Solo Karla, Martin Janet, Lavi Shahar, Kabali Conrad, John-Baptiste Ava, Nevis Immaculate F, Choudhury Tawfiq, Mamas Mamas A, Bagur Rodrigo
Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
Department of Anesthesia and Perioperative Medicine, Centre for Medical Evidence, Decision Integrity & Clinical Impact (MEDICI), Western University, London, Ontario, Canada.
BMJ Open. 2018 Apr 7;8(4):e019555. doi: 10.1136/bmjopen-2017-019555.
The current evidence for the prevention of saphenous vein graft failure (SVGF) after coronary artery bypass graft (CABG) surgery consists of direct head-to-head comparison of treatments (including placebo) in randomised-controlled trials (RCTs) and observational studies. However, summarising the evidence using traditional pairwise meta-analyses does not allow the inclusion of data from treatments that have not been compared head to head. Exclusion of such comparisons could impact the precision of pooled estimates in a meta-analysis. Hence, to address the challenge of whether aspirin alone or in addition to another antithrombotic agent is a more effective regimen to improve SVG patency, a network meta-analysis (NMA) is necessary. The objectives of this study are to synthesise the available evidence on antithrombotic agents (or their combination) and estimate the treatment effects among direct and indirect treatment comparisons on SVGF and major adverse cardiovascular events, and to generate a treatment ranking according to their efficacy and safety outcomes.
We will perform a systematic review of RCTs evaluating antithrombotic agents in patients undergoing CABG. A comprehensive English literature search will be conducted using electronic databases and grey literature resources to identify published and unpublished articles. Two individuals will independently and in duplicate screen potential studies, assess the eligibility of potential studies and extract data. Risk of bias and quality of evidence will also be evaluated independently and in duplicate. We will investigate the data to ensure its suitability for NMA, including adequacy of the outcome data and transitivity of treatment effects. We plan to estimate the pooled direct, indirect and the mixed effects for all antithrombotic agents using a NMA.
Due to the nature of the study, there are no ethical concerns nor informed consent required. We anticipate that this NMA will be the first to simultaneously assess the relative effects of multiple antithrombotic agents in patients undergoing CABG. The results of this NMA will inform clinicians, patients and guideline developers the best available evidence on comparative effects benefits of antithrombotic agents after CABG while considering the side effect profile to support future clinical decision-making. We will disseminate the results of our systematic review and NMA through a peer-reviewed journal.
CRD42017065678.
目前关于冠状动脉旁路移植术（CABG）后预防大隐静脉移植血管失败（SVGF）的证据包括随机对照试验（RCT）和观察性研究中对各种治疗方法（包括安慰剂）进行的直接头对头比较。然而，使用传统的成对荟萃分析来总结证据时，无法纳入未进行头对头比较的治疗方法的数据。排除此类比较可能会影响荟萃分析中合并估计值的准确性。因此，为了应对单独使用阿司匹林或联合另一种抗血栓药物是否是改善SVG通畅性更有效方案这一挑战，有必要进行网络荟萃分析（NMA）。本研究的目的是综合关于抗血栓药物（或其组合）的现有证据，估计直接和间接治疗比较中抗血栓药物对SVGF和主要不良心血管事件的治疗效果，并根据其疗效和安全性结果生成治疗排名。
我们将对评估CABG患者抗血栓药物的RCT进行系统评价。将使用电子数据库和灰色文献资源进行全面的英文文献检索，以识别已发表和未发表的文章。两名研究人员将独立且重复地筛选潜在研究、评估潜在研究的 eligibility 并提取数据。还将独立且重复地评估偏倚风险和证据质量。我们将调查数据以确保其适用于NMA，包括结局数据的充分性和治疗效果的可传递性。我们计划使用NMA估计所有抗血栓药物的合并直接、间接和混合效应。
由于本研究的性质，不存在伦理问题，也无需知情同意。我们预计这项NMA将是首个同时评估多种抗血栓药物对CABG患者相对效果的研究。本NMA的结果将为临床医生、患者和指南制定者提供关于CABG后抗血栓药物比较效果益处的最佳现有证据，同时考虑副作用情况以支持未来的临床决策。我们将通过同行评审期刊传播我们系统评价和NMA的结果。
PROSPERO注册号：CRD42017065678。 （注：“eligibility”此处结合语境推测可能是“合格性”之类意思，但不确定准确意思，需结合完整医学语境进一步确认）
