Aggressive Treatment of Intermediate-Risk Patients with Acute Symptomatic Pulmonary Embolism.
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SUBMITTER: Jimenez D
PROVIDER: S-EPMC6485961 | biostudies-literature | 2018 Sep
REPOSITORIES: biostudies-literature
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Aggressive Treatment of Intermediate-Risk Patients with Acute Symptomatic Pulmonary Embolism.
Jimenez David D Bikdeli Behnood B Marshall Peter S PS Tapson Victor V
Clinics in chest medicine 20180901 3
Contemporary studies of acute pulmonary embolism (PE) have evaluated the role of thrombolytics in intermediate-risk PE. Significant findings are that thrombolytic therapy may prevent hemodynamic deterioration and all-cause mortality but increases major bleeding. Benefits and harms are finely balanced with no convincing net benefit from thrombolytic therapy among unselected patients. Among patients with intermediate risk PE, additional prognostic factors or subtle hemodynamic changes might alter ...[more]
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Project description:Limited information exists about the prevalence, management, and outcomes of intermediate-high risk patients with acute pulmonary embolism (PE). In a prospective cohort study, we evaluated consecutive patients with intermediate-high risk PE at a large, tertiary, academic medical center between January 1, 2015 and March 31, 2019. Adjudicated outcomes included PE-related mortality and a complicated course through 30 days after initiation of PE treatment. Repeat systolic blood pressure (SBP), heart rate (HR), brain natriuretic peptide (BNP), and cardiac troponin I (cTnI) measurements, and echocardiography were performed within 48 hours after diagnosis. Among 1,015 normotensive patients with acute PE, 97 (9.6%) had intermediate-high risk PE. A 30-day complicated course and 30-day PE-related mortality occurred in 23 (24%) and 7 patients (7.2%) with intermediate-high risk PE. Seventeen (18%) intermediate-high risk patients received reperfusion therapy. Within 48 hours after initiation of anticoagulation, normalization of SBP, HR, cTnI, BNP, and echocardiography occurred in 82, 86, 78, 72, and 33% of survivors with intermediate-high risk PE who did not receive immediate thrombolysis. A complicated course between day 2 and day 30 after PE diagnosis for the patients who normalized SBP, HR, cTnI, BNP, and echocardiography measured at 48 hours occurred in 2.9, 1.4, 4.5, 3.3, and 14.3%, respectively. Intermediate-high risk PE occurs in approximately one-tenth of patients with acute symptomatic PE, and is associated with high morbidity and mortality. Normalization of HR 48 hours after diagnosis might identify a group of patients with a very low risk of deterioration during the first month of follow-up.
| S-EPMC6892655 | biostudies-literature
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| S-EPMC9358724 | biostudies-literature
Project description:BackgroundThe management of intermediate-high-risk acute pulmonary embolism (PE) is controversial with increasing interest in more aggressive treatment approaches than anticoagulation alone.Case summaryWe describe the case series of four consecutive patients who presented to emergency room for acute shortness of breath. They were diagnosed with intermediate-high-risk acute PE based on the computed tomography pulmonary angiography and transthoracic echocardiography (TTE) findings and the elevated simplified PE score index. They received bolus of 5 mg thrombolytics recombinant tissue plasminogen activator (rtPA) administered through peripheral intravenous (i.v.) line followed by continuous infusion at a rate of 2 mg/h along with unfractionated heparin (UFH) at a rate of 500 mg/h for additional ≤10 h. There after the dose of UFH was increased to reach a therapeutic level. Rapid clinical improvement and also improvement in TTE parameters were noted at discharge. Patients were discharged home on oral anticoagulation.DiscussionIntermediate-high-risk acute PE carries increased risk of mortality and morbidities. Catheter-directed thrombolysis uses a low rtPA dose for local thrombolysis and is associated with low bleeding risk; however it is expensive and requires expertise and human resources. Low-dose rtPA through a peripheral i.v. line might be safe and effective in the treatment of patient with intermediate-high-risk acute PE. This therapeutic approach is readily available at most medical centres, can be started in the emergency room (ER), and can be alternative to catheter-directed thrombolysis nowadays during the COVID-19 era and in hospitals at the periphery and with limited resources.
| S-EPMC9617477 | biostudies-literature
Project description:BackgroundTo investigate if acute pulmonary vasodilation by sildenafil improves right ventricular function in patients with acute intermediate-high risk pulmonary embolism (PE).MethodsSingle center, explorative trial. Patients with PE were randomized to a single oral dose of sildenafil 50 mg (n?=?10) or placebo (n?=?10) as add-on to conventional therapy. The time from hospital admission to study inclusion was 2.3?±?0.7 days. Right ventricular function was evaluated immediately before and shortly after (0.5-1.5 h) randomization by right heart catheterization (RHC), trans-thoracic echocardiography (TTE), and cardiac magnetic resonance (CMR). The primary efficacy endpoint was cardiac index measured by CMR.ResultsPatients had acute intermediate-high risk PE verified by computed tomography pulmonary angiography, systolic blood pressure of 135?±?18 (mean?±?SD) mmHg, increased right ventricular/left ventricular ratio 1.1?±?0.09 and increased troponin T 167?±?144 ng/L. Sildenafil treatment did not improve cardiac index compared to baseline (0.02?±?0.36 l/min/m2, p?=?0.89) and neither did placebo (0.00?±?0.34 l/min/m2, p?=?0.97). Sildenafil lowered mean arterial blood pressure (-?19?±?10 mmHg, p?<?0.001) which was not observed in the placebo group (0?±?9 mmHg, p?=?0.97).ConclusionA single oral dose of sildenafil 50 mg did not improve cardiac index but lowered systemic blood pressure in patients with acute intermediate-high risk PE. The time from PE to intervention, a small patient sample size and low pulmonary vascular resistance are limitations of this study that should be considered when interpreting the results.Trial registrationThe trial was retrospectively registered at www.clinicaltrials.gov (NCT04283240) February 2nd 2020, https://clinicaltrials.gov/ct2/show/NCT04283240?term=NCT04283240&draw=2&rank=1 .
| S-EPMC7916297 | biostudies-literature
Project description:IntroductionPatients at intermediate-high risk of developing a pulmonary embolism (PE) are very likely to experience adverse outcomes, such as cardiovascular instability and death. The role of thrombolytic therapy in intermediate-high-risk PE remains controversial.ObjectivesThis study aimed to determine the efficacy and safety of low-dose urokinase (UK) thrombolytic therapy for intermediate-high-risk PE.Patients and methodsThis retrospective study included 81 consecutive patients with intermediate-high-risk PE from two centers. Patients received low-dose UK or low-molecular-weight heparin (anticoagulant therapy group). The efficacy outcomes were mortality, computed tomography pulmonary angiography (CTPA)-confirmed absorption, and dyspnea. Safety was assessed as the incidence of bleedings.ResultsThe in-hospital mortality, 9-month mortality, and long-term mortality at the last follow-up were comparable for the low-dose UK group and the anticoagulant therapy group (6.45% vs. 0%, p = 0.144, 9.68% vs. 8.16%, p = 0.815, and 12.90% vs. 12.24%, p = 0.931, respectively). CTPA-confirmed absorption at one month after admission was higher in the low-dose UK group than in the anticoagulant therapy group (p = 0.016). The incidences of short-term dyspnea at discharge and long-term dyspnea at the last follow-up were lower in the low-dose UK group than in the anticoagulant therapy group (27.59% vs. 52%, p = 0.035, 33.33% vs. 58.14%, p = 0.043, respectively). No major bleeding occurred. The incidence of minor bleeding was not significantly different between the two groups (3.23% vs. 6%, p = 0.974).ConclusionIn intermediate-high-risk PE, a low-dose UK might increase CTPA-confirmed absorption and improve short-term and long-term dyspnea without affecting mortality or increasing the bleeding risk.
| S-EPMC7997002 | biostudies-literature
Project description:BackgroundWe determine the predictive value of transthoracic echocardiographic (TTE) metrics for clinical deterioration within 5 days in adults with intermediate-risk pulmonary embolism (PE).MethodsThis was a prospective observational study of intermediate-risk PE patients. To determine associations of TTE and clinical predictors with clinical deterioration, we used univariable analysis, Youden's index for optimal thresholds, and multivariable analyses to report odds ratios (ORs) or area under the curve (AUC).ResultsOf 306 intermediate-risk PE patients, 115 (37.6%) experienced clinical deterioration. PE patients who had clinical deterioration within 5 days had greater baseline right ventricle (RV) dilatation and worse systolic function than the group without clinical deterioration as indicated by the following: RV basal diameter 4.46 ± 0.77 versus 4.20 ± 0.77 cm; RV/LV basal width ratio 1.14 ± 0.29 versus 1.02 ± 0.24; tricuspid annular plane systolic excursion (TAPSE) 1.56 ± 0.55 versus 1.80 ± 0.52 cm; and RV systolic excursion velocity 10.40 ± 3.58 versus 12.1 ± 12.5 cm/s, respectively. Optimal thresholds for predicting clinical deterioration were: RV basal width 3.9 cm (OR 2.85 [1.64, 4.97]), RV-to-left ventricle (RV/LV) ratio 1.08 (OR 3.32 [2.07, 5.33]), TAPSE 1.98 cm (OR 3.3 [2.06, 5.3]), systolic excursion velocity 10.10 cm/s (OR 2.85 [1.75, 4.63]), and natriuretic peptide 190 pg/mL (OR 2.89 [1.81, 4.62]). Significant independent predictors were: transient hypotension 6.1 (2.2, 18.9), highest heart rate 1.02 (1.00, 1.03), highest respiratory rate 1.02 (1.00, 1.04), and RV/LV ratio 1.29 (1.14, 1.47). By logistic regression and random forest analyses, AUCs were 0.80 (0.73, 0.87) and 0.78 (0.70, 0.85), respectively.ConclusionsBasal RV, RV/LV ratio, and RV systolic function measurements were significantly different between intermediate-risk PE patients grouped by subsequent clinical deterioration.
| S-EPMC9166499 | biostudies-literature
Project description:Intermediate-high-risk pulmonary embolism (PE) is characterized by right ventricular (RV) dysfunction and elevated circulating cardiac troponin levels despite apparent hemodynamic stability at presentation. In these patients, full-dose systemic thrombolysis reduced the risk of hemodynamic decompensation or death but increased the risk of life-threatening bleeding. Reduced-dose thrombolysis may be capable of improving safety while maintaining reperfusion efficacy. The Pulmonary Embolism International THrOmbolysis (PEITHO)-3 study (ClinicalTrials.gov Identifier: NCT04430569) is a randomized, placebo-controlled, double-blind, multicenter, multinational trial with long-term follow-up. We will compare the efficacy and safety of a reduced-dose alteplase regimen with standard heparin anticoagulation. Patients with intermediate-high-risk PE will also fulfill at least one clinical criterion of severity: systolic blood pressure ≤110 mm Hg, respiratory rate >20 breaths/min, or history of heart failure. The primary efficacy outcome is the composite of all-cause death, hemodynamic decompensation, or PE recurrence within 30 days of randomization. Key secondary outcomes, to be included in hierarchical analysis, are fatal or GUSTO severe or life-threatening bleeding; net clinical benefit (primary efficacy outcome plus severe or life-threatening bleeding); and all-cause death, all within 30 days. All outcomes will be adjudicated by an independent committee. Further outcomes include PE-related death, hemodynamic decompensation, or stroke within 30 days; dyspnea, functional limitation, or RV dysfunction at 6 months and 2 years; and utilization of health care resources within 30 days and 2 years. The study is planned to enroll 650 patients. The results are expected to have a major impact on risk-adjusted treatment of acute PE and inform guideline recommendations.
| S-EPMC9197594 | biostudies-literature
Project description:ImportanceThe optimal treatment of intermediate-high-risk pulmonary embolism (PE) remains unknown.ObjectiveTo assess the effect of conventional catheter-directed thrombolysis (cCDT) plus anticoagulation vs anticoagulation monotherapy in improving echocardiographic measures of right ventricle (RV) to left ventricle (LV) ratio in acute intermediate-high-risk PE.Design, setting, and participantsThe Catheter-Directed Thrombolysis vs Anticoagulation in Patients with Acute Intermediate-High-Risk Pulmonary Embolism (CANARY) trial was an open-label, randomized clinical trial of patients with intermediate-high-risk PE, conducted in 2 large cardiovascular centers in Tehran, Iran, between December 22, 2018, through February 2, 2020.InterventionsPatients were randomly assigned to cCDT (alteplase, 0.5 mg/catheter/h for 24 hours) plus heparin vs anticoagulation monotherapy.Main outcomes and measuresThe proportion of patients with a 3-month echocardiographic RV/LV ratio greater than 0.9, assessed by a core laboratory, was the primary outcome. The proportion of patients with an RV/LV ratio greater than 0.9 at 72 hours after randomization and the 3-month all-cause mortality were among secondary outcomes. Major bleeding (Bleeding Academic Research Consortium type 3 or 5) was the main safety outcome. A clinical events committee, masked to the treatment assignment, adjudicated clinical outcomes.ResultsThe study was prematurely stopped due to the COVID-19 pandemic after recruiting 94 patients (mean [SD] age, 58.4 [2.5] years; 27 women [29%]), of whom 85 patients completed the 3-month echocardiographic follow-up. Overall, 2 of 46 patients (4.3%) in the cCDT group and 5 of 39 patients (12.8%) in the anticoagulation monotherapy group met the primary outcome (odds ratio [OR], 0.31; 95% CI, 0.06-1.69; P = .24). The median (IQR) 3-month RV/LV ratio was significantly lower with cCDT (0.7 [0.6-0.7]) than with anticoagulation (0.8 [0.7-0.9); P = .01). An RV/LV ratio greater than 0.9 at 72 hours after randomization was observed in fewer patients treated with cCDT (13 of 48 [27.0%]) than anticoagulation (24 of 46 [52.1%]; OR, 0.34; 95% CI, 0.14-0.80; P = .01). Fewer patients assigned to cCDT experienced a 3-month composite of death or RV/LV greater than 0.9 (2 of 48 [4.3%] vs 8 of 46 [17.3%]; OR, 0.20; 95% CI, 0.04-1.03; P = .048). One case of nonfatal major gastrointestinal bleeding occurred in the cCDT group.Conclusions and relevanceThis prematurely terminated randomized clinical trial of patients with intermediate-high-risk PE was hypothesis-generating for improvement in some efficacy outcomes and acceptable rate of major bleeding for cCDT compared with anticoagulation monotherapy and provided support for a definitive clinical outcomes trial.Trial registrationClinicalTrials.gov Identifier: NCT05172115.
| S-EPMC9582964 | biostudies-literature
Project description:BackgroundPatients with intermediate-risk pulmonary embolism (PE) can be treated with anticoagulation monotherapy. However, clinicians are concerned as to whether anticoagulation monotherapy is sufficient to reduce mortality in patients with a large embolic burden, and to resolve vascular obstruction. We investigated whether anticoagulation monotherapy was appropriate in patients with intermediate risk PE in terms of the occurrence of residual pulmonary vascular obstruction (RPVO), and the factors that independently predict the occurrence of RPVO.MethodsThis was a multicenter retrospective observational study of patients at intermediate risk of PE who were admitted to three hospitals between January 2012 and December 2017.ResultsOf total 91 patients, the median age was 72 years and 37 (40.7%) were male. Twenty-five patients (27.5%) were diagnosed with RPVO during follow-up. Multivariate logistic regression revealed chronic lung disease [odds ratio (OR), 4.14; 95% confidence interval (CI), 1.243-13.797; P=0.021] and the ratio of the diameters of the main pulmonary artery and ascending aorta ratio (P/A ratio) >1.0 documented on a chest computed tomography (CT) at presentation (OR, 3.46; 95% CI, 1.113-10.770; P=0.032) were significant independent predictors of RPVO occurrence. The incidence of RPVO in patients without these two factors was only 9.7%, but in those with the two factors it was 60% (P=0.004).ConclusionsAnticoagulation monotherapy did not seem to be a sufficient treatment to reduce RPVO, but the outcome was similar to that of patients treated with other therapies. Therefore, considering the risk-benefit ratio, we do not need to change the initial treatment as systemic thrombolytic therapy or catheter-based therapy in patient with intermediate risk PE. Underlying chronic lung disease and a P/A ratio >1 on the initial chest CT predicted the occurrence of RPVO. Therefore, we should carefully assess persistent of dyspnea and exercise limitations using various methods in patients with these risk factors, to detect the occurrence of chronic thromboembolic pulmonary disease (CTEPD) earlier.
| S-EPMC8339779 | biostudies-literature
Project description:ImportanceThe risk of death from acute pulmonary embolism can range as high as 15%, depending on patient factors at initial presentation. Acute treatment decisions are largely based on an estimate of this mortality risk.ObjectiveTo assess the performance of risk assessment scores in a modern, US cohort of patients with acute pulmonary embolism.Design, setting, and participantsThis multicenter cohort study was conducted between October 2016 and October 2017 at 8 hospitals participating in the Pulmonary Embolism Response Team (PERT) Consortium registry. Included patients were adults who presented with acute pulmonary embolism and had sufficient information in the medical record to calculate risk scores. Data analysis was performed from March to May 2020.Main outcomes and measuresAll-cause mortality (7- and 30-day) and associated discrimination were assessed by the area under the receiver operator curve (AUC).ResultsAmong 416 patients with acute pulmonary embolism (mean [SD] age, 61.3 [17.6] years; 207 men [49.8%]), 7-day mortality in the low-risk groups ranged from 1.3% (1 patient) to 3.1% (4 patients), whereas 30-day mortality ranged from 2.6% (1 patient) to 10.2% (13 patients). Among patients in the highest-risk groups, the 7-day mortality ranged from 7.0% (18 patients) to 16.3% (7 patients), whereas 30-day mortality ranged from 14.4% (37 patients) to 26.3% (26 patients). Each of the risk stratification tools had modest discrimination for 7-day mortality (AUC range, 0.616-0.666) with slightly lower discrimination for 30-day mortality (AUC range, 0.550-0.694).Conclusions and relevanceThese findings suggest that commonly used risk tools for acute pulmonary embolism have modest estimating ability. Future studies to develop and validate better risk assessment tools are needed.
| S-EPMC7450352 | biostudies-literature