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Diagnosis of pulmonary embolism by multidetector CT alone or combined with venous ultrasonography of the leg: a randomised non-inferiority trial.
Lancet 2008; 371(9621):1343-52Lct

Abstract

BACKGROUND

Multislice CT (MSCT) combined with D-dimer measurement can safely exclude pulmonary embolism in patients with a low or intermediate clinical probability of this disease. We compared this combination with a strategy in which both a negative venous ultrasonography of the leg and MSCT were needed to exclude pulmonary embolism.

METHODS

We included 1819 consecutive outpatients with clinically suspected pulmonary embolism in a multicentre non-inferiority randomised controlled trial comparing two strategies: clinical probability assessment and either D-dimer measurement and MSCT (DD-CT strategy [n=903]) or D-dimer measurement, venous compression ultrasonography of the leg, and MSCT (DD-US-CT strategy [n=916]). Randomisation was by computer-generated blocks with stratification according to centre. Patients with a high clinical probability according to the revised Geneva score and a negative work-up for pulmonary embolism were further investigated in both groups. The primary outcome was the 3-month thromboembolic risk in patients who were left untreated on the basis of the exclusion of pulmonary embolism by diagnostic strategy. Clinicians assessing outcome were blinded to group assignment. Analysis was per protocol. This study is registered with ClinicalTrials.gov, number NCT00117169.

FINDINGS

The prevalence of pulmonary embolism was 20.6% in both groups (189 cases in DD-US-CT group and 186 in DD-CT group). We analysed 855 patients in the DD-US-CT group and 838 in the DD-CT group per protocol. The 3-month thromboembolic risk was 0.3% (95% CI 0.1-1.1) in the DD-US-CT group and 0.3% (0.1-1.2) in the DD-CT group (difference 0.0% [-0.9 to 0.8]). In the DD-US-CT group, ultrasonography showed a deep-venous thrombosis in 53 (9% [7-12]) of 574 patients, and thus MSCT was not undertaken.

INTERPRETATION

The strategy combining D-dimer and MSCT is as safe as the strategy using D-dimer followed by venous compression ultrasonography of the leg and MSCT for exclusion of pulmonary embolism. An ultrasound could be of use in patients with a contraindication to CT.

Authors+Show Affiliations

Division of Angiology and Hemostasis, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland. Marc.Righini@hcuge.chNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18424324

Citation

Righini, Marc, et al. "Diagnosis of Pulmonary Embolism By Multidetector CT Alone or Combined With Venous Ultrasonography of the Leg: a Randomised Non-inferiority Trial." Lancet (London, England), vol. 371, no. 9621, 2008, pp. 1343-52.
Righini M, Le Gal G, Aujesky D, et al. Diagnosis of pulmonary embolism by multidetector CT alone or combined with venous ultrasonography of the leg: a randomised non-inferiority trial. Lancet. 2008;371(9621):1343-52.
Righini, M., Le Gal, G., Aujesky, D., Roy, P. M., Sanchez, O., Verschuren, F., ... Perrier, A. (2008). Diagnosis of pulmonary embolism by multidetector CT alone or combined with venous ultrasonography of the leg: a randomised non-inferiority trial. Lancet (London, England), 371(9621), pp. 1343-52. doi:10.1016/S0140-6736(08)60594-2.
Righini M, et al. Diagnosis of Pulmonary Embolism By Multidetector CT Alone or Combined With Venous Ultrasonography of the Leg: a Randomised Non-inferiority Trial. Lancet. 2008 Apr 19;371(9621):1343-52. PubMed PMID: 18424324.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Diagnosis of pulmonary embolism by multidetector CT alone or combined with venous ultrasonography of the leg: a randomised non-inferiority trial. AU - Righini,Marc, AU - Le Gal,Grégoire, AU - Aujesky,Drahomir, AU - Roy,Pierre-Marie, AU - Sanchez,Olivier, AU - Verschuren,Franck, AU - Rutschmann,Olivier, AU - Nonent,Michel, AU - Cornuz,Jacques, AU - Thys,Frédéric, AU - Le Manach,Cédric Petit, AU - Revel,Marie-Pierre, AU - Poletti,Pierre-Alexandre, AU - Meyer,Guy, AU - Mottier,Dominique, AU - Perneger,Thomas, AU - Bounameaux,Henri, AU - Perrier,Arnaud, PY - 2008/4/22/pubmed PY - 2008/5/2/medline PY - 2008/4/22/entrez SP - 1343 EP - 52 JF - Lancet (London, England) JO - Lancet VL - 371 IS - 9621 N2 - BACKGROUND: Multislice CT (MSCT) combined with D-dimer measurement can safely exclude pulmonary embolism in patients with a low or intermediate clinical probability of this disease. We compared this combination with a strategy in which both a negative venous ultrasonography of the leg and MSCT were needed to exclude pulmonary embolism. METHODS: We included 1819 consecutive outpatients with clinically suspected pulmonary embolism in a multicentre non-inferiority randomised controlled trial comparing two strategies: clinical probability assessment and either D-dimer measurement and MSCT (DD-CT strategy [n=903]) or D-dimer measurement, venous compression ultrasonography of the leg, and MSCT (DD-US-CT strategy [n=916]). Randomisation was by computer-generated blocks with stratification according to centre. Patients with a high clinical probability according to the revised Geneva score and a negative work-up for pulmonary embolism were further investigated in both groups. The primary outcome was the 3-month thromboembolic risk in patients who were left untreated on the basis of the exclusion of pulmonary embolism by diagnostic strategy. Clinicians assessing outcome were blinded to group assignment. Analysis was per protocol. This study is registered with ClinicalTrials.gov, number NCT00117169. FINDINGS: The prevalence of pulmonary embolism was 20.6% in both groups (189 cases in DD-US-CT group and 186 in DD-CT group). We analysed 855 patients in the DD-US-CT group and 838 in the DD-CT group per protocol. The 3-month thromboembolic risk was 0.3% (95% CI 0.1-1.1) in the DD-US-CT group and 0.3% (0.1-1.2) in the DD-CT group (difference 0.0% [-0.9 to 0.8]). In the DD-US-CT group, ultrasonography showed a deep-venous thrombosis in 53 (9% [7-12]) of 574 patients, and thus MSCT was not undertaken. INTERPRETATION: The strategy combining D-dimer and MSCT is as safe as the strategy using D-dimer followed by venous compression ultrasonography of the leg and MSCT for exclusion of pulmonary embolism. An ultrasound could be of use in patients with a contraindication to CT. SN - 1474-547X UR - https://www.unboundmedicine.com/medline/citation/18424324/Diagnosis_of_pulmonary_embolism_by_multidetector_CT_alone_or_combined_with_venous_ultrasonography_of_the_leg:_a_randomised_non_inferiority_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0140-6736(08)60594-2 DB - PRIME DP - Unbound Medicine ER -