经皮冠状动脉介入治疗与非 ST 段抬高型急性冠状动脉综合征患者冠状动脉旁路移植术后的药物治疗。
Invasive Versus Medical Management in Patients With Prior Coronary Artery Bypass Surgery With a Non-ST Segment Elevation Acute Coronary Syndrome.
机构信息
Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).
British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., A.B., M.B.M., A.S., A.P.R., C.B.), University of Glasgow, United Kingdom.
出版信息
Circ Cardiovasc Interv. 2019 Aug;12(8):e007830. doi: 10.1161/CIRCINTERVENTIONS.119.007830. Epub 2019 Jul 31.
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.
背景
先前接受过冠状动脉旁路移植术的非 ST 段抬高型急性冠状动脉综合征患者进行常规有创性管理的益处尚不确定，因为这些患者被排除在关键试验之外。
方法
在一项多中心试验中，4 家急性医院前瞻性筛选出先前接受过冠状动脉旁路移植术的非 ST 段抬高型急性冠状动脉综合征患者。病情稳定的患者被随机分为有创管理组（有创组）或非侵入性管理组（医学组）。主要结局是在 30 天内遵循随机策略。一个盲法、独立的临床事件委员会对预先定义的复合结局（全因死亡率、因难治性缺血/心绞痛、心肌梗死、心力衰竭再住院、因心力衰竭住院）和安全性（大出血、卒中和肾功能恶化）进行裁决。
结果
共筛选出 217 例患者，60 例（平均年龄±标准差，71±9 岁，72%为男性）被随机分组（有创组 31 例，医学组 29 例）。有创组有 1/3（n=10）患者最初接受了经皮冠状动脉介入治疗。在医学组中，有 1 例患者在第 30 天交叉到有创治疗，但未行经皮冠状动脉介入治疗。在 2 年的随访期间（中位数[四分位数范围]，744[570-853]天），有创组有 13 例（42%）患者出现疗效复合结局，医学组有 13 例（45%）患者出现疗效复合结局。有创组有 8 例（26%）患者发生安全性复合结局，医学组有 9 例（31%）患者发生安全性复合结局。有创组有 17 例（55%）患者发生疗效或安全性结局，医学组有 16 例（55%）患者发生疗效或安全性结局。两组在 12 个月时的健康状况（EuroQol 5 维度）和心绞痛分级相似。
结论
超过一半的患者发生了严重不良事件。初始的非侵入性管理策略是可行的。在先前接受过冠状动脉旁路移植术的非 ST 段抬高型急性冠状动脉综合征患者中，有创与非侵入性管理的实质性健康结局试验似乎是合理的。
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