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The Journal of Nuclear Medicine Vol. 41 No. 7 1214-1223
© 2000 by Society of Nuclear Medicine
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Acute Thromboscintigraphy with 99mTc-Apcitide: Results of the Phase 3 Multicenter Clinical Trial Comparing 99mTc-Apcitide Scintigraphy with Contrast Venography for Imaging Acute DVT

Raymond Taillefer, Stephen Edell, Grant Innes and John Lister-James

Hotel-Dieu, Montreal, Quebec
Royal Columbian Hospital, Delta, British Columbia, Canada
Delaware SPECT Imaging Center, Newark, Delaware
Diatide, Inc., Londonderry, New Hampshire

Correspondence: For correspondence or reprints contact: Raymond Taillefer, MD, Department of Nuclear Medicine, Center Hospitalier de l'Universite de Montreal, Pavilion Hotel-Dieu, 3840 St-Urbain, Montreal H2W 1T8, Canada.

ABSTRACT

99mTc-apcitide (formerly known as 99mTc-P280) is a radiolabeled peptide that binds with high affinity and specificity to the glycoprotein IIb/IIIa receptors expressed on the activated platelets that are involved in acute thrombosis. The purpose of the phase 3 multicenter clinical trials was to compare 99mTc-apcitide scintigraphy with contrast venography for imaging acute deep venous thrombosis (DVT). Methods: A total of 280 patients were enrolled in 2 clinical trials conducted in North America and Europe. Patients were to be within 10 d of onset of signs and symptoms of acute DVT or within 10 d of surgery associated with a high risk of DVT. 99mTc-apcitide scintigraphy and contrast venography were to be performed within 36 h. Planar scintigraphic images were obtained at 10, 60, and 120–180 min after injection. 99mTc-apcitide scintigrams and contrast venograms were read with masking and also by the institutional investigators. Results: Of a total of 243 patients who were evaluable, 61.7% were receiving heparin at the time of imaging. Masked reading of 99mTc-apcitide scintigraphy, compared with masked reading of contrast venography, had a sensitivity, specificity, and agreement of 73.4%, 67.5%, and 69.1%, respectively, which met the prospectively defined target efficacy endpoint in both trials. Institutional reading of 99mTc-apcitide scintigraphy, compared with institutional reading of contrast venography, had a sensitivity, specificity, and agreement of 75.5%, 72.8%, and 74.0%, respectively. However, the entire trial population included patients with a history of DVT who may have had old, nonacute venous thrombi that could confound the venography results. Therefore, data from patients having no history of DVT or pulmonary embolism and who presented within 3 d of onset of signs and symptoms (n - 63), i.e., patients for whom a venogram would be expected to be positive only if acute DVT were present, also were analyzed as a subset. In these patients, institutional reading of 99mTc-apcitide scintigraphy, compared with institutional reading of contrast venography, had a sensitivity, specificity, and agreement of 90.6%, 83.9%, and 87.3%, respectively. Conclusion: 99mTc-apcitide scintigraphy is a new diagnostic modality that is highly sensitive for imaging acute DVT.

Key Words: 99mTc-apcitide • acute deep venous thrombosis • scintigraphy • venography




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