs versus warfarin for stroke/systemic embolism (0.4% [41/9260] versus 0.5% [31/7168]; RR, 0.95; 95% CI, 0.59-1.55), major bleeding (2.1% versus 2.0%; RR, 1.05; 95% CI, 0.85-1.30), and death (0.7% versus 0.6%; RR, 1.24; 95% CI, 0.76-2.04). The studies were homogeneous ( I2=0.0%) for all calculated pooled associations except for the RR of death in the interrupted strategy ( I2=26.3%). CONCLUSIONS: The short-term safety and efficacy of DOACs and warfarin are not different in patients with nonvalvular atrial fibrillation periprocedurally. Under an uninterrupted anticoagulation strategy, DOACs are associated with a 38% lower risk of major bleeding compared with warfarin.


Assuntos
Anticoagulantes/administração & dosagem , Fibrilação Atrial/tratamento farmacológico , Assistência Perioperatória/métodos , Acidente Vascular Cerebral/prevenção & controle , Procedimentos Cirúrgicos Operatórios , Varfarina/administração & dosagem , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/mortalidade , Ensaios Clínicos Fase III como Assunto , Esquema de Medicação , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Assistência Perioperatória/efeitos adversos , Assistência Perioperatória/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/mortalidade , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Procedimentos Cirúrgicos Operatórios/mortalidade , Fatores de Tempo , Resultado do Tratamento , Varfarina/efeitos adversos
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