Meta-Analysis Comparing Catheter-Directed Thrombolysis Versus Systemic Anticoagulation Alone for Submassive Pulmonary Embolism

Ismayl, Mahmoud; Balakrishna, Akshay Machanahalli; Aboeata, Ahmed; Gupta, Tanush; Young, Michael N.; Altin, S. Elissa; Aronow, Herbert D.; Goldsweig, Andrew M.

doi:10.1016/j.amjcard.2022.06.004

Cited by 24 publications

(5 citation statements)

References 28 publications

(33 reference statements)

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“…Although it is challenging to conduct clinical trials on thrombolysis in acute PE setting, exemplified by a fairly limited number of cases in this multicenter analysis encompassing a 9-year interval, there is need to further evaluate the comparative effectiveness, safety, and costs of the reduced-and full-dose alteplase regimens and to compare them to the catheter-based interventions and third-generation thrombolytic agents that have longer half-life, higher fibrin specificity, and can be administered in a single IV bolus (43)(44)(45)(46). Individualized approach, with treatment algorithms taking into account patient presentation, comorbid conditions, response to the initial treatment, and risks and benefits of reperfusion therapy may result in best outcomes.…”

Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Reduced-Dose Versus Full-Dose Alteplase for Acute Pulmonary Embolism: A Multicenter Observational Comparative Effectiveness Study*

Melamed,

Tierney,

Xia

et al. 2024

Critical Care Medicine

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Objectives: Systemic thrombolysis improves outcomes in patients with pulmonary embolism (PE) but is associated with the risk of hemorrhage. The data on efficacy and safety of reduced-dose alteplase are limited. The study objective was to compare the characteristics, outcomes, and complications of patients with PE treated with full- or reduced-dose alteplase regimens. Design: Multicenter retrospective observational study. Setting: Tertiary care hospital and 15 community and academic centers of a large healthcare system. Patients: Hospitalized patients with PE treated with systemic alteplase. Interventions: None. Measurements and Main Results: Pre- and post-alteplase hemodynamic and respiratory variables, patient outcomes, and complications were compared. Propensity score (PS) weighting was used to adjust for imbalances of baseline characteristics between reduced- and full-dose patients. Separate analyses were performed using the unweighted and weighted cohorts. Ninety-eight patients were treated with full-dose (100 mg) and 186 with reduced-dose (50 mg) regimens. Following alteplase, significant improvements in shock index, blood pressure, heart rate, respiratory rate, and supplemental oxygen requirements were observed in both groups. Hemorrhagic complications were lower with the reduced-dose compared with the full-dose regimen (13% vs. 24.5%, p = 0.014), and most were minor. Major extracranial hemorrhage occurred in 1.1% versus 6.1%, respectively (p = 0.022). Complications were associated with supratherapeutic levels of heparin anticoagulation in 37.5% of cases and invasive procedures in 31.3% of cases. The differences in complications persisted after PS weighting (15.4% vs. 24.7%, p = 0.12 and 1.3% vs. 7.1%, p = 0.067), but did not reach statistical significance. There were no significant differences in mortality, discharge destination, ICU or hospital length of stay, or readmission after PS weighting. Conclusions: In a retrospective, PS-weighted observational study, when compared with the full-dose, reduced-dose alteplase results in similar outcomes but fewer hemorrhagic complications. Avoidance of excessive levels of anticoagulation or invasive procedures should be considered to further reduce complications.

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Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Reduced-Dose Versus Full-Dose Alteplase for Acute Pulmonary Embolism: A Multicenter Observational Comparative Effectiveness Study*

Melamed,

Tierney,

Xia

et al. 2024

Critical Care Medicine

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“…In line with other systematic reviews in the field of CDT, most of the observations and conclusions concerning CDT are based on observational studies. 77 , 78 To minimize selection bias, we excluded observational studies that showed significant baseline differences between groups with respect to PE severity and risk factors. The risk classification of PE and definitions of major bleeding and minor bleeding varied across studies and explicit details regarding these definitions were not always available.…”

Section: Discussionmentioning

confidence: 99%

Catheter-directed thrombolysis compared with systemic thrombolysis and anticoagulation in patients with intermediate- or high-risk pulmonary embolism: systematic review and network meta-analysis

Planer,

Yanko,

Matok

et al. 2023

CMAJ

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Background: Therapeutic options for intermediate- or high-risk pulmonary embolism (PE) include anticoagulation, systemic thrombolysis and catheter-directed thrombolysis (CDT); however, the role of CDT remains controversial. We sought to compare the efficacy and safety of CDT with other therapeutic options using network meta-analysis. Methods: We searched PubMed (MEDLINE), Embase, ClinicalTrials.gov and Cochrane Library from inception to Oct. 18, 2022. We included randomized controlled trials and observational studies that compared therapeutic options for PE, including anticoagulation, systemic thrombolysis and CDT among patients with intermediate- or high-risk PE. The efficacy outcome was in-hospital death. Safety outcomes included major bleeding, intracerebral hemorrhage and minor bleeding. Results: We included data from 44 studies, representing 20 006 patients. Compared with systemic thrombolysis, CDT was associated with a decreased risk of death (odd ratio [OR] 0.43, 95% confidence interval [CI] 0.32–0.57), intracerebral hemorrhage (OR 0.44, 95% CI 0.29–0.64), major bleeding (OR 0.61, 95% CI 0.53–0.70) and blood transfusion (OR 0.46, 95% CI 0.28–0.77). However, no difference in minor bleeding was observed between the 2 therapeutic options (OR 1.11, 95% CI 0.66–1.87). Compared with anticoagulation, CDT was also associated with decreased risk of death (OR 0.36, 95% CI 0.25–0.52), with no increased risk of intracerebral hemorrhage (OR 1.33, 95% CI 0.63–2.79) or major bleeding (OR 1.24, 95% CI 0.88–1.75). Interpretation: With moderate certainty of evidence, the risk of death and major bleeding complications was lower with CDT than with systemic thrombolysis. Compared with anticoagulation, CDT was associated with a probable lower risk of death and a similar risk of intracerebral hemorrhage, with moderate certainty of evidence. Although these findings are largely based on observational data, CDT may be considered as a first-line therapy in patients with intermediate- or high-risk PE. Protocol registration: PROSPERO — CRD42020182163

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“…None of the patients included in this study died within 30 days post-thrombectomy. In FLASH, all-cause mortality at 30 days was 0.8%, [ 12 ] which is lower than the historical 30-day mortality rate for intermediate-risk PE patients receiving anticoagulation only (up to 10%) [ 23 ]. In the absence of evidence from prospective, randomised, controlled trials assessing cardiovascular outcomes, a retrospective analysis comparing patients with intermediate-high and high-risk PE who received mechanical thrombectomy (n = 28) or routine care (n = 30) suggested that mechanical thrombectomy might indeed improve in-hospital mortality (3.6% vs. 23.3%, p < 0.05) [ 24 ].…”

Section: Discussionmentioning

confidence: 99%

Mechanical thrombectomy in intermediate- and high-risk acute pulmonary embolism: hemodynamic outcomes at three months

Lauder,

Pérez Navarro,

Götzinger

et al. 2023

Respir Res

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Background Mechanical thrombectomy has been shown to reduce thrombus burden and pulmonary artery pressure (PAP) and to improve right ventricular (RV) function in patients with high-risk or intermediate-high-risk pulmonary embolism (PE). As hemodynamic data after mechanical thrombectomy for PE are scarce, we aimed to assess the hemodynamic effects of mechanical thrombectomy in acute PE with right heart overload. Methods In this prospective, open-label study, patients with acute symptomatic, computed tomography-documented PE with signs of right heart overload underwent mechanical thrombectomy using the FlowTriever System. Right heart catheterization was performed immediately before and after thrombectomy and after three months. Transthoracic echocardiography was performed before thrombectomy, discharge, and at three months. This analysis was done after 20 patients completed three months of follow-up. Results Twenty-nine patients (34% female) underwent mechanical thrombectomy, of which 20 completed three months follow-up with right heart catheterization. Most patients were at high (17%) or intermediate-high (76%) risk and had bilateral PE (79%). Before thrombectomy, systolic PAP (sPAP) was severely elevated (mean 51.3 ± 11.6 mmHg). Mean sPAP dropped by -15.0 mmHg (95% confidence interval [CI]: -18.9 to -11.0; p < 0.001) immediately after the procedure and continued to decrease from post-thrombectomy to three months (-6.4 mmHg, 95% CI: -10-0 to -2.9; p = 0.002). RV/left ventricular (LV) ratio immediately reduced within two days by -0.37 (95% CI: -0.47 to -0.27; p < 0.001). The proportion of patients with a tricuspid annular plane systolic excursion (TAPSE)/sPAP ratio < 0.31 mm/mmHg decreased from 28% at baseline to 0% before discharge and at three months (p = 0.007). There were no procedure-related major adverse events. Conclusions Mechanical thrombectomy for acute PE was safe and immediately reduced PAP and improved right heart function. The reduction in PAP was maintained at three months follow-up.

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Meta-Analysis Comparing Catheter-Directed Thrombolysis Versus Systemic Anticoagulation Alone for Submassive Pulmonary Embolism

Cited by 24 publications

References 28 publications

Safety and Efficacy of Reduced-Dose Versus Full-Dose Alteplase for Acute Pulmonary Embolism: A Multicenter Observational Comparative Effectiveness Study*

Safety and Efficacy of Reduced-Dose Versus Full-Dose Alteplase for Acute Pulmonary Embolism: A Multicenter Observational Comparative Effectiveness Study*

Catheter-directed thrombolysis compared with systemic thrombolysis and anticoagulation in patients with intermediate- or high-risk pulmonary embolism: systematic review and network meta-analysis

Mechanical thrombectomy in intermediate- and high-risk acute pulmonary embolism: hemodynamic outcomes at three months

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