Chest
Volume 111, Issue 5, May 1997, Pages 1241-1245
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Clinical Investigations: Pulmonary Embolism
Thrombolytic Therapy for Pulmonary Embolism: Frequency of Intracranial Hemorrhage and Associated Risk Factors

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Study objectives

To determine the risk factors and frequency of intracranial hemorrhage among patients undergoing thrombolysis for pulmonary embolism.

Design

A retrospective descriptive and controlled analysis.

Setting

Hospitalized patients at centers in the United States, Canada, and Italy.

Patients

All had evidence of pulmonary embolism on perfusion scans or angiography.

Interventions

None.

Measurements and results

Data were analyzed on 312 patients from five previously reported studies of pulmonary embolism thrombolysis. The frequency of intracranial hemorrhage up to 14 days after pulmonary embolism thrombolysis was 6 of 312 or 1.9% (95% confidence interval, 0.7 to 4.1%). Two of six intracranial hemorrhages were fatal. Two of the six patients received thrombolysis in violation of the protocol because they had pre-existing, known intracranial disease. Average diastolic BP at the time of hospital admission was significantly elevated in patients who developed an intracranial hemorrhage (90.3±15.1 mm Hg) compared with those who did not (77.6±10.9 mm Hg; p=0.04). Other baseline characteristics and laboratory data were similar in both groups. Decreased level of consciousness, hemiparesis, and visual field deficits were the most common clinical signs of intracranial hemorrhage.

Conclusions

Intracranial hemorrhage after pulmonary embolism thrombolysis is an infrequent but often grave complication. Meticulous patient screening before administering thrombolysis is imperative. Diastolic hypertension at the time of hospital admission is a risk factor for intracranial hemorrhage after pulmonary embolism thrombolysis.

Section snippets

MATERIALS AND METHODS

Data on 312 patients from five previously reported studies1, 2, 3, 4, 5, 6, 7 of thrombolysis in PE (as an adjunct to heparin anticoagulation) were analyzed in an overview. The first trial was a dose selection trial of recombinant tissue plasminogen activator (rt-PA) and all 47 patients received 50 to 90 mg over 2 to 6 h.1, 2, 3 The second trial was a study of 45 patients randomized to rt-PA, 100 mg over 2 h vs urokinase, 2,000 Units/lb body weight, as a bolus followed by the same dose per hour

RESULTS

The overall frequency of ICH was 6 of 312 or 1.9% (95% confidence interval [CI], 0.7 to 4.1%) (Table 1). Three patients died, two of ICH and one of recurrent PE or myocardial infarction, but no autopsies were performed. The other three were discharged from the hospital with minor residual neurologic deficits.

Patients with ICH were older (68.1±8.1 years vs 57.3±17.0 years), but this trend did not achieve statistical significance (p=0.14). No patient younger than 50 years of age suffered an ICH,

DISCUSSION

PE thrombolysis can rapidly reverse right ventricular dysfunction and can reduce the rate of recurrent PE.6 This overview demonstrates that ICH after PE thrombolysis is an infrequent but at times fatal complication. The presence of diastolic hypertension on hospital admission is associated with a higher risk of ICH. Younger patients appear to be at very low risk for thrombolysis-related ICH after PE.

The frequency of ICH after thrombolysis for PE in our series (1.9%; 95% CI, 0.7 to 4.1%) is

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