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1.
N Engl J Med ; 370(15): 1402-11, 2014 Apr 10.
Article in English | MEDLINE | ID: mdl-24716681

ABSTRACT

BACKGROUND: The role of fibrinolytic therapy in patients with intermediate-risk pulmonary embolism is controversial. METHODS: In a randomized, double-blind trial, we compared tenecteplase plus heparin with placebo plus heparin in normotensive patients with intermediate-risk pulmonary embolism. Eligible patients had right ventricular dysfunction on echocardiography or computed tomography, as well as myocardial injury as indicated by a positive test for cardiac troponin I or troponin T. The primary outcome was death or hemodynamic decompensation (or collapse) within 7 days after randomization. The main safety outcomes were major extracranial bleeding and ischemic or hemorrhagic stroke within 7 days after randomization. RESULTS: Of 1006 patients who underwent randomization, 1005 were included in the intention-to-treat analysis. Death or hemodynamic decompensation occurred in 13 of 506 patients (2.6%) in the tenecteplase group as compared with 28 of 499 (5.6%) in the placebo group (odds ratio, 0.44; 95% confidence interval, 0.23 to 0.87; P=0.02). Between randomization and day 7, a total of 6 patients (1.2%) in the tenecteplase group and 9 (1.8%) in the placebo group died (P=0.42). Extracranial bleeding occurred in 32 patients (6.3%) in the tenecteplase group and 6 patients (1.2%) in the placebo group (P<0.001). Stroke occurred in 12 patients (2.4%) in the tenecteplase group and was hemorrhagic in 10 patients; 1 patient (0.2%) in the placebo group had a stroke, which was hemorrhagic (P=0.003). By day 30, a total of 12 patients (2.4%) in the tenecteplase group and 16 patients (3.2%) in the placebo group had died (P=0.42). CONCLUSIONS: In patients with intermediate-risk pulmonary embolism, fibrinolytic therapy prevented hemodynamic decompensation but increased the risk of major hemorrhage and stroke. (Funded by the Programme Hospitalier de Recherche Clinique in France and others; PEITHO EudraCT number, 2006-005328-18; ClinicalTrials.gov number, NCT00639743.).


Subject(s)
Fibrinolytic Agents/therapeutic use , Heparin/therapeutic use , Pulmonary Embolism/drug therapy , Tissue Plasminogen Activator/therapeutic use , Age Factors , Aged , Aged, 80 and over , Double-Blind Method , Drug Therapy, Combination , Female , Fibrinolytic Agents/adverse effects , Hemorrhage/chemically induced , Heparin/adverse effects , Humans , Male , Middle Aged , Pulmonary Embolism/complications , Pulmonary Embolism/mortality , Risk Factors , Stroke/chemically induced , Tenecteplase , Tissue Plasminogen Activator/adverse effects , Treatment Outcome , Troponin/blood , Ventricular Dysfunction, Right/etiology
2.
Eur Respir J ; 42(3): 681-8, 2013 Sep.
Article in English | MEDLINE | ID: mdl-23258789

ABSTRACT

We analysed a cohort of patients with normotensive pulmonary embolism (PE) in order to assess whether combining echocardiography and biomarkers with the pulmonary embolism severity index (PESI) improves the risk stratification in comparison to the PESI alone. The PESI was calculated in normotensive patients with PE who also underwent echocardiography and assays of cardiac troponin I and brain natriuretic peptide. 30-day adverse outcome was defined as death, recurrent PE or shock. 529 patients were included, 25 (4.7%, 95% CI 3.2-6.9%) had at least one outcome event. The proportion of patients with adverse events increased from 2.1% in PESI class I-II to 8.4% in PESI class III-IV, and to 14.3% in PESI class V (p<0.001). In PESI class I-II, the rate of outcome events was significantly higher in patients with abnormal values of biomarkers or right ventricular dilatation. In multivariate analysis, the PESI (class III-IV versus I-II, OR 3.1, 95% CI 1.2-8.3; class V versus I-II, OR 5.5, 95% CI 1.5-25.5 and echocardiography (right ventricular/left ventricular ratio, OR (for an increase of 0.1) 1.3, 95% CI 1.1-1.5) were independent predictors of an adverse outcome. In patients with normotensive PE, biomarkers and echocardiography provided additional prognostic information to the PESI.


Subject(s)
Heart Ventricles/diagnostic imaging , Natriuretic Peptide, Brain/blood , Pulmonary Embolism/diagnosis , Troponin I/blood , Aged , Biomarkers/blood , Cohort Studies , Dilatation, Pathologic/diagnostic imaging , Echocardiography , Female , Humans , Logistic Models , Male , Middle Aged , Multivariate Analysis , Prognosis , Pulmonary Embolism/complications , Pulmonary Embolism/mortality , Recurrence , Risk Factors , Severity of Illness Index , Shock, Cardiogenic/etiology
3.
Am J Respir Crit Care Med ; 181(2): 168-73, 2010 Jan 15.
Article in English | MEDLINE | ID: mdl-19910608

ABSTRACT

RATIONALE: The short-term prognosis of pulmonary embolism (PE) depends on hemodynamic status and underlying disease. The prognostic value of right ventricular dysfunction and injury is less well established. OBJECTIVES: To evaluate prognostic factors of PE in a multicenter prospective cohort study. METHODS: Echocardiography, brain natriuretic peptide (BNP), N-terminal-proBNP and cardiac troponin I measurements were done on admission of 570 consecutive patients with an acute PE. A predictive model was based on independent predictors of 30-day adverse events defined as death, secondary cardiogenic shock, or recurrent venous thromboembolism. MEASUREMENTS AND MAIN RESULTS: At 30 days, 42 patients (7.4%; 95% confidence interval [CI], 5.5-9.8%) had adverse events. On multivariate analysis, altered mental state (odds ratio [OR] 6.8; 95% confidence interval [CI], 2.0-23.3), shock on admission (OR 2.8; 95% CI, 1.1-7.5), cancer (OR 2.9; 95% CI, 1.2-6.9), BNP (OR 1.3 for an increase of 250 ng/L; 95% CI, 1.1-1.6) and right to left ventricle diameter ratio (OR 1.2 for an increase of 0.1; 95% CI, 1.1-1.4) were associated with 30-days of adverse events. The predictive performance of the model was good (area under receiver operating characteristics curve 0.84 [95% CI, 0.78-0.90]), making it possible to develop a bedside prognostic score. CONCLUSIONS: BNP and echocardiography may be useful determinants of the short-term outcome for patients with PE, together with clinical findings. Patients with PE can be stratified according to the initial risk of adverse outcome, using a simple score based on clinical, echocardiographic, and biochemical variables.


Subject(s)
Pulmonary Embolism/genetics , Pulmonary Embolism/physiopathology , Acute Disease , Aged , Cause of Death , Cohort Studies , Echocardiography , Female , Hospital Mortality , Humans , Male , Middle Aged , Models, Statistical , Multivariate Analysis , Natriuretic Peptide, Brain/blood , Peptide Fragments/blood , Prognosis , Prospective Studies , Recurrence , Risk Assessment , Shock, Cardiogenic/mortality , Shock, Cardiogenic/physiopathology , Survival Rate , Troponin I/blood , Venous Thromboembolism/mortality , Venous Thromboembolism/physiopathology
4.
Ultrasound Med Biol ; 35(9): 1436-42, 2009 Sep.
Article in English | MEDLINE | ID: mdl-19560253

ABSTRACT

The degree of carotid stenosis (%ST) remains the most frequently used parameter for identifying patients with high risk of stroke but the relationship between %ST and the occurrence of stroke remains controversial. The objectives of this study were to check (1) the relationship between the %ST and the plaque volume index (PVI) as measured by echography and Doppler, (2) the relationship between the intima media thickness (IMT), a vessel wall remodeling index and the PVI an atheromatous growth index. For each of the 128 patients, (165 carotid stenosis), we measured the % ST (section or diameter), the max stenosis velocity (V(max)), the PVI and the common carotid IMT. The %ST (section) ranged from 10% to 93% (mean 66+/-18), V(max) from 0.3m/s to 3m/s (mean 1.2+/-0.8), PVI from 0.61cm(3) to 1.17cm(3) (mean 0.41+/-0.21) and the IMT from 0.08cm up to 0.31cm (mean 0.12+/-0.03). There was no significant correlation between either PVI and %ST (section or diameter), PVI and minimal stenosis section area (S1) or between PVI and V(max). There was no significant correlation between IMT and both %ST area and PVI. PVI was significantly correlated with the whole artery section area (S2) and the plaque length (L). The %ST (section or diameter) was significantly correlated with S1 but not with S2. The absence of correlation between the PVI and the %ST confirm that these two parameters describe two different processes of the atheromatous development.


Subject(s)
Carotid Stenosis/diagnostic imaging , Aged , Blood Flow Velocity , Carotid Artery, Common/diagnostic imaging , Carotid Artery, Common/pathology , Carotid Stenosis/complications , Carotid Stenosis/pathology , Echoencephalography/methods , Female , Humans , Image Interpretation, Computer-Assisted/methods , Male , Middle Aged , Models, Cardiovascular , Risk Assessment/methods , Stroke/etiology , Tunica Intima/diagnostic imaging , Tunica Intima/pathology , Tunica Media/diagnostic imaging , Tunica Media/pathology
5.
Chest ; 133(2): 358-62, 2008 Feb.
Article in English | MEDLINE | ID: mdl-17951624

ABSTRACT

BACKGROUND: In the literature, echocardiographic assessment of the prognosis of acute pulmonary embolism is based on analysis of right ventricle free-wall motion or on a composite index combining right ventricular dilatation, paradoxical septal wall motion, and pulmonary hypertension. The aim of this study was to determine the prognostic value of a single quantitative echocardiographic criterion, the right/left ventricular end-diastolic diameter (RV/LV) ratio. METHODS: Registry data on 1,416 consecutive patients hospitalized for acute pulmonary embolism were used to study retrospectively a population of 950 patients who underwent echocardiographic assessment on hospital admission and for whom the RV/LV ratio was available. RESULTS: The hospital mortality rate for the series was 3.3%. Sensitivity and specificity of RV/LV ratio >or= 0.9 for predicting hospital mortality were 72% and 58%, respectively. Multivariate analysis showed the independent predictive factors for hospital mortality to be the following: systolic BP < 90 mm Hg (odds ratio [OR], 10.73; p < 0.0001), history of left heart failure (OR, 8.99; p < 0.0001), and RV/LV ratio >or= 0.9 (OR, 2.66; p = 0.01). CONCLUSIONS: In our retrospective series, an echocardiographic RV/LV ratio >or= 0.9 was shown to be an independent predictive factor for hospital mortality. This criterion may be of value in selecting cases of submassive pulmonary embolism with a poor prognosis that are liable to benefit from thrombolytic treatment.


Subject(s)
Heart Ventricles/diagnostic imaging , Pulmonary Embolism/diagnostic imaging , Pulmonary Embolism/mortality , Aged , Female , Hospital Mortality , Humans , Logistic Models , Male , Middle Aged , Prognosis , Pulmonary Embolism/physiopathology , Registries , Retrospective Studies , Ultrasonography , Ventricular Dysfunction, Left , Ventricular Dysfunction, Right
6.
Rev Prat ; 57(7): 743-6, 748-50, 2007 Apr 15.
Article in French | MEDLINE | ID: mdl-17626319

ABSTRACT

The diagnosis of major pulmonary embolism should be considered in case of acute respiratory distress, particularly in high thrombo-embolic risk situation. Clinical examination, combined with blood gas analysis, electrocardiogram and chest X-ray are generally suggestive of pulmonary embolism but are not sufficient. In patients with shock, hypotension or after cardiac arrest (massive forms), bedside transthoracic echocardiography is the first choice diagnostic test whereas CT-scan should be considered in less severely ill patients. Troponin dosage and measurement of right upon left ventricular diameter ratio (by echocardiography or CT-scan) are mandatory in the prognostic evaluation of submassive forms (i.e. hemodynamically stable patients with right ventricular dysfunction). Thrombolysis is clearly indicated in patients suffering from massive pulmonary embolism and should be discussed in young patients (less than 70 years), with no identified bleeding risk, suffering from submassive form when troponin rate is increased and/or ventricular diameter ratio is over 0.9. Surgical embolectomy should be considered in case of contraindication or failure of thrombolysis.


Subject(s)
Pulmonary Embolism/diagnosis , Blood Gas Analysis , Echocardiography, Transesophageal , Electrocardiography , Embolectomy , Fibrinolytic Agents , Humans , Pulmonary Embolism/therapy , Radiography, Thoracic , Respiratory Insufficiency/etiology , Risk Factors , Thromboembolism/diagnosis , Thrombolytic Therapy , Tomography, X-Ray Computed , Ventricular Dysfunction, Right/etiology
7.
Cardiovasc Revasc Med ; 8(2): 90-3, 2007.
Article in English | MEDLINE | ID: mdl-17574166

ABSTRACT

BACKGROUND: In the elderly patients, the optimal reperfusion strategy of acute ST-segment elevation myocardial infarction (STEMI) remains a topic of debate. Moreover, there is a lack of data regarding the effect of time to treatment (TT) on prognosis of STEMI in elderly patients. PURPOSE: The goal of our work was to analyze, in real life, the link between TT and 1-year mortality in patients with STEMI (> or =75 years) who were treated with thrombolysis (THL) or primary percutaneous coronary intervention (PCI). METHODS AND MATERIALS: Data were extracted from our university hospital prospective registry. Between 1995 and 2005, all patients who met the criteria (> or =75 years old, has had an acute STEMI <12 h, has been admitted directly into our cardiologic care unit, and has had a revascularization procedure) were included in the analysis. Using logistic regression, we studied the relation between TT and 1-year mortality for each strategy of reperfusion in patients with STEMI who were > or =75 years old. RESULTS: One hundred fifty-nine consecutive patients with STEMI <12 h were analyzed; 35 were treated with THL and 124 were treated with primary PCI. Mean age (+/-S.D.) was 80+/-4 years, and 56% of patients were men. In logistic regression analysis, TT was not associated to death after THL (P=.81), while it was positively correlated after PCI (P=.03). All-cause 1-year mortality was markedly higher in the THL group than in the PCI group (51.4% vs. 15.3%; P<.001). CONCLUSION: Our work suggests that the extrapolation of algorithm of revascularization used in younger patients is not appropriate for elderly patients. Specific algorithm of revascularization and recommendations are needed in elderly patients.


Subject(s)
Algorithms , Angioplasty, Balloon, Coronary , Myocardial Infarction/therapy , Patient Selection , Thrombolytic Therapy , Age Factors , Aged , Aged, 80 and over , Angioplasty, Balloon, Coronary/adverse effects , Female , Humans , Logistic Models , Male , Myocardial Infarction/drug therapy , Myocardial Infarction/mortality , Practice Guidelines as Topic , Prospective Studies , Registries , Risk Assessment , Risk Factors , Thrombolytic Therapy/adverse effects , Time Factors , Treatment Outcome
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