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Australian GRACE Risk Intervention Study - AGRIS
Contribution To Literature:
The AGRIS trial failed to show that risk stratification (GRACE score) with decision support recommendations was superior to standard of care.
Description:
The goal of the trial was to evaluate risk stratification with the GRACE risk score compared with standard of care among patients with an acute coronary syndrome.
Study Design
- Cluster randomization (at the hospital level)
- Parallel
Patients with acute coronary syndrome were randomized to risk stratification with the GRACE risk score (n = 716) versus standard of care (n = 687).
Among patients alive at hospital discharge with a high GRACE score (>118), a Performance Score (maximum AGRIS score = 3) was calculated, which consisted of:
- Inpatient coronary angiography,
- Use of at least 4 out of 5 of aspirin, P2Y12 inhibitor, statin, beta-blocker, angiotensin-converting inhibitor or angiotensin-receptor blocker), and
- Referral to cardiac rehabilitation.
- Total number of enrollees: 1,403
- Duration of follow-up: 6 months
- Mean patient age: 70 years
- Percentage female: 31%
- Percent with diabetes: 36%
Inclusion criteria:
- Hospital participation in CONCORDANCE ACS Registry
- Hospital willingness to participate in risk stratification with the GRACE risk score
Other salient features/characteristics:
- ST-segment elevation myocardial infarction (STEMI): 36%
- Non-STEMI (NSTEMI): 55%
- Unstable angina: 9%
Principal Findings:
At 4.5 years, the Data Safety Monitoring Board recommended termination of the study based on futility to detect a difference between treatment groups.
The primary outcome, mean Performance Score at hospital discharge, was 2.4 in the GRACE risk stratification group compared with 2.4 in the standard of care group (p = 0.75).
Secondary outcomes:
- Coronary angiography: 91% in the GRACE risk stratification group vs. 85% in the standard of care group (p = 0.01)
- Medication compliance: 74% in the GRACE risk stratification group vs. 75% in the standard of care group (p = 0.79)
- Cardiac rehabilitation referral: 77% in the GRACE risk stratification group vs. 76% in the standard of care group (p = 0.87)
- Cardiovascular death, MI, or hospitalization for heart failure at 6 months: 6.4% in the GRACE risk stratification group vs. 6.8% in the standard of care group (p = 0.86)
Interpretation:
Among patients with an acute coronary syndrome, risk stratification with the GRACE score with decision support recommendations failed to improve a performance measure composed of coronary angiography, use of guideline medications, and referral to cardiac rehabilitation. Hospitals that were randomized to risk stratification had a higher frequency of coronary angiography versus standard of care. However, risk stratification failed to increase medication compliance or referral to cardiac rehabilitation versus standard of care. One-third of participants had a diagnosis of STEMI, where early angiography is not based on risk stratification tools. This may have attenuated the ability of routine risk stratification to detect a difference in performance measures.
References:
Presented by Dr. Derek Chew at the European Society of Cardiology Congress, Paris, France, August 31, 2019.
Keywords: ESC 19, ESC Congress, Acute Coronary Syndrome, Angina, Unstable, Angiotensin Receptor Antagonists, Aspirin, Cardiac Rehabilitation, Cardiology Interventions, Coronary Angiography, Heart Failure, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Medical Futility, Medication Adherence, Myocardial Infarction, Risk Factors, Secondary Prevention, Standard of Care
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