Division of Anesthesiology for Cardiovascular Surgery and Intensive Care Medicine, Medical University of Graz, Graz, Austria.
Institute for Medical Informatics, Statistics and Documentation, Medical University of Graz, Graz, Austria.
BMJ Open. 2022 Mar 28;12(3):e060404. doi: 10.1136/bmjopen-2021-060404.
In order to reduce the risk of bleeding in patients on P2Y receptor inhibitors presenting for non-emergent coronary artery bypass grafting (CABG), current guidelines recommend a preoperative discontinuation period of at least three, five and seven days for ticagrelor, clopidogrel and prasugrel, respectively, to allow for recovery of platelet function. However, there is still substantial interinstitutional variation in preoperative management and relevant covariates of CABG-related bleeding are largely elusive so far.
We will search PubMed (July 2013 to November 2021) and EMBASE (January 2014 to November 2021) using the following terms, MeSH terms and their synonyms: clopidogrel, prasugrel, ticagrelor, dual antiplatelet, P2Y receptor inhibitor, CABG, bleeding, haemorrhage. Two independent reviewers will screen all abstracts and full papers for eligibility. Disagreements will be solved by consulting with a third reviewer.The primary outcome is the incidence of Bleeding Academic Research Consortium type-4 bleeding depending on type of P2Y receptor inhibitor and preoperative withdrawal period. The secondary outcomes are mortality and ischaemic events according to the Academic Research Consortium 2 Consensus Document. We will perform an individual patient data meta-analysis (IPD-MA) with drug-specific preoperative withdrawal time and adjust for demographic and procedural variables. Subgroup analyses will be performed for anaemic patients and patients undergoing non-emergent versus urgent/emergent surgery.
This IPD-MA consists of secondary analyses of existing non-identifiable data and meets the criteria for waiver of ethics review by the local Research Ethics Committee. Data sharing and transfer will be subject to a confidentiality agreement and a data use agreement. Findings will be disseminated through peer-reviewed publication and conference presentation.
CRD42022291946.
为降低服用 P2Y 受体抑制剂的患者在非紧急冠状动脉旁路移植术（CABG）前出血的风险，目前的指南建议分别停用替格瑞洛、氯吡格雷和普拉格雷至少 3、5 和 7 天，以恢复血小板功能。然而，术前管理仍存在大量机构间差异，到目前为止，CABG 相关出血的相关协变量仍很大程度上难以捉摸。
我们将使用以下术语、MeSH 术语及其同义词在 PubMed（2013 年 7 月至 2021 年 11 月）和 EMBASE（2014 年 1 月至 2021 年 11 月）中进行搜索：氯吡格雷、普拉格雷、替格瑞洛、双联抗血小板、P2Y 受体抑制剂、CABG、出血、出血。两名独立审查员将筛选所有摘要和全文以确定是否符合入选标准。有分歧时将与第三名审查员协商解决。主要结局是根据 P2Y 受体抑制剂的类型和术前停药时间，发生 Bleeding Academic Research Consortium 4 型出血的发生率。次要结局是根据学术研究联合会 2 号共识文件发生的死亡率和缺血事件。我们将进行个体患者数据荟萃分析（IPD-MA），并根据药物特异性术前停药时间和人口统计学及手术变量进行调整。亚组分析将针对贫血患者和非紧急与紧急/紧急手术患者进行。
这项 IPD-MA 由现有不可识别数据的二次分析组成，符合当地研究伦理委员会豁免伦理审查的标准。数据共享和转让将受保密协议和数据使用协议的约束。研究结果将通过同行评审的出版物和会议报告进行传播。
PROSPERO 注册号：CRD42022291946。
