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(Circulation. 2001;104:2876.)
© 2001 American Heart Association, Inc.

Editorial

Thrombolysis in Pulmonary Embolism

A Large-Scale Clinical Trial Is Overdue

Samuel Z. Goldhaber, MD

From the Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, Mass.

Correspondence to Samuel Z. Goldhaber, MD, Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, 75 Francis St, Tower 3B, Boston, MA 02115. E-mail sgoldhaber@partners.org

Key Words: Editorials • embolism • pulmonary heart disease • thrombolysis • thrombus • veins

Thrombolysis for acute pulmonary embolism (PE) remains a debatable indication because inadequate data exist to provide definitive management guidelines.¹ As cardiologists, we have relied on large-scale randomized clinical trials to determine that thrombolysis benefits patients with ST-segment elevation acute myocardial infarction (MI). Yet, no clinical investigations similar in scope have been undertaken for pulmonary thromboembolism, even though this illness afflicts 100 000 patients annually in the United States² and has a high case fatality rate.³

Intuitively, thrombolysis makes sense, especially for massive PE with cardiogenic shock. Nevertheless, only one small randomized controlled trial of 8 patients has tested this strategy among these desperately ill PE patients.⁴ The thrombolytic regimen was streptokinase, given in the MI dose of 1 500 000 U administered over a period of 1 hour. All 4 patients receiving thrombolysis plus heparin survived, whereas none were treated successfully with anticoagulation alone. Although the investigators originally intended to enroll 40 patients, they halted their trial for ethical reasons after the first 8 patients yielded such disparate results between the 2 groups. Despite these dramatic differences between the 2 groups, we should not craft treatment policy on the basis of an 8-patient trial.

Shockingly, there are only 9 randomized trials of PE thrombolysis versus heparin, with a total of <500 patients.^4–13 Only 2 of these trials have enrolled >100 patients. The first trial, the Urokinase Pulmonary Embolism Trial, enrolled 160 patients who were randomized to thrombolysis plus heparin or heparin alone.⁵ This has been the largest trial to date. . . . [Full Text of this Article]

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