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通过抑制血管紧张素转换酶使用阿替洛尔进行搭桥术后缺血管理(IMAGINE):一项多中心随机试验——设计与原理

Ischemia Management with Accupril post bypass Graft via Inhibition of angiotensin coNverting enzyme (IMAGINE): a multicentre randomized trial - design and rationale.

作者信息

Warnica J Wayne, Gilst Wiek Van, Baillot Richard, Johnstone David, Block Pierre, Myers Martin G, Chocron Sydney, Ave Sonja Dalle, Martineau Pierre, Rouleau Jean-Lucien

机构信息

Foothills Medical Centre, Calgary, Canada.

出版信息

Can J Cardiol. 2002 Nov;18(11):1191-200.

Abstract

BACKGROUND

Coronary artery bypass grafting (CABG) remains the revascularization treatment of choice for patients with severely symptomatic or life-threatening coronary artery disease (CAD). However, 9% to 25% of the patients undergoing CABG will suffer a recurrent ischemic event such as death, recurrent infarction, angina or repeat revascularization. The pathophysiological processes particular to the CABG procedure that may affect graft endothelial function are most active in the early phase after surgery. Angiotensin-converting enzyme (ACE) inhibition has been shown to be effective in reducing or preventing ischemic events in patients with and without left ventricular dysfunction, and in those at high risk for CAD. Nonetheless, no large clinical trail has investigated this role of ACE inhibition in preventing ischemic events early after CABG.

OBJECTIVE

The Ischemia Management with Accupril post bypass Graft via Inhibition of angiotensin coNverting Enzyme (IMAGINE) study addressed whether ACE inhibition initiated early after CABG improves short and long term outcomes in patients after CABG.

PATIENTS AND METHODS

This multicentre, multinational trial recruited 2204 patients with an uncomplicated course early after CABG from 55 to 65 medical care facilities in Canada, The Netherlands, Belgium and France. Eligible patients with normal left ventricular function were randomly assigned to placebo or quinapril (titrated up to 40 mg daily where possible) within seven to 10 days after CABG. All patients were followed up closely for a minimum of 12 months after random placement. The median treatment period is expected to be approximately 27 months.

摘要

背景

冠状动脉旁路移植术(CABG)仍然是有严重症状或危及生命的冠状动脉疾病(CAD)患者血运重建治疗的首选方法。然而,接受CABG治疗的患者中有9%至25%会发生复发性缺血事件,如死亡、复发性梗死、心绞痛或再次血运重建。CABG手术特有的可能影响移植血管内皮功能的病理生理过程在术后早期最为活跃。血管紧张素转换酶(ACE)抑制已被证明可有效减少或预防有或无左心室功能障碍的患者以及CAD高危患者的缺血事件。尽管如此,尚无大型临床试验研究ACE抑制在预防CABG术后早期缺血事件中的作用。

目的

通过抑制血管紧张素转换酶进行搭桥术后依那普利缺血管理(IMAGINE)研究探讨了CABG术后早期开始的ACE抑制是否能改善CABG术后患者的短期和长期预后。

患者和方法

这项多中心、跨国试验从加拿大、荷兰、比利时和法国的55至65个医疗保健机构招募了2204例CABG术后早期病情不复杂的患者。左心室功能正常的符合条件的患者在CABG术后7至10天内被随机分配到安慰剂组或喹那普利组(尽可能滴定至每日40毫克)。所有患者在随机分组后至少随访12个月。预计中位治疗期约为27个月。

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