Paul L den Exter1, Wendy Zondag1, Frederikus A Klok1, Rolf E Brouwer2, Janneke Dolsma3, Michiel Eijsvogel4, Laura M Faber5, Marijke van Gerwen6, Marco J Grootenboers7, Roxane Heller-Baan8, Marcel M Hovens9, Gé J P M Jonkers10, Klaas W van Kralingen11, Christian F Melissant12, Henny Peltenburg13, Judith P Post14, Marcel A van de Ree15, L Th Tom Vlasveld16, Mariëlle J de Vreede17, Menno V Huisman1. 1. 1 Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands. 2. 2 Department of Internal Medicine, Reinier de Graaf Hospital, Delft, the Netherlands. 3. 3 Department of Pulmonary Medicine, Diaconessenhuis, Leiden, the Netherlands. 4. 4 Department of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, the Netherlands. 5. 5 Department of Internal Medicine, Rode Kruis Hospital, Beverwijk, the Netherlands. 6. 6 Department of Internal Medicine, Haga Hospital, The Hague, the Netherlands. 7. 7 Department of Pulmonary Medicine, Amphia Hospital, Brede, the Netherlands. 8. 8 Department of Pulmonary Medicine, Ikazia Hospital, Rotterdam, the Netherlands. 9. 9 Department of Internal Medicine, Rijnstate Hospital, Arnhem, the Netherlands. 10. 10 Department of Internal Medicine, Rijnland Hospital, Leiderdorp, the Netherlands. 11. 11 Department Pulmonary Medicine, Van Weel Bethesda Hospital, Dirksland, the Netherlands. 12. 12 Department of Pulmonary Medicine, Spaarne Hospital, Hoofddorp, the Netherlands. 13. 13 Department of Internal Medicine, Groene Hart Hospital, Gouda, the Netherlands. 14. 14 Department of Internal Medicine, VU University Medical Center, Amsterdam, the Netherlands. 15. 15 Department of Internal Medicine, Diakonessenhuis, Utrecht, the Netherlands. 16. 16 Department of Internal Medicine and. 17. 17 Department of Internal Medicine, Medisch Centrum Haaglanden-Bronovo, The Hague, the Netherlands.
Abstract
RATIONALE: Outpatient treatment of pulmonary embolism (PE) may lead to improved patient satisfaction and reduced healthcare costs. However, trials to assess its safety and the optimal method for patient selection are scarce. OBJECTIVES: To validate the utility and safety of selecting patients with PE for outpatient treatment by the Hestia criteria and to compare the safety of the Hestia criteria alone with the Hestia criteria combined with N-terminal pro-brain natriuretic peptide (NT-proBNP) testing. METHODS: We performed a randomized noninferiority trial in 17 Dutch hospitals. We randomized patients with PE without any of the Hestia criteria to direct discharge or additional NT-proBNP testing. We discharged the latter patients as well if NT-proBNP did not exceed 500 ng/L or admitted them if NT-proBNP was greater than 500 ng/L. The primary endpoint was 30-day adverse outcome defined as PE- or bleeding-related mortality, cardiopulmonary resuscitation, or intensive care unit admission. The noninferiority margin for the primary endpoint was 3.4%. MEASUREMENTS AND MAIN RESULTS: We randomized 550 patients. In the NT-proBNP group, 34 of 275 (12%) had elevated NT-proBNP values and were managed as inpatients. No patient (0 of 34) with an elevated NT-proBNP level treated in hospital (0%; 95% confidence interval [CI], 0-10.2%), versus no patient (0 of 23) with a post hoc-determined elevated NT-proBNP level from the direct discharge group (0%; 95% CI, 0-14.8%), experienced the primary endpoint. In both trial cohorts, the primary endpoint occurred in none of the 275 patients (0%; 95% CI, 0-1.3%) subjected to NT-proBNP testing, versus in 3 of 275 patients (1.1%; 95% CI, 0.2-3.2%) in the direct discharge group (P = 0.25). During the 3-month follow-up, recurrent venous thromboembolism occurred in two patients (0.73%; 95% CI, 0.1-2.6%) in the NT-proBNP group versus three patients (1.1%; 95% CI, 0.2-3.2%) in the direct discharge group (P = 0.65). CONCLUSIONS: Outpatient treatment of patients with PE selected on the basis of the Hestia criteria alone was associated with a low risk of adverse events. Given the low number of patients with elevated NT-proBNP levels, this trial was unable to draw definite conclusions regarding the incremental value of NT-proBNP testing in patients who fulfill the Hestia criteria. Clinical trial registered with www.trialregister.nl/trialreg/admin/rctview.asp?TC=2603 (NTR2603).
RCT Entities:
RATIONALE: Outpatient treatment of pulmonary embolism (PE) may lead to improved patient satisfaction and reduced healthcare costs. However, trials to assess its safety and the optimal method for patient selection are scarce. OBJECTIVES: To validate the utility and safety of selecting patients with PE for outpatient treatment by the Hestia criteria and to compare the safety of the Hestia criteria alone with the Hestia criteria combined with N-terminal pro-brain natriuretic peptide (NT-proBNP) testing. METHODS: We performed a randomized noninferiority trial in 17 Dutch hospitals. We randomized patients with PE without any of the Hestia criteria to direct discharge or additional NT-proBNP testing. We discharged the latter patients as well if NT-proBNP did not exceed 500 ng/L or admitted them if NT-proBNP was greater than 500 ng/L. The primary endpoint was 30-day adverse outcome defined as PE- or bleeding-related mortality, cardiopulmonary resuscitation, or intensive care unit admission. The noninferiority margin for the primary endpoint was 3.4%. MEASUREMENTS AND MAIN RESULTS: We randomized 550 patients. In the NT-proBNP group, 34 of 275 (12%) had elevated NT-proBNP values and were managed as inpatients. No patient (0 of 34) with an elevated NT-proBNP level treated in hospital (0%; 95% confidence interval [CI], 0-10.2%), versus no patient (0 of 23) with a post hoc-determined elevated NT-proBNP level from the direct discharge group (0%; 95% CI, 0-14.8%), experienced the primary endpoint. In both trial cohorts, the primary endpoint occurred in none of the 275 patients (0%; 95% CI, 0-1.3%) subjected to NT-proBNP testing, versus in 3 of 275 patients (1.1%; 95% CI, 0.2-3.2%) in the direct discharge group (P = 0.25). During the 3-month follow-up, recurrent venous thromboembolism occurred in two patients (0.73%; 95% CI, 0.1-2.6%) in the NT-proBNP group versus three patients (1.1%; 95% CI, 0.2-3.2%) in the direct discharge group (P = 0.65). CONCLUSIONS:Outpatient treatment of patients with PE selected on the basis of the Hestia criteria alone was associated with a low risk of adverse events. Given the low number of patients with elevated NT-proBNP levels, this trial was unable to draw definite conclusions regarding the incremental value of NT-proBNP testing in patients who fulfill the Hestia criteria. Clinical trial registered with www.trialregister.nl/trialreg/admin/rctview.asp?TC=2603 (NTR2603).
Authors: David R Vinson; Erik R Hofmann; Elizabeth J Johnson; Suresh Rangarajan; Jie Huang; Dayna J Isaacs; Judy Shan; Karen L Wallace; Adina S Rauchwerger; Mary E Reed; Dustin G Mark Journal: J Gen Intern Med Date: 2022-01-12 Impact factor: 6.473
Authors: Lauren M Westafer; Meng-Shiou Shieh; Penelope S Pekow; Mihaela S Stefan; Peter K Lindenauer Journal: Acad Emerg Med Date: 2020-12-19 Impact factor: 3.451