Chew Derek P, Astley Carolyn M, Luker Heather, Alprandi-Costa Bernadette, Hillis Graham, Chow Clara K, Quinn Steve, Yan Andrew T, Gale Chris P, Goodman Shaun, Fox Keith A A, Brieger David
School of Medicine, Flinders University of South Australia, Adelaide, Australia.
School of Medicine, Flinders University of South Australia, Adelaide, Australia; South Australian Department of Health/Flinders University, Adelaide, Australia.
Am Heart J. 2015 Nov;170(5):995-1004.e1. doi: 10.1016/j.ahj.2015.07.032. Epub 2015 Aug 16.
Assessing risk and weighing the potential benefits from evidence-based therapies are essential in the clinical decision making process of optimizing care and outcomes for patients presenting with acute coronary syndromes (ACS). Such practices are advocated in international clinical guidelines of ACS care. While the GRACE risk score (GRS) is a guideline advocated, well-validated risk stratification tool, its utility in improving care and outcomes remains unproven, and its application has been limited in routine clinical practice.
This study will assess the effectiveness using the GRS tool and treatment recommendations during patient assessment on improving the application of guideline-recommended therapies in ACS care.
This study employs a PROBE (prospective cluster [hospital-level] randomized open-label, blinded endpoint) design to evaluate objective measures of hospital performance, with clinical events adjudicated by a blinded event committee. This randomized study is nested within the established CONCORDANCE registry of ACS patients, with existing methods for data collection and monitoring of care and clinical outcomes. The hospital-level intervention is the integration of the GRS into routine ACS patient assessment process. The study will assess the use of early invasive management, prescription of guideline recommended pharmacology and referral to cardiac rehabilitation by hospital discharge; with the key composite clinical endpoint of cardiovascular death, new or recurrent myocardial infarction, in-hospital heart failure or cardiovascular readmission at 12 months. Health economic impacts of risk stratification implementation will also be evaluated. The study will recruit 3000 patients from 30 hospitals.
The AGRIS trial will establish the effect of routine objective risk stratification using the GRACE risk score on ACS care and clinical outcomes.
在优化急性冠状动脉综合征（ACS）患者护理和治疗结果的临床决策过程中，评估风险并权衡循证疗法的潜在益处至关重要。此类做法在ACS护理的国际临床指南中得到提倡。虽然GRACE风险评分（GRS）是指南推荐的、经过充分验证的风险分层工具，但其在改善护理和治疗结果方面的效用仍未得到证实，并且其在常规临床实践中的应用有限。
本研究将评估在患者评估期间使用GRS工具和治疗建议对改善ACS护理中指南推荐疗法应用的有效性。
本研究采用PROBE（前瞻性整群[医院层面]随机开放标签、盲终点）设计来评估医院绩效的客观指标，临床事件由盲法事件委员会判定。这项随机研究嵌套在已建立的ACS患者CONCORDANCE注册研究中，采用现有的数据收集方法以及护理和临床结果监测方法。医院层面的干预措施是将GRS纳入常规ACS患者评估过程。该研究将评估早期侵入性治疗的使用、指南推荐药物的处方以及出院时转介至心脏康复治疗的情况；主要复合临床终点为心血管死亡、新发或复发性心肌梗死、住院期间心力衰竭或12个月内心血管再入院。还将评估实施风险分层的健康经济影响。该研究将从30家医院招募3000名患者。
AGRIS试验将确定使用GRACE风险评分进行常规客观风险分层对ACS护理和临床结果的影响。
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