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3.
J Thromb Haemost ; 2020 Jan 10.
Artigo em Inglês | MEDLINE | ID: mdl-31925875

RESUMO

BACKGROUND: In patients with suspected pulmonary embolism (PE) and a non-high pretest probability, the use of an age-adjusted D-dimer cutoff (AADD, <500 ng/mL up to 50 years, then $200 000/lost QALY was 79.4%. In sensitivity analyses, the DCER became <+$200 000/lost QALY only if, among patients with D-dimer below the AADD cutoff, the mortality of an undiagnosed PE was >6% or the prevalence of PE was >0.6%. CONCLUSIONS: The AADD cutoff results in a clinically nonsignificant decrease in QALY but important costs reductions. It is a decrementally cost-effective innovation, with a potential of cost savings of >$80 million per year for the United States health care system.

6.
BMC Cardiovasc Disord ; 19(1): 212, 2019 Sep 13.
Artigo em Inglês | MEDLINE | ID: mdl-31519196

RESUMO

BACKGROUND: Smoking is a strong risk factor for cancer and atherosclerosis. Cancer mortality, especially from lung cancer, overtakes cardiovascular (CV) death rate in patients with peripheral arterial disease (PAD). Only a few patients with lung cancer after PAD management may benefit from surgical excision. Circulating tumor cells (CTC) associated with low-dose chest CT (LDCT) may improve early cancer detection. This study focuses on a screening strategy that can address not only lung cancer but all tobacco-related cancers in this high-risk population. METHODS: DETECTOR Project is a prospective cohort study in two French University hospitals. Participants are smokers or former smokers (≥30 pack-years, quitted ≤15 years), aged ≥55 to 80 years, with atherosclerotic PAD or abdominal aortic aneurysm. After the first screening round combining LDCT and CTC search on a blood sample, two other screening rounds will be performed at one-year interval. Incidental lung nodule volume, volume doubling time and presence of CTC will be taken into consideration for adapted diagnostic management. In case of negative LDCT and presence of CTC, a contrast enhanced whole-body PET/CT will be performed for extra-pulmonary malignancy screening. Psychological impact of this screening strategy will be evaluated in population study using a qualitative methodology. Assuming 10% prevalence of smoking-associated cancer in the studied population, a total of at least 300 participants will be enrolled. DISCUSSION: Epidemiological data underline an increase incidence in cancer and related death in the follow-up of patients with PAD, compared with the general population, particularly for tobacco-related cancers. The clinical benefit of a special workup for neoplasms in patients with PAD and a history of cigarette smoking has never been investigated. By considering CTCs detection in this very high-risk selected PAD population for tobacco-induced cancer, we expect to detect earlier pulmonary and extra-pulmonary malignancies, at a potentially curable stage. TRIAL REGISTRATION: The study was registered in the French National Agency for Medicines and Health Products Safety (No N° EUDRACT_ID RCB: 2016-A00657-44) and was approved by the ethics Committee for Persons Protection (IRB number 1072 and n° initial agreement 2016-08-02; ClinicalTrials.gov identifier NCT02849041).

9.
Res Pract Thromb Haemost ; 3(3): 364-371, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31294323

RESUMO

Introduction: VTE-BLEED is a validated score for identification of patients at increased risk of major bleeding during extended anticoagulation for venous thromboembolism (VTE). It is unknown whether VTE-BLEED high-risk patients also have an increased risk for recurrent VTE, which would limit the potential usefulness of the score. Methods: This was a post hoc analysis of the randomized, double-blind, placebo-controlled PADIS-PE trial that randomized patients with a first unprovoked pulmonary embolism (PE) initially treated during 6 months to receive an additional 18-month of warfarin vs. placebo. The primary outcome of this analysis was recurrent VTE during 2-year follow-up after anticoagulant discontinuation, that is, after the initial 6-month treatment in the placebo arm and after 24 months of anticoagulation in the active treatment arm. This rate, adjusted for study treatment allocation, was compared between patients in the high- vs. low-risk VTE-BLEED group. Results: In complete case analysis (n = 308; 82.4% of total population), 89 (28.9%) patients were classified as high risk; 44 VTE events occurred after anticoagulant discontinuation during 668 patient-years. The cumulative incidence of recurrent VTE was 16.4% (95% confidence interval [CI], 10.0%-26.1%; 14 events) and 14.6% (95% CI, 10.4%-20.3%; 30 events) in the high-risk and low-risk VTE-BLEED groups, respectively, for an adjusted hazard ratio of 1.16 (95% CI, 0.62-2.19). Conclusion: In this study, patients with unprovoked PE classified at high risk of major bleeding by VTE-BLEED did not have a higher incidence of recurrent VTE after cessation of anticoagulant therapy, supporting the potential yield of the score for making management decisions on the optimal duration of anticoagulant therapy.

11.
Thromb Res ; 181: 59-63, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31352267

RESUMO

BACKGROUND: The Ottawa score was previously developed to predict recurrent venous thromboembolism (VTE) in cancer patients with VTE. The performance of this score in patients with incidental VTE is currently unclear. AIM: To evaluate the performance of the Ottawa risk score in cancer patients with incidental pulmonary embolism included in an international, prospective, observational cohort study. METHODS: The score was used to classify patients as high (≥1), intermediate (0), or low risk (≤-1). The discriminative performance of the score was estimated by calculating the cumulative incidence of recurrent VTE for all groups, the time-dependent c-statistic, and the sub-distribution hazard ratio (SHR), using a competing risk approach. RESULTS: Of the 691 patients for which the Ottawa score could be calculated, 25 (3.6%) had recurrent VTE during 6-month follow-up and 38 (5.5%) during 12-month follow-up. The c-statistics of the continuous score at 6 and 12 months were 0.45 (95% CI, 0.36-0.54) and 0.51 (95% CI, 0.46-0.59), respectively. The 6-month cumulative incidences of recurrent VTE for those at low, intermediate, and high risk were 3.9% (95% CI, 1.5-8.4), 3.6% (95% CI, 1.9-6.2), and 3.6% (95% CI, 1.8-6.5), respectively. A sensitivity analysis restricted to the on-treatment period yielded similar results. None of the Ottawa risk score items were significantly associated with recurrent VTE. CONCLUSION: In cancer patients with incidental pulmonary embolism, the Ottawa risk score has a poor predictive value for recurrent VTE, which does not support the use of the score in this patient population.


Assuntos
Anticoagulantes/uso terapêutico , Neoplasias/complicações , Embolia Pulmonar/etiologia , Tromboembolia Venosa/etiologia , Idoso , Anticoagulantes/farmacologia , Feminino , Humanos , Masculino , Embolia Pulmonar/patologia , Tromboembolia Venosa/patologia
12.
Thromb Haemost ; 119(9): 1489-1497, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31230343

RESUMO

BACKGROUND: We aimed to identify risk factors for residual pulmonary vascular obstruction after a first unprovoked pulmonary embolism (PE). METHODS: Analyses were based on data from the double-blind randomized "PADIS-PE" trial that included 371 patients with a first unprovoked PE initially treated during 6 uninterrupted months; all patients underwent baseline ventilation-perfusion lung scanning at inclusion (i.e., after 6 months of anticoagulation). Each patient's pulmonary vascular obstruction indexes (PVOIs) at PE diagnosis and at inclusion were centrally assessed. RESULTS: Among the 371 included patients, residual PVOI was available in 356 patients, and 150 (42.1%) patients had PVOI ≥ 5%. At multivariable analysis, age > 65 years (odds ratio [OR], 2.81, 95% confidence interval [CI], 1.58-5.00), PVOI ≥ 25% at PE diagnosis (OR, 3.53, 95% CI, 1.94-6.41), elevated factor VIII (OR, 3.89, 95% CI, 1.41-10.8), and chronic respiratory disease (OR, 2.18, 95% CI, 1.11-4.26) were independent predictors for residual PVOI ≥ 5%. Patients with ≥ 1 of these factors represented 94.5% (123 patients) of all patients with residual PVOI ≥ 5%. CONCLUSION: Six months after a first unprovoked PE, age > 65 years, PVOI ≥ 25% at PE diagnosis, elevated factor VIII, or chronic respiratory disease were found to be independent predictors for residual pulmonary vascular obstruction. CLINICAL TRIALS REGISTRATION: URL: http://www.controlled-trials.com. Unique identifier: NCT00740883.


Assuntos
Fatores Etários , Embolia Pulmonar/diagnóstico , Estenose de Veia Pulmonar/diagnóstico , Método Duplo-Cego , Fator VIII/metabolismo , Feminino , França/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Valor Preditivo dos Testes , Prognóstico , Embolia Pulmonar/epidemiologia , Risco , Sensibilidade e Especificidade , Estenose de Veia Pulmonar/epidemiologia
13.
J Thromb Haemost ; 17(8): 1329-1334, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31108013

RESUMO

INTRODUCTION: The recently proposed YEARS algorithm was shown to safely exclude pulmonary embolism (PE) and reduce the use of computed tomography pulmonary angiography (CTPA) among pregnant women with suspected PE. Our aim was to externally validate this finding. METHODS: We performed a post hoc analysis of a prospective management outcome study for PE diagnosis in pregnant women. PE was diagnosed with an algorithm that combined the revised Geneva score, D-dimer testing, bilateral lower-limb compression ultrasonography, and CTPA. All women had a 3-month follow-up. All of the items necessary to use the YEARS algorithm were prospectively collected at the time of the study. RESULTS: Of the 395 women included in the original study, 371 were available for the present analysis. The PE prevalence was 6.5%. Ninety-one women had no YEARS items, and 280 had one or more items. When the YEARS items were combined with D-dimer levels (<1000 ng/mL in women with no items, and <500 ng/mL in women with one or more items), 77 women (21%) met the criteria for PE exclusion and would not have undergone CTPA as per the YEARS algorithm. None of these 77 women had PE diagnosed during the initial work-up or 3-month follow-up. Therefore, the failure rate of the YEARS algorithm in our pregnant women population was 0/77 (95% confidence interval 0.0-3.9). CONCLUSION: In our study, application of the YEARS algorithm would have resulted in safe exclusion of PE in one of five pregnant women without the need for radiation exposure, further supporting the use of the algorithm in this population.

14.
J Clin Oncol ; 37(20): 1713-1720, 2019 07 10.
Artigo em Inglês | MEDLINE | ID: mdl-31116676

RESUMO

PURPOSE: Pulmonary embolism is incidentally diagnosed in up to 5% of patients with cancer on routine imaging scans. The clinical relevance and optimal therapy for incidental pulmonary embolism, particularly distal clots, is unclear. The aim of the current study was to assess current treatment strategies and the long-term clinical outcomes of incidentally detected pulmonary embolism in patients with cancer. PATIENTS AND METHODS: We conducted an international, prospective, observational cohort study between October 22, 2012, and December 31, 2017. Unselected adults with active cancer and a recent diagnosis of incidental pulmonary embolism were eligible. Outcomes were recurrent venous thromboembolism, major bleeding, and all-cause mortality during 12 months of follow-up. Outcome events were centrally adjudicated. RESULTS: A total of 695 patients were included. Mean age was 66 years and 58% of patients were male. Most frequent cancer types were colorectal (21%) and lung cancer (15%). Anticoagulant therapy was initiated in 675 patients (97%), of whom 600 (89%) were treated with low-molecular-weight heparin. Recurrent venous thromboembolism occurred in 41 patients (12-month cumulative incidence, 6.0%; 95% CI, 4.4% to 8.1%), major bleeding in 39 patients (12-month cumulative incidence, 5.7%; 95% CI, 4.1% to 7.7%), and 283 patients died (12-month cumulative incidence, 43%; 95% CI, 39% to 46%). The 12-month incidence of recurrent venous thromboembolism was 6.4% in those with subsegmental pulmonary embolism compared with 6.0% in those with more proximal pulmonary embolism (subdistribution hazard ratio, 1.1; 95% CI, 0.37 to 2.9; P = .93). CONCLUSION: In patients with cancer with incidental pulmonary embolism, risk of recurrent venous thromboembolism is significant despite anticoagulant treatment. Patients with subsegmental pulmonary embolism seemed to have a risk of recurrent venous thromboembolism comparable to that of patients with more proximal clots.

15.
Haematologica ; 104(7): 1493-1501, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30606789

RESUMO

The optimal duration of anticoagulation after a first episode of unprovoked deep-vein thrombosis is uncertain. We aimed to assess the benefits and risks of an additional 18 months of treatment with warfarin versus placebo, after an initial 6 months of anticoagulation for a first unprovoked proximal deep-vein thrombosis. We conducted a multicenter, randomized, double-blind, controlled trial comparing an additional 18 months of warfarin with placebo in patients with a unprovoked proximal deep-vein thrombosis initially treated for 6 months (treatment period: 18 months; follow up after treatment period: 24 months). The primary outcome was the composite of recurrent venous thromboembolism or major bleeding at 18 months. Secondary outcomes were the composite at 42 months, as well as each component of the composite, and death unrelated to pulmonary embolism or major bleeding, at 18 and 42 months. All outcomes were centrally adjudicated. A total of 104 patients, enrolled between July 2007 and October 2013 were analyzed on an intention-to-treat basis; no patient was lost to follow-up. During the 18-month treatment period, the primary outcome occurred in none of the 50 patients in the warfarin group and in 16 out of 54 patients (cumulative risk, 29.6%) in the placebo group (hazard ratio, 0.03; 95% confidence interval: 0.01 to 0.09; P<0.001). During the entire 42-month study period, the composite outcome occurred in 14 patients (cumulative risk, 36.8%) in the warfarin group and 17 patients (cumulative risk, 31.5%) in the placebo group (hazard ratio, 0.72; 95% confidence interval: 0.35-1.46). In conclusion, after a first unprovoked proximal deep-vein thrombosis initially treated for 6 months, an additional 18 months of warfarin therapy reduced the composite of recurrent venous thrombosis and major bleeding compared to placebo. However, this benefit was not maintained after stopping anticoagulation. Clinical registration: this trial was registered at www.clinicaltrials.gov as #NCT00740493.

18.
Clin Res Cardiol ; 108(7): 772-778, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30564950

RESUMO

INTRODUCTION: Symptoms and functional limitation are frequently reported by survivors of acute pulmonary embolism (PE). However, current guidelines provide no specific recommendations on which patients should be followed after acute PE, when follow-up should be performed, and which tests it should include. Definition and classification of late PE sequelae are evolving, and their predictors remain to be determined. METHODS: In a post hoc analysis of the Pulmonary Embolism Thrombolysis (PEITHO) trial, we focused on 219 survivors of acute intermediate-risk PE with clinical and echocardiographic follow-up 6 months after randomisation as well as over the long term (median, 3 years after acute PE). The primary outcome was a composite of (1) confirmed chronic thromboembolic pulmonary hypertension (CTEPH) or (2) 'post-PE impairment' (PPEI), defined by echocardiographic findings indicating an intermediate or high probability of pulmonary hypertension along with New York Heart Association functional class II-IV. RESULTS: Confirmed CTEPH or PPEI occurred in 29 (13.2%) patients, (6 with CTEPH and 23 with PPEI). A history of chronic heart failure at baseline and incomplete or absent recovery of echocardiographic parameters at 6 months predicted CTEPH or PPEI at long-term follow-up. CONCLUSIONS: CTEPH or PPEI occurs in almost one out of seven patients after acute intermediate-risk PE. Six-month echocardiographic follow-up may be useful for timely detection of late sequelae.


Assuntos
Ecocardiografia/métodos , Ventrículos do Coração/diagnóstico por imagem , Embolia Pulmonar/diagnóstico , Recuperação de Função Fisiológica , Tenecteplase/uso terapêutico , Terapia Trombolítica/métodos , Função Ventricular Direita/fisiologia , Doença Aguda , Progressão da Doença , Feminino , Fibrinolíticos/uso terapêutico , Seguimentos , Ventrículos do Coração/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Embolia Pulmonar/tratamento farmacológico , Embolia Pulmonar/fisiopatologia , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
19.
Eur Heart J ; 40(11): 902-910, 2019 Mar 14.
Artigo em Inglês | MEDLINE | ID: mdl-30590531

RESUMO

AIMS: Patients with acute pulmonary embolism (PE) classified as low risk by the Pulmonary Embolism Severity Index (PESI), its simplified version (sPESI), or the Hestia criteria may be considered for early discharge. We investigated whether the presence of right ventricular (RV) dysfunction may aggravate the early prognosis of these patients. METHODS AND RESULTS: We did a systematic review and meta-analysis of studies including low-risk patients with acute PE to investigate the prognostic value of RV dysfunction. Diagnosis of RV dysfunction was based on echocardiography or computed tomography pulmonary angiography. In addition, we investigated the prognostic value of elevated troponin or natriuretic peptide levels. The primary outcome was all-cause mortality at 30 days or during hospitalization. We included 22 studies (N = 3295 low-risk patients) in the systematic review: 21 were selected for quantitative analysis. Early all-cause mortality rates in patients with vs. without RV dysfunction on imaging were 1.8% [95% confidence interval (CI) 0.9-3.5%] vs. 0.2% (95% CI 0.03-1.7%), respectively, [odds ratio (OR) 4.19, 95% CI 1.39-12.58]. For troponins, rates were 3.8% (95% CI 2.1-6.8%) vs. 0.5% (95% CI 0.2-1.3%), (OR 6.25, 95% CI 1.95-20.05). For natriuretic peptides, only data on early PE-related mortality were available: rates were 1.7% (95% CI 0.4-6.9%) vs. 0.4% (95% CI 0.1-1.1%), (OR 3.71, 95% CI 0.81-17.02). CONCLUSIONS: In low-risk patients with acute PE, the presence of RV dysfunction on admission was associated with early mortality. Our results may have implications for the management of patients who appear at low risk based on clinical criteria alone, but present with RV dysfunction as indicated by imaging findings or laboratory markers.

20.
Eur Respir J ; 52(5)2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30337447

RESUMO

Residual pulmonary vascular obstruction (RPVO) and chronic thromboembolic pulmonary hypertension (CTEPH) are both long-term complications of acute pulmonary embolism, but it is unknown whether RPVO can be predicted by variants of fibrinogen associated with CTEPH.We used the Akaike information criterion to select the best predictive models for RPVO in two prospectively followed cohorts of acute pulmonary embolism patients, using as candidate variables the extent of the initial obstruction, clinical characteristics and fibrinogen-related data. We measured the selected models' goodness of fit by analysis of deviance and compared models using the Chi-squared test.RPVO occurred in 29 (28.4%) out of 102 subjects in the first cohort and 46 (25.3%) out of 182 subjects in the second. The best-fit predictive model derived in the first cohort (p=0.0002) and validated in the second cohort (p=0.0005) implicated fibrinogen Bß-chain monosialylation in the development of RPVO. When the derivation procedure excluded clinical characteristics, fibrinogen Bß-chain monosialylation remained a predictor of RPVO in the best-fit predictive model (p=0.00003). Excluding fibrinogen characteristics worsened the predictive model (p=0.03).Fibrinogen Bß-chain monosialylation, a common structural attribute of fibrin, helped predict RPVO after acute pulmonary embolism. Fibrin structure may contribute to the risk of developing RPVO.


Assuntos
Arteriopatias Oclusivas/diagnóstico , Fibrinogênio/metabolismo , Artéria Pulmonar , Embolia Pulmonar/complicações , Adulto , Idoso , Arteriopatias Oclusivas/etiologia , Feminino , França , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Estudos Prospectivos
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