番茄社区

As a stricter gatekeeper to nonculprit lesion intervention in people with acute myocardial infarction (MI) going for complete revascularization, fractional flow reserve (FFR) guidance was projected to save medical costs and increase quality of life, according to a prespecified analysis of the FRAME-AMI trial.

The FFR strategy increased quality-adjusted life-years (QALYs) by 0.06 compared with angiography-guided percutaneous coronary intervention (PCI) of non-culprit lesions, and at a cumulative total cost that was $1,208 less per patient, to boot, reported Joo Myung Lee, MD, MPH, PhD, of Samsung Medical Center in Seoul, South Korea, and colleagues in .

FFR was ultimately deemed more cost-effective for people with acute MI and multivessel disease, indicated by the incremental cost-effectiveness ratio of -$19,484 and incremental net monetary benefit of $3,378 between FFR- vs angiography-guided PCI over a time horizon of 4 years.

These findings were consistent across all key subgroups and applied across U.S., Korean, and European healthcare systems in a sensitivity analysis incorporating outside trial data, the investigators noted.

Given the questionable functional significance of some intermediate coronary stenoses viewed with angiography, Lee's team suggested that "routine angiography-guided PCI for all non-IRA [infarct-related artery] lesions with diameter stenosis greater than 50%, even without inducible myocardial ischemia, may be accompanied by unnecessary procedures with additional stents, greater contrast media use, and increased risk of procedure-related complications, which may result in worse long-term patient prognosis."

"In this regard, FFR-guided PCI would reduce unnecessary PCI for functionally insignificant stenosis and would be superior to angiography-guided PCI for patients with stable ischemic heart disease and for those with acute myocardial infarction and multivessel disease," the group wrote.

The main results of FRAME-AMI had strongly favored FFR guidance for deciding which nonculprit lesions to intervene in, in this population with respect to long-term clinical outcomes, in contrast to the FLOWER-MI trial that gave FFR no superiority over angiographic guidance.

Lee's team reported that study participants randomized to FFR guidance underwent PCI for non-IRA lesions in 64.1% of cases, whereas this figure reached 97.1% in the angiography-guided group.

"Of note, deferral of PCI for non-IRA based on FFR provided at least comparable clinical outcomes in the FLOWER-MI trial or superior clinical outcomes in the FRAME-AMI trial compared with angiography-guided PCI," the researchers wrote. "Considering that FFR-guided PCI resulted in much lower rates of non-IRA PCI than angiography-guided PCI in both trials, it should be noted that FFR-guided PCI would save additional medical resources and costs without an apparent safety signal for patient prognosis."

"These cost-effectiveness data are an important addition to the mixed body of evidence in this domain and may tip the scales toward adoption of an FFR-based strategy to achieve complete revascularization and combat rising costs in AMI, although larger trials powered for hard outcomes ... will also play a crucial role in determining the preferred strategy in this evolving clinical paradigm," commented Rushi Parikh, MD, of University of California Los Angeles, and colleagues.

"The consistent cost-effectiveness of FFR-guided complete revascularization in AMI across divergent health care systems is particularly noteworthy and may inform future policies," they wrote in an .

People with left main coronary artery disease or chronic total occlusion in non-IRA lesions had been excluded from FRAME-AMI, however.

The present analysis was based on 562 patients with acute MI and multivessel disease who were randomized to FFR or angiographic guidance of complete revascularization in the FRAME-AMI trial.

Participants averaged 63.3 years of age, and 84.5% were men. The population was split between the 47.2% presenting with ST-segment elevation MI and the 52.8% presenting with non-ST-segment elevation MI.

The number of stents used per patient for non-IRA lesions reached an average of 0.9 in the FFR-guided PCI group and 1.3 in the angiography-guided PCI group (P<0.001).

Among the limitations of the FRAME-AMI cost-effectiveness was its reliance on limited country-level healthcare system data. The study had also been stopped early due to the COVID-19 pandemic.

"The utility of FFR-guided PCI in stable ischemic heart disease is well established, with more than 2 decades of randomized clinical trial data demonstrating its clinical benefit and cost-effectiveness," Parikh's group maintained.

"In the acute MI population, an FFR-guided complete revascularization strategy is associated with improved clinical outcomes compared with an IRA-only revascularization strategy, but whether FFR is superior to angiography alone to achieve complete revascularization remains unclear," the editorialists said.

Lee and colleagues cited ongoing trials in this arena, namely FULL REVASC, OPTION-STEMI, and COMPLETE 2.

Comment