Complex PCI Not Without Risk in Elderly Patients With SIHD: Yale Study

Older patients with stable ischemic heart disease (SIHD) who undergo complex PCI are at higher risk of all-cause death by 1 year than are those who undergo noncomplex PCI, according to new observational data. At the same time, these more-challenging cases resulted in less need for repeat revascularization after the initial procedures.

“Older adults have historically been underrepresented in randomized trials, especially [those] that we see clinically, with multimorbidity and frailty and prevalent geriatric syndromes,” said senior author Michael G. Nanna, MD (Yale School of Medicine, New Haven, CT).

Their goal in doing the study, stressed Nanna, was to help operators and their patients know what results to expect when treating people ages 75 and up. “Our purpose was not to generate a comparative effectiveness analysis to assess the treatment effect of complex PCI versus noncomplex PCI. That isn’t really clinically relevant. It’s not feasible with an observational analysis like this. So I think it would be misguided to infer causality related to the procedure,” he explained.

The data also can’t address the question—a controversial one in SIHD—of whether medical therapy or an invasive strategy is better, he added.

“What our results do highlight is that the population of older adults who undergo PCI for stable ischemic heart disease, and especially that undergo complex PCI, have a high all-cause mortality at 1 year, and there are likely unmeasured risk factors for all-cause mortality in this population,” said Nanna.

The implication, he said, is that older age “is just one competing risk that we as clinicians and our patients should include when we’re considering the overall risk-benefit calculus [for] treatment options.”

Writing in an editorial, Rhian E. Davies, DO (WellSpan Health, York, PA), and colleagues agree.

“Because of the exclusion of older, particularly multimorbid and frail older adults from most of our clinical trials, the optimal treatment of CAD in this population is often unclear, but such information is critical to improving their outcomes,” they say. “A patient-centered approach that takes into consideration the patient’s overall condition including comorbidities, functional status, frailty, cognitive skills, and personal preferences should be the goal, with age itself being only one factor.”

Gregory J. Dehmer, MD (Carilion Clinic, Roanoke, VA), commenting on the study for TCTMD, said its methodology is strong and the results are consistent with what many clinicians have experienced firsthand. “I think if you were to ask any interventional cardiologist, ‘How do elderly individuals do?’, they would probably say, ‘Well, they don’t do quite as well.’ That’s my personal experience,” said Dehmer. In this population, he added, "you have to be very thoughtful."

Ultimately, decisions must be individualized, he advised. “Have a discussion with the patient and their family and get their input.”

Mortality Twice as High at 1 Year

Led by Jonathan M. Hanna, MD (Yale School of Medicine), the paper was published recently in the Journal of the American Heart Association.

The researchers analyzed outcomes of 513 patients with SIHD (mean age 81 years; 27.7% female) who underwent PCI in Yale New Haven Health system’s five network hospitals over a nearly 3-year period ending in March 2021. For two-thirds of the patients, the goal of PCI was symptom control.

In all, 44% received complex PCI, defined broadly as “any PCI including a procedure or lesion that may carry inherently elevated risk of complications or PCI failure.” Examples include treatment of multivessel or left main disease, calcified lesions, and chronic total occlusions.

Clinical characteristics such as CVD-related features, noncardiac comorbidities, use of guideline-directed medical therapy, and frailty did not differ between the complex and noncomplex PCI groups.

Compared with patients who received noncomplex PCI, those treated with complex PCI had a lower 1-year risk of target lesion revascularization (2.2% vs 3.5%; adjusted HR 0.32; 95% CI 0.11-0.93) and a similar risk of bleeding (25.3% vs 20.5%; adjusted OR 1.26; 95% CI 0.80-1.98).

It would be misguided to infer causality related to the procedure. Michael G. Nanna

One takeaway from their data, said Nanna, is that it’s “reassuring to clinicians that target vessel patency is pretty good in older adults undergoing PCI, and that’s even if they require more complex, technical approaches.”

Event-free survival—freedom from all-cause death, nonfatal MI, stroke, and major bleeding—was lower in the complex PCI patients (80.4% vs 86.8%), though this relationship was no longer significant when accounting for patient demographics, clinical characteristics, and PCI features (HR 1.38; 95% CI 0.88-2.16).

While the risk of CV death was similar in the two groups, the rate of all-cause death at 1 year was nearly twice as high for complex PCI than for noncomplex procedures (10.2% vs 5.9%). Here the association maintained its statistical significance after adjustment (HR 1.97; 95% CI 1.02-3.79).

‘Holistic Approach’ Needed

“Given the dramatic difference in death risk for older adults receiving complex PCI, we suggest that such interventions in this exceptionally vulnerable population should be approached with additional caution and that further investigations are needed to define causality,” the study authors conclude.

That said, “with an observational design, and without the benefit of adjudication as exists in prospective trials, speculation about the root cause of the higher death risk is limited,” they note.

In their editorial, Davies et al point out that this gap in all-cause death “was seen in the context of there not being any differences between the baseline patient or procedural characteristics and after statistical adjustment,” which suggests there are perhaps as yet unmeasured confounders driving the disparity. Additional studies can inform causality and thus aid in decision-making, they say.

For now, they advise that if older patients are slated for PCI, there needs to be a detailed conversation about risks and benefits. “The benefits include but are not limited to the overall improvement in their quality of life, functional ability, and decrease in symptom burden (which may lessen the need for antianginal medications),” the editorialists note. “Risk assessment should incorporate sociodemographics, signs, symptoms, risk factors, comorbid conditions, and test results.”

Dehmer suggested that a key unknown in this dataset is how patients felt a year after their PCI—did they see a reduction in symptoms and did that improvement last? This information could help inform discussions with patients, he said.

The study results, according to Nanna, are a reminder of “how important it is to take a holistic approach when you’re making treatment decisions with older adults.”

It’s a situation “where these competing risks, which may be unrelated to the procedure itself, can really contribute to the benefits and harms and trade-offs that the patient is going to experience following the procedure,” he concluded.