残余肺血管阻塞和急性肺栓塞后复发：一项系统评价和个体参与者数据荟萃分析的方案。
Residual pulmonary vascular obstruction and recurrence after acute pulmonary embolism: protocol for a systematic review and meta-analysis of individual participant data.
机构信息
Département de Médecine Nucléaire, Centre Hospitalier Régional Universitaire de Brest, Brest, France.
EA3878 (GETBO), Université de Brest, Brest, France.
出版信息
BMJ Open. 2018 Nov 28;8(11):e023939. doi: 10.1136/bmjopen-2018-023939.
BACKGROUND
In patients with a first, unprovoked venous thromboembolism (VTE), the optimal duration of anticoagulant therapy (AT) is controversial due to tightly balanced risks and benefits of indefinite anticoagulation. The objective of this study is to assess among patients with a first acute pulmonary embolism (PE) who received ≥3 months of AT and thereafter had a planar lung scan, whether residual pulmonary vascular obstruction (RPVO) is associated with VTE recurrence after discontinuation of AT.
METHODS AND ANALYSIS
We will conduct a systematic review with a meta-analysis of individual participant data of contemporary studies evaluating the prognostic significance of RPVO in patients with a first acute PE. We will search from inception to 24 January 2018, PubMed, Medline, Embase and Cochrane's Central Registry for Randomized Controlled Trials, CENTRAL for randomized controlled trials and prospective cohort studies. Two reviewers will conduct all screening and data collection independently. The methodological quality and risk of bias of eligible studies will be carefully and rigorously assessed using the Risk Of Bias In Non-randomised Studies of Interventions tool. The primary objective will be to assess the relationship between RPVO on ventilation-perfusion scan after completion of at least 3 months of AT after an acute PE event, and the risk of an objectively confirmed symptomatic recurrent VTE (including deep vein thrombosis or PE) or death due to PE. The secondary objectives will include the assessment of the optimal RPVO cut-off and the risk of recurrent VTE, as well as the relationship between the relative change in RPVO between PE diagnosis and at discontinuation of AT (≥3 months) and risk of recurrent VTE.
ETHICS AND DISSEMINATION
This study of secondary data does not require ethics approval. It will be presented internationally and published in the peer-reviewed literature.
PROSPERO REGISTRATION NUMBER
CRD42017081080.
背景
在首次无诱因静脉血栓栓塞症（VTE）患者中，由于长期抗凝治疗的风险和获益紧密平衡，抗凝治疗（AT）的最佳持续时间存在争议。本研究旨在评估首次急性肺栓塞（PE）患者接受至少 3 个月的 AT 治疗后行平面肺扫描，残留肺血管阻塞（RPVO）是否与 AT 停药后 VTE 复发相关。
方法和分析
我们将对评估首次急性 PE 患者中 RPVO 预后意义的当代研究进行系统回顾和个体参与者数据的荟萃分析。我们将从建库至 2018 年 1 月 24 日检索 PubMed、Medline、Embase 和 Cochrane 对照试验中心注册库（CENTRAL）的随机对照试验，以及 CENTRAL 的前瞻性队列研究。两名评审员将独立进行所有筛选和数据收集。将使用干预措施非随机研究的偏倚风险评估工具（Risk Of Bias In Non-randomised Studies of Interventions tool）仔细和严格地评估合格研究的方法学质量和偏倚风险。主要目的是评估在急性 PE 事件后至少 3 个月 AT 治疗结束后行通气灌注扫描时存在 RPVO 与客观证实的症状性复发性 VTE（包括深静脉血栓形成或 PE）或 PE 相关死亡的风险之间的关系。次要目的将包括评估最佳 RPVO 截断值和复发性 VTE 的风险，以及 PE 诊断和 AT 停药（≥3 个月）时 RPVO 之间的相对变化与复发性 VTE 的风险之间的关系。
伦理和传播
这项二次数据分析研究不需要伦理批准。它将在国际上进行报告，并发表在同行评议的文献中。
PROSPERO 注册号：CRD42017081080。
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