PAD Patients’ Views on Decisions and Outcomes Hinge on Sex, Race/Ethnicity: ELEGANCE

WASHINGTON, DC—How patients weigh the opinions of their family and friends when making decisions about PAD varies by sex and race/ethnicity, according to data from a global registry with high concentrations of women and minority groups. The registry also revealed differences in how patients perceived the outcomes of the chosen treatment.

While most people who were queried said their primary-care physician and other doctors were important in their healthcare decisions, women and men differed as to who else they consulted before having a peripheral vascular procedure.

“Female patients are less [likely] to rely on their spouse. Male patients are more likely to look to their spouse, so there are some differences at the gender level in terms of how decisions are made,” said Eric Secemsky, MD (Beth Israel Deaconess Medical Center, Boston, MA), who presented data here last week at TCT 2024 from the first 500 patients enrolled in the ELEGANCE postmarket registry. The patients were all treated with drug-coated devices and completed surveys at baseline, 30 days, and 6 months.

“When we look at this on a background of race and ethnicity, we see that for patients who identify as Hispanic or Asian background, they're more likely to rely on their family support system than on spouses for this decision-making,” he added.

The findings are timely because over the last year scientific statements from the American Heart Association and the Journal of the American College of Cardiology have highlighted the importance of addressing inequities in PAD care.

The ELEGANCE investigators set out to enroll more than 40% women and more than 40% underrepresented minorities, garnering their feedback to gain a better understanding of the patient lived experience of PAD care. By PAD severity, the breakdown of those in the registry is roughly 60% claudicants and 40% with chronic-limb threatening ischemia (CLTI). The 40% goals for both women and unrepresented minorities have already been surpassed.

“We spend a lot of time trying to think about outcomes that are important for the patient, but decision-making also is important to the patient, and this is giving us a look at what shared decision-making looks like at the local level,” Secemsky told TCTMD. “We know there’s misinformation out there, we know there may be some fears of physicians in the vascular space. So, it's time for us as clinicians to own the whole aspect of patient decision-making by ensuring that their questions are answered, that they have the education they need, and they have familiarity with the procedure.”

Differences in Outcome Satisfaction

When asked about clinical information that physicians provided to them that may have influenced the decision to receive interventional treatment, the top three concerns, in order, were how symptoms could be improved, how effective the device is, and how long the treatment benefit would last.

The registry also captures feedback on expectations and satisfaction with the procedure as well as symptoms and recovery.

While 90% or more of patients said their procedure went as expected or better and that they would still have chosen to have it knowing what they know now, 9% to 14% said it went worse than expected, with reasons for that assessment differing between female and male patients.

Compared with men, women were more likely to say their reasons for reporting a worse-than-expected procedure was that it didn’t go as planned. Overall, pain was a predominant driver of worse outcomes at both 30 days and 6 months, with men more likely than women to report more pain than expected.

When questioned about why they would have chosen not to have the procedure knowing what they know now, males were more likely than females to cite lack of symptom improvement (60% vs 54% at 6 months). However, “another reason” was chosen by 46% of females compared with just 13% of males (P = 0.03).

Secemsky said the good news is that about 70% of all patients who completed the assessments reported no pain or only some discomfort starting at the first follow-up at 30 days and continuing through 12 months.  

He noted that one thing he has learned from the registry data and carried into clinical practice when discussing a potential intervention with patients is to ask: “Is everybody here, or should we call anyone who is part of the decision-making process?”

Panelist Jennifer Rymer, MD (Duke University Medical Center, Durham, NC), noted that for the 40% of patients in the registry with CLTI, the decision may not have been as complicated as for those with claudication. She questioned whether the registry captures decisions about medical therapy versus an intervention in that subset.

According to Secemsky, the registry enrolled patients once they were already consented for a drug-coated device intervention.

“So, we lose that ability to really understand what's probably as important or more important—the question of how did we get to the table. And [for] those who didn't get to the table, why aren't they now in a procedure? I think that's important future work,” he added.