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Catheter-directed therapy for acute pulmonary embolism: navigating gaps in the evidence.

ABSTRACT: Systemic thrombolysis for acute pulmonary embolism (PE) reduces the risk of death and cardiovascular collapse but is associated with an increased rate of bleeding. The desire to minimize the risk of bleeding events has driven the development of catheter-based strategies for pulmonary reperfusion in PE. These catheter-based strategies utilize lower-dose fibrinolytic regimens or purely mechanical techniques to expedite removal of the embolus. Several devices providing mechanical or suction embolectomy and catheter-directed thrombolysis, with or without facilitation by ultrasound, have been tested. Data are inconsistent regarding the efficacy and safety of mechanical and suction embolectomy. The most comprehensive data on catheter-based techniques stem from trials of ultrasound-facilitated catheter fibrinolysis. Ultrasound-facilitated catheter fibrinolysis relieves right ventricular pressure overload with a lower risk of major bleeding and intracranial haemorrhage than historical rates with systemic fibrinolysis. However, further research is required to determine the optimal application of ultrasound-facilitated catheter fibrinolysis and other catheter-based therapies in patients with acute PE.

SUBMITTER: Chopard R

PROVIDER: S-EPMC6868391 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Catheter-directed therapy for acute pulmonary embolism: navigating gaps in the evidence.

Chopard Romain R Ecarnot Fiona F Meneveau Nicolas N

European heart journal supplements : journal of the European Society of Cardiology 20191121 Suppl I

Systemic thrombolysis for acute pulmonary embolism (PE) reduces the risk of death and cardiovascular collapse but is associated with an increased rate of bleeding. The desire to minimize the risk of bleeding events has driven the development of catheter-based strategies for pulmonary reperfusion in PE. These catheter-based strategies utilize lower-dose fibrinolytic regimens or purely mechanical techniques to expedite removal of the embolus. Several devices providing mechanical or suction embolec ...[more]

PMID: 31777454

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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.

Dataset Information

Catheter-directed therapy for acute pulmonary embolism: navigating gaps in the evidence.

Publications

Catheter-directed therapy for acute pulmonary embolism: navigating gaps in the evidence.

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