AMSTERDAM — Complete revascularization improved outcomes over culprit-lesion-only stenting in older Acute Myocardial Infarction (MI) patients, the FIRE trial affirmed.

Among a population ages 75 and older, the composite risk of death, MI, stroke, or any revascularization came out a relative 27% less common when addressing all the stenosed vessels during the same hospitalization (15.7% vs 21.0%, P=0.01), for a number needed to treat on this primary endpoint of just 19.

The main secondary endpoint — a composite of cardiovascular death or new MI — was also less common with complete revascularization than with the culprit-lesion approach (8.9% vs 13.5%, HR 0.64, 95% CI 0.47-0.88), as was mortality alone (9.2% vs 12.8%, HR 0.70, 95% CI 0.51-0.96), with numbers needed to treat of 22 and 27, respectively.

“Probably our practice has to shift from a minimalistic approach to rather complete revascularization guided by physiology also in Older Patients,” said Simone Biscaglia, MD, of Azienda Ospedaliero Universitaria di Ferrara in Italy, during a press conference at the European Society of Cardiology conference. The findings were simultaneously published in the New England Journal of Medicine (NEJM).

Around 20% of older patients (at least age 80) develop MI, but older patients are poorly represented in conventional randomized controlled trials, Biscaglia said. Registry data has shown that the majority of older patients in Western countries have been getting culprit-only treatment, and the proportion is even higher in other developing regions, he told MedPage Today at the press conference.

The findings confirm those from younger populations with multivessel acute MI in trials like COMPLETE, noted Shamir R. Mehta, MD, of the Population Health Research Institute and McMaster University in Hamilton, Ontario, in an accompanying NEJM editorial.

“The reduction in mortality with complete revascularization at 1 year is particularly notable and reinforces the finding that complete revascularization should be considered in all patients presenting with acute myocardial infarction, regardless of age,” he wrote.

At the same time, Mehta added, “it merits consideration that treatment decisions in older patients with acute myocardial infarction should not be based solely on chronologic age. Such patients differ widely with respect to cognitive status, physical ability, and severity of underlying coexisting illnesses.”

“A combination of shared decision making that is informed by evidence from randomized trials and individualized goals of therapy is therefore critical when managing acute myocardial infarction and multivessel coronary artery disease in this vulnerable patient population,” he concluded.

The trial included 1,445 patients (median age 80, 36.5% women) with MI and multivessel disease who were undergoing percutaneous coronary intervention (PCI) of the culprit lesion. They were randomized to receive either physiology-guided complete revascularization of nonculprit lesions or no further revascularization. The trial “strongly suggested” use of sirolimus-eluting, biodegradable polymer, ultrathin Supraflex Cruz stents (approved for use in Europe but not the U.S. market), as the only second-generation drug-eluting stent with data in patients over age 70.

Notably the trial included mainly patients admitted for non-ST-segment elevation MI (NSTEMI, 64.8%).

“Although there are important differences in the initial triage and treatment of patients who present with STEMI as compared with NSTEMI, the data from this trial suggest that older patients benefited to a similar extent from complete revascularization regardless of the presence or absence of ST-segment elevation,” Mehta wrote. “This finding suggests that the underlying mechanism of recurrent events in the two conditions is likely to be more similar than different.”

While the trial showed no safety issues from the complete revascularization strategy compared with a culprit-lesion approach, Biscaglia noted that the trial identified functionally significant nonculprit lesions with wire-based fractional flow reserve (FFR) or angiography-derived physiology (quantitative flow ratio) measurements.

“The idea of the study was to treat the flow limiting lesion because in older patients we have a huge amount of data showing that periprocedural complication are more frequent and more impactful on prognosis,” he said. In the trial, 50% of non-culprit lesions deemed by the operator as visually important and amenable for treatment resulted in a negative physiological assessment.

“So we cannot say that if we would have used angiography-based ‘eyeballing’ PCI, the result would have been the same because we would have overtreated patients in 50% of the vessels or more, and probably the signal we see from the safety here … I cannot say that would have been the same with an angiography-derived PCI,” he added.

Mehta pointed to the large, ongoing COMPLETE-2 trial of physiology-guided versus angiography-guided revascularization to help answer that question. “Intracoronary imaging may have an important role in identifying patients with these high-risk lesions who may be more likely to benefit from revascularization,” he wrote.