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• W4307735161 abstract "Take-Home MessageIn patients with submassive pulmonary embolism, catheter-directed thrombolysis was associated with lower overall inhospital, 30-day, and 90-day mortality compared with systemic anticoagulation.Methods▪▪▪Data SourcesThe authors searched PubMed, EMBASE, Cochrane, and Google Scholar databases from inception to May 26, 2022, for relevant studies. They searched ClinicalTrials.gov to identify completed but not yet published studies, and authors also searched the reference lists of the included articles. The individual study investigators were contacted for additional data as needed.Study SelectionThe meta-analysis authors included randomized and nonrandomized studies evaluating safety and efficacy outcomes of catheter direct thrombolysis versus systemic anticoagulation in patients with submassive pulmonary embolism.1Ismayl M. Machanahalli Balakrishna A. Aboeata A. et al.Meta-analysis comparing catheter-directed thrombolysis versus systemic anticoagulation alone for submassive pulmonary embolism.Am J Cardiol. 2022; (S0002-9149(22)00632-00634)Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar There were no restrictions on language, publication date, sample size, or publication status. Studies lacking clinical outcomes data, case studies, reviews, correspondences, or editorials were not eligible for inclusion. Two reviewers independently screened abstracts, with disagreements resolved by a third reviewer. Primary outcomes included inhospital mortality, 30-day mortality, 90-day mortality, and 1-year mortality. Secondary outcomes included major and minor bleeding, blood transfusion (assessed as a dichotomous outcome), right ventricle recovery (defined as normal right ventricle size and function on follow-up echocardiogram), and hospital length of stay.Data Extraction and SynthesisFor each selected study, 2 investigators independently extracted baseline characteristics, definitions of outcomes, and numbers of events. For dichotomous outcomes, random effects modeling was used to calculate pooled risk ratios (RR) and 95% confidence intervals (CI). For continuous outcomes, the authors calculated mean differences with 95% CIs. Two authors assessed study quality using the Risk of Bias Assessment Tool from the Cochrane Handbook for randomized controlled trials and the Newcastle-Ottawa Scale for observational studies.2Higgins JPT, Thomas J, Chandler J, et al. Cochrane Handbook for Systematic Reviews of Interventions, 2nd edition.Google Scholar Heterogeneity was assessed with I2. Publication bias was assessed using a funnel plot. In patients with submassive pulmonary embolism, catheter-directed thrombolysis was associated with lower overall inhospital, 30-day, and 90-day mortality compared with systemic anticoagulation. ▪▪▪ The authors searched PubMed, EMBASE, Cochrane, and Google Scholar databases from inception to May 26, 2022, for relevant studies. They searched ClinicalTrials.gov to identify completed but not yet published studies, and authors also searched the reference lists of the included articles. The individual study investigators were contacted for additional data as needed. The meta-analysis authors included randomized and nonrandomized studies evaluating safety and efficacy outcomes of catheter direct thrombolysis versus systemic anticoagulation in patients with submassive pulmonary embolism.1Ismayl M. Machanahalli Balakrishna A. Aboeata A. et al.Meta-analysis comparing catheter-directed thrombolysis versus systemic anticoagulation alone for submassive pulmonary embolism.Am J Cardiol. 2022; (S0002-9149(22)00632-00634)Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar There were no restrictions on language, publication date, sample size, or publication status. Studies lacking clinical outcomes data, case studies, reviews, correspondences, or editorials were not eligible for inclusion. Two reviewers independently screened abstracts, with disagreements resolved by a third reviewer. Primary outcomes included inhospital mortality, 30-day mortality, 90-day mortality, and 1-year mortality. Secondary outcomes included major and minor bleeding, blood transfusion (assessed as a dichotomous outcome), right ventricle recovery (defined as normal right ventricle size and function on follow-up echocardiogram), and hospital length of stay. For each selected study, 2 investigators independently extracted baseline characteristics, definitions of outcomes, and numbers of events. For dichotomous outcomes, random effects modeling was used to calculate pooled risk ratios (RR) and 95% confidence intervals (CI). For continuous outcomes, the authors calculated mean differences with 95% CIs. Two authors assessed study quality using the Risk of Bias Assessment Tool from the Cochrane Handbook for randomized controlled trials and the Newcastle-Ottawa Scale for observational studies.2Higgins JPT, Thomas J, Chandler J, et al. Cochrane Handbook for Systematic Reviews of Interventions, 2nd edition.Google Scholar Heterogeneity was assessed with I2. Publication bias was assessed using a funnel plot. Tabled 1Table. Primary outcomes among patients with submassive pulmonary embolism receiving catheter direct thrombolysis versus systemic anticoagulation.OutcomeNo. of Studies (No. of Participants)Risk Ratio (95% CI)Heterogeneity (I2)Inhospital mortality7 (9,147)0.41 (0.30-0.56)0%30-day mortality3 (833)0.37 (0.18-0.73)0%90-day mortality4 (785)0.36 (0.17-0.72)0%1-y mortality4 (814)0.56 (0.29-1.05)36%CI, confidence interval. Open table in a new tab CI, confidence interval. The authors identified 3,154 unique citations, of which 12 studies (n=9,789 patients with submassive pulmonary embolism) were included in the meta-analysis. Of these, 1,871 patients underwent catheter-directed thrombolysis, and 7,918 received systemic anticoagulation alone. One study was a randomized controlled trial, and 11 were observational.3Kucher N. Boekstegers P. Müller O.J. et al.Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism.Circulation. 2014; 129: 479-486Crossref PubMed Scopus (643) Google Scholar The definition of submassive pulmonary embolism was similar in all studies, including evidence of pulmonary embolism with signs of right ventricle strain (ie, echocardiographic evidence of increased pressure, right-to-left ventricular ratio ≥1.0, or systolic dysfunction; biomarker elevation such as elevated troponin I or N-terminal pro−b-type natriuretic peptide) without hemodynamic instability (systolic blood pressure < 90 mmHg). All studies used alteplase as the thrombolytic. Definitions of major and minor bleeding were similar in all included studies. The mean age of the patients ranged from 53.9 to 67.1 years. Baseline comorbidities were similar between the catheter-directed thrombolysis and systemic anticoagulation groups, but the catheter-directed thrombolysis group had higher rates of obesity, and the systemic anticoagulation group had higher rates of renal failure. While all studies included submassive pulmonary embolism, one study also included 8 patients with massive pulmonary embolism.4Sista A.K. Friedman O.A. Dou E. et al.A pulmonary embolism response team's initial 20 month experience treating 87 patients with submassive and massive pulmonary embolism.Vasc Med. 2018; 23: 65-71Crossref PubMed Scopus (32) Google Scholar There was a statistically significant difference in outcomes, including inhospital mortality, 30-day mortality, and 90-day mortality with catheter-directed thrombolysis compared with systemic anticoagulation (Table). There was no difference in the secondary outcomes of right ventricle recovery (RR 1.34; 95% CI, 0.98 to 1.84), hospital length of stay (mean difference −0.35 days; 95% CI, −2.73 to 2.04), risk of major bleeding (RR 1.31; 95% CI, 0.57 to 3.01), risk of minor bleeding (RR 1.67; 95% CI, 0.77 to 3.63), and rates of blood transfusion (RR 0.34, 95% CI; 0.10 to 1.15). There was no evidence of publication bias for any of the outcomes. Pulmonary embolism accounts for approximately one-third of cardiovascular deaths in the United States.5Turetz M. Sideris A.T. Friedman O.A. et al.Epidemiology, pathophysiology, and natural history of pulmonary embolism.Semin Intervent Radiol. 2018; 35: 92-98Crossref PubMed Scopus (75) Google Scholar Approximately 25% of hemodynamically stable patients will have submassive pulmonary embolism, defined by abnormal cardiac biomarkers or right ventricle dysfunction.6Frémont B. Pacouret G. Jacobi D. et al.Prognostic value of echocardiographic right/left ventricular end-diastolic diameter ratio in patients with acute pulmonary embolism: results from a monocenter registry of 1,416 patients.Chest. 2008; 133: 358-362Abstract Full Text Full Text PDF PubMed Scopus (195) Google Scholar,7Kucher N. Rossi E. De Rosa M. et al.Prognostic role of echocardiography among patients with acute pulmonary embolism and a systolic arterial pressure of 90 mm Hg or higher.Arch Intern Med. 2005; 165: 1777-1781Crossref PubMed Scopus (350) Google Scholar There is currently a significant debate regarding the optimal management of submassive pulmonary embolism. However, the 2019 European Society of Cardiology and the 2021 American College of Chest Physicians guidelines recommend against systemic thrombolysis for hemodynamically stable patients, with systemic anticoagulation recommended instead.8Konstantinides S.V. Meyer G. Becattini C. et al.2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS).Eur Heart J. 2020; 41: 543-603Crossref PubMed Scopus (1625) Google Scholar, 9Stevens S.M. Woller S.C. Kreuziger L.B. et al.Antithrombotic therapy for VTE disease: second update of the CHEST guideline and expert panel report.Chest. 2021; 160: e545-e608Abstract Full Text Full Text PDF PubMed Scopus (165) Google Scholar, 10Secemsky E. Chang Y. Jain C.C. et al.Contemporary management and outcomes of patients with massive and submassive pulmonary embolism.Am J Med. 2018; 131 (e0): 1506-1514Abstract Full Text Full Text PDF PubMed Scopus (54) Google Scholar, 11Murphy E. Lababidi A. Reddy R. et al.The role of thrombolytic therapy for patients with a submassive pulmonary embolism.Cureus. 2018; 10 (Published 2018 Jun 15)e2814Google Scholar Catheter-directed thrombolysis may be an optimal treatment for submassive pulmonary embolism, as it localizes the delivery of a thrombolytic agent and may reduce bleeding risk. Recent literature has suggested that catheter-directed thrombolysis is safe and efficacious in treating submassive pulmonary embolism, but there are conflicting data regarding mortality comparing catheter-directed thrombolysis and systemic anticoagulation as individual treatment modalities for submassive pulmonary embolism.3Kucher N. Boekstegers P. Müller O.J. et al.Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism.Circulation. 2014; 129: 479-486Crossref PubMed Scopus (643) Google Scholar,12Avgerinos E.D. Liang N.L. El-Shazly O.M. et al.Improved early right ventricular function recovery but increased complications with catheter-directed interventions compared with anticoagulation alone for submassive pulmonary embolism.J Vasc Surg Venous Lymphat Disord. 2016; 4: 268-275Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar,13Piazza G. Hohlfelder B. Jaff M.R. et al.A prospective, single-arm, multicenter trial of ultrasound-facilitated, catheter-directed, low-dose fibrinolysis for acute massive and submassive pulmonary embolism: The SEATTLE II Study.JACC Cardiovasc Interv. 2015; 8: 1382-1392Crossref PubMed Scopus (537) Google Scholar Furthermore, there are ongoing debates regarding optimal dosing of thrombolytics and the value of ultrasound in catheter-directed thrombolysis, the risk of bleeding, and which patient population benefits most from this therapy.14Lichtblau M. Piccari L. Ramjug S. et al.ERS International Congress 2021: highlights from the pulmonary vascular diseases assembly.ERJ Open Res. 2022; 8: 00665-02021Crossref PubMed Scopus (1) Google Scholar This meta-analysis suggests that catheter-directed thrombolysis reduces inhospital, 30-day, and 90-day mortality for patients with submassive pulmonary embolism, but there was no difference in mortality at 1 year, right ventricle recovery, rates of major or minor bleeding, or transfusions.1Ismayl M. Machanahalli Balakrishna A. Aboeata A. et al.Meta-analysis comparing catheter-directed thrombolysis versus systemic anticoagulation alone for submassive pulmonary embolism.Am J Cardiol. 2022; (S0002-9149(22)00632-00634)Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar However, there are important limitations to consider. While this meta-analysis included 9,789 patients with submassive pulmonary embolism, only one study was a randomized control trial.3Kucher N. Boekstegers P. Müller O.J. et al.Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism.Circulation. 2014; 129: 479-486Crossref PubMed Scopus (643) Google Scholar Death at 90 days was a primary outcome in the included randomized control trials, but there was only 1 death in the systemic anticoagulation group and no deaths in the catheter-directed thrombolysis group.3Kucher N. Boekstegers P. Müller O.J. et al.Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism.Circulation. 2014; 129: 479-486Crossref PubMed Scopus (643) Google Scholar This limits the ability of the meta-analysis to draw conclusions regarding this outcome. All remaining studies were observational and, thus, at risk of confounding and selection bias. Of the 9,147 patients analyzed for inpatient mortality, 8,170 came from a single observational study based on administrative data, which increases the risk of confounding and bias.15Stein P.D. Matta F. Hughes M.J. Catheter-directed thrombolysis in submassive pulmonary embolism and acute cor pulmonale.Am J Cardiol. 2020 Sep 15; 131: 109-114Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar Although rates of obesity and renal failure differed between the systemic anticoagulation and catheter-directed thrombolysis groups, this is unlikely to affect the primary outcomes of interest. The thrombolytic used in all included studies for catheter-directed thrombolysis was alteplase, but there were varying dose protocols used among the trials. The catheter-directed thrombolysis device also differed among the included studies (eg, conventional catheter-directed thrombolysis and various commercially available catheter-directed thrombolysis devices with ultrasound assistance such as EkoSonic), and the authors were unable to perform subgroup analysis based on the specific type of catheter-directed thrombolysis. Five studies did not specify the length of follow-up, and in the other 7 studies, follow-up varied from 1 to 24 months. Importantly, loss to follow-up rates was not addressed in this meta-analysis, which can reduce the effective sample size and increase the risk of bias. Four studies provided no data on mortality following discharge from the hospital. Finally, there was significant heterogeneity in the right ventricle recovery and the hospital length of stay. This meta-analysis found that catheter-directed thrombolysis compared with systemic anticoagulation appears to be associated with lower rates of inhospital, 30-day, and 90-day mortality with no significantly increased risk of major bleeding, minor bleeding, or blood transfusions.1Ismayl M. Machanahalli Balakrishna A. Aboeata A. et al.Meta-analysis comparing catheter-directed thrombolysis versus systemic anticoagulation alone for submassive pulmonary embolism.Am J Cardiol. 2022; (S0002-9149(22)00632-00634)Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar Catheter-directed thrombolysis may be a safe and effective therapy for submassive pulmonary embolism compared with systemic anticoagulation, but further randomized data with large sample sizes are needed to delineate specific patient populations who would benefit from this therapy, specific devices and approaches for catheter-directed thrombolysis, and any potential risks including bleeding. Further studies are also needed in patients with intermediate-low risk, intermediate-high risk, and high-risk or massive pulmonary embolism, the cost effectiveness of catheter-directed thrombolysis, and the use of catheter-directed thrombolysis as a component of pulmonary embolism response teams." @default.
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• W4307735161 date "2023-05-01" @default.
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• W4307735161 title "What Is the Efficacy of Catheter-Directed Thrombolysis Versus Systemic Anticoagulation Alone for Submassive Pulmonary Embolism?" @default.
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