Marquis-Gravel Guillaume, Neely Megan L, Valgimigli Marco, Costa Francesco, Van Klaveren David, Altner Rituparna, Bhatt Deepak L, Armstrong Paul W, Fox Keith A A, White Harvey D, Ohman E Magnus, Roe Matthew T
Duke Clinical Research Institute, Durham, NC (G.M.G., M.L.N., R.A., E.M.O., M.T.R.).
Swiss Cardiovascular Center Bern, Bern University Hospital, Switzerland (M.V., F.C.).
Circ Cardiovasc Qual Outcomes. 2020 Sep;13(9):e006582. doi: 10.1161/CIRCOUTCOMES.120.006582. Epub 2020 Aug 31.
Longitudinal bleeding risk scores have been validated in patients treated with dual antiplatelet therapy (DAPT) following percutaneous coronary intervention. How these scores apply to the population of patients with acute coronary syndrome (ACS) treated without revascularization remains unknown. The objective was to evaluate and compare the performances of the PRECISE-DAPT, PARIS, and DAPT (bleeding component) bleeding risk scores in the medically managed patients with ACS treated with DAPT.
TRILOGY ACS (Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes) was a double-blind, placebo-controlled randomized trial conducted from 2008 to 2012 over a median follow-up of 17.0 months in 966 sites (52 countries). High-risk patients with unstable angina or non-ST-segment-elevation myocardial infarction who did not undergo revascularization were randomized to prasugrel or clopidogrel. The PRECISE-DAPT, PARIS, and DAPT (bleeding component) risk scores were applied in the TRILOGY ACS population to evaluate their performance to predict adjudicated non-coronary artery bypass grafting-related GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) severe/life-threatening/moderate and TIMI (Thrombolysis in Myocardial Infarction) major/minor bleeding with time-dependent c-indices. Among the 9326 participants, median age was 66 years (interquartile range, 59-74 years), and 3650 were females (39.1%). A total of 158 (1.69%) GUSTO severe/life-threatening/moderate and 174 (1.87%) TIMI major/minor non-coronary artery bypass grafting bleeding events occurred. The c-indices (95% CI) of the PRECISE-DAPT, PARIS, and DAPT (bleeding component) scores through 12 months were 0.716 (0.677-0.758), 0.693 (0.658-0.733), and 0.674 (0.637-0.713), respectively, for GUSTO bleeding and 0.624 (0.582-0.666), 0.612 (0.578-0.651), and 0.608 (0.571-0.649), respectively, for TIMI bleeding. There was no significant difference in the c-indices of each score based upon pairwise comparisons.
Among medically managed patients with ACS treated with DAPT, the performances of the PRECISE-DAPT, PARIS, and DAPT (bleeding component) scores were reasonable and similar to their performances in the derivation percutaneous coronary intervention populations. Bleeding risk scores may be used to predict longitudinal bleeding risk in patients with ACS treated with DAPT without revascularization and help support shared decision making. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00699998.
纵向出血风险评分已在经皮冠状动脉介入治疗后接受双联抗血小板治疗（DAPT）的患者中得到验证。这些评分如何应用于未进行血运重建治疗的急性冠状动脉综合征（ACS）患者群体仍不清楚。目的是评估和比较PRECISE-DAPT、PARIS和DAPT（出血部分）出血风险评分在接受DAPT治疗的药物治疗ACS患者中的表现。
TRILOGY ACS（靶向血小板抑制以明确药物治疗急性冠状动脉综合征的最佳策略）是一项双盲、安慰剂对照的随机试验，于2008年至2012年进行，在966个地点（52个国家）进行了为期17.0个月的中位随访。未进行血运重建的高危不稳定型心绞痛或非ST段抬高型心肌梗死患者被随机分配接受普拉格雷或氯吡格雷治疗。将PRECISE-DAPT、PARIS和DAPT（出血部分）风险评分应用于TRILOGY ACS人群，以评估其预测经判定的非冠状动脉旁路移植术相关的全球急性冠状动脉综合征注册研究（GUSTO，全球应用策略开通闭塞冠状动脉）严重/危及生命/中度出血以及心肌梗死溶栓试验（TIMI）主要/次要出血的表现，并计算时间依赖性c指数。在9326名参与者中，中位年龄为66岁（四分位间距，59 - 74岁），女性有3650名（39.1%）。共发生158例（1.69%）GUSTO严重/危及生命/中度出血事件和174例（1.87%）TIMI主要/次要非冠状动脉旁路移植术出血事件。PRECISE-DAPT、PARIS和DAPT（出血部分）评分在12个月时对于GUSTO出血的c指数（95%CI）分别为0.716（0.677 - 0.758）、0.693（0.658 - 0.733）和0.674（0.637 - 0.713），对于TIMI出血的c指数分别为0.624（0.582 - 0.666）、0.612（0.578 - 0.651）和0.608（0.571 - 0.649）。基于两两比较，各评分的c指数无显著差异。
在接受DAPT治疗的药物治疗ACS患者中，PRECISE-DAPT、PARIS和DAPT（出血部分）评分的表现合理，且与它们在推导的经皮冠状动脉介入治疗人群中的表现相似。出血风险评分可用于预测未进行血运重建的接受DAPT治疗的ACS患者的纵向出血风险，并有助于支持共同决策。注册信息：网址：https://www.clinicaltrials.gov；唯一标识符：NCT00699998。
