Abstract
BACKGROUND In patients with ST-elevation myocardial infarction (STEMI) who have multivessel disease, percutaneous coronary intervention (PCI) for nonculprit lesions (complete revascularization) is superior to treatment of the culprit lesion alone. However, whether complete revascularization that is guided by fractional flow reserve (FFR) is superior to an angiography-guided procedure is unclear. METHODS In this multicenter trial, we randomly assigned patients with STEMI and multivessel disease who had undergone successful PCI of the infarct-related artery to receive complete revascularization guided by either FFR or angiography. The primary outcome was a composite of death from any cause, nonfatal myocardial infarction, or unplanned hospitalization leading to urgent revascularization at 1 year. RESULTS The mean (±SD) number of stents that were placed per patient for nonculprit lesions was 1.01±0.99 in the FFR-guided group and 1.50±0.86 in the angiographyguided group. During follow-up, a primary outcome event occurred in 32 of 586 patients (5.5%) in the FFR-guided group and in 24 of 577 patients (4.2%) in the angiography-guided group (hazard ratio, 1.32; 95% confidence interval, 0.78 to 2.23; P = 0.31). Death occurred in 9 patients (1.5%) in the FFR-guided group and in 10 (1.7%) in the angiography-guided group; nonfatal myocardial infarction in 18 (3.1%) and 10 (1.7%), respectively; and unplanned hospitalization leading to urgent revascularization in 15 (2.6%) and 11 (1.9%), respectively. CONCLUSIONS In patients with STEMI undergoing complete revascularization, an FFR-guided strategy did not have a significant benefit over an angiography-guided strategy with respect to the risk of death, myocardial infarction, or urgent revascularization at 1 year. However, given the wide confidence intervals for the estimate of effect, the findings do not allow for a conclusive interpretation. (Funded by the French Ministry of Health and Abbott; FLOWER-MI ClinicalTrials.gov number, NCT02943954.)
| Original language | English |
|---|---|
| Pages (from-to) | 297-308 |
| Number of pages | 12 |
| Journal | The New England Journal of Medicine |
| Volume | 385 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - 22 Jul 2021 |
| Externally published | Yes |
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In: The New England Journal of Medicine, Vol. 385, No. 4, 22.07.2021, p. 297-308.
Research output: Contribution to journal › Article › Research › peer-review
TY - JOUR
T1 - Multivessel PCI guided by FFR or angiography for myocardial infarction
AU - Puymirat, Etienne
AU - Cayla, Guillaume
AU - Simon, Tabassome
AU - Steg, Philippe G.
AU - Montalescot, Gilles
AU - Durand-Zaleski, Isabelle
AU - Le Bras, Alicia
AU - Gallet, Romain
AU - Khalife, Khalife
AU - Morelle, Jean François
AU - Motreff, Pascal
AU - Lemesle, Gilles
AU - Dillinger, Jean Guillaume
AU - Lhermusier, Thibault
AU - Silvain, Johanne
AU - Roule, Vincent
AU - Labèque, Jean Noel
AU - Rangé, Grégoire
AU - Ducrocq, Grégory
AU - Cottin, Yves
AU - Blanchard, Didier
AU - Nelson, Anaïs Charles
AU - De Bruyne, Bernard
AU - Chatellier, Gilles
AU - Danchin, Nicolas
AU - for the FLOWER-MI Study Investigators
N1 - Funding Information: The trial was funded by a grant from the Programme Hospitalier de Recherche Clinique issued by the French Ministry of Health. The trial was sponsored by Assistance Publique–Hôpitaux de Paris, with an unrestricted grant from St. Jude Medical (now Abbott), which provided the coronary pressure guidewires (Radi Medical Systems). None of the funders had a role in the design or conduct of the trial, data collection, or management. The steering committee vouches for the accuracy and completeness of the data and for the fidelity of the trial to the protocol. Funding Information: Dr. Puymirat reports receiving lecture fees from Abbott, Amgen, Bristol Myers Squibb, Biotronik, Daiichi Sankyo, Eli Lilly, and Pfizer, consulting fees, lecture fees, and travel support from AstraZeneca, MSD, and Servier, grant support, consulting fees, and lecture fees from Bayer, and consulting fees and lecture fees from Boehringer Ingelheim, Novartis, and Sanofi; Dr. Cayla, receiving lecture fees from AstraZeneca, Biotronik, Bristol Myers Squibb, Pfizer, Sanofi, and Microport and grant support, paid to his institution, and lecture fees from Medtronic; Dr. Simon, receiving grant support, fees for executive board membership, and lecture fees from AstraZeneca, consulting fees from Ablative Solutions, grant support and advisory board fees from Bayer and Novartis, grant support, fees for board membership, and consulting fees from Sanofi, grant support from Boehringer Ingelheim, Eli Lilly, and GSK; Dr. Steg, receiving grant support and steering committee fees from Amarin, consulting fees and lecture fees from Amgen and Novo Nordisk, consulting fees, lecture fees, and travel support from AstraZeneca, lecture fees and steering committee fees from Bayer and Bristol Myers Squibb, steering committee fees from Boehringer Ingelheim, Idorsia, and Lexicon, consulting fees, steering committee fees, and lecture fees from Novartis, critical event committee fees from Pfizer, grant support and fees for serving as a registry chair from Servier, consulting fees from Myokardia, grant support, fees for serving as trial cochair, and steering committee fees from Sanofi, consulting fees and fees for serving as trial cochair from Regeneron, and holding patent 14/657,192 on alirocumab for cardiovascular risk reduction, licensed to Sanofi; Dr. Montalescot, receiving grant support, lecture fees, and consulting fees from Abbott, Amgen, AstraZeneca, Bayer, Boston Scientific, Bristol Myers Squibb, Servier, Novartis, Quantum Genomics, and Sanofi-Aventis, lecture fees and consulting fees from Boehringer Ingelheim, Cell-Prothera, and Europa, and grant support from COR2ED, CSL Behring, Idorsia, Medtronic, MSD, and Pfizer; Dr. Durand-Zaleski, receiving consulting fees and lecture fees from Boston Scientific and Medtronic; Dr. Motreff, receiving consulting fees and lecture fees from Abbott Vascular; Dr. Lemesle, receiving consulting fees and lecture fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, MSD, Daiichi Sankyo, Eli Lilly, Mylan, Novartis, Novo Nordisk, Pfizer, Sanofi Aventis, and Servier; Dr. Lhermusier, receiving consulting fees and lecture fees from Abbott and Boston Scientific; Dr. Silvain, receiving grant support, lecture fees, and consulting fees from AstraZeneca France, travel support from Abbott Medical France and Terumo France, lecture fees and consulting fees from Bayer HealthCare, Boehringer Ingelheim, BPI France, CSL Behring, Gilead Science, Sanofi Aventis, and Zoll, and owning stock in 4P-Pharma; Dr. Roule, receiving consulting fees and lecture fees from Bristol Myers Squibb and Pfizer; Dr. Ducrocq, receiving consulting fees and lecture fees from Amgen, Janssen, Sanofi, Terumo, and Novo Nordisk and consulting fees, lecture fees, and travel support from AstraZeneca, Bayer, and Bristol Myers Squibb; Dr. Cottin, receiving consulting fees and lecture fees from Servier, Novartis, AstraZeneca, Pfizer, Boehringer Ingelheim, and Bristol Myers Squibb; Dr. De Bruyne, receiving grant support from Abbott Vascular and Boston Scientific and holding equity in Opsens, HeartFlow, GE, Siemens, Edwards Lifesciences, Celyad, Bayer, Sanofi, and Philips; and Dr. Danchin, receiving grant support, consulting fees, lecture fees, and travel support from Amgen, AstraZeneca, Bayer, and Bristol Myers Squibb, lecture fees from Boehringer Ingelheim, Intercept, MSD, and Novartis, grant support, consulting fees, and lecture fees from Sanofi, steering committee fees from Servier, consulting fees from Novo Nordisk and UCB, and critical events committee membership fees from Vifor. No other potential conflict of interest relevant to this article was reported. Funding Information: Supported by a grant from the French Ministry of Health and an unrestricted grant from Abbott . Publisher Copyright: Copyright © 2021 Massachusetts Medical Society.
PY - 2021/7/22
Y1 - 2021/7/22
N2 - BACKGROUND In patients with ST-elevation myocardial infarction (STEMI) who have multivessel disease, percutaneous coronary intervention (PCI) for nonculprit lesions (complete revascularization) is superior to treatment of the culprit lesion alone. However, whether complete revascularization that is guided by fractional flow reserve (FFR) is superior to an angiography-guided procedure is unclear. METHODS In this multicenter trial, we randomly assigned patients with STEMI and multivessel disease who had undergone successful PCI of the infarct-related artery to receive complete revascularization guided by either FFR or angiography. The primary outcome was a composite of death from any cause, nonfatal myocardial infarction, or unplanned hospitalization leading to urgent revascularization at 1 year. RESULTS The mean (±SD) number of stents that were placed per patient for nonculprit lesions was 1.01±0.99 in the FFR-guided group and 1.50±0.86 in the angiographyguided group. During follow-up, a primary outcome event occurred in 32 of 586 patients (5.5%) in the FFR-guided group and in 24 of 577 patients (4.2%) in the angiography-guided group (hazard ratio, 1.32; 95% confidence interval, 0.78 to 2.23; P = 0.31). Death occurred in 9 patients (1.5%) in the FFR-guided group and in 10 (1.7%) in the angiography-guided group; nonfatal myocardial infarction in 18 (3.1%) and 10 (1.7%), respectively; and unplanned hospitalization leading to urgent revascularization in 15 (2.6%) and 11 (1.9%), respectively. CONCLUSIONS In patients with STEMI undergoing complete revascularization, an FFR-guided strategy did not have a significant benefit over an angiography-guided strategy with respect to the risk of death, myocardial infarction, or urgent revascularization at 1 year. However, given the wide confidence intervals for the estimate of effect, the findings do not allow for a conclusive interpretation. (Funded by the French Ministry of Health and Abbott; FLOWER-MI ClinicalTrials.gov number, NCT02943954.)
AB - BACKGROUND In patients with ST-elevation myocardial infarction (STEMI) who have multivessel disease, percutaneous coronary intervention (PCI) for nonculprit lesions (complete revascularization) is superior to treatment of the culprit lesion alone. However, whether complete revascularization that is guided by fractional flow reserve (FFR) is superior to an angiography-guided procedure is unclear. METHODS In this multicenter trial, we randomly assigned patients with STEMI and multivessel disease who had undergone successful PCI of the infarct-related artery to receive complete revascularization guided by either FFR or angiography. The primary outcome was a composite of death from any cause, nonfatal myocardial infarction, or unplanned hospitalization leading to urgent revascularization at 1 year. RESULTS The mean (±SD) number of stents that were placed per patient for nonculprit lesions was 1.01±0.99 in the FFR-guided group and 1.50±0.86 in the angiographyguided group. During follow-up, a primary outcome event occurred in 32 of 586 patients (5.5%) in the FFR-guided group and in 24 of 577 patients (4.2%) in the angiography-guided group (hazard ratio, 1.32; 95% confidence interval, 0.78 to 2.23; P = 0.31). Death occurred in 9 patients (1.5%) in the FFR-guided group and in 10 (1.7%) in the angiography-guided group; nonfatal myocardial infarction in 18 (3.1%) and 10 (1.7%), respectively; and unplanned hospitalization leading to urgent revascularization in 15 (2.6%) and 11 (1.9%), respectively. CONCLUSIONS In patients with STEMI undergoing complete revascularization, an FFR-guided strategy did not have a significant benefit over an angiography-guided strategy with respect to the risk of death, myocardial infarction, or urgent revascularization at 1 year. However, given the wide confidence intervals for the estimate of effect, the findings do not allow for a conclusive interpretation. (Funded by the French Ministry of Health and Abbott; FLOWER-MI ClinicalTrials.gov number, NCT02943954.)
UR - http://www.scopus.com/inward/record.url?scp=85109917036&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa2104650
DO - 10.1056/NEJMoa2104650
M3 - Article
C2 - 33999545
AN - SCOPUS:85109917036
SN - 0028-4793
VL - 385
SP - 297
EP - 308
JO - The New England Journal of Medicine
JF - The New England Journal of Medicine
IS - 4
ER -