NEJM: 经皮血运重建术治疗缺血性左心室功能不全

BACKGROUND

Whether revascularization by percutaneous coronary intervention (PCI) can im- prove event-free survival and left ventricular function in patients with severe ischemic left ventricular systolic dysfunction, as compared with optimal medical therapy (i.e., individually adjusted pharmacologic and device therapy for heart failure) alone, is unknown. 目前尚不清楚对于重度缺血性左心室收缩功能不全患者，与单纯最佳内科治疗（即针对心力衰竭的个体化药物和器械治疗）相比，通过经皮冠状动脉介入（PCI）实施的血运重建术可否改善无事件生存期和左心室功能。

METHODS

We randomly assigned patients with a left ventricular ejection fraction of 35% or less, extensive coronary artery disease amenable to PCI, and demonstrable myocar- dial viability to a strategy of either PCI plus optimal medical therapy (PCI group) or optimal medical therapy alone (optimal-medical-therapy group). The primary com- posite outcome was death from any cause or hospitalization for heart failure. Major secondary outcomes were left ventricular ejection fraction at 6 and 12 months and quality-of-life scores. 我们将左心室射血分数≤35%，有可行PCI的广泛冠状动脉病变，并且有明显心肌活性的患者随机分组，两组分别接受PCI+最佳内科治疗（PCI组）或单纯最佳内科治疗（最佳内科治疗组）。主要复合结局是全因死亡或心力衰竭住院。关键次要结局是6个月和12个月时左心室射血分数和生活质量评分。

RESULTS

A total of 700 patients underwent randomization — 347 were assigned to the PCI group and 353 to the optimal-medical-therapy group. Over a median of 41 months, a primary-outcome event occurred in 129 patients (37.2%) in the PCI group and in 134 patients (38.0%) in the optimal-medical-therapy group (hazard ratio, 0.99; 95% confidence interval [CI], 0.78 to 1.27; P=0.96). The left ventricular ejection fraction was similar in the two groups at 6 months (mean difference, −1.6 percent- age points; 95% CI, −3.7 to 0.5) and at 12 months (mean difference, 0.9 percentage points; 95% CI, −1.7 to 3.4). Quality-of-life scores at 6 and 12 months appeared to favor the PCI group, but the difference had diminished at 24 months. 共计700例患者接受随机分组，PCI组347例，最佳内科治疗组353例。在中位41个月期间，PCI组129例患者（37.2%）和最佳内科治疗组134例患者（38.0%）发生主要结局事件（风险比，0.99；95%置信区间[CI]，0.78~1.27；P=0.96）。6个月（平均差异，-1.6个百分点；95% CI，-3.7~0.5）和12个月时（平均差异，0.9个百分点；95% CI，-1.7~3.4），两组左心室射血分数相似。6个月和12个月时，PCI组生活质量评分似乎优于最佳内科治疗组，但24个月时两组差异已缩小。

CONCLUSIONS

Among patients with severe ischemic left ventricular systolic dysfunction who re- ceived optimal medical therapy, revascularization by PCI did not result in a lower incidence of death from any cause or hospitalization for heart failure. (Funded by the National Institute for Health and Care Research Health Technology Assess- ment Program; REVIVED-BCIS2 ClinicalTrials.gov number, NCT01920048.) 在接受最佳内科治疗的重度缺血性左心室收缩功能不全患者中，PCI血运重建术并未降低全因死亡或心力衰竭住院发生率。（由英国国家卫生和医疗研究所[National Institute for Health and Care Research]卫生技术评估项目[Health Technology Assessment Program]资助；REVIVED-BCIS2在ClinicalTrials.gov注册号为NCT01920048。）