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Guideline adoption could lead to more use of thrombolytic therapy.
The European Society of Cardiology (ESC) released new guidelines for the management of acute pulmonary embolism.
A pulmonary embolism episode may lead to lifelong risk of venous thromboembolism (VTE). With help from 44 national cardiac societies, the recommendations were based off peer-reviewed literature on adult patients with the condition.
“Adoption of this guideline will likely lead to more evidence-based use of thrombolytic therapy for patients most likely to benefit from its use,” the organizations wrote.
The organizations recommended stratification of patients without hemodynamic instability but with acute pulmonary embolism into intermediate- and low-risk categories. Further, systemic thrombolytic therapy was recommended for high-risk patients. The recommendations were based off data from nearly 2000 patients who demonstrated significant reductions in pulmonary embolism-related morality (3% vs .6%; OR, .29; 95% CI, .14-.6) and recurrentpulmonary embolism (2.9% vs 1.3%; OR, .5; 95% CI, .27-.94) at the cost of severe bleeding (9.9% vs 3.6%; OR, 2.91; 95% CI, 1.95-4.36) and intracranial hemorrhage (1.7% vs .3%; OR, 3.18; 95% CI, 1.25-8.11).
They recommended percutaneous catheter-directed treatment or surgical embolectomy as alternative treatments for such patients, despite less evidence supporting the therapies.
System thrombolysis was not recommended as an initial therapy for intermediate-risk patients, however, largely due to high rates of major bleeding (11.5% with tenecteplase vs 2.4% with placebo) and hemorrhagic stroke (2% vs .2%) with no significant difference in death (1.2% vs 1.8%). The therapy showed improvement in the outcome of death from any cause or hemodynamic decompensation at 7 days (2.6% with tenecteplase vs 5.6% with placebo.
Rescue thrombolytic therapy was suggested for patients with hemodynamic deterioration while receiving anticoagulation treatment.
A direct oral anticoagulant (DOAC) was recommended over a vitamin K antagonist when oral anticoagulation is initiated in a patient with pulmonary embolism who is eligible for a DOAC. Indefinite oral anticoagulation treatment was suggested for those with recurrent VTE not related to a major transient or reversible risk factor and for patients with a first pulmonary embolism and no identifiable risk factor.
The recommendation was based off the results of a meta-analysis of DOAC versus vitamin K antagonist trials including 24,555 patients with acute VTE. In the trials, patients demonstrated no significant difference in recurrent VTE (2% vs 2.2%), fatal pulmonary embolism (.07% vs .07%), and overall mortality (2.4% vs 2.4%). There was a lower risk of major bleeding with DOACs compared to vitamin K antagonists (1.1% vs 1.7%; relative risk, .6; 95% CI, .41-.88).
The guidelines emphasized the importance of risk stratification before selecting therapies for patients with acute pulmonary embolism. Clinicians should use imaging studies, biomarkers, and physiologic metrics to select high-risk patients who might benefit from reperfusion therapy like systemic treatment, surgical embolectomy, or catheter-directed thrombolysis.
The organizations suggested the discontinuation of anticoagulation in patients with a first pulmonary embolism/VTE secondary to a major transient risk factor after 3 months.
Because VTE risk is increased with many other conditions, the guidelines no longer support the terms “provoked” or “unprovoked” for VTE and instead favor “reversible,” “any persistent,” or “no identifiable” risk factors.
The guidelines, “Management of Acute Pulmonary Embolism,” were published online on JAMA.