Effect of the Pulmonary Embolism Rule-Out Criteria on Subsequent Thromboembolic Events Among Low-Risk Emergency Department Patients,JAMA

当前位置： X-MOL 学术 › JAMA › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

Effect of the Pulmonary Embolism Rule-Out Criteria on Subsequent Thromboembolic Events Among Low-Risk Emergency Department Patients
JAMA ( IF 63.1 ) Pub Date : 2018-02-13 , DOI: 10.1001/jama.2017.21904
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} ,

Affiliation

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

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

中文翻译：

肺栓塞排除标准对低危急诊科患者后续血栓栓塞事件的影响

重要性肺栓塞排除标准 (PERC) 是一项旨在排除肺栓塞 (PE) 的 8 项临床标准块，其安全性尚未在随机临床试验中进行评估。目的前瞻性验证基于 PERC 策略排除 PE 的安全性。设计、设置和患者在法国 14 个急诊科进行的交叉整群随机临床非劣效性试验。2015 年 8 月至 2016 年 9 月期间，PE 格式塔临床概率低的患者被纳入，并随访至 2016 年 12 月。干预措施每个中心随机进行干预期序列。在 PERC 期间，如果 PERC 规则的所有 8 项均为阴性，则排除 PE 的诊断，无需进一步测试。主要结果和措施主要终点是在 3 个月的随访期间发生了最初未被诊断的血栓栓塞事件。非劣效性边际设定为 1.5%。次要终点包括计算机断层扫描肺血管造影 (CTPA) 率、急诊科住院时间的中位数和住院率。结果在整群随机分组的 1916 名患者（平均年龄 44 岁，980 名 [51%] 女性）中，962 名被分配到 PERC 组，954 名被分配到对照组。共有 1749 名患者完成了试验。对照组的 26 名患者 (2.7%) 与 PERC 组的 14 名 (1.5%) 患者在初次就诊时被诊断为 PE（差异，1.3% [95% CI，-0.1% 至 2.7%]；P = .052 ）。一个 PE (0. PERC 组在随访期间诊断出 1%），而对照组没有诊断（差异，0.1% [95% CI，-∞ 至 0.8%]）。PERC 组与对照组中接受 CTPA 的患者比例为 13% 与 23%（差异，-10% [95% CI，-13% 至 -6%]；P < .001）。在 PERC 组中，中位急诊住院时间（平均缩短，36 分钟 [95% CI，4 至 68]）和住院（差异，3.3% [95% CI，0.1% 至 6.6 %]）。结论和相关性在疑似 PE 的极低风险患者中，随机化到 PERC 策略与传统策略相比，3 个月内血栓栓塞事件的发生率并未降低。这些发现支持 PERC 对急诊科就诊的极低风险患者的安全性。试验注册clinicaltrials.gov 标识符：

更新日期：2018-02-13

点击分享查看原文

点击收藏

公开下载

阅读更多本刊最新论文