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Thrombolysis for Submassive Pulmonary Embolism
Thrombolysis reduced the rate of clinical deterioration in hemodynamically stable patients with submassive pulmonary embolism.
Thrombolysis is an accepted practice for treating massive pulmonary embolism and hemodynamic instability. These authors evaluated whether thrombolysis is also effective for patients with submassive embolism and hemodynamic stability. In a double-blind, randomized, manufacturer-supported trial, 256 patients at 40 centers received heparin and placebo or heparin and alteplase (10-mg bolus followed by 90-mg infusion over 2 hours).
Inclusion criteria were echocardiographic evidence of right ventricular dysfunction, echocardiographic evidence of pulmonary hypertension, electrocardiographic evidence of PE, or pulmonary hypertension on cardiac catheterization; the latter 3 criteria had to be followed by confirmation of PE. Exclusion criteria included hemodynamic instability, age older than 80, and the usual contraindications to thrombolysis. The primary endpoint was death or clinical deterioration that required "an escalation of treatment" after the infusion was finished.
The primary endpoint occurred significantly more often in the placebo group than in the alteplase group (24.6% vs. 11.0%; P=0.006). Death was rare and occurred in the 2 groups at similar rates (2.2% and 3.4%, respectively), but clinical deterioration was significantly more common in the placebo group (24.6% vs. 10.2%, P=0.004). Adverse events, such as major bleeding (2.3%), fatal bleeding (0.4%), and ischemic stroke (0.4%), occurred less often than in previous trials of thrombolytic therapy, and there were no cases of hemorrhagic stroke.
Comment: An editorialist states that this study definitely extends the indications for thrombolysis in patients with pulmonary embolism. Yet transferring this recommendation to the average emergency department will be problematic in the absence of emergency on-call echocardiography. Hospitals may have to consider introducing such echocardiography, which is similar to systems used for trauma and specialized radiology such as angiography.
J. Stephen Bohan, MS, MD, FACP, FACEP
Published in Journal Watch Emergency Medicine November 26, 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.
- Original article (Subscription may be required)
- Medline abstract (Free)
Goldhaber SZ. Thrombolysis for pulmonary embolism. N Engl J Med 2002 Oct 10; 347:1131-2.
- Original article (Subscription may be required)
- Medline abstract (Free)
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