缺血性左心室功能障碍的经皮血管重建术。

Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction.

作者信息

Perera Divaka, Clayton Tim, O'Kane Peter D, Greenwood John P, Weerackody Roshan, Ryan Matthew, Morgan Holly P, Dodd Matthew, Evans Richard, Canter Ruth, Arnold Sophie, Dixon Lana J, Edwards Richard J, De Silva Kalpa, Spratt James C, Conway Dwayne, Cotton James, McEntegart Margaret, Chiribiri Amedeo, Saramago Pedro, Gershlick Anthony, Shah Ajay M, Clark Andrew L, Petrie Mark C

机构信息

From the National Institute for Health and Care Research Biomedical Research Centre and the British Heart Foundation Centre of Research Excellence, School of Cardiovascular and Metabolic Medicine and Sciences, King's College London (D.P., M.R., H.P.M., A.C., A.M.S.), Guy's and St. Thomas' NHS Foundation Trust (D.P., S.A., K.D.S.), the London School of Hygiene and Tropical Medicine (T.C., M.D., R.E., R.C.), Barts Health NHS Trust (R.W.), St. George's University Hospitals NHS Foundation Trust (J.C.S.), and King's College Hospital NHS Foundation Trust (A.M.S.), London, University Hospitals Dorset NHS Foundation Trust, Bournemouth (P.D.O.), Leeds Teaching Hospitals NHS Trust, Leeds (J.P.G.), Belfast Health and Social Care NHS Trust, Belfast (L.J.D.), Newcastle Hospitals NHS Foundation Trust, Newcastle (R.J.E.), University Hospitals Bristol NHS Foundation Trust, Bristol (K.D.S.), Mid Yorkshire Hospitals NHS Trust, Wakefield (D.C.), Royal Wolverhampton NHS Trust, Wolverhampton (J.C.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (M.M., M.C.P.), the University of York, York (P.S.), University Hospitals of Leicester NHS Trust, Leicester (A.G.), and Hull University Teaching Hospitals NHS Trust, Hull (A.L.C.) - all in the United Kingdom.

出版信息

N Engl J Med. 2022 Oct 13;387(15):1351-1360. doi: 10.1056/NEJMoa2206606. Epub 2022 Aug 27.

DOI:10.1056/NEJMoa2206606

PMID:36027563

Abstract

BACKGROUND

Whether revascularization by percutaneous coronary intervention (PCI) can improve 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.

METHODS

We randomly assigned patients with a left ventricular ejection fraction of 35% or less, extensive coronary artery disease amenable to PCI, and demonstrable myocardial viability to a strategy of either PCI plus optimal medical therapy (PCI group) or optimal medical therapy alone (optimal-medical-therapy group). The primary composite 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.

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 percentage 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.

CONCLUSIONS

Among patients with severe ischemic left ventricular systolic dysfunction who received 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 Assessment Program; REVIVED-BCIS2 ClinicalTrials.gov number, NCT01920048.).

摘要

背景

与单纯的最佳药物治疗（即针对心力衰竭进行个体化调整的药物和器械治疗）相比，经皮冠状动脉介入治疗（PCI）进行血运重建能否改善严重缺血性左心室收缩功能障碍患者的无事件生存期和左心室功能，目前尚不清楚。

方法

我们将左心室射血分数为35%或更低、适合PCI的广泛冠状动脉疾病且有可证实的心肌存活的患者随机分为PCI联合最佳药物治疗策略组（PCI组）或单纯最佳药物治疗组（最佳药物治疗组）。主要复合结局是任何原因导致的死亡或因心力衰竭住院。主要次要结局是6个月和12个月时的左心室射血分数以及生活质量评分。

结果

共有700例患者接受随机分组，347例被分配到PCI组，353例被分配到最佳药物治疗组。在中位41个月的时间里，PCI组有129例患者（37.2%）发生主要结局事件，最佳药物治疗组有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至1.27；P = 0.96）。两组在6个月时（平均差异，-1.6个百分点；95%CI，-3.7至0.5）和12个月时（平均差异，0.9个百分点；95%CI，-1.7至3.4）的左心室射血分数相似。6个月和12个月时的生活质量评分似乎有利于PCI组，但在24个月时差异已减小。