Acute coronary syndrome (ACS) patients did not receive better care when high-performing hospitals implemented routine GRACE risk assessment to guide clinical treatment, the AGRIS trial suggested.
In the cluster-randomized trial of 24 hospitals without a preexisting risk stratification decision support system for patients with ACS, similarly higher-than-expected rates of adherence with guideline recommendations were seen with both implementation and usual care, according to researchers led by Derek Chew, MBBS, MPH, PhD, of Flinders University in Adelaide, Australia.
Hospitals in the intervention group achieved three aspects of guideline-recommended clinical care for 59.9% of ACS patients versus a rate of 55.2% in the usual care hospitals (OR 1.04, 95% CI 0.63-1.71), Chew and colleagues reported in their study published online in JAMA Cardiology.
The intervention consisted of hospitals adopting routine GRACE risk stratification, using a worksheet for each patient, along with decision support recommendations.
However, the AGRIS trial had limited power to detect a difference due to low event rates and premature study discontinuation.
“There were no specific hospital-level or patient-level characteristics that substantially influenced the effect of routine objective risk stratification on the provision of overall care, although there was a modest and unexplained interaction between the use of the GRS [Grace risk score] and poorer adherence to guideline-recommended care and female sex,” the investigators noted.
European Society of Cardiology guidelines recommend the GRACE risk score to guide ACS treatment, given that it has been shown to be superior to other risk models.
“While there has been a proliferation of risk scores guiding clinical treatment in cardiovascular care, to our knowledge, this study is the first to prospectively evaluate the effect of risk scoring on the use of guideline-recommended care and clinical outcomes in patients with ACS,” study authors asserted.
“The true test of routine risk stratification may require the conduct of similar trials in acute environments without ready access to cardiac clinical expertise,” according to them.
Only one out of the three individual components of the performance measure gave an advantage to the GRACE risk score intervention over usual care: early invasive treatment (91.8% vs 83.6%, OR 2.26, 95% CI 1.30-3.96).
Results didn’t differ significantly between groups for the other components: prescription of four of five guideline-recommended pharmacotherapies (about 77% in both) and cardiac rehabilitation (75% vs 73%).
“The GRS’s greatest utility may reside in crystallizing the risk-benefit decisions for the near-term outcomes associated with early angiography. This is perhaps unsurprising because the decision for invasive vs conservative treatment among lower-risk patients is subject to the greatest variation in physician’s risk-benefit perception and practice,” Chew’s group said.
“In contrast, the lack of effect of risk stratification on decisions to prescribe secondary prevention pharmacotherapies and referral to cardiac rehabilitation may be anticipated because therapeutic interventions are expected to improve long-term outcome regardless of baseline risk. Hence, the GRS does not offer a decision threshold advocating the use or withholding of these therapies,” the group reasoned.
Checklists and other reminder tools might have greater value optimizing such care, the authors suggested.
They also reported that centers randomized to the intervention arm had no significant reduction in the composite of all-cause death or MI (9.2% vs 13.4%, OR 0.66, 95% CI 0.38-1.14).
Yet “risk stratification may still have a role” in ACS survival, argued Robert Harrington, MD, of Stanford University, California, and E. Magnus Ohman, MBBS, of Duke University in Durham, North Carolina.
In an accompanying editorial, the pair pointed out that all-cause mortality trended numerically lower with the intervention in the overall cohort at 12 months (5.2% vs 8.0%) and was significantly reduced in the high-risk subgroup (4.5% vs 8.8%, P=0.03).
“The limited sample size and early termination prevent us from making a conclusive statement on mortality, but the findings are intriguing,” Harrington and Ohman said.
Moreover, the editorialists suggested that the researchers did themselves no favors by including in the study patients with ST elevation, who commonly get primary percutaneous coronary intervention regardless of risk score. The non-ST elevation group is more likely to benefit from risk stratification, they argued.
AGRIS was conducted at hospitals with continual onsite emergency and cardiology services. All had cardiology services, cardiac catheterization laboratories, echocardiographic capability, and cardiology training programs. Participating hospitals contributed a median 89 patients each.
In total, there were 2,318 patients hospitalized with ST-segment elevation or non-ST-segment elevation ACS (median age 65 years, 29.5% women) included in the study. They were enrolled from June 2014 to March 2018.
Chew’s team acknowledged that they could not be certain that physicians at control institutions did not access GRACE risk calculators independently.
The study was funded by an unrestricted grant from AstraZeneca.
Chew also reported grants from Edwards Lifesciences.
Harrington is immediate past president and current member of the board of directors of the American Heart Association.
Ohman had no disclosures.