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1.
J Am Coll Cardiol ; 78(19): 1875-1885, 2021 11 09.
Article in English | MEDLINE | ID: mdl-34736563

ABSTRACT

BACKGROUND: There is limited evidence that fractional flow reserve (FFR) is effective in guiding therapeutic strategy in multivessel coronary artery disease (CAD) beyond prespecified percutaneous coronary intervention or coronary graft surgery candidates. OBJECTIVES: The FUTURE (FUnctional Testing Underlying coronary REvascularization) trial aimed to evaluate whether a treatment strategy based on FFR was superior to a traditional strategy without FFR in the treatment of multivessel CAD. METHODS: The FUTURE trial is a prospective, randomized, open-label superiority trial. Multivessel CAD candidates were randomly assigned (1:1) to treatment strategy based on FFR in all stenotic (≥50%) coronary arteries or to a traditional strategy without FFR. In the FFR group, revascularization (percutaneous coronary intervention or surgery) was indicated for FFR ≤0.80 lesions. The primary endpoint was a composite of major adverse cardiac or cerebrovascular events at 1 year. RESULTS: The trial was stopped prematurely by the data safety and monitoring board after a safety analysis and 927 patients were enrolled. At 1-year follow-up, by intention to treat, there were no significant differences in major adverse cardiac or cerebrovascular events rates between groups (14.6% in the FFR group vs 14.4% in the control group; hazard ratio: 0.97; 95% confidence interval: 0.69-1.36; P = 0.85). The difference in all-cause mortality was nonsignificant, 3.7% in the FFR group versus 1.5% in the control group (hazard ratio: 2.34; 95% confidence interval: 0.97-5.18; P = 0.06), and this was confirmed with a 24 months' extended follow-up. FFR significantly reduced the proportion of revascularized patients, with more patients referred to exclusively medical treatment (P = 0.02). CONCLUSIONS: In patients with multivessel CAD, we did not find evidence that an FFR-guided treatment strategy reduced the risk of ischemic cardiovascular events or death at 1-year follow-up. (Functional Testing Underlying Coronary Revascularisation; NCT01881555).


Subject(s)
Coronary Artery Bypass , Coronary Artery Disease , Coronary Stenosis , Coronary Vessels , Fractional Flow Reserve, Myocardial/physiology , Percutaneous Coronary Intervention , Postoperative Complications/mortality , Aged , Coronary Angiography/methods , Coronary Artery Bypass/adverse effects , Coronary Artery Bypass/methods , Coronary Artery Disease/diagnosis , Coronary Artery Disease/mortality , Coronary Artery Disease/physiopathology , Coronary Artery Disease/surgery , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/etiology , Coronary Stenosis/surgery , Coronary Vessels/diagnostic imaging , Coronary Vessels/physiopathology , Early Termination of Clinical Trials , Female , Humans , Long Term Adverse Effects/mortality , Male , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Predictive Value of Tests , Risk Assessment/methods , Severity of Illness Index
2.
J Cardiovasc Electrophysiol ; 14(3): 227-33, 2003 Mar.
Article in English | MEDLINE | ID: mdl-12716101

ABSTRACT

INTRODUCTION: The aim of this study was to determine whether impaired adaptation of the QT interval to changes in heart rate predicts sudden death after an acute myocardial infarction. METHODS AND RESULTS: The Groupe d'Etude du Pronostic de l'Infarctus du Myocarde (GREPI) trial was a prospective multicenter study designed to evaluate the long-term outcome of myocardial infarction. QT dynamicity was evaluated in 265 patients by analyzing 24-hour Holter recordings obtained 9 to 14 days after myocardial infarction. The linear regression slope of QT intervals measured to the apex and to the end of the T wave (QTe) plotted against RR intervals was calculated using a dedicated Holter algorithm. The value of QT/RR in predicting sudden death and total mortality was compared with those of ejection fraction, heart rate variability, and late potentials. Mean follow-up was 81 +/- 27 months. There were 73 deaths, of which 23 were sudden. Of all the parameters, an increased diurnal QTe/RR slope (>0.18) was the strongest independent predictor of sudden death (relative risk 6.07, confidence interval 1.48-24.95, P = 0.01). CONCLUSION: Increased diurnal QTe dynamicity is independently predictive of sudden death among patients with myocardial infarction. This simple parameter may help to stratify risk and select patients who may benefit from antiarrhythmic prophylaxis.


Subject(s)
Death, Sudden, Cardiac/etiology , Heart Rate/physiology , Myocardial Infarction/mortality , Aged , Electrocardiography, Ambulatory , Female , Follow-Up Studies , Humans , Male , Middle Aged , Myocardial Infarction/complications , Myocardial Infarction/diagnosis , Myocardial Infarction/physiopathology , Prognosis , Prospective Studies , Risk Assessment , Stroke Volume/physiology , Survival Analysis
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