Efficacy and Safety of Outpatient Treatment Based on the Hestia Clinical Decision Rule With or Without NT-proBNP Testing in Patients With Acute Pulmonary Embolism: A Randomized Clinical Trial.
Am J Respir Crit Care Med. 2016 Mar 31;
Authors: den Exter PL, Zondag W, Klok FA, Brouwer RE, Dolsma J, Eijsvogel M, Faber LM, van Gerwen M, Grootenboers MJ, Heller-Baan R, Hovens MM, Jonkers GJ, van Kralingen KW, Melissant CF, Peltenburg H, Post JP, van de Ree MA, Vlasveld T, de Vreede MJ, Huisman MV, Vesta Study Investigators
Abstract
RATIONALE: Outpatient treatment of pulmonary embolism (PE) may lead to improved patient satisfaction and reduced health care costs. However, trials to assess its safety and the optimal method for patient selection are scarce.
OBJECTIVES: To investigate the safety of selecting PE patients for outpatient treatment by the Hestia criteria alone compared to clinical criteria combined with NT-proBNP testing.
METHODS: We performed a randomized non-inferiority trial in 17 Dutch hospitals. PE patients without any of the Hestia criteria were randomized to direct discharge or additional NT-proBNP testing. The latter patients were discharged as well if NT-proBNP was ≤500ng/L or admitted if NT-proBNP was >500ng/L. Primary endpoint was 30-day adverse outcome defined as PE- or bleeding-related mortality, cardiopulmonary resuscitation or intensive care admission. The non-inferiority margin for the primary endpoint was 3.4%. Measurements main results: 550 patients were randomized. In the NT-proBNP group, 34/275 (12%) had elevated NT-proBNP values and were managed as inpatients. The primary endpoint occurred in none of these 275 patients (0%; 95%CI: 0-1.3%), versus in 3/275 patients (1.1%; 95%CI 0.2-3.2%) in the direct discharge group (p=0.25); all three had NT-proBNP levels <500ng/L measured post-hoc. During 3-month follow-up, recurrent VTE occurred in 2 patients (0.73%; 95%CI 0.1-2.6%) in the NT-proBNP group versus 3 patients (1.1%; 95%CI: 0.2-3.2%) in the direct discharge group (p=0.65).
CONCLUSIONS: Outpatient treatment of PE patients selected by the Hestia criteria alone was associated with a low risk of adverse events. Additional prognostic assessment based on NT-proBNP levels did not appear to affect the 30-day prognosis. Clinical trial registration available at http://www.trialregister.nl/, ID NTR984.
PMID: 27030891 [PubMed - as supplied by publisher]