Data_Sheet_1_Ischemic and Bleeding Outcomes According to the Academic Research Consortium High Bleeding Risk Criteria in All Comers Treated by Percutaneous Coronary Interventions.docx

Background: The Academic Research Consortium have identified a set of major and minor risk factors in order to standardize the definition of a High Bleeding Risk (ACR-HBR).
Aims: The aim of this study is to stratify the bleeding risk in patients included in the Cardio-Fribourg registry, according to the Academic Research Consortium for High Bleeding Risk (ACR-HBR) definition, and to report ischemic and hemorrhagic events at 2-year of clinical follow-up.
Methods: Between 2015 and 2017, consecutive patients undergoing percutaneous coronary intervention were prospectively included in the Cardio-Fribourg registry. Patients were considered high (HBR) or low (LBR) bleeding risk depending on the ARC-HBR definition. Primary endpoints were hierarchical major bleeding events as defined by the Bleeding Academic Research Consortium (BARC) grade 3–5, and ARC patient-oriented major adverse cardiac events (POCE) at 2-year follow-up.
Results: Follow-up was complete in 1,080 patients. There were 354 patients in the HBR group (32.7%) and 726 patients in the low-bleeding risk (LBR) group (67.2%). At 2-year follow-up, cumulative BARC 3–5 bleedings were higher in HBR (10.5%) compared to LBR patients (1.5%, p < 0.01) and the impact of HBR risk factors was incremental. At 2-year follow-up, POCE were more frequent in HBR (27.4%) compared to LBR group (18.2%, <0.01). Overall mortality was higher in HBR (14.0%) vs. LBR (2.9%, p < 0.01).
Conclusions: ARC-HBR criteria appropriately identified a population at a higher risk of bleeding after percutaneous coronary intervention. An increased risk of bleeding is also associated with an increased risk of ischemic events at 2-year follow-up.

研究背景：为统一高出血风险（ACR-HBR）的定义，学术研究联盟已明确一套主次风险因素。
研究目的：本研究旨在依据高出血风险学术研究联盟（Academic Research Consortium for High Bleeding Risk, ACR-HBR）的定义，对纳入弗里堡心血管注册研究的患者进行出血风险分层，并报告其临床随访2年时的缺血与出血事件发生情况。
研究方法：2015年至2017年间，所有接受经皮冠状动脉介入治疗的连续患者均前瞻性纳入弗里堡心血管注册研究。依据ACR-HBR定义，将患者分为高出血风险（HBR）组与低出血风险（LBR）组。本研究的主要终点为随访2年时，符合出血学术研究联盟（Bleeding Academic Research Consortium, BARC）3~5级标准的分级主要出血事件，以及患者导向的主要不良心血管事件（Patient-Oriented Major Adverse Cardiac Events, POCE）。
研究结果：本研究共纳入1080例完成完整随访的患者，其中HBR组354例（32.7%），LBR组726例（67.2%）。随访2年时，HBR组的累积BARC 3~5级出血事件发生率（10.5%）显著高于LBR组（1.5%，p<0.01），且HBR相关风险因素的影响呈递增趋势。随访2年时，HBR组的POCE发生率（27.4%）显著高于LBR组（18.2%，p<0.01）；HBR组的总体死亡率（14.0%）亦高于LBR组（2.9%，p<0.01）。
研究结论：ACR-HBR标准可有效识别经皮冠状动脉介入治疗后出血风险升高的人群；随访2年时，出血风险升高亦与缺血事件风险增加显著相关。