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Invasive Versus Medical Management in Patients With Prior Coronary Artery Bypass Surgery With a Non-ST Segment Elevation Acute Coronary Syndrome.
Circulation: Cardiovascular Interventions ( IF 5.6 ) Pub Date : 2019-07-31 , DOI: 10.1161/circinterventions.119.007830
Matthew M Y Lee 1, 2, 3, 4, 5 , Mark C Petrie 1, 2, 5 , Paul Rocchiccioli 1, 2, 5 , Joanne Simpson 1, 2 , Colette E Jackson 1, 2 , David S Corcoran 1, 2 , Kenneth Mangion 1, 2 , Ammani Brown 2, 3 , Pio Cialdella 1 , Novalia P Sidik 1 , Margaret B McEntegart 1, 2, 3 , Aadil Shaukat 1, 2, 5 , Alan P Rae 1, 2, 5 , Stuart H M Hood 1, 4 , Eileen E Peat 1, 4 , Iain N Findlay 4 , Clare L Murphy 4 , Alistair J Cormack 4 , Nikolay B Bukov 6 , Kanarath P Balachandran 6 , Keith G Oldroyd 1 , Ian Ford 7 , Olivia Wu 8 , Alex McConnachie 7 , Sarah J E Barry 9 , Colin Berry 1, 2, 3 ,
Affiliation  

BACKGROUND The benefits of routine invasive management in patients with prior coronary artery bypass grafts presenting with non-ST elevation acute coronary syndromes are uncertain because these patients were excluded from pivotal trials. METHODS In a multicenter trial, non-ST elevation acute coronary syndromes patients with prior coronary artery bypass graft were prospectively screened in 4 acute hospitals. Medically stabilized patients were randomized to invasive management (invasive group) or noninvasive management (medical group). The primary outcome was adherence with the randomized strategy by 30 days. A blinded, independent Clinical Event Committee adjudicated predefined composite outcomes for efficacy (all-cause mortality, rehospitalization for refractory ischemia/angina, myocardial infarction, hospitalization because of heart failure) and safety (major bleeding, stroke, procedure-related myocardial infarction, and worsening renal function). RESULTS Two hundred seventeen patients were screened and 60 (mean±SD age, 71±9 years, 72% male) were randomized (invasive group, n=31; medical group, n=29). One-third (n=10) of the participants in the invasive group initially received percutaneous coronary intervention. In the medical group, 1 participant crossed over to invasive management on day 30 but percutaneous coronary intervention was not performed. During 2-years' follow-up (median [interquartile range], 744 [570-853] days), the composite outcome for efficacy occurred in 13 (42%) subjects in the invasive group and 13 (45%) subjects in the medical group. The composite safety outcome occurred in 8 (26%) subjects in the invasive group and 9 (31%) subjects in the medical group. An efficacy or safety outcome occurred in 17 (55%) subjects in the invasive group and 16 (55%) subjects in the medical group. Health status (EuroQol 5 Dimensions) and angina class in each group were similar at 12 months. CONCLUSIONS More than half of the population experienced a serious adverse event. An initial noninvasive management strategy is feasible. A substantive health outcomes trial of invasive versus noninvasive management in non-ST elevation acute coronary syndromes patients with prior coronary artery bypass grafts appears warranted. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT01895751.

中文翻译:

具有非ST段抬高的急性冠状动脉综合征的先前冠状动脉搭桥手术患者的侵入性治疗与药物治疗。

背景技术对于先前有非ST段抬高急性冠状动脉综合征的冠状动脉旁路移植术患者,常规侵入性治疗的益处尚不确定,因为这些患者被排除在关键性试验之外。方法在一项多中心试验中,前瞻性地在4家急性医院筛查了非ST段抬高的急性冠状动脉综合症患者,该患者先有冠状动脉搭桥术。医学稳定的患者被随机分为侵入性治疗(侵入性组)或非侵入性治疗(医疗组)。主要结果是在30天之前坚持随机策略。盲目的,独立的临床事件委员会对疗效的预定义综合结果(所有原因的死亡率,难治性缺血/心绞痛的住院治疗,心肌梗死,因心力衰竭而住院)和安全性(大出血,中风,与手术相关的心肌梗塞和肾功能恶化)。结果对217例患者进行了筛查,随机分配了60例(平均年龄±SD,71±9岁,男性占72%)(浸润组,n = 31;医疗组,n = 29)。侵入组中三分之一(n = 10)的参与者最初接受了经皮冠状动脉介入治疗。在医疗组中,有30名参与者在第30天越过侵入性处理,但未进行经皮冠状动脉介入治疗。在2年的随访期间(中位[四分位间距] 744 [570-853]天),侵入性治疗组的13位(42%)受试者和13位(45%)的受试者发生了综合疗效。医疗组。综合安全性结果发生在浸润组的8位(26%)受试者和医疗组的9位(31%)受试者中。在侵入性组中有17名(55%)受试者在医疗组中有16名(55%)受试者发生了疗效或安全性结果。每组的健康状况(EuroQol 5维度)和心绞痛等级在12个月时相似。结论超过一半的人口经历了严重的不良事件。最初的无创管理策略是可行的。一项有先例冠状动脉搭桥术的非ST段抬高急性冠脉综合征患者的侵入性与非侵入性治疗实质性健康结果试验似乎是有必要的。临床试验注册网址:https://www.clinicaltrials.gov。唯一标识符:NCT01895751。在侵入性组中有17名(55%)受试者在医疗组中有16名(55%)受试者发生了疗效或安全性结果。每组的健康状况(EuroQol 5维度)和心绞痛等级在12个月时相似。结论超过一半的人口经历了严重的不良事件。最初的非侵入性管理策略是可行的。一项有先例冠状动脉搭桥术的非ST段抬高急性冠脉综合征患者的侵入性与非侵入性治疗实质性健康结果试验似乎是有必要的。临床试验注册网址:https://www.clinicaltrials.gov。唯一标识符:NCT01895751。在侵入性组中有17名(55%)受试者在医疗组中有16名(55%)受试者发生了疗效或安全性结果。每组的健康状况(EuroQol 5维度)和心绞痛等级在12个月时相似。结论超过一半的人口经历了严重的不良事件。最初的非侵入性管理策略是可行的。一项有先例冠状动脉搭桥术的非ST段抬高急性冠脉综合征患者的侵入性与非侵入性治疗实质性健康结果试验似乎是有必要的。临床试验注册网址:https://www.clinicaltrials.gov。唯一标识符:NCT01895751。结论超过一半的人口经历了严重的不良事件。最初的无创管理策略是可行的。一项有先例冠状动脉搭桥术的非ST段抬高急性冠脉综合征患者的侵入性与非侵入性治疗实质性健康结果试验似乎是有必要的。临床试验注册网址:https://www.clinicaltrials.gov。唯一标识符:NCT01895751。结论超过一半的人口经历了严重的不良事件。最初的非侵入性管理策略是可行的。一项有先例冠状动脉搭桥术的非ST段抬高急性冠脉综合征患者的侵入性与非侵入性治疗实质性健康结果试验似乎是有必要的。临床试验注册网址:https://www.clinicaltrials.gov。唯一标识符:NCT01895751。
更新日期:2019-07-31
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