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- Title
Effect of the Pulmonary Embolism Rule-Out Criteria on Subsequent Thromboembolic Events Among Low-Risk Emergency Department Patients: The PROPER Randomized Clinical Trial.
- Authors
Freund, Yonathan; Cachanado, Marine; Aubry, Adeline; Orsini, Charlotte; Raynal, Pierre-Alexis; Féral-Pierssens, Anne-Laure; Charpentier, Sandrine; Dumas, Florence; Baarir, Nacera; Truchot, Jennifer; Desmettre, Thibaut; Tazarourte, Karim; Beaune, Sebastien; Leleu, Agathe; Khellaf, Mehdi; Wargon, Mathias; Bloom, Ben; Rousseau, Alexandra; Simon, Tabassome; Riou, Bruno
- Abstract
<bold>Importance: </bold>The safety of the pulmonary embolism rule-out criteria (PERC), an 8-item block of clinical criteria aimed at ruling out pulmonary embolism (PE), has not been assessed in a randomized clinical trial.<bold>Objective: </bold>To prospectively validate the safety of a PERC-based strategy to rule out PE.<bold>Design, Setting, and Patients: </bold>A crossover cluster-randomized clinical noninferiority trial in 14 emergency departments in France. Patients with a low gestalt clinical probability of PE were included from August 2015 to September 2016, and followed up until December 2016.<bold>Interventions: </bold>Each center was randomized for the sequence of intervention periods. In the PERC period, the diagnosis of PE was excluded with no further testing if all 8 items of the PERC rule were negative.<bold>Main Outcomes and Measures: </bold>The primary end point was the occurrence of a thromboembolic event during the 3-month follow-up period that was not initially diagnosed. The noninferiority margin was set at 1.5%. Secondary end points included the rate of computed tomographic pulmonary angiography (CTPA), median length of stay in the emergency department, and rate of hospital admission.<bold>Results: </bold>Among 1916 patients who were cluster-randomized (mean age 44 years, 980 [51%] women), 962 were assigned to the PERC group and 954 were assigned to the control group. A total of 1749 patients completed the trial. A PE was diagnosed at initial presentation in 26 patients in the control group (2.7%) vs 14 (1.5%) in the PERC group (difference, 1.3% [95% CI, -0.1% to 2.7%]; P = .052). One PE (0.1%) was diagnosed during follow-up in the PERC group vs none in the control group (difference, 0.1% [95% CI, -∞ to 0.8%]). The proportion of patients undergoing CTPA in the PERC group vs control group was 13% vs 23% (difference, -10% [95% CI, -13% to -6%]; P < .001). In the PERC group, rates were significantly reduced for the median length of emergency department stay (mean reduction, 36 minutes [95% CI, 4 to 68]) and hospital admission (difference, 3.3% [95% CI, 0.1% to 6.6%]).<bold>Conclusions and Relevance: </bold>Among very low-risk patients with suspected PE, randomization to a PERC strategy vs conventional strategy did not result in an inferior rate of thromboembolic events over 3 months. These findings support the safety of PERC for very low-risk patients presenting to the emergency department.<bold>Trial Registration: </bold>clinicaltrials.gov Identifier: NCT02375919.
- Subjects
PULMONARY embolism; DIAGNOSIS of embolism; COMPUTED tomography; ANGIOGRAPHY; PULMONARY artery diseases; COMPARATIVE studies; CROSSOVER trials; DECISION making; HOSPITAL emergency services; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; MEDICAL protocols; RESEARCH; THROMBOEMBOLISM; EVALUATION research; RANDOMIZED controlled trials; RELATIVE medical risk; DIAGNOSIS
- Publication
JAMA: Journal of the American Medical Association, 2018, Vol 319, Issue 6, p559
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2017.21904