Lack of female-specific data for myocardial revascularization: SCAI

When it comes to myocardial revascularization in women, there are still many unknowns due to lack of data, and the Society for Cardiovascular Angiography and Interventions (SCAI) hopes to accelerate research into the issue by identifying knowledge gaps in a new consensus statement.

Women, especially those who are younger and have STEMI or cardiogenic shock, tend to receive less aggressive treatment than men, and this is thought to contribute to poorer outcomes, Alexandra Lansky, MD (School of Medicine at Yale University, New Haven, CT), chair of the paper’s writing group, told TCTMD.

Additionally, women have historically been underrepresented in clinical studies, and therefore practice guidelines do not contain gender-specific information, Lansky said.

This consensus statement, published online last week in the Journal of the Society of Angiography and Cardiovascular Procedureshighlights what is known and what is not known about myocardial revascularization in the female population in a format mirroring the guideline documents.

“While the guidelines give us general recommendations for both men and women, our consensus focuses on what is known and where the evidence is, so that we can make informed decisions about the best treatment options for women,” said Lansky said. Efforts are already underway to build additional evidence around revascularization in women, “and we hope to encourage more,” she added.

The paper reviews existing sex-specific literature and identifies gaps related to the epidemiology of ischemic heart disease; various diagnostic tools used to guide procedures; revascularization across the spectrum of coronary artery disease; considerations in specific patient populations; device and injury considerations during percutaneous revascularization; and vascular access and health outcomes in women.

Some of the areas identified as lacking information include the true prevalence of obstructive and non-obstructive CAD in women presenting with MI, potential gender differences when various diagnostic tools are used to guide procedures, and choice of CABG or PCI for women with multiple conditions.

Providing an example of a scenario requiring additional data, Lansky noted that the latest U.S. guidelines on myocardial revascularization—published in december—recommend PCI or coronary artery bypass grafting in patients with left main stem or tri-vessel disease and lower SYNTAX scores. However, women made up only 20-25% of patients included in trials informing this advice, and there is evidence that female patients would do better with bypass surgery. “Whether or not this is true is not entirely clear, but we need more randomized data for our patients so we can understand [how to get] the best treatment recommendations and the best outcomes,” Lansky said.

How women with STEMI and shock are managed is another area that needs attention, she pointed out, noting that patients often do not receive adequate treatment. “One of the strong recommendations of this consensus is to better define the care pathways for women where delays or too often the absence of standard treatments are known to worsen the results.

But it’s not all bad, Lansky said, citing evidence from the use of intravascular lithotripsy that indicates women fare better than men, with fewer complications. “We hope to inform and change practices for treating calcified lesions with safer approaches whenever possible,” she said.

In a broader sense, the consensus document is a “call to action” for accelerated access to care for all patients. “It draws attention to differences in outcomes between men and women, disparities in access to care and under-representation [of women] in clinical studies,” Lansky said.

Regarding how this statement might be used, the authors note that “in many clinical scenarios, the level of evidence to support clinical decisions in women is low due to insufficient data”, but adds that “clinicians can use the observations highlighted in this document to guide practice” .

“Until further investigation in women is performed, interventional cardiologists should continue to apply relevant randomized trial evidence to inform clinical judgment and best practice in women undergoing PCI,” advise- they.

In an accompanying editorial, Birgit Vogel, MD (Icahn School of Medicine at Mount Sinai, New York, NY), and colleagues note in a report published last year by a Lancet Commission on Women and Cardiovascular Disease, ischemic heart disease was one of the areas where gender disparities in diagnosis and care were particularly significant.

“Substantial differences between women and men with ischemic heart disease in pathophysiology, clinical presentation, risk factor patterns, quality of care, and outcome are increasingly recognized,” they write. “Therefore, gender-specific considerations in myocardial revascularization as a cornerstone of treatment of ischemic heart disease are of particular interest.”

In this context, “this expert consensus statement is a powerful reminder of how little strong evidence there is on ischemic heart disease and myocardial revascularization in women,” say Vogel et al. “It is, further, a call to action to urgently build the evidence base for gender-specific recommendations, where appropriate, and improve care for women with cardiovascular disease. “