BACKGROUND: Previous studies comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with multivessel coronary disease not involving the left main have shown significantly lower rates of death, myocardial infarction (MI), or stroke after CABG. These studies did not routinely use current-generation drug-eluting stents or fractional flow reserve (FFR) to guide PCI. METHODS: FAME 3 (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) is an investigator-initiated, multicenter, international, randomized trial involving patients with 3-vessel coronary artery disease (not involving the left main coronary artery) in 48 centers worldwide. Patients were randomly assigned to receive FFR-guided PCI using zotarolimus drug-eluting stents or CABG. The prespecified key secondary end point of the trial reported here is the 3-year incidence of the composite of death, MI, or stroke. RESULTS: A total of 1500 patients were randomized to FFR-guided PCI or CABG. Follow-up was achieved in >96% of patients in both groups. There was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI compared with CABG (12.0% versus 9.2%; hazard ratio [HR], 1.3 [95% CI, 0.98-1.83]; P=0.07). The rates of death (4.1% versus 3.9%; HR, 1.0 [95% CI, 0.6-1.7]; P=0.88) and stroke (1.6% versus 2.0%; HR, 0.8 [95% CI, 0.4-1.7]; P=0.56) were not different. MI occurred more frequently after PCI (7.0% versus 4.2%; HR, 1.7 [95% CI, 1.1-2.7]; P=0.02). CONCLUSIONS: At 3-year follow-up, there was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI with current-generation drug-eluting stents compared with CABG. There was a higher incidence of MI after PCI compared with CABG, with no difference in death or stroke. These results provide contemporary data to allow improved shared decision-making between physicians and patients with 3-vessel coronary artery disease. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02100722.

• Klíčová slova
• coronary artery bypass, drug-eluting stents, percutaneous coronary intervention,
• MeSH
• cévní mozková příhoda * epidemiologie   etiologie   MeSH
• frakční průtoková rezerva myokardu * MeSH
• infarkt myokardu * MeSH
• koronární angioplastika * škodlivé účinky   MeSH
• koronární bypass škodlivé účinky   MeSH
• lidé MeSH
• následné studie MeSH
• nemoci koronárních tepen * chirurgie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH

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.).

• MeSH
• délka operace MeSH
• délka pobytu MeSH
• frakční průtoková rezerva myokardu * MeSH
• Kaplanův-Meierův odhad MeSH
• kardiovaskulární nemoci epidemiologie   MeSH
• koronární angioplastika škodlivé účinky   metody   MeSH
• koronární bypass * škodlivé účinky   MeSH
• koronární stenóza mortalita   chirurgie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• reoperace MeSH
• senioři MeSH
• stenty MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• hodnocení ekvivalence MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH

AIMS: In the randomized GRAFFITI trial, surgeons drew their strategy based on coronary angiography. When patients were randomized to fractional flow reserve (FFR)-guidance, surgeons were informed of the FFR values and asked to redraw their strategy. The aim of this study was to investigate the changes induced by FFR knowledge. METHODS AND RESULTS: The intended and performed strategy (before and after FFR) were compared. Among 172 patients, 84 with 300 lesions were randomized to the FFR-guided group. The intended strategy was to bypass 236 stenoses:108 with a venous and 128 with an arterial graft. After disclosing FFR, a change in strategy occurred in 64 lesions (21.3%) of 48 (55%) patients. Among 64 lesions for which the intended strategy was medical therapy, 16 (25%) were bypassed after disclosing FFR. The number of procedures with >1 venous graft planned was significantly reduced from 37 to 27 patients (p = .031). The proportion of on-pump surgery was significantly reduced from 71 to 61 patients (p = .006). The rates of clinical events at 1 year were similar between patients with or without at least one change in strategy. DISCUSSION: FFR-guided CABG is associated with a simplified surgical procedure in 55% of the patients, with similar clinical outcomes.

• Klíčová slova
• coronary artery disease, coronary bypass grafts, fractional flow reserve,
• MeSH
• frakční průtoková rezerva myokardu * MeSH
• koronární angiografie MeSH
• koronární bypass škodlivé účinky   MeSH
• koronární stenóza * diagnostické zobrazování   chirurgie   MeSH
• lidé MeSH
• následné studie MeSH
• nemoci koronárních tepen * diagnostické zobrazování   chirurgie   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH

UNLABELLED: Clinical benefit of invasive functionally guided revascularization has been mostly investigated and proven for percutaneous coronary intervention. It has never been prospectively evaluated whether a systematic fractional flow reserve (FFR) assessment is also beneficial in guiding coronary artery bypass graft surgery (CABG). The objective of the GRAft patency after FFR-guided versus angiography-guIded CABG (GRAFFITI) trial was to compare an FFR-guided revascularization strategy to the traditional angiography-guided revascularization strategy for patients undergoing CABG. Patients were enrolled with significantly diseased left anterior descending or left main stem and at least one major coronary artery with angiographically intermediate stenosis (30-90% diameter stenosis) that was assessed by FFR. Thereafter, while the FFR values were kept concealed, cardiac surgeons decided their intended procedural strategy based on the coronary angiography alone. At this point, patients underwent 1:1 randomization to either an FFR-guided or an angiography-guided CABG strategy. In case the patient was randomized to angiography-guided arm, cardiac surgeons kept their intended procedural strategy, i.e., CABG was guided solely on the basis of the coronary angiography. In case the patient was randomized to the FFR-guided arm, FFR values were disclosed to the surgeons who revised the surgical protocol according to the functional significance of each coronary stenosis. The primary endpoint of the trial was the rate of graft occlusion at 12 months, assessed by coronary computed tomography or coronary angiography. The secondary endpoints were (1) length of postoperative hospital stay; (2) changes in surgical strategy depending upon FFR results (in FFR-guided group only); and (3) rate of major adverse cardiac and cerebrovascular events, i.e., composite of death, myocardial infarction, stroke, and any revascularization during the follow-up period. This study is the first prospective randomized trial investigating potential clinical benefits, associated with FFR-guided surgical revascularization. TRIAL REGISTRATION: NCT01810224.

• Klíčová slova
• Coronary angiography, Coronary artery bypass graft surgery, Fractional flow reserve, Graft patency,
• MeSH
• cévní protézy * MeSH
• chirurgie s pomocí počítače metody   MeSH
• frakční průtoková rezerva myokardu fyziologie   MeSH
• jednoduchá slepá metoda MeSH
• koronární angiografie metody   MeSH
• koronární bypass metody   MeSH
• koronární cévy diagnostické zobrazování   patofyziologie   chirurgie   MeSH
• lidé MeSH
• následné studie MeSH
• nemoci koronárních tepen diagnóza   patofyziologie   chirurgie   MeSH
• prospektivní studie MeSH
• průchodnost cév * MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH

BACKGROUND: We hypothesized that fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) would be superior to medical therapy as initial treatment in patients with stable coronary artery disease. METHODS: Among 1220 patients with angiographically significant stenoses, those in whom at least one stenosis was hemodynamically significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus medical therapy or to medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy and were entered into a registry. The primary end point was a composite of death, myocardial infarction, or urgent revascularization. RESULTS: A total of 888 patients underwent randomization (447 patients in the PCI group and 441 in the medical-therapy group). At 5 years, the rate of the primary end point was lower in the PCI group than in the medical-therapy group (13.9% vs. 27.0%; hazard ratio, 0.46; 95% confidence interval [CI], 0.34 to 0.63; P<0.001). The difference was driven by urgent revascularizations, which occurred in 6.3% of the patients in the PCI group as compared with 21.1% of those in the medical-therapy group (hazard ratio, 0.27; 95% CI, 0.18 to 0.41). There were no significant differences between the PCI group and the medical-therapy group in the rates of death (5.1% and 5.2%, respectively; hazard ratio, 0.98; 95% CI, 0.55 to 1.75) or myocardial infarction (8.1% and 12.0%; hazard ratio, 0.66; 95% CI, 0.43 to 1.00). There was no significant difference in the rate of the primary end point between the PCI group and the registry cohort (13.9% and 15.7%, respectively; hazard ratio, 0.88; 95% CI, 0.55 to 1.39). Relief from angina was more pronounced after PCI than after medical therapy. CONCLUSIONS: In patients with stable coronary artery disease, an initial FFR-guided PCI strategy was associated with a significantly lower rate of the primary composite end point of death, myocardial infarction, or urgent revascularization at 5 years than medical therapy alone. Patients without hemodynamically significant stenoses had a favorable long-term outcome with medical therapy alone. (Funded by St. Jude Medical and others; FAME 2 ClinicalTrials.gov number, NCT01132495 .).

• MeSH
• angina pectoris terapie   MeSH
• antihypertenziva terapeutické užití   MeSH
• frakční průtoková rezerva myokardu * MeSH
• infarkt myokardu epidemiologie   prevence a kontrola   MeSH
• inhibitory agregace trombocytů terapeutické užití   MeSH
• Kaplanův-Meierův odhad MeSH
• koronární angioplastika * MeSH
• koronární nemoc farmakoterapie   mortalita   terapie   MeSH
• koronární stenóza farmakoterapie   patofyziologie   terapie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• následné studie MeSH
• opakovaná terapie statistika a číselné údaje   MeSH
• senioři MeSH
• stenty uvolňující léky MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• antihypertenziva MeSH
• inhibitory agregace trombocytů MeSH

BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI), the use of percutaneous coronary intervention (PCI) to restore blood flow in an infarct-related coronary artery improves outcomes. The use of PCI in non-infarct-related coronary arteries remains controversial. METHODS: We randomly assigned 885 patients with STEMI and multivessel disease who had undergone primary PCI of an infarct-related coronary artery in a 1:2 ratio to undergo complete revascularization of non-infarct-related coronary arteries guided by fractional flow reserve (FFR) (295 patients) or to undergo no revascularization of non-infarct-related coronary arteries (590 patients). The FFR procedure was performed in both groups, but in the latter group, both the patients and their cardiologist were unaware of the findings on FFR. The primary end point was a composite of death from any cause, nonfatal myocardial infarction, revascularization, and cerebrovascular events at 12 months. Clinically indicated elective revascularizations performed within 45 days after primary PCI were not counted as events in the group receiving PCI for an infarct-related coronary artery only. RESULTS: The primary outcome occurred in 23 patients in the complete-revascularization group and in 121 patients in the infarct-artery-only group that did not receive complete revascularization, a finding that translates to 8 and 21 events per 100 patients, respectively (hazard ratio, 0.35; 95% confidence interval [CI], 0.22 to 0.55; P<0.001). Death occurred in 4 patients in the complete-revascularization group and in 10 patients in the infarct-artery-only group (1.4% vs. 1.7%) (hazard ratio, 0.80; 95% CI, 0.25 to 2.56), myocardial infarction in 7 and 28 patients, respectively (2.4% vs. 4.7%) (hazard ratio, 0.50; 95% CI, 0.22 to 1.13), revascularization in 18 and 103 patients (6.1% vs. 17.5%) (hazard ratio, 0.32; 95% CI, 0.20 to 0.54), and cerebrovascular events in 0 and 4 patients (0 vs. 0.7%). An FFR-related serious adverse event occurred in 2 patients (both in the group receiving infarct-related treatment only). CONCLUSIONS: In patients with STEMI and multivessel disease who underwent primary PCI of an infarct-related artery, the addition of FFR-guided complete revascularization of non-infarct-related arteries in the acute setting resulted in a risk of a composite cardiovascular outcome that was lower than the risk among those who were treated for the infarct-related artery only. This finding was mainly supported by a reduction in subsequent revascularizations. (Funded by Maasstad Cardiovascular Research and others; Compare-Acute ClinicalTrials.gov number, NCT01399736 .).

• MeSH
• balónková koronární angioplastika metody   MeSH
• frakční průtoková rezerva myokardu MeSH
• infarkt myokardu s elevacemi ST úseků patologie   terapie   MeSH
• Kaplanův-Meierův odhad MeSH
• koronární angioplastika MeSH
• lidé středního věku MeSH
• lidé MeSH
• přežití po terapii bez příznaků nemoci MeSH
• senioři MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH