Source / Disclosures
Puymirat E et al. Joint American College of Cardiology / New England Journal of Medicine Late Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Session; May 15-17, 2021 (virtual meeting).
Disclosures: The study was sponsored by Assistance Publique-HÃ´pitaux de Paris, with an unrestricted grant from Abbott, who provided the coronary pressure guidewire (Radi Medical Systems). Puymirat reports that he received research grant / support from Abbott / St. Jude Medical and Bayer and conference and / or consultant fees from Abbott, Amgen, AstraZeneca, Bayer, Biotronik, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, Merck Sharpe & Dohme, Novartis, Pfizer, Sanofi and Servier. Please see the study for relevant financial information from all other authors.
Among STEMI patients who underwent complete revascularization, a fractional flow reserve-guided strategy did not improve outcomes compared to an angiography-guided strategy, according to the results of the FLOWER-MI trial.
Researchers randomly assigned 1,171 patients (mean age, 62 years; 83% male) who had STEMI and multivascular disease and who underwent successful culprit artery PCI to receive either an FFR-guided or guided-guided strategy. angiography for complete revascularization. Etienne Puymirat, MD, PhD, Professor of Cardiology at the University of Paris and Director of the ICU of Cardiology at the Georges Pompidou European Hospital, presented the results, which were simultaneously published in The New England Journal of Medicine, at the scientific session of the American College of Cardiology.
Previous studies have determined that FFR-guided PCI is superior to angiography-guided PCI in patients with chronic coronary syndromes, and that FFR-guided and angiography-guided strategies for complete revascularization are superior to a strategy. treatment only by culprit lesion in patients with STEMI and multivascular disease, but FLOWER-MI was needed “to determine whether FFR-guided complete revascularization results in better clinical outcomes compared to angiography-guided complete revascularization in STEMI patients with multivascular disease, âPuymirat said during his presentation.
Operators opted for staged procedures in 96% of both groups, he said.
In the angiography-guided group, the average number of stents placed in non-cervical lesions was 1.5, while in the FFR-guided group, it was 1.01, according to the researchers.
The main outcome of all-cause death, myocardial infarction, or unplanned hospitalization leading to urgent revascularization at 1 year occurred in 5.5% of patients in the FFR group versus 4.2% of those in the angiography group (HR = 1.32; 95% CI, 0.78-2.23; P = 0.31), said Puymirat during his presentation.
There was also no difference in all-cause deaths (FFR, 1.5%; angiography, 1.7%; HR = 0.89; 95% CI, 0.36-2.2), Non-fatal MI (FFR, 3.1%; angiography, 1.7%; HR = 1.77; 95% CI, 0.82-3.84) or unplanned hospitalization leading to urgent revascularization (FFR, 2, 6%; angiography, 1.9%; HR = 1.34; 95% CI, 0.62-2.92) at 1 year, according to the researchers.
At 1 year, Puymirat said, there was no difference between groups in stent thrombosis, any revascularization, hospitalization for IC, recurrent ischemia, hospitalization for recurrent ischemia, life years adjusted for quality or number of antianginal drugs used, but the FFR group had a higher rate of CV-related hospitalization (11.6% vs. 8%; HR = 1.49; 95% CI, 1.03-2.17).
The adjusted costs at 1 year were higher in the FFR group than in the angiography group (P
“In patients with STEMI and multivascular disease … the event rate at 1 year is very low,” he said. “FFR-guided PCI of non-infarct-related lesions does not reduce the risk of a composite outcome … compared to angiography-guided PCI.”
In a discussion after the presentation, William Fearon, MD, professor of medicine and director of interventional cardiology at Stanford University School of Medicine and chief of the cardiology section of the VA Palo Alto healthcare system, questioned whether the study was insufficient.
âBoth groups of patients suffered from STEMI treated with primary PCI, which is probably the most important predictor of future adverse events,â he said. âWe don’t expect a difference between the two groups from there. In the FFR group, 55% had a positive non-cervical lesion, and 66% actually had PCI of a non-cervical lesion, meaning that all of these patients were treated the same as the angio-guided patients. Therefore, we also do not expect a difference in the results. This means that only about a third of the patients guided by FFR, or about 200 patients, did not receive brainless PCI, and therefore, it is only in this small group that we might expect a difference in the results of the angio-guided group. Also, it looks like you were expecting an almost twice as high event rate with the angio-guided group, at 15% vs. 9.5% … I wonder if that was a little too optimistic.
Puymirat said the study was designed in 2015 based on event rates from data available at that time.