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