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急性冠状动脉综合征后的二级预防联盟。ALLEPRE 试验:一项多中心、完全由护士协调的强化干预方案。

ALLiance for sEcondary PREvention after an acute coronary syndrome. The ALLEPRE trial: A multicenter fully nurse-coordinated intensive intervention program.

机构信息

Division of Cardiology, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.

Division of Cardiology, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.

出版信息

Am Heart J. 2018 Sep;203:12-16. doi: 10.1016/j.ahj.2018.06.001. Epub 2018 Jun 12.

Abstract

The main objective of cardiovascular disease prevention is to reduce morbidity and mortality by promoting a healthy lifestyle, reducing risk factors, and improving adherence to medications. Secondary prevention after an acute coronary syndrome has proved to be effective in reducing new cardiovascular events, but its limited use in everyday clinical practice suggests that there is considerable room for improvement. The short-term results of evidence-based studies of nurse-coordinated secondary prevention programs have been positive, but there is a lack of long-term outcome data. The Alliance for the Secondary Prevention of Cardiovascular Disease in the Emilia-Romagna region (ALLEPRE) is a multicenter, randomized, controlled trial designed to compare the effects of a structured nurse-coordinated intensive intervention on long-term outcomes and risk profiles after an acute coronary syndrome with those of the standard of care. All of the patients randomized to the intervention group take part in 9 one-to-one sessions with an experienced nurse from the participating centers with the aim at promoting healthy lifestyles, reducing risk factors, and increasing adherence to medication over a mean period of 5 years. The primary clinical end point is the reduction in the risk of the 5-year occurrence of major adverse events (a composite of cardiovascular mortality, nonfatal reinfarction, and nonfatal stroke). The primary surrogate end point is the achievement of prespecified targets relating to classical risk factors, lifestyle modifications, and adherence to pharmacological therapy after 2 years of follow-up. Coronary heart disease is a chronic degenerative disease, and patients who recover from an acute coronary syndrome (ACS) are at high risk of developing recurrent events.1 Although secondary prevention measures have proved to be effective and are strongly recommended by all of the international guidelines,2., 3. the 4 EUROASPIRE surveys4., 5., 6., 7., 8. showed that there was still a high prevalence of conventional risk factors, that secondary prevention measures were inadequately implemented, and that their main goals were often not reached. In addition, there were considerable discrepancy in secondary prevention practices between centers and countries, and a widespread underuse of cardiac prevention and rehabilitation programs despite their demonstrated effectiveness in reducing cardiovascular risk over time.9., 10. Over the last 10 years, nurses have been increasingly involved in successful cardiovascular risk management,11., 12., 13. but although this has improved levels of cardiovascular risk, no clear reduction in hard end points such as major cardiovascular adverse events and mortality has been demonstrated.10 The aim of the ALLEPRE trial is to evaluate the benefit of a homogeneous, structured, secondary prevention intervention program, fully coordinated by nurses from in- and outpatient clinics, in terms of cardiovascular risk profiles and major clinical events in ACS patients living in the large Emilia-Romagna region of Italy.

摘要

心血管疾病预防的主要目标是通过促进健康的生活方式、减少危险因素和提高药物依从性来降低发病率和死亡率。急性冠状动脉综合征后的二级预防已被证明可有效减少新的心血管事件,但在日常临床实践中的应用有限,表明仍有很大的改进空间。基于证据的护士协调二级预防计划的短期结果是积极的,但缺乏长期结果数据。艾米利亚-罗马涅地区心血管疾病二级预防联盟(ALLEPRE)是一项多中心、随机、对照试验,旨在比较结构化护士协调强化干预对急性冠状动脉综合征后长期结局和风险特征的影响与标准护理的影响。所有随机分配到干预组的患者都参加了由参与中心的经验丰富的护士进行的 9 次一对一的会议,目的是促进健康的生活方式、减少危险因素并在 5 年内提高药物依从性。主要临床终点是降低 5 年内主要不良事件(心血管死亡率、非致死性再梗死和非致死性卒中的复合终点)的风险。主要替代终点是在 2 年随访后达到与经典危险因素、生活方式改变和药物治疗依从性相关的预设目标。冠心病是一种慢性退行性疾病,从急性冠状动脉综合征(ACS)中恢复的患者发生复发事件的风险很高。1 尽管二级预防措施已被证明有效,并得到所有国际指南的强烈推荐,但 2、4、5、6、7、8 项 EUROASPIRE 调查表明,传统危险因素的患病率仍然很高,二级预防措施实施不足,其主要目标往往无法实现。此外,中心和国家之间的二级预防实践存在相当大的差异,尽管心脏预防和康复计划已被证明可随时间降低心血管风险,但使用率仍然很低。9、10 在过去的 10 年中,护士越来越多地参与成功的心血管风险管理,11、12、13. 但尽管这提高了心血管风险水平,但在重大心血管不良事件和死亡率等硬性终点方面并未显示出明显的降低。10.ALLEPRE 试验的目的是评估由门诊和住院护士充分协调的同质、结构化二级预防干预计划在意大利大型艾米利亚-罗马涅地区 ACS 患者的心血管风险特征和主要临床事件方面的益处。

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