Azienda Ospedaliera Santa Maria Nuova, IRCCS, Reggio Emilia, Italy.
JACC Cardiovasc Interv. 2012 Sep;5(9):906-16. doi: 10.1016/j.jcin.2012.06.008.
This study sought to determine the risk versus benefit ratio of an early aggressive (EA) approach in elderly patients with non-ST-segment elevation acute coronary syndromes (NSTEACS).
Elderly patients have been scarcely represented in trials comparing treatment strategies in NSTEACS.
A total of 313 patients ≥ 75 years of age (mean 82 years) with NSTEACS within 48 h from qualifying symptoms were randomly allocated to an EA strategy (coronary angiography and, when indicated, revascularization within 72 h) or an initially conservative (IC) strategy (angiography and revascularization only for recurrent ischemia). The primary endpoint was the composite of death, myocardial infarction, disabling stroke, and repeat hospital stay for cardiovascular causes or severe bleeding within 1 year.
During admission, 88% of the patients in the EA group underwent angiography (55% revascularization), compared with 29% (23% revascularization) in the IC group. The primary outcome occurred in 43 patients (27.9%) in the EA group and 55 (34.6%) in the IC group (hazard ratio [HR]: 0.80; 95% confidence interval [CI]: 0.53 to 1.19; p = 0.26). The rates of mortality (HR: 0.87; 95% CI: 0.49 to 1.56), myocardial infarction (HR: 0.67; 95% CI: 0.33 to 1.36), and repeat hospital stay (HR: 0.81; 95% CI: 0.45 to 1.46) did not differ between groups. The primary endpoint was significantly reduced in patients with elevated troponin on admission (HR: 0.43; 95% CI: 0.23 to 0.80), but not in those with normal troponin (HR: 1.67; 95% CI: 0.75 to 3.70; p for interaction = 0.03).
The present study does not allow a definite conclusion about the benefit of an EA approach when applied systematically among elderly patients with NSTEACS. The finding of a significant interaction for the treatment effect according to troponin status at baseline should be confirmed in a larger size trial. (Italian Elderly ACS Study; NCT00510185).
本研究旨在确定非 ST 段抬高型急性冠状动脉综合征（NSTEACS）老年患者早期积极（EA）治疗策略的风险与获益比。
在比较 NSTEACS 治疗策略的临床试验中，老年患者的代表性不足。
共纳入 313 例年龄≥75 岁（平均 82 岁）、发病 48 小时内的 NSTEACS 患者，随机分配至 EA 策略（72 小时内行冠状动脉造影检查，并在必要时行血运重建）或初始保守（IC）策略（仅对再发缺血行血管造影和血运重建）。主要终点是 1 年内因心血管原因或严重出血导致的死亡、心肌梗死、致残性卒中及再次住院的复合终点。
住院期间，EA 组 88%的患者行血管造影检查（55%行血运重建），而 IC 组为 29%（23%行血运重建）。EA 组有 43 例（27.9%）患者发生主要终点事件，IC 组有 55 例（34.6%）患者发生主要终点事件（风险比[HR]：0.80；95%置信区间[CI]：0.53 至 1.19；p=0.26）。两组死亡率（HR：0.87；95%CI：0.49 至 1.56）、心肌梗死（HR：0.67；95%CI：0.33 至 1.36）和再次住院（HR：0.81；95%CI：0.45 至 1.46）的发生率无差异。入院时肌钙蛋白升高的患者主要终点事件显著减少（HR：0.43；95%CI：0.23 至 0.80），而肌钙蛋白正常的患者无显著差异（HR：1.67；95%CI：0.75 至 3.70；p 交互=0.03）。
本研究不能明确得出 NSTEACS 老年患者系统应用 EA 策略是否获益的结论。根据基线时肌钙蛋白状态治疗效果的显著交互作用，应在更大规模的试验中进行确认。（意大利老年 ACS 研究；NCT00510185）
