Tom van der Hulle1, Whitney Y Cheung2, Stephanie Kooij3, Ludo F M Beenen4, Thomas van Bemmel5, Josien van Es6, Laura M Faber7, Germa M Hazelaar8, Christian Heringhaus9, Herman Hofstee10, Marcel M C Hovens11, Karin A H Kaasjager12, Rick C J van Klink13, Marieke J H A Kruip14, Rinske F Loeffen15, Albert T A Mairuhu3, Saskia Middeldorp2, Mathilde Nijkeuter12, Liselotte M van der Pol3, Suzanne Schol-Gelok14, Marije Ten Wolde16, Frederikus A Klok1, Menno V Huisman17. 1. Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, Netherlands. 2. Department of Vascular Medicine, Academic Medical Center, Amsterdam, Netherlands. 3. Department of Internal Medicine, Haga Hospital, The Hague, Netherlands. 4. Department of Radiology, Academic Medical Center, Amsterdam, Netherlands. 5. Department of Medicine, Gelre Hospital, Apeldoorn, Netherlands. 6. Department of Pulmonology, Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, Netherlands. 7. Department of Medicine, Red Cross Hospital, Beverwijk, Netherlands. 8. Department of Pulmonology, Rijnstate Hospital, Arnhem, Netherlands. 9. Department of Emergency Medicine, Leiden University Medical Center, Leiden, Netherlands. 10. Department of Medicine, Medisch Centrum Haaglanden, The Hague, Netherlands. 11. Department of Medicine, Rijnstate Hospital, Arnhem, Netherlands. 12. Department of Medicine, University Medical Center Utrecht, Utrecht, Netherlands. 13. Department of Pulmonology, Alrijne Hospital, Leiderdorp, Netherlands. 14. Department of Hematology, Erasmus Medical Center, Rotterdam, Netherlands. 15. Department of Medicine, Alrijne Hospital, Leiderdorp, Netherlands. 16. Department of Medicine, Flevo Hospital, Almere, Netherlands. 17. Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, Netherlands. Electronic address: m.v.huisman@lumc.nl.
Abstract
BACKGROUND: Validated diagnostic algorithms in patients with suspected pulmonary embolism are often not used correctly or only benefit subgroups of patients, leading to overuse of computed tomography pulmonary angiography (CTPA). The YEARS clinical decision rule that incorporates differential D-dimer cutoff values at presentation, has been developed to be fast, to be compatible with clinical practice, and to reduce the number of CTPA investigations in all age groups. We aimed to prospectively evaluate this novel and simplified diagnostic algorithm for suspected acute pulmonary embolism. METHODS: We did a prospective, multicentre, cohort study in 12 hospitals in the Netherlands, including consecutive patients with suspected pulmonary embolism between Oct 5, 2013, to July 9, 2015. Patients were managed by simultaneous assessment of the YEARS clinical decision rule, consisting of three items (clinical signs of deep vein thrombosis, haemoptysis, and whether pulmonary embolism is the most likely diagnosis), and D-dimer concentrations. In patients without YEARS items and D-dimer less than 1000 ng/mL, or in patients with one or more YEARS items and D-dimer less than 500 ng/mL, pulmonary embolism was considered excluded. All other patients had CTPA. The primary outcome was the number of independently adjudicated events of venous thromboembolism during 3 months of follow-up after pulmonary embolism was excluded, and the secondary outcome was the number of required CTPA compared with the Wells' diagnostic algorithm. For the primary outcome regarding the safety of the diagnostic strategy, we used a per-protocol approach. For the secondary outcome regarding the efficiency of the diagnostic strategy, we used an intention-to-diagnose approach. This trial is registered with the Netherlands Trial Registry, number NTR4193. FINDINGS: 3616 consecutive patients with clinically suspected pulmonary embolism were screened, of whom 151 (4%) were excluded. The remaining 3465 patients were assessed of whom 456 (13%) were diagnosed with pulmonary embolism at baseline. Of the 2946 patients (85%) in whom pulmonary embolism was ruled out at baseline and remained untreated, 18 patients were diagnosed with symptomatic venous thromboembolism during 3-month follow-up (0·61%, 95% CI 0·36-0·96) of whom six had fatal pulmonary embolism (0·20%, 0·07-0·44). CTPA was not indicated in 1651 (48%) patients with the YEARS algorithm compared with 1174 (34%) patients, if Wells' rule and fixed D-dimer threshold of less than 500 ng/mL would have been applied, a difference of 14% (95% CI 12-16). INTERPRETATION: In our study pulmonary embolism was safely excluded by the YEARS diagnostic algorithm in patients with suspected pulmonary embolism. The main advantage of the YEARS algorithm in our patients is the absolute 14% decrease of CTPA examinations in all ages and across several relevant subgroups. FUNDING: This study was supported by unrestricted grants from the participating hospitals.
BACKGROUND: Validated diagnostic algorithms in patients with suspected pulmonary embolism are often not used correctly or only benefit subgroups of patients, leading to overuse of computed tomography pulmonary angiography (CTPA). The YEARS clinical decision rule that incorporates differential D-dimer cutoff values at presentation, has been developed to be fast, to be compatible with clinical practice, and to reduce the number of CTPA investigations in all age groups. We aimed to prospectively evaluate this novel and simplified diagnostic algorithm for suspected acute pulmonary embolism. METHODS: We did a prospective, multicentre, cohort study in 12 hospitals in the Netherlands, including consecutive patients with suspected pulmonary embolism between Oct 5, 2013, to July 9, 2015. Patients were managed by simultaneous assessment of the YEARS clinical decision rule, consisting of three items (clinical signs of deep vein thrombosis, haemoptysis, and whether pulmonary embolism is the most likely diagnosis), and D-dimer concentrations. In patients without YEARS items and D-dimer less than 1000 ng/mL, or in patients with one or more YEARS items and D-dimer less than 500 ng/mL, pulmonary embolism was considered excluded. All other patients had CTPA. The primary outcome was the number of independently adjudicated events of venous thromboembolism during 3 months of follow-up after pulmonary embolism was excluded, and the secondary outcome was the number of required CTPA compared with the Wells' diagnostic algorithm. For the primary outcome regarding the safety of the diagnostic strategy, we used a per-protocol approach. For the secondary outcome regarding the efficiency of the diagnostic strategy, we used an intention-to-diagnose approach. This trial is registered with the Netherlands Trial Registry, number NTR4193. FINDINGS: 3616 consecutive patients with clinically suspected pulmonary embolism were screened, of whom 151 (4%) were excluded. The remaining 3465 patients were assessed of whom 456 (13%) were diagnosed with pulmonary embolism at baseline. Of the 2946 patients (85%) in whom pulmonary embolism was ruled out at baseline and remained untreated, 18 patients were diagnosed with symptomatic venous thromboembolism during 3-month follow-up (0·61%, 95% CI 0·36-0·96) of whom six had fatal pulmonary embolism (0·20%, 0·07-0·44). CTPA was not indicated in 1651 (48%) patients with the YEARS algorithm compared with 1174 (34%) patients, if Wells' rule and fixed D-dimer threshold of less than 500 ng/mL would have been applied, a difference of 14% (95% CI 12-16). INTERPRETATION: In our study pulmonary embolism was safely excluded by the YEARS diagnostic algorithm in patients with suspected pulmonary embolism. The main advantage of the YEARS algorithm in our patients is the absolute 14% decrease of CTPA examinations in all ages and across several relevant subgroups. FUNDING: This study was supported by unrestricted grants from the participating hospitals.
Authors: Linda A Russell; Alana E Sigmund; Jackie Szymonifka; Shari T Jawetz; Sarah E Grond; Shirin A Dey; Anne R Bass Journal: J Thromb Thrombolysis Date: 2018-04 Impact factor: 2.300
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