title: Clinical outcomes of deferred revascularisation using fractional flow reserve in patients with and without diabetes mellitus.
abstract: OBJECTIVE
  Deferred revascularisation based upon fractional flow reserve (FFR >0.80) is associated with a low incidence of target lesion failure (TLF). Whether deferred revascularisation is also as safe in diabetes mellitus (DM) patients is unknown.
  
  
  METHODS
  All DM patients and the next consecutive Non-DM patients who underwent a FFR-assessment between 1/01/2010 and 31/12/2013 were included, and followed until 1/07/2015. Patients with lesions FFR >0.80 were analysed according to the presence vs. absence of DM, while patients who underwent index revascularisation in FFR-assessed or other lesions were excluded. The primary endpoint was the incidence of TLF; a composite of target lesion revascularisation (TLR) and target vessel myocardial infarction (TVMI).
  
  
  RESULTS
  A total of 250 patients (122 DM, 128 non-DM) who underwent deferred revascularisation of all lesions (FFR >0.80) were compared. At a mean follow up of 39.8 ± 16.3 months, DM patients compared to non-DM had a higher TLF rate, 18.1 vs 7.5 %, logrank p ≤ 0.01, Cox regression-adjusted HR 3.65 (95 % CI 1.40-9.53, p < 0.01), which was largely driven by a higher incidence of TLR (17.2 vs. 7.5 %, HR 3.52, 95 % CI 1.34-9.30, p = 0.01), whilst a non-significant but numerically higher incidence of TVMI (6.1 vs. 2.0 %, HR 3.34, 95 % CI 0.64-17.30, p = 0.15) was observed.
  
  
  CONCLUSIONS
  This study, the largest to directly compare the clinical outcomes of FFR-guided deferred revascularisation in patients with and without DM, shows that DM patients are associated with a significantly higher TLF rate. Whether intravascular imaging, additional invasive haemodynamics or stringent risk factor modification may impact on this higher TLF rate remains unknown.
authors.affiliation: Isala Hartcentrum, Docter Van Heesweg 2, Zwolle, The Netherlands.|Diagram CRO, Zwolle, The Netherlands.
authors.forename: Mark W
authors.initials: MW
authors.lastname: Kennedy
authors.affiliation: Isala Hartcentrum, Docter Van Heesweg 2, Zwolle, The Netherlands.
authors.forename: Eliza
authors.initials: E
authors.lastname: Kaplan
authors.affiliation: Isala Hartcentrum, Docter Van Heesweg 2, Zwolle, The Netherlands.
authors.forename: Rik S
authors.initials: RS
authors.lastname: Hermanides
authors.affiliation: Isala Hartcentrum, Docter Van Heesweg 2, Zwolle, The Netherlands.|Diagram CRO, Zwolle, The Netherlands.
authors.forename: Enrico
authors.initials: E
authors.lastname: Fabris
authors.affiliation: Isala Hartcentrum, Docter Van Heesweg 2, Zwolle, The Netherlands.
authors.forename: Veemal
authors.initials: V
authors.lastname: Hemradj
authors.affiliation: Diagram CRO, Zwolle, The Netherlands.
authors.forename: Petra C
authors.initials: PC
authors.lastname: Koopmans
authors.affiliation: Isala Hartcentrum, Docter Van Heesweg 2, Zwolle, The Netherlands.|Diagram CRO, Zwolle, The Netherlands.
authors.forename: Jan-Hank E
authors.initials: JH
authors.lastname: Dambrink
authors.affiliation: Isala Hartcentrum, Docter Van Heesweg 2, Zwolle, The Netherlands.
authors.forename: A T
authors.initials: AT
authors.lastname: Marcel Gosselink
authors.affiliation: Isala Hartcentrum, Docter Van Heesweg 2, Zwolle, The Netherlands.
authors.forename: Arnoud W J
authors.initials: AW
authors.lastname: Van't Hof
authors.affiliation: Isala Hartcentrum, Docter Van Heesweg 2, Zwolle, The Netherlands.
authors.forename: Jan Paul
authors.initials: JP
authors.lastname: Ottervanger
authors.affiliation: Isala Hartcentrum, Docter Van Heesweg 2, Zwolle, The Netherlands.
authors.forename: Vincent
authors.initials: V
authors.lastname: Roolvink
authors.affiliation: Isala Hartcentrum, Docter Van Heesweg 2, Zwolle, The Netherlands.
authors.forename: Wouter S
authors.initials: WS
authors.lastname: Remkes
authors.affiliation: Isala Hartcentrum, Docter Van Heesweg 2, Zwolle, The Netherlands.
authors.forename: Aize
authors.initials: A
authors.lastname: van der Sluis
authors.affiliation: Diagram CRO, Zwolle, The Netherlands.
authors.forename: Harry
authors.initials: H
authors.lastname: Suryapranata
authors.affiliation: Isala Hartcentrum, Docter Van Heesweg 2, Zwolle, The Netherlands. e.kedhi@isala.nl.
authors.forename: Elvin
authors.initials: E
authors.lastname: Kedhi
mesh_terms: D000328:Adult; D000368:Aged; D017023:Coronary Angiography / Q000379:methods; D023921:Coronary Stenosis / Q000150:complications / Q000628:therapy*; D048909:Diabetes Complications / Q000150:complications / Q000503:physiopathology; D003920:Diabetes Mellitus / Q000503:physiopathology; D005260:Female; D053805:Fractional Flow Reserve, Myocardial / Q000502:physiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications / Q000628:therapy*; D009204:Myocardial Revascularization / Q000379:methods; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects; D016896:Treatment Outcome
keywords: Deferred revascularisation; Diabetes mellitus; Fractional flow reserve; Target lesion failure; Target lesion revascularisation