Complete revascularization timing in ST-segment elevation myocardial infarction and multivessel disease with heart failure: the OPTION-STEMI trial.

Methods

The OPTION-STEMI (Optimal Timing of Fractional Flow Reserve-Guided Complete Revascularization for Non-Infarct-Related Artery in ST-segment Elevation Myocardial Infarction with Multivessel Disease) trial compared immediate vs staged complete revascularization during the index admission in patients with STEMI and multivessel disease.

OPTION-STEMI（ST段抬高型心肌梗死患者非梗死相关动脉的即时与分期完全血运重建的优化时机）试验比较了在初次住院期间立即与分期完全血运重建的疗效，研究对象为ST段抬高型心肌梗死（STEMI）和多血管疾病的患者。

In the OPTION-STEMI trial, immediate complete revascularization was not found to be non-inferior for the primary endpoint compared with staged complete revascularization.

在OPTION-STEMI试验中，立即完全血运重建与分阶段完全血运重建相比，并未显示出在主要终点上的非劣效性。

Pre-specified subgroup analysis was performed according to heart failure at admission, defined as Killip class II or III.

根据入院时的心力衰竭情况进行了预先设定的亚组分析，定义为Killip II级或III级。

The primary endpoint was a composite of death from any cause, non-fatal myocardial infarction, or any unplanned revascularization at 1 year.

主要终点是1年内因任何原因死亡、非致命性心肌梗死或任何计划外的血管重建术的复合终点。

Results

Among 994 randomized patients, 329 (33.1%) had heart failure at admission.

在994名随机患者中，有329名（33.1%）在入院时患有心力衰竭。

These patients had a higher risk of primary endpoint than those without heart failure (18.2% vs 8.7%; adjusted HR 1.63; 95% CI 1.11-2.40; P = .013).

与没有心力衰竭的患者相比，这些患者的主要终点风险更高（18.2%对比8.7%；调整后风险比1.63；95%置信区间1.11-2.40；P = .013）。

At 1 year, immediate complete revascularization was associated with a higher incidenceof the primary endpoint than staged complete revascularization in patients with heart failure (22.8% vs 13.3%; HR 1.79; 95% CI 1.05-3.04), but not in those without heart failure (8.0% vs 9.5%; HR 0.84; 95% CI .50-1.40).

在1年时，立即完全血运重建与分期完全血运重建相比，心力衰竭患者的主要终点发生率更高（22.8%对比13.3%；风险比1.79；95%置信区间1.05-3.04），而在没有心力衰竭的患者中则没有这种差异（8.0%对比9.5%；风险比0.84；95%置信区间.50-1.40）。

A significant interaction was observed between heart failure status and randomized strategy (P = .043).

观察到心力衰竭状态与随机策略之间存在显著的相互作用（P = .043）。

Conclusions

In the OPTION-STEMI trial, among patients with STEMI and multi-vessel disease who were not in cardiogenic shock, immediate complete revascularization was not non-inferior compared with staged complete revascularization.

在OPTION-STEMI试验中，对于未发生心源性休克的STEMI和多血管疾病患者，立即完全血运重建与分期完全血运重建相比，并未显示出非劣效性。

However, subgroup analysis suggests that the worse outcomes with immediate complete revascularization may be limited to patients with heart failure at admission.

然而，亚组分析表明，立即完全血运重建的不良结果可能仅限于入院时有心力衰竭的患者。

Further studies are required to demonstrate the non-inferiority of immediate complete revascularization compared with staged complete revascularization in patients without heart failure.

需要进一步的研究来证明，在没有心力衰竭的患者中，立即完全血运重建与分期完全血运重建相比的非劣效性。