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Randomized Controlled Trial
. 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

Yonathan Freund  1   2 , Marine Cachanado  3 , Adeline Aubry  2 , Charlotte Orsini  4 , Pierre-Alexis Raynal  5 , Anne-Laure Féral-Pierssens  6 , Sandrine Charpentier  7 , Florence Dumas  8 , Nacera Baarir  9 , Jennifer Truchot  10 , Thibaut Desmettre  11 , Karim Tazarourte  12 , Sebastien Beaune  13 , Agathe Leleu  14 , Mehdi Khellaf  15 , Mathias Wargon  16 , Ben Bloom  17 , Alexandra Rousseau  3 , Tabassome Simon  1   3 , Bruno Riou  1   2 ; PROPER Investigator Group
Affiliations
Randomized Controlled Trial

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

Yonathan Freund et al. JAMA. .

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.

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Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Freund reports receipt of nonfinancial support from Sanofi, and lecture fees from Bristol-Myers Squibb and AstraZeneca outside the submitted work. Dr Simon reports receipt of a grant from the Delegation for Clinical Research and Innovation (DRCI [APHP]) during the conduct of the study; grants from AstraZeneca, Daiichi-Sankyo, Eli Lilly, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, sanofi-aventis, and Pfizer; and personal fees for board membership, consultancy services, or lecture fees from AstraZeneca, Bristol-Myers Squibb, Novartis, and sanofi-aventis outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. Flow of Patients With Workup for Pulmonary Embolism With the Use of Pulmonary Embolism Rule-Out Criteria vs Initial Standard Workup (Control)
The number of eligible patients screened but not included was not recorded. ED indicates emergency department; PERC indicates pulmonary embolism rule-out criteria.
See this image and copyright information in PMC

Comment in

References

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