National Institute for Health Research Biomedical Research Center and British Heart Foundation Center of Research Excellence at the School of Cardiovascular Medicine and Sciences, King's College London, United Kingdom (D.P., H.P.M., M.R.).
Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom (D.P., C.A.R.).
Circulation. 2023 Sep 12;148(11):862-871. doi: 10.1161/CIRCULATIONAHA.123.065300. Epub 2023 Aug 9.
Ventricular arrhythmia is an important cause of mortality in patients with ischemic left ventricular dysfunction. Revascularization with coronary artery bypass graft or percutaneous coronary intervention is often recommended for these patients before implantation of a cardiac defibrillator because it is assumed that this may reduce the incidence of fatal and potentially fatal ventricular arrhythmias, although this premise has not been evaluated in a randomized trial to date.
Patients with severe left ventricular dysfunction, extensive coronary disease, and viable myocardium were randomly assigned to receive either percutaneous coronary intervention (PCI) plus optimal medical and device therapy (OMT) or OMT alone. The composite primary outcome was all-cause death or aborted sudden death (defined as an appropriate implantable cardioverter defibrillator therapy or a resuscitated cardiac arrest) at a minimum of 24 months, analyzed as time to first event on an intention-to-treat basis. Secondary outcomes included cardiovascular death or aborted sudden death, appropriate implantable cardioverter defibrillator (ICD) therapy or sustained ventricular arrhythmia, and number of appropriate ICD therapies.
Between August 28, 2013, and March 19, 2020, 700 patients were enrolled across 40 centers in the United Kingdom. A total of 347 patients were assigned to the PCI+OMT group and 353 to the OMT alone group. The mean age of participants was 69 years; 88% were male; 56% had hypertension; 41% had diabetes; and 53% had a clinical history of myocardial infarction. The median left ventricular ejection fraction was 28%; 53.1% had an implantable defibrillator inserted before randomization or during follow-up. All-cause death or aborted sudden death occurred in 144 patients (41.6%) in the PCI group and 142 patients (40.2%) in the OMT group (hazard ratio, 1.03 [95% CI, 0.82-1.30]; =0.80). There was no between-group difference in the occurrence of any of the secondary outcomes.
PCI was not associated with a reduction in all-cause mortality or aborted sudden death. In patients with ischemic cardiomyopathy, PCI is not beneficial solely for the purpose of reducing potentially fatal ventricular arrhythmias.
URL: https://www.
gov; Unique identifier: NCT01920048.
室性心律失常是缺血性左心室功能障碍患者死亡的重要原因。对于这些患者，常建议在植入心脏除颤器之前进行冠状动脉旁路移植术或经皮冠状动脉介入治疗，因为人们认为这可能降低致命和潜在致命性室性心律失常的发生率，尽管迄今为止，这一前提尚未在随机试验中得到评估。
严重左心室功能障碍、广泛冠状动脉疾病和存活心肌的患者被随机分配接受经皮冠状动脉介入治疗（PCI）加最佳药物和器械治疗（OMT）或单独 OMT。主要复合终点为 24 个月以上的全因死亡或心搏骤停（定义为适当的植入式心脏复律除颤器治疗或复苏性心脏骤停），按意向治疗进行首次事件时间分析。次要结局包括心血管死亡或心搏骤停、适当的植入式心脏复律除颤器（ICD）治疗或持续性室性心律失常，以及适当的 ICD 治疗次数。
2013 年 8 月 28 日至 2020 年 3 月 19 日，英国 40 个中心共纳入 700 例患者。共 347 例患者被分配至 PCI+OMT 组，353 例患者被分配至 OMT 组。参与者的平均年龄为 69 岁；88%为男性；56%有高血压；41%有糖尿病；53%有心肌梗死的临床病史。左心室射血分数中位数为 28%；53.1%在随机分组前或随访期间植入了植入式除颤器。PCI 组有 144 例（41.6%）患者发生全因死亡或心搏骤停，OMT 组有 142 例（40.2%）患者发生全因死亡或心搏骤停（风险比，1.03[95%CI，0.82-1.30]；=0.80）。两组间任何次要结局的发生均无差异。
PCI 与全因死亡率或心搏骤停的降低无关。在缺血性心肌病患者中，PCI 对降低潜在致命性室性心律失常没有益处。
网址：[URL] gov；独特标识：NCT01920048。
