Fox K A A, Poole-Wilson P, Clayton T C, Henderson R A, Shaw T R D, Wheatley D J, Knight R, Pocock S J
Centre for Cardiovascular Science, Department of Medical and Radiological Sciences, University of Edinburgh, Edinburgh EH16 4SB, UK.
Lancet. 2005;366(9489):914-20. doi: 10.1016/S0140-6736(05)67222-4.
The long-term outcome of an interventional strategy in patients with non-ST-elevation acute coronary syndrome is unknown. We tested whether an interventional strategy (routine angiography followed by revascularisation) was better than a conservative strategy (ischaemia-driven or symptom-driven angiography) over 5 years' follow-up.
In a multicentre randomised trial, 1810 patients (from 45 hospitals in England and Scotland, UK) with non-ST-elevation acute coronary syndrome were randomly assigned to receive an early intervention (n=895) or a conservative strategy (n=915) within 48 h of the index episode of cardiac pain. In each group, the aim was to provide the best medical treatment, and also to undertake coronary arteriography within 72 h in the interventional strategy with subsequent management guided by the angiographic findings. Analysis was by intention to treat and the primary outcome (composite of death or non-fatal myocardial infarction) had masked independent adjudication. RITA 3 has been assigned the International Standard Randomised Control Trial Number ISRCTN07752711.
At 1-year follow-up, rates of death or non-fatal myocardial infarction were similar. However, at a median of 5 years' follow-up (IQR 4.6-5.0), 142 (16.6%) patients with intervention treatment and 178 (20.0%) with conservative treatment died or had non-fatal myocardial infarction (odds ratio 0.78, 95% CI 0.61-0.99, p=0.044), with a similar benefit for cardiovascular death or myocardial infarction (0.74, 0.56-0.97, p=0.030). 234 (102 [12%] intervention, 132 [15%] conservative) patients died during follow-up (0.76, 0.58-1.00, p=0.054). The benefits of an intervention strategy were mainly seen in patients at high risk of death or myocardial infarction (p=0.004), and for the highest risk group, the odds ratio of death or non-fatal myocardial infarction was 0.44 (0.25-0.76).
In patients with non-ST-elevation acute coronary syndrome, a routine invasive strategy leads to long-term reduction in risk of death or non-fatal myocardial infarction, and this benefit is mainly in high-risk patients. The findings provide support for national and international guidelines in the need for more robust risk stratification in acute coronary syndrome.
非ST段抬高型急性冠状动脉综合征患者介入治疗策略的长期疗效尚不清楚。我们测试了在5年的随访中，介入治疗策略（常规血管造影随后进行血运重建）是否优于保守治疗策略（缺血驱动或症状驱动的血管造影）。
在一项多中心随机试验中，1810例非ST段抬高型急性冠状动脉综合征患者（来自英国英格兰和苏格兰的45家医院）在心脏疼痛发作后的48小时内被随机分配接受早期介入治疗（n = 895）或保守治疗策略（n = 915）。在每组中，目标是提供最佳的药物治疗，并在介入治疗策略中于72小时内进行冠状动脉造影，随后根据血管造影结果进行管理。分析采用意向性治疗，主要结局（死亡或非致命性心肌梗死的复合结局）由独立的盲法判定。RITA 3已被分配国际标准随机对照试验编号ISRCTN07752711。
在1年的随访中，死亡或非致命性心肌梗死的发生率相似。然而，在中位5年的随访期（四分位间距4.6 - 5.0），介入治疗组有142例（16.6%）患者死亡或发生非致命性心肌梗死，保守治疗组有178例（20.0%）（比值比0.78，95%可信区间0.61 - 0.99，p = 0.044），心血管死亡或心肌梗死的获益相似（0.74，0.56 - 0.97，p = 0.030）。234例（介入治疗组102例[12%]，保守治疗组132例[15%]）患者在随访期间死亡（0.76，0.58 - 1.00，p = 0.054）。介入治疗策略的益处主要见于死亡或心肌梗死高危患者（p = 0.004），对于最高危组，死亡或非致命性心肌梗死的比值比为0.44（0.25 - 0.76）。
在非ST段抬高型急性冠状动脉综合征患者中，常规侵入性策略可导致死亡或非致命性心肌梗死风险的长期降低，且这种益处主要见于高危患者。这些发现为国家和国际指南中关于急性冠状动脉综合征需要更有力的风险分层提供了支持。
