A pilot randomised trial of catheter-directed thrombolysis or standard anticoagulation for patients with intermediate-high risk acute pulmonary embolism

Kroupa, J; Buk, Michal; Weichet, J.; Malíková, Hana; Bartova, Lucie; Línková, Hana; Ionita, Oana; Kozel, Martin; Moťovská, Zuzana; Kočka, Viktor

doi:10.4244/eij-d-21-01080

Cited by 23 publications

(12 citation statements)

References 19 publications

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“…Several observational studies investigating intermediate to high‐risk PE reported that CDT was not associated with higher bleeding risks 18,19 . This trend was further corroborated by RCTs as well 5,17 . Moreover, previous studies have described a lower bleeding risk of CDT than ST, possibly because of lower or no thrombolytic therapy 20 .…”

Section: Discussionmentioning

confidence: 70%

“…Third, we included many observational studies, and only 11 were RCTs. Only three RCTs were investigating CDT in our study 5,17,26 . These studies have a small population; hence the results are difficult to generalize.…”

Section: Discussionmentioning

confidence: 96%

“…It is also suggested to have higher bleeding risks compared to CDT and SE. In terms of CDT, it is shown to have a comparable safety profile even when compared to AC 5,15–17 . Several observational studies investigating intermediate to high‐risk PE reported that CDT was not associated with higher bleeding risks 18,19 .…”

Section: Discussionmentioning

confidence: 99%

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Comparison of interventions for intermediate to high‐risk pulmonary embolism: A network meta‐analysis

Ishisaka

Watanabe

Fujisaki

et al. 2023

Cathet Cardio Intervent

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Background Multiple interventions, including catheter‐directed therapy (CDT), systemic thrombolysis (ST), surgical embolectomy (SE), and therapeutic anticoagulation (AC) have been used to treat intermediate to high‐risk pulmonary embolism (PE), but the most effective and safest treatment remains unclear. Our study aimed to investigate the efficacy and safety outcomes of each intervention. Methods We queried PubMed and EMBASE in January 2023 and performed a network meta‐analysis of observational studies and randomized controlled trials (RCT), including high or intermediate‐risk PE patients, and comparing AC, CDT, SE, and ST. The primary outcomes were in‐hospital mortality and major bleeding. The secondary outcomes included long‐term mortality (≥6 months), recurrent PE, minor bleeding, and intracranial hemorrhage. Results We identified 11 RCTs and 42 observational studies involving 157,454 patients. CDT was associated with lower in‐hospital mortality than ST (odds ratio [OR] [95% confidence interval (CI)]: 0.41 [0.31−0.55]), AC (OR [95% CI]: 0.33 [0.20−0.53]), and SE (OR [95% CI]: 0.61 [0.39−0.96]). Recurrent PE in CDT was lower than ST (OR [95% CI]: 0.66 [0.50−0.87]), AC (OR [95% CI]: 0.36 [0.20−0.66]), and trended lower than SE (OR [95% CI]: 0.71 [0.40−1.26]). Notably, ST had higher major bleeding risks than CDT (OR [95% CI]: 1.51 [1.19−1.91]) and AC (OR [95% CI]: 2.21 [1.53−3.19]). By rankogram analysis, CDT presented the highest p‐score in in‐hospital mortality, long‐term mortality, and recurrent PE. Conclusion In this network meta‐analysis of observational studies and RCTs involving patients with intermediate to high‐risk PE, CDT was associated with improved mortality outcomes compared to other therapies, without significant additional bleeding risk.

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Section: Discussionmentioning

confidence: 70%

Section: Discussionmentioning

confidence: 96%

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Comparison of interventions for intermediate to high‐risk pulmonary embolism: A network meta‐analysis

Ishisaka

Watanabe

Fujisaki

et al. 2023

Cathet Cardio Intervent

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“…In 2022, the use of CDT was compared with anticoagulation alone in an RCT of 23 patients with intermediate-risk PE 109 (Table 4 ). The investigators used the Cragg–McNamara catheter to infuse 20 mg of alteplase directly into the pulmonary vasculature.…”

Section: Interventional Therapiesmentioning

confidence: 99%

Interventional therapies for pulmonary embolism

et al. 2023

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Pulmonary embolism (PE) is the leading cause of in-hospital death and the third most frequent cause of cardiovascular death. The clinical presentation of PE is variable, and choosing the appropriate treatment for individual patients can be challenging. Traditionally, treatment of PE has involved a choice of anticoagulation, thrombolysis or surgery; however, a range of percutaneous interventional technologies have been developed that are under investigation in patients with intermediate–high-risk or high-risk PE. These interventional technologies include catheter-directed thrombolysis (with or without ultrasound assistance), aspiration thrombectomy and combinations of the aforementioned principles. These interventional treatment options might lead to a more rapid improvement in right ventricular function and pulmonary and/or systemic haemodynamics in particular patients. However, evidence from randomized controlled trials on the safety and efficacy of these interventions compared with conservative therapies is lacking. In this Review, we discuss the underlying pathophysiology of PE, provide assistance with decision-making on patient selection and critically appraise the available clinical evidence on interventional, catheter-based approaches for PE treatment. Finally, we discuss future perspectives and unmet needs.

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“…The CDT group met the primary efficacy endpoint (improvement of right ventricle (RV) function, decrease in pulmonary artery (PA) pressure and reduction of thrombus burden) more frequently than the group on standard anticoagulation, and no major bleeding events were reported. 3 The STRATIFY Trial, for instance, compares low-dose systemic thrombolysis to ultrasound-assisted thrombolysis (USAT) and conventional anticoagulation ( https://clinicaltrials.gov/ct2/show/record/NCT04088292 ). Catheter-directed mechanical thrombectomy offers an effectiveness profile comparable with that of CDT, but a favourable safety profile regarding major bleeding events.…”

Section: Introductionmentioning

confidence: 99%

Unexpected paradoxical embolization following catheter-directed thrombectomy with the FlowTriever™ system in a patient with pulmonary embolism: a case report

Uecker

Rosenkranz

Bunck

et al. 2023

European Heart Journal - Case Reports

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Background The optimal therapy for patients suffering from acute pulmonary embolism classified as intermediate-high-risk still needs to be identified. Catheter directed thrombectomy (CDTE) is a safe procedure to reduce thrombus burden immediately. The lack of randomized trials is one reason, CDT hast not yet received a clear recommendation in our guidelines. Herein we report an unexpected event in the course of a patient with PE treated with CDTE using the FlowTrieverTM system, the only FDA approved catheter system for percutaneous mechanical thrombectomy regarding this indication. Case Summary A 57-year old male presented with dyspnea at the emergency department of our university hospital. The CT scan showed bilateral pulmonary embolism and ultrasound of the left lower limb revealed deep venous thrombosis. According to the current ESC guidelines he was classified intermediate-high risk. We performed bilateral catheter directed thrombectomy. On the first and third day post-intervention our patient presented neurological deficits. Whereas the first CT scan of the cerebrum remained normal, the CT-scan at day 3 showed demarcated embolic stroke. Further imaging diagnostic gave evidence to an ischemic lesion in the left kidney. Transesophageal echocardiography revealed a patent foramen ovale (PFO) as the origin of paradoxical embolism and thus mechanism of both ischemic lesions. Compliant to the current recommendations, percutaneous PFO-closure was performed. Our patient recovered properly without any sequelae. Discussion Whether the deep venous thrombosis is the source of embolization or the catheter directed retrieval of clots may have transported clot material to the right atrium which further on embolized systemically will remain unclear. Yet, we have to consider it as a potential complication in catheter directed treatment of pulmonary embolism in patients with a PFO.

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A pilot randomised trial of catheter-directed thrombolysis or standard anticoagulation for patients with intermediate-high risk acute pulmonary embolism

Cited by 23 publications

References 19 publications

Comparison of interventions for intermediate to high‐risk pulmonary embolism: A network meta‐analysis

Comparison of interventions for intermediate to high‐risk pulmonary embolism: A network meta‐analysis

Interventional therapies for pulmonary embolism

Unexpected paradoxical embolization following catheter-directed thrombectomy with the FlowTriever™ system in a patient with pulmonary embolism: a case report

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