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1.
Thromb Res ; 197: 13-15, 2020 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-33160115

RESUMO

BACKGROUND: The risk of venous thromboembolism (VTE) is increased in patients with active cancer and the risk is highest in those with metastatic disease. The risks and benefits of thromboprophylaxis among cancer patients with metastatic disease initiating chemotherapy treatment are unknown. To address this important knowledge gap, we evaluated the efficacy and safety of apixaban thromboprophylaxis in patients with and without metastatic disease. METHODS: Post-hoc analysis of the AVERT trial, which was a randomized, placebo-controlled, double-blind trial comparing apixaban therapy to placebo for VTE prophylaxis among cancer patients who were intermediate-to-high risk for VTE and who were initiating chemotherapy. The hazards ratios (HRs) for VTE and major bleeding episodes in patients with and without metastatic disease were calculated using a Cox regression model controlling for age, gender, and center. RESULTS: A total of 574 patients underwent randomization and 365 patients could be stratified according to the presence (n = 138) or absence (n = 227) of metastatic disease. In patients with metastatic disease, those receiving apixaban had a significantly lower risk of VTE (HR 0.55; 95% CI 0.32 to 0.97) without a significant increase in major bleeding complications (HR 1.36 95% CI 0.27 to 6.93) compared to those on placebo. In patients without metastatic disease, the use of apixaban was also associated with a significantly lower risk of VTE (HR 0.34 95% CI 0.19 to 0.60) without a significant increase in major bleeding complications (HR 1.14 95% CI 0.08 to 15.91). CONCLUSIONS: In patients with and without metastatic disease, apixaban thromboprophylaxis was associated with a significantly lower rate of VTE compared to placebo.

2.
ESMO Open ; 5(6)2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33229505

RESUMO

Patients with cancer are at high risk of venous thromboembolic events, and this risk can be further increased in patients with certain cancer types and by cancer treatments. Guidelines on the prevention of cancer-associated thrombosis (CAT) recommend thromboprophylaxis for hospitalised patients; however, this is not routinely recommended for ambulatory patients receiving chemotherapy and is limited to specified high-risk patients. Identification of the ambulatory patients at risk of CAT who would most benefit from anticoagulant therapy is therefore critical to reduce the incidence of this complication. For patients receiving thromboprophylaxis for CAT, treatment options include low molecular weight heparin, acetylsalicylic acid, warfarin or direct oral anticoagulants (apixaban or rivaroxaban), dependent on the cancer type and cancer treatment regimen. This review discusses emerging clinical trial data and their potential clinical impact.

3.
Artigo em Inglês | MEDLINE | ID: mdl-33079379

RESUMO

Venous thromboembolic disease (VTE) is a common complication among patients with cancer. Data reporting risk of VTE among patients receiving chemotherapy for recurrent cancer compared to those with newly diagnosed tumors is scarce. Furthermore, it is unclear if thromboprophylaxis is beneficial and safe in these specific patient populations. Post-hoc analysis of the AVERT trial which was a randomized, placebo-controlled, double-blind trial comparing apixaban therapy to placebo for VTE prophylaxis among cancer patients who were intermediate-to-high risk for VTE and who were initiating chemotherapy. The HRs for recurrent VTE and major bleeding episodes in patients with newly diagnosed and recurrent cancers were calculated using a Cox regression model controlling for age, gender, and center. Of the 563 included patients 469 and 93 patients had newly diagnosed and recurrent cancers, respectively. Patients with recurrent cancer have a higher risk of VTE (Hazard ratio (HR): 1.53 (95% CI 1.0 to 2.33; p = 0.047) and major bleeding episodes (HR 2.89 (95% CI 1.52 to 5.49; p = 0.001) compared to those with newly diagnosed cancer. In patients with newly diagnosed cancers, the use of apixaban was associated with a significantly lower risk of VTE (HR 0.45; 95% CI 0.27-0.76; p = 0.002) and a higher rate of major bleeding (HR 2.10; 95% CI 1.09-4.08; p = 0.028). In patients with recurrent cancer, apixaban was associated with a significant lower rate of VTE (HR 0.26; 95% CI 0.13-0.53; p < 0.001) without an associated significantly increased risk of major bleeding (HR 1.82; 95% CI 0.36-9.15; p = 0.466). Patients with recurrent cancer seem to be at higher risk of recurrent VTE and major bleeding complications compared to those with newly diagnosed tumors. Apixaban appears to be safe and effective in these patient populations.

4.
Oncologist ; 2020 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-32969580

RESUMO

BACKGROUND: Thromboprophylaxis for ambulatory patients with cancer is effective, although uncertainties remain on who should be targeted. Using D-dimer values from individuals enrolled to the AVERT trial, we sought to identify and validate a more efficient venous thromboembolism (VTE) risk threshold for thromboprophylaxis. MATERIALS AND METHODS: The AVERT trial compared thromboprophylaxis with apixaban with placebo among patients with cancer with a Khorana Risk Score ≥2. The D-dimer measured at randomization was used to calculate an individualized 6-month VTE risk using the validated CATScore. A modified intention-to-treat analysis was used to assess efficacy (VTE) and safety (major and overall bleeding) in the (a) complete cohort and (b) ≥8% and < 8% 6-month VTE risk thresholds. RESULTS: Five hundred seventy-four patients were randomized in the AVERT trial; 466 (81%) with baseline D-dimer were included in the study. Two hundred thirty-seven subjects received apixaban; 229 received placebo. In the complete cohort, there were 13 (5.5%) VTE events in the apixaban arm compared with 26 (11.4%) events in the placebo arm (adjusted hazard ratio [aHR] 0.49 [0.25-0.95], p < .05). Number needed to treat (NNT) to prevent one VTE = 17. Eighty-two (35%) and 72 (31%) patients in the apixaban and placebo arms, respectively, had a 6-month VTE risk ≥8%. In this subgroup, 7 (8.4%) VTE events occurred with apixaban and 19 (26.3%) events with placebo (aHR 0.33 [0.14-0.81], p < .05), NNT = 6. Individuals with a VTE risk <8% derived no benefit from apixaban thromboprophylaxis (aHR 0.89 [0.30-2.65), p = .84). Increased rates of overall bleeding were observed with apixaban in both the complete (aHR 2.11 [1.09-4.09], p < .05) and ≥ 8% predicted risk cohorts (aHR 2.87 [0.91-9.13], p = .07). CONCLUSION: A 6-month VTE risk threshold of ≥8% increases the efficiency of risk-targeted thromboprophylaxis in ambulatory patients with cancer. IMPLICATIONS FOR PRACTICE: Ambulatory patients with cancer receiving chemotherapy have an increased risk of venous thromboembolism (VTE). A Khorana Risk Score (KRS) ≥2 is currently the suggested threshold for thromboprophylaxis. Using baseline D-dimer values from individuals enrolled to the AVERT trial, this retrospective validation study identifies a 6-month VTE risk of ≥8% as a more efficient threshold for thromboprophylaxis. At this threshold, the number needed to treat to prevent one VTE is 6, compared with 17 when using a KRS ≥2. Conversely, individuals with a predicted risk of <8% derive no clinical benefit from thromboprophylaxis. Future prospective studies should validate this threshold for outpatient thromboprophylaxis.

5.
Crit Care Clin ; 36(3): 437-448, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32473690

RESUMO

Given the broad treatment options, risk stratification of pulmonary embolism is a highly desirable component of management. The ideal tool identifies patients at risk of death from the original or recurrent pulmonary embolism. Using all-cause death in the first 30-days after pulmonary embolism diagnosis as a surrogate, clinical parameters, biomarkers, and radiologic evidence of right ventricular dysfunction and strain are predictive. However, no study has demonstrated improved mortality rates after implementation of a risk stratification strategy to guide treatment. Further research should use better methodology to study prognosis and test new management strategies in patients at high risk for death.

6.
PLoS One ; 15(6): e0234957, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32579570

RESUMO

INTRODUCTION: To summarize and compare the effectiveness of pharmacological thromboprophylaxis to pneumatic compression devices (PCD) for the prevention of venous thromboembolism in patients with acute intracerebral hemorrhage. METHODS: MEDLINE, PUBMED, EMBASE, and CENTRAL were systematically searched to identify randomized and non-randomized studies that compared each intervention directly to each other or against a common control (hydration, anti-platelet agents, stockings) in adults with acute spontaneous intracerebral hemorrhage. Two investigators independently screened the studies, extracted data, and appraised risk of bias. Studies with a high risk of bias were excluded from our final analysis. The primary outcome was the occurrence of venous thromboembolism (proximal deep vein thrombosis or pulmonary embolism) in the first 30 days. RESULTS: 8,739 articles were screened; four articles, all randomized control trials, met eligibility criteria. Bayesian network meta-analysis was performed to calculate risk estimates using both fixed and random effects analyses. 607 patients were included in the network analysis. PCD were associated with a significant decrease in venous thromboembolism compared to control (OR: 0.43, 95% Credible Limits [CrI]: 0.23-0.80). We did not find evidence of statistically significant differences between pharmacological thromboprophylaxis and control (OR: 0.93, 95% CrI: 0.19-4.37) or between PCD and pharmacological thromboprophylaxis (OR: 0.47, 95% CrI: 0.09-2.54). CONCLUSION: PCDs are superior to control interventions, but meaningful comparisons with pharmacotherapy are not possible due to a lack of data. This requires further exploration via large pragmatic clinical trials. TRIAL REGISTRATION: PROSPERO: CRD42018090960.


Assuntos
Hemorragia Cerebral/complicações , Tromboembolia Venosa/prevenção & controle , Humanos , Metanálise em Rede , Viés de Publicação , Risco , Tromboembolia Venosa/terapia
7.
Crit Care Med ; 48(4): 515-524, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32205598

RESUMO

OBJECTIVES: Patients with major bleeding are commonly admitted to the ICU. A growing number are on either oral or parenteral anticoagulation, but the impact of anticoagulation on patient outcomes is unknown. We sought to examine this association between anticoagulation therapy and mortality, as well as the independent effects of warfarin compared to direct oral anticoagulants. DESIGN: Analysis of a prospectively collected registry (2011-2017) of consecutive ICU patients admitted with major bleeding (as defined by International Society on Thrombosis and Haemostasis clinical criteria). SETTING: Two hospitals within a single tertiary care level hospital system. PATIENTS: We analyzed 1,598 patients identified with major bleeding, of which 245 (15.3%) had been using anticoagulation at the time of ICU admission. Of patients on anticoagulation, 149 were using warfarin, and 60 were using a direct oral anticoagulant. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The primary outcome, in-hospital mortality, was analyzed using a multivariable logistic regression model. Patients with anticoagulation-associated major bleeding had higher in-hospital mortality (adjusted odds ratio, 1.49; 95% CI, 1.16-1.92). Among survivors, anticoagulation use was associated with longer median hospital length of stay, and higher mean costs. No differences in hospital mortality were seen between warfarin- and direct oral anticoagulant-associated major bleeding. Patients with warfarin-associated major bleeding had longer median length of stay (11 vs 6 d; p = 0.02), and higher total costs than patients with direct oral anticoagulant-associated major bleeding. CONCLUSIONS: Among ICU patients admitted with major bleeding, pre-admission anticoagulation use was associated with increased hospital mortality, prolonged length of stay, and higher costs among survivors. As compared to direct oral anticoagulants, patients with warfarin-associated major bleeding had increased length of stay and costs. These findings have important implications in the care of ICU patients with major bleeding.

8.
Haematologica ; 105(5): 1436-1442, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-31273089

RESUMO

In patients with cancer-associated venous thromboembolism, knowledge of the estimated rate of recurrent events is important for clinical decision-making regarding anticoagulant therapy. The Ottawa score is a clinical prediction rule designed for this purpose, stratifying patients according to their risk of recurrent venous thromboembolism during the first six months of anticoagulation. We conducted a systematic review and meta-analysis of studies validating either the Ottawa score in its original or modified versions. Two investigators independently reviewed the relevant articles published from 1st June 2012 to 15th December 2018 and indexed in MEDLINE and EMBASE. Nine eligible studies were identified; these included a total of 14,963 patients. The original score classified 49.3% of the patients as high-risk, with a sensitivity of 0.7 [95% confidence interval (CI): 0.6-0.8], a 6-month pooled rate of recurrent venous thromboembolism of 18.6% (95%CI: 13.9-23.9). In the low-risk group, the recurrence rate was 7.4% (95%CI: 3.4-12.5). The modified score classified 19.8% of the patients as low-risk, with a sensitivity of 0.9 (95%CI: 0.4-1.0) and a 6-month pooled rate of recurrent venous thromboembolism of 2.2% (95%CI: 1.6-2.9). In the high-risk group, recurrence rate was 10.2% (95%CI: 6.4-14.6). Limitations of our analysis included type and dosing of anticoagulant therapy. We conclude that new therapeutic strategies are needed in patients at high risk for recurrent cancer-associated venous thromboembolism. Low-risk patients, as per the modified score, could be good candidates for oral anticoagulation. (This systematic review was registered with the International Prospective Registry of Systematic Reviews as: PROSPERO CRD42018099506).

10.
J Thromb Haemost ; 17(12): 2141-2151, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31420937

RESUMO

BACKGROUND: It is unclear if direct oral anticoagulant (DOAC) is efficacious and safe for prophylaxis of venous thromboembolism (VTE) in ambulatory patients with cancer. METHODS: We performed a systematic review using EMBASE, MEDLINE, and CENTRAL. Inclusion criteria included adult ambulatory patients with cancer, prophylactic use of DOAC, and randomized controlled trials. Exclusion criteria included pediatric patients, inpatient or postoperative setting, therapeutic indication of DOAC, or non-phase III randomized controlled trial. Two authors screened/reviewed articles and abstracted the data. Meta-analysis was performed using random-effects model. Efficacy outcome included overall and symptomatic VTE incidence during the first 6 months. Safety outcomes included major bleeding and clinically relevant non-major bleeding (CRNMB) incidence during the on-treatment period. Subgroup analysis was performed for intermediate- and high-risk Khorana score. RESULTS: A total of 202 records were identified and 28 full-text articles were assessed. Two studies with 1415 participants were included for meta-analysis. For DOAC vs placebo, the relative risks for overall and symptomatic VTE incidence by 6 months were 0.56 (0.35-0.89) and 0.58 (0.29-1.13), respectively. The relative risks for major bleeding and CRNMB while on-treatment were 1.96 (0.80-4.82) and 1.28 (0.74-2.20), respectively. Patients with high-risk Khorana score (3+) derived the largest absolute risk reduction of VTE. CONCLUSIONS: Low-dose DOAC reduces the rate of overall VTE in higher risk cancer patients starting systemic chemotherapy. It may reduce the rate of symptomatic VTE but increase the likelihood of bleeding.

11.
Thromb Res ; 182: 12-19, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31434018

RESUMO

INTRODUCTION: Direct oral anticoagulants (DOACs) have expanded the options for antithrombotic therapy. DOAC-related major bleeds are associated with favorable outcomes compared to warfarin in clinical trials and routine practice. However, it is unclear whether management of DOAC-associated major bleeding incurs higher resource utilization and costs. MATERIALS AND METHODS: We screened medical records of patients ≥ 66 years with atrial fibrillation admitted to one of five tertiary care hospitals in Ontario, Canada with a hemorrhage. We abstracted bleeds involving DOACs or warfarin and linked them to administrative databases to capture length of hospital stay, blood product use, procedural interventions, intensive care unit (ICU) utilization and related direct medical costs. To control for confounders, multivariate logistic and linear regressions were used for binary and linear outcomes respectively. RESULTS: Among 19,061 records screened, 1978 (10.4%) cases involving 1632 patients met criteria of oral anticoagulant-associated bleeding. Baseline characteristics between DOAC and warfarin groups were similar. Blood product costs were higher for DOACs (all comparisons DOACs vs. warfarin, $1456 vs. $1109, mean difference $347, 95% CI $185 to $509), but length of stay and ICU use were similar. Mean direct medical costs did not differ ($9217 vs. $10,790, adjusted relative ratio 0.94, 95% CI 0.84-1.05). CONCLUSIONS: Prior to introduction of DOAC-specific reversal agents, resource utilization and medical costs were comparable between DOAC- and warfarin-associated major bleeds, despite marginally higher blood product costs incurred by the former. Resource intensity associated with anticoagulant-related bleeding remains high, and our data provide measures for cost-effectiveness evaluation of emerging DOAC antidotes.


Assuntos
Anticoagulantes/efeitos adversos , Inibidores do Fator Xa/efeitos adversos , Hemorragia/induzido quimicamente , Varfarina/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Transfusão de Sangue/economia , Efeitos Psicossociais da Doença , Gerenciamento Clínico , Inibidores do Fator Xa/uso terapêutico , Feminino , Custos de Cuidados de Saúde , Acesso aos Serviços de Saúde , Hemorragia/economia , Humanos , Unidades de Terapia Intensiva/economia , Tempo de Internação/economia , Masculino , Estudos Retrospectivos , Varfarina/uso terapêutico
16.
N Engl J Med ; 380(8): 711-719, 2019 02 21.
Artigo em Inglês | MEDLINE | ID: mdl-30511879

RESUMO

BACKGROUND: Patients with active cancer have an increased risk of venous thromboembolism, which results in substantial morbidity, mortality, and health care expenditures. The Khorana score (range, 0 to 6, with higher scores indicating a higher risk of venous thromboembolism) has been validated to identify patients with cancer at elevated risk for this complication and may help select those who could benefit from thromboprophylaxis. METHODS: We conducted a randomized, placebo-controlled, double-blind clinical trial assessing the efficacy and safety of apixaban (2.5 mg twice daily) for thromboprophylaxis in ambulatory patients with cancer who were at intermediate-to-high risk for venous thromboembolism (Khorana score, ≥2) and were initiating chemotherapy. The primary efficacy outcome was objectively documented venous thromboembolism over a follow-up period of 180 days. The main safety outcome was a major bleeding episode. RESULTS: Of the 574 patients who underwent randomization, 563 were included in the modified intention-to-treat analysis. Venous thromboembolism occurred in 12 of 288 patients (4.2%) in the apixaban group and in 28 of 275 patients (10.2%) in the placebo group (hazard ratio, 0.41; 95% confidence interval [CI], 0.26 to 0.65; P<0.001). In the modified intention-to-treat analysis, major bleeding occurred in 10 patients (3.5%) in the apixaban group and in 5 patients (1.8%) in the placebo group (hazard ratio, 2.00; 95% CI, 1.01 to 3.95; P = 0.046). During the treatment period, major bleeding occurred in 6 patients (2.1%) in the apixaban group and in 3 patients (1.1%) in the placebo group (hazard ratio, 1.89; 95% CI, 0.39 to 9.24). CONCLUSIONS: Apixaban therapy resulted in a significantly lower rate of venous thromboembolism than did placebo among intermediate-to-high-risk ambulatory patients with cancer who were starting chemotherapy. The rate of major bleeding episodes was higher with apixaban than with placebo. (Funded by the Canadian Institutes of Health Research and Bristol-Myers Squibb-Pfizer Alliance; AVERT ClinicalTrials.gov number, NCT02048865.).


Assuntos
Inibidores do Fator Xa/uso terapêutico , Neoplasias/tratamento farmacológico , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Tromboembolia Venosa/prevenção & controle , Administração Oral , Idoso , Antineoplásicos/uso terapêutico , Método Duplo-Cego , Inibidores do Fator Xa/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Humanos , Incidência , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Neoplasias/complicações , Pirazóis/efeitos adversos , Piridonas/efeitos adversos , Fatores de Risco , Tromboembolia Venosa/etiologia
17.
Res Pract Thromb Haemost ; 2(4): 670-677, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30349885

RESUMO

Introduction: Risk factors for exercise limitation after acute pulmonary embolism (PE) are unknown. As a planned sub-study of the prospective, multicenter ELOPE (Evaluation of Long-term Outcomes after PE) Study, we aimed to describe the results of serial imaging by computed tomography pulmonary angiography (CTPA) and perfusion scan during 1 year after a first episode of acute pulmonary embolism, and to assess the association between imaging parameters and exercise limitation at 1 year. Methods: In a prospective cohort study, 100 patients were recruited between June 2010 and February 2013 at five Canadian university-affiliated hospitals. CT pulmonary angiography was performed at baseline and 12 months, perfusion scan at 6 and 12 months, and cardio-pulmonary exercise testing at 1 and 12 months. Imaging parameters included: on CT pulmonary angiography, CT obstruction index (CTO) (% clot burden in the pulmonary vasculature), and on perfusion scan, pulmonary vascular obstruction (PVO) (% perfusion defect). Abnormal cardio-pulmonary exercise test (primary outcome) was defined as percent of predicted peak oxygen uptake (VO2) <80%. Results: Mean (median; SD) CT obstruction index was 28.1% (27.5%; 18.3%) at baseline, 1.2% (0%; 4.3%) at 12 months. Mean (median; SD) pulmonary vascular obstruction was 6.0% (0%; 9.6%) at 6 months, 5.6% (0%; 9.8%) at 12 months. Eighty-six patients had exercise testing at 12 months, and 46.5% had VO2 < 80% predicted. Mean (median; SD) CT obstruction index at 1 year was similar in patients with percent-predicted VO2 peak <80% vs >80% on 1-year cardio-pulmonary exercise testing (1.4% [0%; 5.7%] vs 1.0% [0%; 2.4%]; P = .70). Mean (SD) pulmonary vascular obstruction at 6 and at 12 months was similar in patients with percent-predicted VO2 peak <80% vs >80% (6 months: 5.9% [0%; 10.4%] vs 6.2% [4.5%; 9.0%]; P = .91; 12 months: 5.1% [0%; 10.2%] vs 6.0% [0%; 9.7%]; P = .71). Conclusions: Imaging findings after pulmonary embolism did not predict exercise limitation. Residual thrombus does not appear to explain long-term functional limitation after pulmonary embolism.

18.
JAMA ; 320(15): 1583-1594, 2018 Oct 16.
Artigo em Inglês | MEDLINE | ID: mdl-30326130

RESUMO

Importance: Venous thromboembolism (VTE), comprising deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common and potentially fatal disease. Objective: To summarize the advances in diagnosis and treatment of VTE of the past 5 years. Evidence Review: A systematic search was conducted in EMBASE Classic, EMBASE, Ovid MEDLINE, and other nonindexed citations using broad terms for diagnosis and treatment of VTE to find systematic reviews and meta-analyses, randomized trials, and prospective cohort studies published between January 1, 2013, and July 31, 2018. The 10th edition of the American College of Chest Physicians Antithrombotic Therapy Guidelines was screened to identify additional studies. Screening of titles, abstracts, and, subsequently, full-text articles was performed in duplicate, as well as data extraction and risk-of-bias assessment of the included articles. Findings: Thirty-two articles were included in this review. The application of an age-adjusted D-dimer threshold in patients with suspected PE has increased the number of patients in whom imaging can be withheld. The Pulmonary Embolism Rule-Out Criteria safely exclude PE when the pretest probability is low. The introduction of direct oral anticoagulants has allowed for a simplified treatment of VTE with a lower risk of bleeding regardless of etiology or extent of the VTE (except for massive PE) and has made extended secondary prevention more acceptable. Thrombolysis is best reserved for patients with massive PE or those with DVT and threatened limb loss. Insertion of inferior vena cava filters should be avoided unless anticoagulation is absolutely contraindicated in patients with recent acute VTE. Graduated compression stockings are no longer recommended to treat DVT but may be used when acute or chronic symptoms are present. Anticoagulation may no longer be indicated for patients with isolated distal DVT at low risk of recurrence. Conclusions and Relevance: Over the past 5 years, substantial progress has been made in VTE management, allowing for diagnostic and therapeutic strategies tailored to individual patient characteristics, preferences, and values.


Assuntos
Anticoagulantes/uso terapêutico , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/terapia , Administração Oral , Produtos de Degradação da Fibrina e do Fibrinogênio/análise , Humanos , Trombólise Mecânica , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/terapia , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/terapia
19.
Chest ; 154(6): 1371-1378, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30201406

RESUMO

BACKGROUND: Using data from the Reduced-Dose Rivaroxaban in the Long-Term Prevention of Recurrent Symptomatic Venous Thromboembolism (EINSTEIN-CHOICE) trial, this study assessed cost impact of continued anticoagulation therapy with rivaroxaban vs aspirin. METHODS: Total health-care costs (2016 USD) associated with rivaroxaban and aspirin were calculated as the sum of clinical event costs and drug costs from a US managed care perspective. Clinical event costs were calculated by multiplying event rate by cost of care. One-year Kaplan-Meier clinical event rates for recurrent pulmonary embolism, recurrent DVT, all-cause mortality, and bleeding were obtained from EINSTEIN-CHOICE. Cost of care was determined by literature review. Drug costs were the product of drug price (wholesale acquisition cost) and treatment duration. A one-way sensitivity analysis was conducted. RESULTS: Rivaroxaban users had lower per patient per month (PPPM) clinical event costs compared with aspirin users ($123, $243, and $381 for rivaroxaban 10 mg, rivaroxaban 20 mg, and aspirin, respectively). However, vs aspirin, PPPM total health-care costs were $24 higher for patients treated with rivaroxaban 10 mg ($143 higher for rivaroxaban 20 mg) due to higher cost of rivaroxaban. With a 15% discount for rivaroxaban 10 mg, the lower cost of clinical events for the rivaroxaban-treated patients more than fully offset the higher drug costs, and yielded a $19 lower total health-care cost. CONCLUSIONS: Continued therapy with rivaroxaban 10 and 20 mg vs aspirin was associated with lower clinical event costs but higher total health-care costs; with a 15% drug discount rivaroxaban 10 mg had lower total health-care costs than aspirin.


Assuntos
Aspirina , Custos de Cuidados de Saúde/estatística & dados numéricos , Hemorragia , Embolia Pulmonar , Rivaroxabana , Tromboembolia Venosa , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Anticoagulantes/economia , Aspirina/administração & dosagem , Aspirina/efeitos adversos , Aspirina/economia , Redução de Custos/métodos , Relação Dose-Resposta a Droga , Monitoramento de Medicamentos/economia , Feminino , Hemorragia/induzido quimicamente , Hemorragia/economia , Humanos , Masculino , Pessoa de Meia-Idade , Embolia Pulmonar/tratamento farmacológico , Embolia Pulmonar/economia , Embolia Pulmonar/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , Rivaroxabana/administração & dosagem , Rivaroxabana/efeitos adversos , Rivaroxabana/economia , Prevenção Secundária/economia , Prevenção Secundária/métodos , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/economia , Tromboembolia Venosa/prevenção & controle
20.
Thromb Res ; 168: 121-129, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-30064683

RESUMO

BACKGROUND: Full- or lower-dose anticoagulant therapy or aspirin can be used for extended therapy in patients with venous thromboembolism (VTE), but information on their relative benefit-risk profiles is limited. METHODS: Data from the EINSTEIN-CHOICE trial were used to compare the benefit-risk profiles of extended treatment with rivaroxaban (20 or 10 mg once daily) and aspirin (100 mg once daily) in VTE patients who had completed 6 to 12 months of anticoagulation therapy. One-year cumulative incidences of recurrent VTE and major bleeding were estimated and benefits and risks were calculated by determining the between group differences in a hypothetical population of 10,000 VTE patients treated for 1 year. FINDINGS: A total of 1107 patients were treated with 20 mg of rivaroxaban, 1127 with 10 mg of rivaroxaban, and 1131 with aspirin. The cumulative incidences of recurrent VTE in the rivaroxaban 20-mg, rivaroxaban 10-mg and aspirin groups were 1.9%, 1.6%, and 5.0%, respectively, whereas the cumulative incidences of major bleeding were 0.7%, 0.4% and 0.5%, respectively. The incidences of the combined outcome of recurrent VTE and major bleeding were 2.8% and 3.4% lower in the rivaroxaban 20-mg and 10-mg groups than in the aspirin group. For 10,000 patients treated for 1 year, there would be 284 (95% confidence interval [CI] 106 to 462) and 339 (95% CI 165 to 512) fewer events with rivaroxaban 20 mg or 10 mg than with aspirin. INTERPRETATION: Compared with aspirin, extended anticoagulation with once daily rivaroxaban reduces recurrent VTE with a favourable benefit-risk profile. FUNDING: Bayer AG.


Assuntos
Aspirina/efeitos adversos , Inibidores do Fator Xa/efeitos adversos , Inibidores da Agregação de Plaquetas/efeitos adversos , Rivaroxabana/efeitos adversos , Tromboembolia Venosa/tratamento farmacológico , Aspirina/farmacologia , Aspirina/uso terapêutico , Inibidores do Fator Xa/farmacologia , Feminino , Humanos , Masculino , Inibidores da Agregação de Plaquetas/farmacologia , Inibidores da Agregação de Plaquetas/uso terapêutico , Fatores de Risco , Rivaroxabana/farmacologia , Rivaroxabana/uso terapêutico , Tromboembolia Venosa/patologia
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