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JAMA. 2018 Feb 13;319(6):559-566. doi: 10.1001/jama.2017.21904.

Effect of the Pulmonary Embolism Rule-Out Criteria on Subsequent Thromboembolic Events Among Low-Risk Emergency Department Patients: The PROPER Randomized Clinical Trial.

Author information

1
Sorbonne Université, INSERM UMRS 1166, IHU ICAN, Paris, France.
2
Emergency Department, Hôpital Universitaire Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.
3
Clinical Research Platform (URC-CRC-CRB), AP-HP Hôpital Saint-Antoine, Paris, France.
4
Emergency Department, Hôpital Avicenne, APHP, Bobigny, France.
5
Emergency Department, Hôpital Saint-Antoine, APHP, Paris, France.
6
Emergency Department, Hôpital Européen Georges Pompidou, APHP, Paris, France.
7
Université Toulouse III Paul Sabatier, INSERM UMR 1027, CHU Toulouse, Toulouse, Emergency Department, Toulouse, France.
8
Université Paris Descartes, INSERM UMR970, APHP, Emergency Department, Hôpital Cochin, Paris, France.
9
Emergency Department, Hôpital Tenon, APHP, Paris, France.
10
Emergency Department, Hôpital Lariboisière, APHP, Paris, France.
11
Université Bourgogne Franche-Comté, Emergency Department, CHRU Minjoz, Besançon, France.
12
Université Claude Bernard Lyon1, HESPER EA 7425, Hospices Civils de Lyon, Emergency Department, Hôpital Edouard Herriot, Lyon, France.
13
Emergency Department, Hôpital Ambroise-Paré, APHP, Boulogne, France.
14
Emergency Department, Hôpital Bichat, APHP, Paris, France.
15
Université Paris Est, INSERM U955, APHP, Emergency Department, Hôpital Henri Mondor, Créteil, France.
16
Emergency Department, Hôpital Saint Camille, Bry sur Marne, France.
17
Emergency Department, Barts Health NHS Trust, London, United Kingdom.

Abstract

Importance:

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.

Objective:

To prospectively validate the safety of a PERC-based strategy to rule out PE.

Design, Setting, and Patients:

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.

Interventions:

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.

Main Outcomes and Measures:

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.

Results:

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%]).

Conclusions and Relevance:

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.

Trial Registration:

clinicaltrials.gov Identifier: NCT02375919.

PMID:
29450523
PMCID:
PMC5838786
DOI:
10.1001/jama.2017.21904
[Indexed for MEDLINE]
Free PMC Article

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