Fractional flow reserve–guided PCI as compared with coronary bypass surgery

Autor: Filip Casselman, Kreton Mavromatis, Adel Aminian, Gintaras Kalinauskas, Victoria Y. Ding, Philip MacCarthy, Nawwar Al-Attar, Bernard De Bruyne, Nico H.J. Pijls, Oskar Angerås, Giedrius Davidavičius, Y. Joseph Woo, Di Lu, Petr Kala, Jan-Henk E. Dambrink, Nikolaos Östlund-Papadogeorgos, Michael J. Reardon, Laszlo Szekely, Jaydeep Sarma, Manisha Desai, Keith G. Oldroyd, Kenneth W. Mahaffey, Rajesh Kharbanda, Pim A.L. Tonino, Albert H.M. van Straten, Nils Witt, Nikola Jagic, Evald Høj Christiansen, Fame Study Investigators, Zsolt Piroth, William F Fearon, Mark A. Hlatky, Samer Mansour, Steven E S Miner, Alan C. Yeung, Yuhei Kobayashi, Frederik M. Zimmermann, Thomas Engstrøm, Olaf Wendler
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Reoperation
Male
medicine.medical_specialty
CLINICAL-OUTCOMES
EVEROLIMUS-ELUTING STENTS
Coronary Artery Bypass/adverse effects
medicine.medical_treatment
Operative Time
UNIVERSAL DEFINITION
Fractional flow reserve
Kaplan-Meier Estimate
030204 cardiovascular system & hematology
ANGIOGRAPHY
Coronary artery disease
03 medical and health sciences
0302 clinical medicine
Internal medicine
medicine
Humans
030212 general & internal medicine
Myocardial infarction
cardiovascular diseases
Stroke
Coronary Stenosis/mortality
Percutaneous Coronary Intervention/adverse effects
Aged
FAME 3 TRIAL
GRAFT-SURGERY
business.industry
Cardiovascular Diseases/epidemiology
Hazard ratio
Percutaneous coronary intervention
General Medicine
Length of Stay
Middle Aged
medicine.disease
3. Good health
Fractional Flow Reserve
Myocardial

surgical procedures
operative

Bypass surgery
Conventional PCI
Cardiology
REVASCULARIZATION
Female
Stents
business
INTERVENTION
Zdroj: Fearon, W F, Zimmermann, F M, de Bruyne, B, Piroth, Z, van Straten, A H M, Szekely, L, Davidavičius, G, Kalinauskas, G, Mansour, S, Kharbanda, R, Östlund-Papadogeorgos, N, Aminian, A, Oldroyd, K G, Al-Attar, N, Jagic, N, Jan-Henk, E D, Kala, P, Angerås, O, MacCarthy, P, Wendler, O, Casselman, F, Witt, N, Mavromatis, K, Miner, S E S, Sarma, J, Engstrøm, T, Christiansen, E H, Tonino, P A L, Reardon, M J, Lu, D, Ding, V Y, Kobayashi, Y, Hlatky, M A, Mahaffey, K W, Desai, M, Woo, Y J, Yeung, A C, Pijls, N H J & for the FAME 3 Investigators 2022, ' Fractional flow reserve–guided PCI as compared with coronary bypass surgery ', New England Journal of Medicine, vol. 386, no. 2, pp. 128-137 . https://doi.org/10.1056/NEJMoa2112299
FAME 3 Investigators 2022, ' Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery ', The New England Journal of Medicine, vol. 386, no. 2, pp. 128-137 . https://doi.org/10.1056/NEJMoa2112299
DOI: 10.1056/NEJMoa2112299
Popis: BACKGROUND: Patients with three-vessel coronary artery disease have been found to have better outcomes with coronary-artery bypass grafting (CABG) than with percutaneous coronary intervention (PCI), but studies in which PCI is guided by measurement of fractional flow reserve (FFR) have been lacking.METHODS: In this multicenter, international, noninferiority trial, patients with three-vessel coronary artery disease were randomly assigned to undergo CABG or FFR-guided PCI with current-generation zotarolimus-eluting stents. The primary end point was the occurrence within 1 year of a major adverse cardiac or cerebrovascular event, defined as death from any cause, myocardial infarction, stroke, or repeat revascularization. Noninferiority of FFR-guided PCI to CABG was prespecified as an upper boundary of less than 1.65 for the 95% confidence interval of the hazard ratio. Secondary end points included a composite of death, myocardial infarction, or stroke; safety was also assessed.RESULTS: A total of 1500 patients underwent randomization at 48 centers. Patients assigned to undergo PCI received a mean (±SD) of 3.7±1.9 stents, and those assigned to undergo CABG received 3.4±1.0 distal anastomoses. The 1-year incidence of the composite primary end point was 10.6% among patients randomly assigned to undergo FFR-guided PCI and 6.9% among those assigned to undergo CABG (hazard ratio, 1.5; 95% confidence interval [CI], 1.1 to 2.2), findings that were not consistent with noninferiority of FFR-guided PCI (P = 0.35 for noninferiority). The incidence of death, myocardial infarction, or stroke was 7.3% in the FFR-guided PCI group and 5.2% in the CABG group (hazard ratio, 1.4; 95% CI, 0.9 to 2.1). The incidences of major bleeding, arrhythmia, and acute kidney injury were higher in the CABG group than in the FFR-guided PCI group.CONCLUSIONS: In patients with three-vessel coronary artery disease, FFR-guided PCI was not found to be noninferior to CABG with respect to the incidence of a composite of death, myocardial infarction, stroke, or repeat revascularization at 1 year. (Funded by Medtronic and Abbott Vascular; FAME 3 ClinicalTrials.gov number, NCT02100722.).
Databáze: OpenAIRE