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The Bedside Investigation of Pulmonary Embolism Diagnosis Study
A Double-blind Randomized Controlled Trial Comparing Combinations of 3 Bedside Tests vs Ventilation-Perfusion Scan for the Initial Investigation of Suspected Pulmonary Embolism
Marc A. Rodger, MD, MSc;
Christopher N. Bredeson, MD, MSc;
Gwynne Jones, MD;
Pasteur Rasuli, MD;
François Raymond, MD;
Anne Marie Clement, RN;
Alan Karovitch, MD;
Helene Brunette, RRT;
Dimitri Makropoulos, MD;
Mark Reardon, MD;
Ian Stiell, MD, MSc;
Rama Nair, PhD;
Philip S. Wells, MD, MSc
Arch Intern Med. 2006;166:181-187.
Background We sought to determine whether using combinations of 3 bedside tests (7-variable clinical model, non–enzyme-linked immunosorbent assay D-dimer test, and alveolar dead-space fraction) to exclude pulmonary embolism (PE) before diagnostic imaging was as safe as a standard strategy of starting with ventilation-perfusion (V/Q) scan.
Methods In this double-blind, randomized, controlled equivalency trial, patients were randomized to initial bedside tests or to initial V/Q scan without bedside tests. Patients assigned to the bedside test group had a sham V/Q scan performed if at least 2 of 3 bedside test results were negative; otherwise, they underwent an actual V/Q scan. Further diagnostic management was determined by a blinded physician after V/Q scan. The primary outcome measure was recurrent venous thromboembolic events during 3 months among patients who were not taking anticoagulant agents after the initial investigations were completed.
Results Four hundred fifty-eight consecutive adults with suspected PE were eligible for the study; 398 of 399 consenting and randomized patients completed the study. The follow-up venous thromboembolic event rate was 2.4% in the bedside test group vs 3.0% in the V/Q scan group (P = .76). Pulmonary embolism was excluded in 34% (67/199) of the bedside test group patients with at least 2 negative results on 3 bedside tests vs 18% (35/199) excluded using only the 7-variable clinical model and the D-dimer test.
Conclusion Excluding PE with at least 2 negative results on 3 bedside tests safely eliminates the need for diagnostic imaging in 34% of patients with suspected PE.
Author Affiliations: University of Ottawa, Ottawa Health Research Institute, and Departments of Medicine (Drs Rodger, Jones, Karovitch, and Wells and Ms Clement), Radiology (Drs Rasuli and Raymond), Emergency Medicine (Drs Makropoulos, Reardon, and Stiell), Respiratory Therapy (Ms Brunette), and Epidemiology and Community Medicine (Dr Nair), Ottawa Hospital, Ottawa, Ontario; and Department of Medicine, Medical College of Wisconsin, Milwaukee (Dr Bredeson).
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