FUnctional Testing Underlying REvascularization The FUTURE trial

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1 FUnctional Testing Underlying REvascularization The FUTURE trial Gilles Rioufol, François Roubille, Thibault Perret, Pascal Motreff, Denis Angoulvant, Yves Cottin, Ludovic Meunier,Nathan Mewton, Michel Ovize, Gérard Finet, on behalf of the FUTURE trial investigators, France NCT

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3 Background - Fractional Flow Reserve (FFR) is recommended for guiding PCI in multivessel disease patients eligible for PCI (IIaB)1. - In randomized trial, less than half of patients with angiographically multivessel disease eligible for PCI has actually functional multivessel disease (FFR 0.80) 2 - In registries, FFR modifies PCI revascularization strategy in nearly 4 /10 patients 3 Whether FFR helps to decide among different treatment strategies (PCI or CABG or optimal medical treatment only (OMT)) remains unknown 1 Windecker et al. EHJ 2014;35: Tonino et al. JACC 2010;55: Van Belle et al. Circulation 2014;129:173

4 FUTURE Study Hypothesis In multivessel disease patients, does FFR help to guide treatment strategy (PCI or CABG or medical treatment only) and thereby improve clinical prognosis compared to traditional management? FUTURE Primary Composite Endpoint, at one year All cause mortality + Myocardial Infarction + Repeat revascularization + Stroke - Multicenter, randomized, prospective, open-label, controlled study in 31 french centers Academic Sponsor : Hospices Civils de Lyon - NCT French Health Ministry grant (Programme Hospitalier de Recherche Clinique 2011) Superiority design for 30% lower RRR MACE at 1 year in the FFR group 1728 patients to be recruited (864/group)

5 Study design exclusion criteria STEMI<12h no LAD disease CI to FFR All-comer Patient with stable or stabilized angina Multivx-disease (>50% stenosis) including LAD at the time of angiography Randomisation 1:1 FFR-guided FFR on all target lesions Only lesions with FFR 0.80 included in stratification PCI + OMT CABG + OMT OMT only Angio-guided FFR>0.80 lesions disregarded for TT non-invasive tests allowed All lesions with %S>50 included in stratification PCI + OMT CABG + OMT OMT only

6 Recruitement stop at n=938 patients after DSMB recommendation All-cause death at one year - safety analysis

7 Population - ITT n=937

8 Angio and Functionnal characteristics

9 Treatment decision 12% 12% 79% 71% ad hoc PCI 91% ad hoc PCI 90% 9% 17%

10 Primary endpoint (death MI revasc stroke) at one year - ITT

11 Primary endpoint (death MI revasc stroke) median FU at 2 years - ITT

12 Endpoints at one year - ITT

13 Primary-endpoint: Pre-specified sub-group analysis - ITT Favors FFR Favors control

14 All-cause mortality: exploratory analysis only in death cases

15 Conclusions Place of FFR for treatment strategy decision in multivx-disease? Ø FFR based strategy decreases the rate of revascularization largely dominated by PCI Ø Treatment decision based on FFR in all-comer multivessel-disease patients did not demonstrate any improvement in the primary endpoint at one year. Ø The FUTURE trial was prematurely halted because of an excess of all-cause mortality in the FFR group. Ø Hypothesis to explain this excess of mortality: Lower than expected rate of CABG in multivessel disease patients high rate of PCI in severe patients with Syntax Score >32, high rate of ad hoc PCI

16 Aknowledgments Steering committee: Gilles Rioufol, Lyon Gérard Finet, Lyon Michel Ovize, Lyon Nathan Mewton, Lyon DSMB Jacques Beaune, Lyon Didier Carrié, Toulouse Michel Cucherat, Lyon Coordination Centre d Investigation Clinique, Lyon Biostatistics Muriel Rabilloud, Lyon Primary Investigators Gilles Rioufol, Lyon Nathan Mewton, Lyon François Roubille, Montpellier Thibault Perret, Lyon Pascal Motreff, Clermont-Ferrand Denis Angoulvant, Tours Yves Cottin, Dijon Ludovic Meunier, La Rochelle Pierre Coste, Bordeaux Primary Investigators (con t) Guillaume Cayla, Nîmes Brahim Harbaoui, Lyon Olivier Roth, Mulhouse Eric Van Belle, Lille Christophe Pouillot, la Réunion Loïc Belle, Annecy Jean-François Morelle, Caen François-Xavier Soto, Auxerre Christophe Caussin, Paris Bernard Bertrand, Grenoble Thierry Lefevre, Massy Patrick Dupouy, Melun Pierre-François Lesault, Le Havre Franck Albert, Chartres Olivier Barthelemy, Paris Riadh Rihani, Lomme René Koning, Rouen Laurent Leborgne, Amiens Pierre Barnay, Avignon Philippe Chapon, Valence Sebastien Armero, Marseille Antoine Lafont, Paris Christophe Piot, Montpellier

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18 Population characteristics among treatment arms

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