An introduction to the Global Registry of Acute Coronary Events: GRACE

An introduction to the Global Registry of Acute Coronary Events: GRACE
Description:
Acute coronary syndromes, which comprise AMI, non-Q-wave MI and UA, are a major cause of mortality and morbidity in the western world. Each year, approximately 6.3 million people worldwide suffer an AMI, up to 25% of whom die as a result. In the USA in 1995, over 2 million patients were admitted to hospital with AMI, and more than 250 000 others died within 1 hour of the onset of symptoms, before they could reach a hospital. Despite the importance of ACS in public health terms, and the escalation of research efforts into UA and non-Q-wave MI, remarkably little reliable data are available about the prevalence and routine management of ACS. Much of the existing data originate from clinical trials or are restricted by geographic region, and the patients do not represent the population as a whole. Furthermore, it is difficult to compare clinical trials because inclusion criteria and definitions of UA vary from one study to the next. There is therefore a need for an international observational registry covering the full spectrum of ACS, to allow comparison of management practices and outcomes of patients hospitalized with ACS at the local, national and multinational level. Registry studies Several registry studies have been conducted in patients with UA and AMI (Table). The MONICA Project sponsored by the World Health Organization, has produced valuable data from across the world, but is restricted to patients with AMI. 1,2 The OASIS registry included patients with UA and non-Q-wave MI from 95 hospitals in six countries. 3 However, the centers participating in this study were not representative of the countries as a whole. The PRAIS-UK study examined data from patients with UA or NSTEMI at 56 hospitals in the UK. 4,5 Data from throughout Europe have also been collected by the ENACT survey. 6 This registry was designed to provide a snapshot, based on patients admitted over a 7-day period, and no longitudinal data were collected. None of the registry studies of patients with UA or non-Q-wave MI have provided insight into the various therapeutic options used, the relationship between the process of care and outcomes, or the clinical decision-making process. Furthermore, data from randomized clinical trials cannot be extrapolated to the real-world population because trials are, by their very nature, selective, and patients known to be at high risk are often excluded. GRACE The GRACE study is a multinational, prospective, observational study of clinical management practices and patient outcomes across the full spectrum of ACS. By describing treatment practices and providing data to cardiologists, GRACE aims to enhance understanding of patient management and outcomes, both on an individual hospital level and from a global perspective. Study design GRACE uses a unique cluster design to ensure that the registry reflects the sociodemographic makeup of the community. Each cluster represents a population of 150 000300 000, and the total enrollment target is 10 000 patients per year. The feasibility of this design was validated in a pilot study involving 18 cluster sites, five in the USA and 13 in Europe, Argentina, Brazil and Australia. Approximately 100 hospitals from 14 countries take part in the full study. GRACE is an observational study, collecting data on real-life patient management, with the patients physician determining the type of treatment administered. Patients aged over 18 years are eligible for enrollment, and participating hospitals are required to enroll the first 20 consecutive patients each month who meet the inclusion criteria. Individuals who are transferred from another hospital or from a registry hospital to another hospital within 24 hours of the onset of symptoms are included. At centers adopting a community-based approach to the study, only patients residing within a specified geographic area are eligible for inclusion. An introduction to the Global Registry of Acute Coronary Events: GRACE K.A.A. Fox Department of Cardiology, The Royal Infirmary of Edinburgh, Edinburgh, Scotland, UK Eur Heart J 2000; 2 (suppl F): F214. GRACE MANUSCRIPTS Data collection Information relating to demographic characteristics, medical history, time of presentation, presenting symptoms, clinical and treatment characteristics and in-hospital outcomes are collected by trained study coordinators. The case report form includes information collected during the patients stay in various hospital departments. In some cases data may be collected at discharge, using hospital records. Patients are followed up approximately 6 months after discharge from hospital to provide information about specific longer-term outcomes. Conclusions GRACE is the first large observational registry to collect data on the full spectrum of patients with ACS from a multinational perspective. With data collected each year from around 10 000 ACS patients, GRACE has the potential to contribute greatly to our understanding of current management practices and outcomes. Furthermore, by providing a benchmark for current practice, GRACE will allow clinicians to measure the impact of randomized clinical trial results on future patterns of clinical practice. References 1. WHO MONICA Project Principal Investigators. The World Health Organization MONICA Project (monitoring trends and determinants in cardiovascular
disease): a major international collaboration. J Clin Epidemiol 1988; 41:
10514. 2. Tunstall-Pedoe H, Kuulasmaa K, Amouyel P, et al. Myocardial infarction and coronary deaths in the World Health Organization MONICA project.
Registration procedures, event rates, and case-fatality rates in 38 populations
from 21 countries in four continents. Circulation 1994; 90: 583612. 3. Yusuf S, Flather M, Pogue J, et al. for the OASIS (Organisation to Assess Strategies for Ischaemic Syndromes) Registry Investigators. Variations
between countries in invasive cardiac procedures and outcomes in patients
with suspected unstable angina or myocardial infarction without initial ST
elevation. Lancet 1998; 352: 50714. 4. Collinson J, Flather M, Wright A, et al. Markers of risk in patients with unstable angina and MI without ST elevation: UK Prospective Registry of
Acute Ischaemic Syndromes (PRAIS-UK) [abstract]. Eur Heart J 1999; 20
(suppl): P1561. 5. Flather M, Collinson J, Wright A, et al. Practice patterns for unstable angina and MI without ST elevation: U.K. Prospective registry of acute ischaemic
syndromes (PRAIS-UK) [abstract]. Eur Heart J 1999; 20 (suppl): P2235. 6. Fox KAA, Cokkinos DV, Decker J, et al., for the ENACT Investigators. The ENACT study: a pan-European survey of acute coronary syndromes. Eur Heart
J 2000; 21: 14409. 7. Maynard C, Weaver WD, Lambrew C, et al. for the Participants in the National Registry of Myocardial Infarction. Factors influencing the time to
administration of thrombolytic therapy with recombinant tissue plasminogen
activator (data from the National Registry of Myocardial Infarction). Am J
Cardiol 1995; 76: 54852. 8. Barron HV, Bowlby LJ, Breen T, et al. Use of reperfusion therapy for acute myocardial infarction in the United States: data from the National Registry of
Myocardial Infarction 2. Circulation 1998; 97: 11506. GRACE MANUSCRIPTS Table. Characteristics of registry studies in UA and AMI Registry Clinical Number Number of Period of Limitations target of centers countries interest ENACT 6 UA or MI 389 29 In-hospital No longitudinal data GRACE UA or MI 100 17 In-hospital, 6 months after discharge MONICA 2 MI 38 21 28 days Restricted to AMI patients NRMI 7,8 STEMI 1073 USA only In-hospital Restricted to USA and STEMI patients OASIS 3 UA or 95 6 In-hospital and Not population-based NSTEMI 6 months PRAIS- UA or 56 UK only In-hospital Restricted to UK UK 4,5 NSTEMI
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