Pulmonary embolism (PE) remains a diagnostic challenge. False negative testing exposes patient to the risk of potentially fatal recurrence. False positive testing exposes patients to potentially fatal unduly side effects of anticoagulants. Current diagnostic strategies rely on the sequential use of pretest clinical probability, Ddimer test, and chest imaging. Two chest imaging modalities have been validated for PE diagnostic exclusion: Computed Tomography Pulmonary Angiography (CTPA) and planar V/Q scan. Main limitations of planar V/Q are the high proportion of non-conclusive results, therefore requiring additional testing and more complex diagnostic algorithms. Main limitations of CTPA are its higher radiation dose and contraindications (renal failure). In a randomized trial that compared strategies based on CTPA and on planar V/Q scan, a 30% increase in the rate of PE diagnoses was found in the arm using CTPA, raising the hypothesis of over-diagnosing and over-treating PE when using CTPA. V/Q Single Photon Emission CT (SPECT) is a new method of scintigraphic acquisition that has been reported to improve the diagnostic performances of the test, which could reduce the number of non-conclusive tests and allow simplified diagnostic algorithms. The investigators hypothesize that a strategy based on V/Q SPECT could be an alternative to the two usual approaches responding rightly to the two mains issues and combining the advantages of CTPA (simplified diagnostic approach) and planar V/Q (no overdiagnosis, lower radiation exposure, no contraindication). Although a recent survey showed that up to 70% of nuclear medicine centers perform SPECT rather than planar imaging for diagnosing PE, a diagnostic management outcome study, in which diagnostic decision would be made on the basis of a standardized algorithm based on the V/Q SPECT is lacking. Such a study needs to be conducted to ensure that the safety of diagnostic exclusion using a V/Q SPECT based strategy is non-inferior to that of previously validated strategies, and to verify that the use of V/Q SPECT does not lead to over-diagnosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
611
Strategy based on planar pulmonary scintigraphy
Strategy based on pulmonary angiography
Strategy based on pulmonary tomoscintigraphy
Ottawa
Ottawa, Canada
Hopital Saint Esprit
Agen, France
CHU d'ANGERS
Angers, France
CHRU de Brest
Brest, France
CHU Clermont Ferrand
Clermont-Ferrand, France
CH des Pays de Morlaix
Morlaix, France
Hegp - Ap-Hp
Paris, France
CHU la Réunion
Saint-Denis, France
CHU de Saint Etienne
Saint-Etienne, France
CH Toulon
Toulon, France
...and 1 more locations
Thromboembolic events rate in a 3 month follow-up period in patients left untreated after a negative diagnostic strategy.
Rate of symptomatic objectively confirmed thromboembolic events during the 3-month follow-up period in patients left untreated after a negative diagnostic work-up in V/Q SPECT-based strategy in comparison with planar V/Q-based strategy and CTPA-based strategy.
Time frame: 3 months
Proportion of PE diagnostic in each arm
Proportion of patients deemed to have PE according to the strategy in each arm.
Time frame: 3 months
Proportion of additionnal tests required in each arm
Proportion of patients for whom additional tests are requested in each arm.
Time frame: 3 months
Major bleeding incidence in each arm
Incidence of major bleeding episodes in each arm.
Time frame: 3 months
Incidence and cause of death in each arm
Incidence and cause of death in each arm
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.