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Thrombolytic Therapy for Submassive Pulmonary Embolism?

Heparin-alteplase recipients suffered significantly less early clinical deterioration than did heparin-placebo recipients.

Thrombolytic therapy is recommended for hemodynamically unstable patients with pulmonary embolism (PE). However, there is no consensus on whether thrombolytic therapy is beneficial for patients with submassive PE -- that is, PE with measurable hemodynamic effects that have not resulted in clinical instability.

This double-blind, randomized German trial involved 256 patients with acute PE and right ventricular dysfunction or pulmonary hypertension (according to echocardiographic or electrocardiographic findings) but with no systemic hypotension. The patients received unfractionated heparin plus either the thrombolytic agent alteplase or placebo (given intravenously over 2 hours). The primary endpoint (in-hospital death or clinical deterioration that required escalation of treatment) occurred significantly less often in the alteplase group than in the placebo group (11% vs. 25%). This difference was almost entirely attributable to a higher rate of rescue thrombolysis -- given for worsening symptoms or signs, or for persistent echocardiographic abnormalities -- in the placebo group. There were no significant differences between groups in the incidences of death, recurrent PE, or major bleeding.

Comment: In this study, thrombolytic therapy for submassive PE did not reduce mortality, but it did minimize early clinical deterioration, which required treatment with rescue thrombolysis in a subset of patients. Thus, in a sense, these investigators compared immediate and delayed thrombolytic therapy. The authors do not tell us whether hospital or ICU stays were reduced in the heparin-alteplase group, and the extent of the additional burden of illness in the heparin-placebo group is unclear. A key issue is whether the low risk for major bleeding -- only 1% in the heparin-alteplase group -- can be duplicated in community settings. An editorialist adds a sensible commentary to this study.

— Allan S. Brett, MD

Published in Journal Watch General Medicine October 18, 2002

Citation(s):

Konstantinides S et al. Heparin plus alteplase compared with heparin alone in patients with submassive pulmonary embolism. N Engl J Med 2002 Oct 10; 347:1143-50.

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Goldhaber SZ. Thrombolysis for pulmonary embolism. N Engl J Med 2002 Oct 10; 347:1131-2.

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• Medline abstract (Free)