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心肌梗死后独立结构化教育计划:一项随机研究。

A stand-alone structured educational programme after myocardial infarction: a randomised study.

作者信息

Giannopoulos Georgios, Karageorgiou Sofia, Vrachatis Dimitrios, Anagnostopoulos Ioannis, Kousta Maria S, Lakka Eleni, Giotaki Sotiria, Raisakis Konstantinos, Sianos Georgios, Toutouzas Konstantinos, Cleman Michael, Deftereos Spyridon

机构信息

Department of Cardiology, Athens General Hospital "G. Gennimatas", Athens, Greece

2nd Department of Cardiology, National and Kapodistrian University of Athens, Faculty of Medicine, Athens, Greece.

出版信息

Heart. 2021 Jun 11;107(13):1047-1053. doi: 10.1136/heartjnl-2020-318414.

Abstract

BACKGROUND

Acute myocardial infarction (MI) is a major clinical manifestation of coronary artery disease. Post-MI morbidity and mortality can be reduced by lifestyle changes and aggressive risk factor modification. These changes can be applied more effectively if the patient is actively involved in the process. The hypothesis of this study was that an educational programme in post-MI patients could lead to reduced incidence of cardiovascular events.

METHODS

Post-MI patients were prospectively randomised into two groups. Patients in the intervention arm were scheduled to attend an 8-week-long educational programme on top of usual treatment, while controls received optimal treatment. The primary endpoint was the composite of all-cause death, MI, cerebrovascular event and unscheduled hospitalisation for cardiovascular causes. Endpoint adjudication was blinded.

RESULTS

329 patients (238 men) were included, with a mean follow-up time of 17±4 months. In the primary analysis, mean primary end point-free survival time was 597 days (95% CI 571 to 624) in controls, compared with 663 days (95% CI 638 to 687) in the intervention group (p<0.001). The HR in the univariate Cox regression analysis was 0.48 (95% CI 0.32 to 0.73; p=0.001). The raw rates of the primary endpoint were 20.8% (6 deaths, 13 MIs, 2 strokes and 14 hospitalisations) vs 36.6% (8 deaths, 22 MIs, 7 strokes and 22 hospitalisations), respectively (OR 0.46, 95% CI 0.28 to 0.74; p=0.002).

CONCLUSION

These results suggest that a relatively short adult education programme offered to post-MI patients has beneficial effects, resulting in reduced risk of cardiovascular events.

TRIAL REGISTRATION NUMBER

NCT04007887.

摘要

背景

急性心肌梗死(MI)是冠状动脉疾病的主要临床表现。通过改变生活方式和积极控制危险因素,可以降低心肌梗死后的发病率和死亡率。如果患者积极参与这一过程,这些改变可以更有效地实施。本研究的假设是,针对心肌梗死后患者的教育项目可以降低心血管事件的发生率。

方法

对心肌梗死后患者进行前瞻性随机分组。干预组患者在常规治疗的基础上,计划参加为期8周的教育项目,而对照组接受最佳治疗。主要终点是全因死亡、心肌梗死、脑血管事件和因心血管原因非计划住院的综合指标。终点判定采用盲法。

结果

共纳入329例患者(238例男性),平均随访时间为17±4个月。在初步分析中,对照组的平均无主要终点生存时间为597天(95%可信区间571至624),而干预组为663天(95%可信区间638至687)(p<0.001)。单因素Cox回归分析中的风险比为0.48(95%可信区间0.32至0.73;p=0.001)。主要终点的原始发生率分别为20.8%(6例死亡、13例心肌梗死、2例中风和14例住院)和36.6%(8例死亡、22例心肌梗死、7例中风和22例住院)(比值比为0.46,95%可信区间0.28至0.74;p=0.002)。

结论

这些结果表明,为心肌梗死后患者提供的相对较短的成人教育项目具有有益效果,可降低心血管事件风险。

试验注册号

NCT04007887。

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