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

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.

SUBMITTER: Freund Y

PROVIDER: S-EPMC5838786 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe diagnosis of Pulmonary Embolism (PE) in the emergency department (ED) is crucial. As emergency physicians fear missing this potential life-threatening condition, PE tends to be over-investigated, exposing patients to unnecessary risks and uncertain benefit in terms of outcome. The Pulmonary Embolism Rule-out Criteria (PERC) is an eight-item block of clinical criteria that can identify patients who can safely be discharged from the ED without further investigation for PE. The endorsement of this rule could markedly reduce the number of irradiative imaging studies, ED length of stay, and rate of adverse events resulting from both diagnostic and therapeutic interventions. Several retrospective and prospective studies have shown the safety and benefits of the PERC rule for PE diagnosis in low-risk patients, but the validity of this rule is still controversial. We hypothesize that in European patients with a low gestalt clinical probability and who are PERC-negative, PE can be safely ruled out and the patient discharged without further testing.Methods/designThis is a controlled, cluster randomized trial, in 15 centers in France. Each center will be randomized for the sequence of intervention periods: a 6-month intervention period (PERC-based strategy) followed by a 6-month control period (usual care), or in reverse order, with 2 months of "wash-out" between the 2 periods. Adult patients presenting to the ED with a suspicion of PE and a low pre test probability estimated by clinical gestalt will be eligible. The primary outcome is the percentage of failure resulting from the diagnostic strategy, defined as diagnosed venous thromboembolic events at 3-month follow-up, among patients for whom PE has been initially ruled out.DiscussionThe PERC rule has the potential to decrease the number of irradiative imaging studies in the ED, and is reported to be safe. However, no randomized study has ever validated the safety of PERC. Furthermore, some studies have challenged the safety of a PERC-based strategy to rule-out PE, especially in Europe where the prevalence of PE diagnosed in the ED is high. The PROPER study should provide high-quality evidence to settle this issue. If it confirms the safety of the PERC rule, physicians will be able to reduce the number of investigations, associated subsequent adverse events, costs, and ED length of stay for patients with a low clinical probability of PE.Trial registrationNCT02375919 .

Project description:BACKGROUND: Emergency department (ED) patients with venous thromboembolism (VTE) are eventually treated with a standard dose of warfarin despite the fact that a number of patients are known to be sensitive to warfarin and may experience supra-therapeutic INRs and adverse bleeding events. Pharmacogenetics is an emerging field of medical practice that seeks to improve drug safety and efficacy in an individual patient by tailoring treatment to the patient's known genetic makeup. OBJECTIVE: To identify patients with risk for warfarin sensitivity among an ED population with VTE and to assess if the warfarin sensitivity mutations were of significant enough prevalence to be of clinical significance in customizing treatment of VTE. We sought in a pilot study to identify if testing for common CYP2C9 and VKORC1 single nucleotide polymorphisms (SNPs) in patients who were likely to begin warfarin treatment was feasible in an ED setting. METHODS: A prospective study that identified and enrolled patients presenting to our ED with high clinical suspicion of VTE. Those with high clinical suspicion of VTE were defined as those who had a Doppler ultrasound or computed tomography pulmonary angiography (CTPA) ordered by the primary emergency physician. Blood was taken and processed to ascertain the following SNPs: CYP2C9*2, CYP2C9*3, and VKORC1 3673. RESULTS: Of the 194 patients enrolled, 132 (68.0%) had at least one known warfarin sensitivity mutation and 114 (58.8%) had the most clinically significant VKORC1 3673 mutation. CONCLUSION: A majority of our patients had at least one mutation associated with the atypical metabolism of warfarin. Over half of our population had the most clinically significant VKORC1 3673 mutation. They would likely benefit from individualized warfarin dosing if ever needing anticoagulation. Our initial pilot study shows that allele frequencies of target warfarin sensitivity SNPs in our patient population are frequent enough to make initiation of personalized warfarin dosing feasible.

Project description:IntroductionMany emergency department (ED) patients with acute pulmonary embolism (PE) who meet low-risk criteria may be eligible for a short length of stay (LOS) (<24 hours), with expedited discharge home either directly from the ED or after a brief observation or hospitalization. We describe the association between expedited discharge and site of discharge on care satisfaction and quality of life (QOL) among patients with low-risk PE (PE Severity Index [PESI] Classes I-III).MethodsThis phone survey was conducted from September 2014 through April 2015 as part of a retrospective cohort study across 21 community EDs in Northern California. We surveyed low-risk patients with acute PE, treated predominantly with enoxaparin bridging and warfarin. All eligible patients were called 2-8 weeks after their index ED visit. PE-specific, patient-satisfaction questions addressed overall care, discharge instruction clarity, and LOS. We scored physical and mental QOL using a modified version of the validated Short Form Health Survey. Satisfaction and QOL were compared by LOS. For those with expedited discharge, we compared responses by site of discharge: ED vs. hospital, which included ED-based observation units. We used chi-square and Wilcoxon rank-sum tests as indicated.ResultsSurvey response rate was 82.3% (424 of 515 eligible patients). Median age of respondents was 64 years; 47.4% were male. Of the 145 patients (34.2%) with a LOS<24 hours, 65 (44.8%) were discharged home from the ED. Of all patients, 89.6% were satisfied with their overall care and 94.1% found instructions clear. Sixty-six percent were satisfied with their LOS, whereas 17.5% would have preferred a shorter LOS and 16.5% a longer LOS. There were no significant differences in satisfaction between patients with LOS<24 hours vs. ≥24 hours (p>0.13 for all). Physical QOL scores were significantly higher for expedited-discharge patients (p=0.01). Patients with expedited discharge home from the ED vs. the hospital had no significant difference in satisfaction (p>0.20 for all) or QOL (p>0.19 for all).ConclusionED patients with low-risk PE reported high satisfaction with their care in follow-up surveys. Expedited discharge (<24 hours) and site of discharge were not associated with differences in patient satisfaction.

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

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