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评价在国立心脏病研究所(PHASE-MX)中,ST 段抬高型急性心肌梗死患者中应用药物侵入性策略与经皮冠状动脉介入治疗的效果。

Evaluation of pharmacoinvasive strategy versus percutaneous coronary intervention in patients with acute myocardial infarction with ST-segment elevation at the National Institute of Cardiology (PHASE-MX).

机构信息

Department of Emergency, Coronary Care Unit, Instituto Nacional de Cardiología Ignacio Chávez. Mexico City, Mexico.

Occupational Health Research Unit, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social. Mexico City, Mexico.

出版信息

Arch Cardiol Mex. 2020;90(2):137-141. doi: 10.24875/ACME.M20000107.

Abstract

OBJECTIVE

The objective of PHASE-MX registry is to validate the efficacy and safety of the pharmacoinvasive strategy in comparison with percutaneous coronary intervention (PCI) in patients with acute myocardial infarction with ST segment elevation (STEMI) in a metropolitan region of Mexico. The primary outcome will consist of the composite of cardiovascular death, re-infarction, stroke and cardiogenic shock.

METHODS

The PHASE-MX registry will include a prospective cohort of patients with STEMI who received reperfusion treatment (mechanical of pharmacological) in the first 12 h after the onset of symptoms. The registry is designed to compare the efficacy and safety of primary PCI and pharmacoinvasive strategy. The simple size was calculated in 344 patients divided into two groups, with an estimated loss rate of 10%. Patients included in the PHASE-MX cohort will be followed for up to one year.

CONCLUSION

In Mexico, only 5 out of 10 patients with STEMI have access to reperfusion therapy. Pharmacoinvasive strategy is takes advantage of the accessibility of fibrinolysis and the effectiveness of PCI. The present research protocol aims to provide information that serves as a link between information derived from controlled clinical trials and records derived from real world experience.

摘要

目的

PHASE-MX 注册研究的目的是在墨西哥大都市地区,比较药物介入策略与经皮冠状动脉介入治疗(PCI)在急性 ST 段抬高型心肌梗死(STEMI)患者中的疗效和安全性。主要结局将包括心血管死亡、再梗死、卒中和心原性休克的复合事件。

方法

PHASE-MX 注册研究将纳入在症状发作后 12 小时内接受再灌注治疗(机械或药物)的 STEMI 患者前瞻性队列。该注册研究旨在比较直接 PCI 和药物介入策略的疗效和安全性。根据预计 10%的失访率,计算出 344 例患者分为两组的简单样本量。PHASE-MX 队列中的患者将随访长达一年。

结论

在墨西哥,仅有 5/10 的 STEMI 患者能够获得再灌注治疗。药物介入策略利用了纤溶酶原激活物的可及性和 PCI 的有效性。本研究方案旨在提供信息,将来自对照临床试验的信息与真实世界经验的记录联系起来。

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