iFR vs FFR for guiding coronary revascularization – DEFINE-FLAIR Justin E Davies, MD, PhD on behalf of the DEFINE-FLAIR investigators Hammersmith Hospital, Imperial College London F unctional L esion A ssessment of I ntermediate stenosis to guide R evascularization
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DEFINE-FLAIR revascularization – coronary iFR vs FFR for ... · iFR vs FFR for guiding coronary revascularization ... • Previous CABG • LMS >50% • Tandem stenosis not ...
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iFR vs FFR for guiding coronary revascularization –DEFINE-FLAIR Justin E Davies, MD, PhD on behalf of the DEFINE-FLAIR investigatorsHammersmith Hospital, Imperial College London
Functional Lesion Assessment of Intermediate stenosis to guide Revascularization
Disclosures
Volcano-Philips Consultant, Research grants, IP royaltiesMedtronic Consultant, Research grantsRECOR Consultant, Research grantsAstra Zeneca Research support
Study supported by an unrestricted educational grant from Volcano-Philips
1. Van de Hoef TP et al. Circ Cardiovasc Interv. 2012;5:508-14; 2. Sen S et al. J Am Coll Cardiol. 2013;61:1409-20; 3. Van de Hoef TP et al. EuroIntervention. 2015;11:914-25; 4. Sen S et al. J Am Coll Cardiol. 2013;62:566; 5. Petraco R et al. Circ. Int. 2014;7:492-502; 6. de Waard G et al. J Am Coll Cardiol. 2014;63:A1692.
iFR and FFR have similar diagnostic power in head-to-head studies
Aims and benefits of DEFINE-FLAIR
Strategy study comparing iFR- and FFR-guided revascularization in real world clinical decision-making
• Imperial College Trials Unit (ICTU)• 100% Clinical Record Form (eCRF) monitoring• On-site case record verification• Screenshot documentation of iFR/FFR traces• Blinding of patients / follow-up teams to study arm
Global recruitment
49 Centers19 Countries
Consort diagram
Patient demographics
* Non-culprit lesions only
Procedural characteristics
FFR value distribution reflecting real world practice of physiology
3%
50%47%
DEFER*583/1250
PCI***625/1250
CABG**42/1250
Treatment allocation with iFR and FFR
2%
45%52%
DEFER*652/1242
PCI***565/1242
CABG**25/1242
iFR FFR
DEFER* p=0.003CABG** p=0.04PCI*** p=0.02
p for comparison between patients randomized to iFR and FFR
Significantly less revascularization based on iFR interrogation
FFR (7.02%)
iFR (6.79%)
Primary endpoint (MACE) iFR equivalent to FFR with less PCI and CABG
FFR (7.02%)
iFR (6.79%)
Primary endpoint (MACE) iFR equivalent to FFR with less PCI and CABG
Sam Lehman Flinders University, Adelaide AustraliaJames Sapontis Monash Heart, Melbourne AustraliaDarren Walters The Prince Charles Hospital, Brisbane AustraliaRavinay Bhindi Royal North Shore Hospital, Sydney AustraliaChristiaan Vrints UZA - Antwerp University Hospital,
AntwerpBelgium
Luc Janssens Imelda Hospital, Bonheiden BelgiumAhmed Khashaba Al Dorrah Heart Care Hospital, Cairo EgyptMika Laine Helsinki University Hospital, Helsinki FinlandOlaf Göing Sana Klinikum Lichtenberg, Berlin GermanyWaldemar
BojaraGemeinschaftsklinikum Mittelrhein, Koblenz
Germany
Florian Krackhardt Charité Universitätsmedizin Berlin, Berlin Germany
Giampaolo Niccoli Catholic University of the Sacred Heart, Rome
Italy
Flavio Ribichini University Hospital Verona, Verona ItalyCiro Indolfi University Magna Graecia, Catanzaro ItalyHiroaki Takashima Aichi Medical University Hospital, Aichi JapanHiroyoshi Yokoi Fukuoka Sanno Hospital, Fukuoka JapanNob Tanaka Tokyo Medical University Hospital, Tokyo JapanYuetsu Kikuta Fukuyama Cardiovascular Hospital,
Fukuyama JapanHitoshi Matsuo Gifu Heart Centre, Gifu JapanAndrejs Erglis Pauls Stradins Clinical Hospital, Riga LatviaSérgio Baptista Hospital Prof. Doutor Fernando Fonseca,
AmadoraPortugal
Pedro Canas Da Silva
Hospital Santa Maria, Lisbon Portugal
Hugo Vinhas Hospital Garcia de Orta, Almada Portugal
Ali Al-Ghamdi King Abdulaziz MedicalCity Cardiac Centre, Riyadh Saudi Arabia
Farrel Hellig Sunninghill Hospital, Johannesburg South AfricaBon-Kwon Koo Seoul National University Hospital, Seoul South KoreaChang-Wook
Nam Keimyung University Dongsan Medical Center, Daegu
South Korea
Eun-Seok Shin Ulsan University Hospital, Ulsan South KoreaJoon-Hyung
Doh Inje University Ilsan Paik Hospital, Goyang-si South Korea
Eduardo Alegria-Barrero
Torrejon University Hospital, MadridSpain
Javier Escaned Hospital Clinico San Carlos, Madrid SpainSalvatore Brugaletta Hospital Clinico Y Provincial, Barcelona SpainMartijn Meuwissen Amphia Hospital, Breda The NetherlandsJan Piek Academic Medical Centre, Amsterdam The NetherlandsNiels Van Royen VU University Medical Center, Amsterdam The NetherlandsMurat Sezer Istanbul University Hospital, Istanbul TurkeyCarlo Di Mario Royal Brompton Hospital, London UKRajesh Kharbanda John Radcliffe Hospital, Oxford UKAndrew Sharp Royal Devon and Exeter University Hospital,
ExeterUK
Bob Gerber Conquest Hospital, St Leonards on Sea UKIqbal Malik Hammersmith Hospital, Imperial College
LondonUK
Kare Tang Basildon University Hospital, Basildon UKSuneel Talwar Royal Bournemouth Hospital, Bournemouth UKHabib Samady Emory University Hospital, Atlanta USAArnold Seto UC Irvine VA/VA Long Beach, Long Beach USARichard Bach Washington University in St Louis, St Louis USAAllen Jeremias Stony Brook Medicine, New York USAJohn Altman Colorado Heart and Vascular, Lakewood USA