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Published byChristopher Gray Modified over 9 years ago
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Clinical Trials
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Date & location – January-November 1998, stress SPECT patients randomly received tetrofosmin or sestamibi (n~1550) Inclusion criteria – Dual isotope protocol – No prior MI, PCI, CABG – Angiography within 90 days of SPECT Data required – Clinical history, stress test, medications and angiogram Patients enrolled –110 patients identified with all criteria (>98%) Hachamovitch R, et al. Circulation. 2001 (abstract 2899). Sestamibi and Tetrofosmin Ischemia Prediction in Stress SPECT - Clinical trial MI = Myocardial infarction, PCI = Percutaneous coronary intervention, CABG = Coronary artery bypass graft See prescribing information
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Study objectives – Determine what variables best predict ischemia using stress SPECT MPI The model was very predictive (R 2 = 0.86) Variables – Anti-ischemic medications, type of stress, ECG response, patient age and symptoms Conclusion – Type of isotope used was predictive of how much ischemia was detected Hachamovitch R, et al. Circulation. 2001 (abstract 2899). Sestamibi and Tetrofosmin Ischemia Prediction in Stress SPECT - Clinical Trial cont’d See prescribing information
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Impact of Isotope Used* Hachamovitch R, et al. Circulation. 2001; Abstract 2899. Sestamibi and Tetrofosmin Ischemia Prediction in Stress SPECT - Clinical Trial cont’d See prescribing information * All differences were statistically significant
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Event Rates as Function of SPECT MPI Results by Gender Hachamovitch R, et al. J Am Coll Cardiol 1996;28:34-44. Copyright 1996 by the American College of Cardiology. 0 2 4 6 8 10 12 14 16 Def Normal Prob Normal EquivocalProb Abnormal Def Abnormal Men Women Event Rate, % Scan Interpretation n = 4,136
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Crossover Study
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Dipyridamole stress SPECT Direct comparison using both tracers in the same patients Mild-to-moderate CAD (50-90% stenosis, 1 or 2 vessels) Randomized order of tracer use Two centers: 88 patients (1496 segments) Comparative data: –Blinded analysis of clinical data –Segmental analysis –Number, extent and severity of perfusion defects –Quantitative assessment of defect severity ratio Soman P, et al. J Am Coll Cardiol. 2001;37:458–462. Sestamibi and Tetrofosmin Crossover Study Ability to detect reversible perfusion defects See prescribing information
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Crossover Study cont’d Ability to detect reversible perfusion defects cont’d Soman P, et al. J Am Coll Cardiol. 2001;37:458–462. SestamibiTetrofosminp value Reversible segments 363285< 0.0001 Defect extent (% LV involved) 15.8±12.3% 12 11.4% < 0.01 Defect severity (defect/normal wall count ratio) 0.60±0.15 0.73 0.14 0.01 See prescribing information
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Segmental analysis: Of 119 segments classified as normal by tetrofosmin, sestamibi demonstrated reversible and fixed defects in 101 and 18 segments, respectively (P<0.001) Conversely, there were 54 segments classified as normal by sestamibi, where tetrofosmin detected abnormalities (49 reversible, 5 fixed) (P<0.001) Overall, sestamibi demonstrated more perfusion defects and demonstrated their extent, severity, and reversibility with greater accuracy than tetrofosmin (P<0.001) Soman P, et al. J Am Coll Cardiol. 2001;37:458–462. Crossover Study cont’d Ability to detect reversible perfusion defects cont’d See prescribing information
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