Department of Cardiology Rigshospitalet Copenhagen University Hospital Copenhagen Denmark.
Department of Cardiology Zealand University Hospital Roskilde Denmark.
J Am Heart Assoc. 2021 Oct 5;10(19):e022333. doi: 10.1161/JAHA.121.022333. Epub 2021 Sep 29.
Background The optimal timing of invasive examination and treatment of high-risk patients with non-ST-segment-elevation acute coronary syndrome has not been established. We investigated the efficacy of early invasive coronary angiography compared with standard-care invasive coronary angiography on the risk of all-cause mortality according to the GRACE (Global Registry of Acute Coronary Events) risk score in a predefined subgroup analysis of the VERDICT (Very Early Versus Deferred Invasive Evaluation Using Computerized Tomography) trial. Methods and Results Patients with clinical suspicion of non-ST-segment-elevation acute coronary syndrome with ECG changes indicating new ischemia and/or elevated troponin, in whom invasive coronary angiography was clinically indicated and deemed logistically feasible within 12 hours, were eligible for inclusion. Patients were randomized 1:1 to an early (≤12 hours) or standard (48-72 hours) invasive strategy. The primary outcome of the present study was all-cause mortality. Of 2147 patients randomized in the VERDICT trial, 2092 patients had an available GRACE risk score. Of these, 1021 (48.8%) patients had a GRACE score >140. During a median follow-up of 4.1 years, 192 (18.8%) and 54 (5.0%) patients died in the high and low GRACE score groups, respectively. The risk of death with the early invasive strategy was increased in patients with a GRACE score ≤140 (hazard ratio [HR], 2.04 [95% CI, 1.16-3.59]), whereas there was a trend toward a decreased risk of death with the early invasive strategy in patients with a GRACE score >140 (HR, 0.83 [95% CI, 0.63-1.10]) (=0.006). Conclusions In patients with non-ST-segment-elevation acute coronary syndrome, we found a significant interaction between timing of invasive coronary angiography and GRACE score on the risk of death. Randomized clinical trials are warranted to establish the efficacy and safety among high-risk and low-risk patients with non-ST-segment-elevation acute coronary syndrome. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02061891.
对于非 ST 段抬高型急性冠状动脉综合征高危患者,侵入性检查和治疗的最佳时机尚未确定。我们根据 GRACE(全球急性冠状动脉事件注册)风险评分,在 VERDICT(使用计算机断层扫描进行早期与延迟侵入性评估)试验的预先设定亚组分析中,研究了早期(≤12 小时)与标准(48-72 小时)侵入性策略在全因死亡率方面的疗效差异。
对于心电图提示新发缺血和/或肌钙蛋白升高的临床疑似非 ST 段抬高型急性冠状动脉综合征患者,且在 12 小时内进行侵入性冠状动脉造影具有临床指征且在操作上可行,有资格入选本研究。患者按照 1:1 随机分配到早期(≤12 小时)或标准(48-72 小时)侵入性策略组。本研究的主要终点为全因死亡率。在 VERDICT 试验中,2147 例随机患者中,有 2092 例患者具有可用的 GRACE 风险评分。其中,1021 例(48.8%)患者的 GRACE 评分>140。在中位随访 4.1 年期间,高 GRACE 评分组有 192 例(18.8%)和低 GRACE 评分组有 54 例(5.0%)患者死亡。在 GRACE 评分≤140 的患者中,早期侵入性策略的死亡风险增加(危险比 [HR],2.04 [95%置信区间,1.16-3.59]),而在 GRACE 评分>140 的患者中,早期侵入性策略的死亡风险有降低趋势(HR,0.83 [95%置信区间,0.63-1.10])(=0.006)。
在非 ST 段抬高型急性冠状动脉综合征患者中,我们发现侵入性冠状动脉造影的时机与 GRACE 评分对死亡率的影响之间存在显著的交互作用。需要进行随机临床试验来确定高危和低危非 ST 段抬高型急性冠状动脉综合征患者中该策略的疗效和安全性。