Fibrinolysis for Acute Care of Pulmonary Embolism in the Intermediate Risk Patient.
Controversy over the role of fibrinolysis in patients with intermediate-risk pulmonary embolism (PE) has persisted because of the lack of adequately sized trials. The PEITHO study now allows a more precise estimate of the risk to benefit ratio of fibrinolysis in these patients. This trial enrolled patients with intermediate-risk PE who were randomized to receive heparin with either tenecteplase or placebo. Fibrinolysis was associated with a significant reduction in the combined end-point of death or hemodynamic decompensation, but also with a significant increase in the risk of major bleeding. The primary efficacy end-point occurred in 2.6 % of the patients in the tenecteplase group and in 5.6 % of the patients in the placebo group (OR, 0.44; 95 % CI, 0.23 to 0.87), conversely, major extracranial bleeding occurred in 6.3 % and 1.2 % in the tenecteplase and placebo groups, respectively (OR, 5.55; 95 % CI, 2.3 to 13.39) and stroke occurred in 2.4 % and in 0.2 % of the patients in the tenecteplase group and in the placebo group, respectively (OR, 12.10; 95 % CI, 1.57 to 93.39). No difference was observed for the risk of death alone and the risk of full-dose thrombolytic therapy outweighs its benefit in patients with intermediate-risk PE. Recent meta-analyses suggest that fibrinolysis may be associated with a slight reduction in overall mortality offset by an increase in major bleeding. Two pilot studies suggest that a reduced dose of fibrinolysis may produce significant hemodynamic improvement with a low risk of major bleeding. These options need to be evaluated in larger studies including patients with a higher risk of adverse outcome than those included in the PEITHO study.
Service de Pneumologie-soins intensifs, Hôpital Européen Georges Pompidou, Assistance Publique Hopitaux de Paris, 20 rue Leblanc, 75015, Paris, France. guy.meyer@egp.aphp.fr.|Université Paris Descartes, Sorbonne Paris Cité, Paris, France. guy.meyer@egp.aphp.fr.|INSERM UMRS 970, Paris, France. guy.meyer@egp.aphp.fr.|INSERM CIC 1418, Paris, France. guy.meyer@egp.aphp.fr.
Guy
G
Meyer
INSERM UMRS 965, Paris, France. Benjamin.planquette@egp.aphp.fr.
Benjamin
B
Planquette
Service de Pneumologie-soins intensifs, Hôpital Européen Georges Pompidou, Assistance Publique Hopitaux de Paris, 20 rue Leblanc, 75015, Paris, France. Olivier.sanchez@egp.aphp.fr.|Université Paris Descartes, Sorbonne Paris Cité, Paris, France. Olivier.sanchez@egp.aphp.fr.|INSERM CIC 1418, Paris, France. Olivier.sanchez@egp.aphp.fr.|INSERM UMRS 965, Paris, France. Olivier.sanchez@egp.aphp.fr.
Olivier
O
Sanchez
D000208:Acute Disease; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D011655:Pulmonary Embolism / Q000188:drug therapy* / Q000601:surgery*; D013510:Pulmonary Surgical Procedures; D012306:Risk; D000077785:Tenecteplase; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use
D005343:Fibrinolytic Agents; D006493:Heparin; D010959:Tissue Plasminogen Activator; D000077785:Tenecteplase
Bleeding; Fibrinolysis/Risk stratification; Mortality; Pulmonary embolism