MACE risk after PCI higher for Black vs. white patients
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Black race independently predicted worse outcomes after PCI, according to an analysis of 10 randomized trials that included Black, white, Asian and Hispanic patients.
The analysis, which was published in JACC: Cardiovascular Interventions, found that Black, Hispanic and Asian patients enrolled in these trials had more comorbidities compared with white patients.
“Improving health care and outcomes for minorities is essential, and we are hopeful that our work may help direct these efforts,” Gregg W. Stone, MD, director of academic affairs for the Mount Sinai Heart Health System, professor of medicine (cardiology) and of population health sciences and policy at The Zena and Michael A. Wiener Cardiovascular Institute at Icahn School of Medicine at Mount Sinai, told Healio. “This won’t happen without active concerted efforts to promote change and opportunity, a task for government, regulators, payers, hospital administrators, physicians and all health care providers.”
Trials on coronary artery interventions
Researchers analyzed data from 22,638 patients from 10 prospective, randomized controlled trials focused on coronary artery interventions. Race was either determined by the investigator or self-reported. Comorbidities assessed included CV risk factors and prior cardiac interventions.
Principal outcomes of interest were MI, all-cause death and MACE, defined as a composite of MI, cardiac death or ischemia-driven target lesion revascularization, all of which were assessed at 30 days, 1 year and 5 years.
Of the patients in this analysis, 90.9% were white, 4.1% were Black, 1.8% were Asian and 2.1% were Hispanic.
Angiographic and baseline characteristics were different among groups. Compared with white patients, Black patients were more often younger (59.4 years vs. 62.8 years) and women (42.4% vs. 27.4%), had a higher BMI (31.7 kg/m2 vs. 29.6 kg/m2) and had a higher prevalence of diabetes (42.7% vs. 25%), hypertension (84.6% vs. 67.4%), smoking (33.3% vs. 28.5%) and hyperlipidemia (69% vs. 64.2%).
Hispanic patients, compared with white patients, were more often women (36.8% vs. 27.4%), had a higher BMI (30.3 kg/m2 vs. 29.6 kg/m2) and had a higher prevalence of hypertension (75.9% vs. 67.4%), diabetes (47.4% vs. 25%) and a history of CAD. In contrast, they were less likely to smoke (21.5% vs. 28.5%).
Compared with white patients, Asian patients were less likely to be smokers (20.5% vs. 28.5%), had a lower BMI (25.5 kg/m2 vs. 29.6 kg/m2) and had a higher prevalence of hyperlipidemia (73.8% vs. 64.2%).
At 5 years, MACE occurred in 18.8% of white patients, 23.9% of Black patients (P vs. white patients = .0009), 11.2% in Asian patients (P vs. white patients = .0007) and 21.5% of Hispanic patients (P vs. white patients = .07).
Multivariate analysis determined that Black race was independently associated with increased risk for MACE at 5 years (HR = 1.28; 95% CI, 1.05-1.57).
“Achieving representative proportions of minorities in clinical trials is essential, but has proven challenging,” Stone said in an interview. “We must ensure that adequate numbers of hospitals and providers that are serving these patients participate in multicenter trials. Trust has to be developed so that minority populations have confidence to enroll in studies. Language can be a barrier, requiring translation services and extra time and effort. Involvement of the families and primary care physicians who have an established relationship with patients in clinical trial discussions is useful. For outpatient studies, community outreach may be effective, as seen in the barbershop hypertension trial. Finally, enrollment of ‘non-Hispanic white’ patients can be capped at a certain proportion of the total to ensure adequate enrollment of other racial and ethnic groups.”
‘Crucial and pressing priority’
In a related editorial, Michael G. Nanna, MD, cardiology fellow at Duke University School of Medicine, and Eric D. Peterson, MD, MPH, professor of medicine, Fred Cobb, MD Distinguished Professor of Medicine, core faculty member at Duke-Margolis Center for Health Policy and member in the Duke Clinical Research Institute at Duke University School of Medicine, wrote: “Solving racial health disparities is a crucial and pressing priority for all in health care. The findings from Golomb et al remind us just how large the racial gaps in CVD care and outcomes continue to be. Yet, rather than merely observe these differences over and over again for the next 30 years, there is an urgent need for action to address these both locally and nationally.”
Reference:
For more information:
Gregg W. Stone, MD, can be reached at gregg.stone@mountsinai.org; Twitter: @greggwstone.
Perspective
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Chima Nwaukwa, MD, FACC
The impact of race on CV care and outcomes has been well established in multiple studies. These observed differences have largely been explained by the distribution of CV risk factors in different populations as well as issues related to access to care. This study by Golomb et al highlights the impact of race on patients undergoing PCI, that shows a patient’s race as a prognostic marker above and beyond the traditional risk factors and access to care issues.
This study demonstrated that Black and Hispanic patients had worse angiographic and clinical outcomes after undergoing percutaneous interventions compared with their white counterparts despite having more favorable lesion characteristics at baseline. These observed differences persisted after accounting for the traditional risk factors, which includes diabetes, hypertension, obesity and smoking. Moreover, Black patients were found to have increased mortality after undergoing PCI compared with their white counterparts. However, the cause for the poor angiographic outcomes as well as the increased mortality was not adequately explained in this study.
This study raises more questions than answers at this stage. Further research still needs to be done to figure out what accounts for the increased poor outcomes in the minority population. This would help us understand how to address the imbalance. For instance, is there an unknown genetic marker that affects PCI results in Black patients? More importantly, are minority patients getting the same standard of care compared with their white counterparts? Is this a red flag for possible underlying racism in the delivery of care to minority patients? Seeing that these were prospective, randomized controlled clinical trials, this would not appear to be the case. In terms of relevance to clinical practice, this should raise the awareness for all practicing interventional cardiologists and, indeed, all physicians to make sure that minority patients need to be treated more aggressively to mitigate these poorer outcomes.
There are several limitations to this study that makes the findings more hypothesis-generating rather than conclusive. Even though this was a pooled dataset of randomized controlled studies, these studies were not originally designed to study the impact of race on PCI outcomes. Additionally, there was gross underrepresentation of minorities in these studies, with nearly 91% of all study participants reported as the white race. Consequently, this raises the need for a prospective, randomized clinical trial that is designed to study the effect of race on CV outcomes in patients undergoing PCI.
Randomized clinical trials had historically underrepresented the minority population compared with the white population in their enrollment. There are so many factors that contribute to this disparity. These include bias in trial designs that tend to recruit from large academic centers that may not cater to minority populations, lack of minority study investigators, restricted access to care for minority patients and also perhaps the unwillingness of minority patients to enroll in study trials based on historical trust issues with state-sanctioned unethical studies in the past. There are efforts to address these issues, but there should be a commitment by present and future trial designers to dedicate a percentage of study participation to minority patients that more closely represent their distribution in the general population.
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