Standardizing STEMI Care Boosts Care, Outcomes for Women

Patrice Wendling

May 10, 2018

A four-step protocol to standardize care of all patients with ST-segment elevation myocardial infarction (STEMI) narrows or eliminates decades-old gaps seen in the care and outcomes of women, new research shows.

After implementation of the protocol at the Cleveland Clinic in Ohio, men and women were on equal footing for administration of guideline-directed medical therapy (GDMT), door-to-balloon time, or any in-hospital adverse event.

Women continued to have higher absolute 30-day mortality, although the difference between the sexes declined from 6.1% to 3.2% after implementation of the protocol, according to the study, published in the May 15 issue of the Journal of the American College of Cardiology.

"These disparities in both care processes and clinical outcomes can be impacted and changed," senior author, Umesh N. Khot, MD, Cleveland Clinic, said in an interview. "I think that's the biggest message — that this is not something that is inevitable due to higher risk."

For decades, studies have shown that women receive less ideal care and have longer door-to-balloon times, leading to higher rates of complications and mortality with STEMI. Interestingly, there are even more reports in the very recent literature that these gaps are persisting and not narrowing as overall care processes in general have gotten better, he said.

Part of the assumption is that these outcomes may be inevitable because women are about 4 years older and tend to be sicker when they present with STEMI, Khot said. However, from an operational standpoint it made sense to drive down care variability through a single STEMI pathway of care. "We also know that men and women benefit in the same way from these treatments, so we really didn't think there needed to be a different pathway for women versus men," he said.

After much groundwork, the 1437-bed Cleveland Clinic hospital and its regional network of 10 hospitals and three freestanding emergency departments (EDs) implemented the four-step STEMI protocol in July 15, 2014. It calls for the following:

  • Catheterization lab activation by the ED physician without requiring a cardiology consultation;

  • Use of a STEMI Safe Handoff Checklist that outlines key roles of ED, cardiology nurses, and physicians; provides guidance on choice and route of GDMT; and notifies the cath lab of factors that may lead to an increased risk for percutaneous coronary intervention (PCI) complications;

  • Immediate transfer to an available cath lab; and

  • Use of the radial artery as the initial strategy.

In contrast, before the protocol:

  • Cath lab activation was made jointly by the ED physician, on-call cardiology fellow, and cath lab physician.

  • Triage and management, including GDMT, varied based on the expertise and preferences of the treating ED and cardiology physicians.

  • Transfers from the ED or an inpatient unit were made after an initial assessment was completed and the cath lab was deemed ready.

  • PCI access was operator-dependent.

For the present analysis, lead author, Chetan P. Huded, MD, Cleveland Clinic, and his colleagues, reviewed data on 1272 patients (32% women) with STEMI treated from January 2011 to July 14, 2014, and from July 15, 2014, to December 2016. During both periods, women were older and had more comorbidities.

Before implementation of the protocol, women received less GDMT than men prior to arterial sheath insertion for primary PCI (68.5% vs 76.7%; P = .019) and prior to completion of primary PCI (93.1% vs 96.7%; P = .028).

After the protocol was put in place, however, the gap between the sexes narrowed for both outcomes (80.1% vs 83.6% [P = .320]; 98.2% vs 97.4% [P = .0525]).

Median door-to-balloon time for women lagged behind men by 8 minutes before the protocol (112 vs 104 minutes; P = .023) and by 2 minutes after the changes were made (91 vs 89 minutes; P = .150).

In terms of in-hospital adverse events, be it stroke, bleeding, or vascular complications, all moved substantially in the right direction, Khot said.

Thirty-day mortality rates improved from 10.7% in women and 4.6% in men before the protocol (P = .002) to 6.5% vs 3.3% after the protocol (P = .09). The study was underpowered to show a definitive difference in mortality, although 1- and 2-year follow-up is being examined to see whether the benefit persists, he said.

"What we were able to show, probably for one of the first times in the literature, is that if you have a very strong, structured process for this protocol then these differences in care processes go away," Khot said. "There really was no difference in medication administration and no difference in door-to-balloon time. These we think then led to improvements in outcomes and again, because women were higher risk, they tended to have a greater improvement in complications and in mortality."

Khot said he is frequently asked which of the four processes is most important but says the full portfolio is needed because it's not possible to predict when a patient shows up what they're going to benefit from. Admittedly, having an in-house cath lab at the ready may not be possible at smaller community hospitals, but he noted that the team previously reported that in-house critical care nursing can provide a bridge.

"There can be local adaptations and a little bit different models that still get to the same point that patients should not wait in the emergency department for the cath lab to be ready," he said. "How you do that, you can come up with a lot of different ways, different sizing, different resources. It doesn't have to be one size fits all."

"Bias, Not Biology"

Even with the size and scope of the Cleveland Clinic, Khot said it still requires constant re-education and constant reinforcement to sustain the gains made for women. Asked whether current movements such as #TimesUp or #MeToo may provide greater motivation or prospects for full equity in care, he said it remains to be seen.

"In the context of what's changing in society overall, the message I would say is that this is the first step to action, to actually do something," Khot said. "We could have just reported the same disparities that we saw in the beginning, but back in 2014, actually before all of this, we worked to address them, to fix them. It is now time to not just look at these and just say, 'Oh well, this is the way it is,' but to work to change the care so that all patients but in this case, particularly women, benefit from this."

In an accompanying editorial, J. Dawn Abbott, MD, Brown Medical School, Providence, Rhode Island, and Jeptha P. Curtis, MD, Yale University School of Medicine, New Haven, Connecticut, write, "Health care disparities manifest as differences in quality of care and outcomes that are not related to the appropriateness of an intervention, clinical need, or patient preference. In short, disparities reflect bias, not biology."

They point out that otherwise highly successful efforts to improve the quality of care for the entire population have had an inconsistent impact on sex disparities. Closer scrutiny of the present study, however, provides additional opportunities to decrease disparities.

For example, door-to-balloon times for interhospital transfers, a STEMI performance measure that accounted for more than two thirds of the population, were significantly shorter in men and women after the intervention. Sex differences in nonsystem delay in PCI also resolved after the intervention. Both measures are known to be more common in women and independently associated with inhospital mortality.

"These examples emphasize the importance of surveilling for disparities in quality of care among key patient subgroups. However, this information is not always easy to find, measure, or act upon," the editorialists write. "At present, neither the quarterly benchmark reports nor the online dashboards of the National Cardiovascular Data Registry CathPCI provide information on disparities. Similarly, information on the presence and extent of disparities is notably absent from public reporting efforts such as Hospital Compare."

Abbott and Curtis acknowledge victories, such as the National Institutes of Health requirement that female cells and animals be included in preclinical studies, but also call out the lack of diversity in race and sex in cardiology. The American College of Cardiology (ACC) Task Force on Diversity aims to change the culture to be more inclusive and equitable, but "Ultimately, multiple strategies will need to be brought to bear to close the gender gap in cardiovascular care," they conclude.

The funding source was unrestricted philanthropic support to the Heart and Vascular Institute Center for Healthcare Delivery Innovation, Cleveland Clinic. Khot reports having served as a consultant for AstraZeneca. Abbott is the chair of the ACC Cath PCI Research and Publication Committee. Curtis receives support from the ACC and the Centers for Medicare & Medicaid Services.

J Am Coll Cardiol. 2018;71:2122-2132. Article, Editorial

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