2-Year Outcome Data From

DEFINE-FLAIR and
Swedeheart: A Critical
Appraisal
Matthias Götberg, MD, PhD
 Disclosure Statement of Financial Interest

I, (insert name) DO NOT have a financial interest/arrangement

or affiliation with one or more organizations that could be
perceived as a real or apparent conflict of interest in the context
of the subject of this presentation.
 Disclaimer

2-year DEFINE-FLAIR data is to be presented tomorrow

I don’t know the outcome

 Study design
Patients with a clinical
indication for physiology
Define-Flair guided lesion assessment
iFR-Swedeheart
 iFR-SWEDEHEART
Primary Endpoint at 12 months
(Death, MI, Unplanned revascularization)

N=2019

iFR (6.7%)
FFR (6.1%)

HR = 1.12 (95% CI: 0.79, 1.58)

P=0.53

Götberg, M et al, N Engl J Med. 2017, 376:1813-1823

 DEFINE-FLAIR
Primary Endpoint at 12 months
(Death, MI, Unplanned revascularization)

N=2492

FFR (7.0%)
iFR (6.8%)

HR = 0.95 (95% CI: 0.68, 1.33)

P=0.78

Davies, J, et al, N Engl J Med 2017; 376:1824-1834

Davies et al NEJM 2017

Pooled analysis: DEFINE-FLAIR and iFR-SWEDEHEART
Primary Endpoint at 12 months
(Death, MI, Unplanned revascularization)

N=4486

IFR 6.47%
FFR 6.41%

HR = 1.03 (95% CI: 0.81, 1.31)

P=0.81

Escaned J, , et al, JACC: Cardiovascular

Interventions, Volume 11, Issue 15, 13 August 2018,
Pages 1437-1449
 iFR-SWEDEHEART
Primary Endpoint at 2 years
(Death, MI, Unplanned revascularization)

N=2019

FFR 8.7%
IFR 8.7%

log-rank p = 0.93

Götberg, et al, TCT 2018

 iFR-SWEDEHEART
All-cause mortality at 2 years
N=2019

FFR 2.7%
IFR 2.6%

log-rank p = 0.88

Götberg, et al, TCT 2018

 iFR-SWEDEHEART
Myocardial infarction at 2 years
N=2019

IFR 2.2%
FFR 2.0%

log-rank p = 0.758

Götberg, et al, TCT 2018

 iFR-SWEDEHEART
Unplanned revascularization at 2 years
N=2019

FFR 6.0%
IFR 5.7%

log-rank p= 0.854

Götberg, et al, TCT 2018

 iFR-SWEDEHEART
Subgroup analysis at 2 years

Higher MACE among diabetics

with FFR

OR = 2.06 (95% CI: 1.03, 4-13)

P=0.041

Götberg, et al, TCT 2018

Pooled analysis: DEFINE-FLAIR and iFR-SWEDEHEART
Deferred patients

Escaned J, , et al, JACC: Cardiovascular

Interventions, Volume 11, Issue 15, 13 August 2018,
Pages 1437-1449
Pooled analysis: DEFINE-FLAIR and iFR-SWEDEHEART
Deferred patients at 1-year
N=2130

iFR (4.12%)
FFR (4.05%)

HR = 1.13 (95% CI: 0.72, 1.79)

P=0.60

Escaned J, , et al, JACC: Cardiovascular

Interventions, Volume 11, Issue 15, 13 August 2018,
Pages 1437-1449
DEFINE-FLAIR –analysis deferred LAD

N=872

FFR (5.46%)
iFR (2.44%)

HR = 0.46 (95% CI: 0.22, 0.96)

P=0.04

Sen S, et al, J Am Coll Cardiol, 2019:73(4);444-53

SWEDEHEART Registry deferred patients and outcome
Death, MI, or unplanned revascularization

N=12279

1-year End of study

FFR (9.4%) FFR (16.8%)
iFR (8.7%) iFR (14.4%)

HR = 0.98 (95% CI: 0.86, 1.12)

P=0.79
Median follow-up: 1.77 years
Follow-up >4 years Yndigegn et al, TCT 2019
SWEDEHEART Registry deferred patients and outcome
Death, MI, or unplanned revascularization

Similar outcome in death, MI,

unplanned recascularization

iFR FFR

Death 4.6% 5.4%

MI 1.7% 2.2%
Revasc. 10.2% 11.8%

Similar outcome in subgroups

Yndigegn et al, TCT 2019
 Summary
Overall iFR and FFR have similar clinical outcome:

DEFINE-FLAIR 1-year follow-up

iFR-Swedeheart 1-year, and 2-year follow-up
Merged DEFINE-FLAIR and iFR-Swedeheart 1-year follow-up
Swedeheart registry >12000 deferred patients >4-year follow-up

FFR may be associated with higher MACE among LAD, and diabetics
iFR-Swedeheart / Swedeheart-registry vessel analysis ongoing

Planned merger of 2-year data from DEFINE-FLAIR and iFR-Swedeheart including

deferred patients and relevant subgroups
Thank you!