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DEFER STUDY: 5-YEAR FOLLOW-UP. A Multicenter Randomized Study to Compare Deferral Versus Performance of PCI of Non-Ischemia-Producing Stenoses. Principal investigators. Nico H.J. Pijls, MD, PhD Catharina Hospital Eindhoven, The Netherlands.

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DEFER STUDY: 5-YEAR FOLLOW-UP

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Defer study 5 year follow up

DEFER STUDY:

5-YEAR FOLLOW-UP

A Multicenter Randomized Study

to Compare Deferral Versus Performance of PCI

of Non-Ischemia-Producing Stenoses

Principal investigators

Nico H.J. Pijls, MD, PhD

Catharina Hospital

Eindhoven, The Netherlands

Bernard De Bruyne, MD, PhD

Cardiovascular Center Aalst

Aalst, Belgium


Defer study 5 year follow up

NOTE

  • Any treatment in health care should be directed

  • either to

  • Releave symptoms ( improve functional class )

  • or to

  • Improve outcome ( prognosis, longevity)

  • No other justification for any treatment is possible !


Defer study 5 year follow up

DEFER study: background (1)

  • In patients with coronary artery disease,

  • the most important factor with respect to both

  • functional class (symptoms)

  • and prognosis (outcome)

  • Is the presence and extent of inducible ischemia

  • (many invasive & non-invasive studies in > 100,000 patients)

If a stenosis is responsible for reversible

ischemia, revascularization improves symptoms

(if present) and outcome…..


Defer study 5 year follow up

DEFER study: background (2)

If a stenosis is responsible for reversible

ischemia, revascularization is justified……

……But what if a stenosis or “plaque” is

NOT responsible for reversible ischemia ?

(functionally “non-significant” , “non-culprit”)

PCI is often performed in such lesions,

yet the benefit of such treatment is not clear


Defer study 5 year follow up

  • female, 58-y-old

  • underwent PCI of severe LCX lesion a minute before

  • 50 % stenosis in mid RCA

Should this lesion be stented ??

158 vb38/interm.RCA/Buddem (1)


Defer study 5 year follow up

DEFER study: background (3)

  • Fractional Flow Reserve, calculated from

  • coronary pressure measurement, is an accurate,

  • invasive, and lesion-specific index to demonstrate

  • or exclude whether a particular coronary stenosis

  • can cause reversible ischemia.

  • FFR can be determined easily, in the cath-lab,

  • immediately prior to a planned intervention

FFR based strategy for PCI in equivocal stenosis

( DEFER – Study)


Defer study 5 year follow up

The DEFER Study: Design

prospective randomized multicentric trial

(14 centers) in 325 patients with stable

chest pain and an intermediate stenosis

without objective evidence of ischemia

Aalst

Amsterdam

Eindhoven

Essen

Gothenborg Hamburg

Liège

Maastricht

Madrid

Osaka

Rotterdam

Seoul

Utrecht

Zwolle

data collection & analysis:

Jan Willem Bech, MD, PhD

Pepijn van Schaardenburgh, MD


Defer study 5 year follow up

The DEFER Study: Objectives

Primary objective

  • to test safety of deferring PCI of stenoses

  • not responsible for inducible ischemia as

  • indicated by FFR > 0.75 ( “outcome”)

  • Secondary objective

  • to compare quality of life in such patients,

  • whether or not treated by PCI

  • (CCS-class, need for anti-anginal drugs)

  • (“symptoms”)


Defer study 5 year follow up

The DEFER Study: Flow Chart

deferral of PTCA

(167)

FFR < 0.75

(68)

PTCA

Patients scheduled for PCI without Proof of Ischemia (n=325)

Randomization

performance of PTCA (158)

FFR  0.75

(91)

FFR < 0.75

(76)

FFR  0.75

(90)

PTCA

No PTCA

PTCA

PERFORM Group

DEFER Group

REFERENCE Group


Defer study 5 year follow up

THE DEFER STUDY: RANDOMIZATION

deferral of PCI

performance of PCI

1 : 1 randomization

If FFR < 0.75 performance anyway

reference group

If FFR > 0.75 randomization followed

defer PCI perform PCI


Defer study 5 year follow up

The DEFER Study: Catheterization

  • 6 or 7 F guiding catheter for measurement of

  • aortic pressure(Pa)

  • QCA from 2 orthogonal views

  • Coronary pressure measurement (Pd)by

  • 0.014” pressure wire (Radi Medical Systems)

  • Maximum hyperemia by i.v. adenosine (140 ug/kg/min)

  • Calculation of Fractional Flow Reserve by:

FFR = Pd / Pa


Defer study 5 year follow up

Diabetes (%) 13 12

Hypertension (%) 41 35

Hyperlipidemia(%) 47 48

Current Smoker (%) 30 25

Family History CAD (%) 50 49

The DEFER Study: Base line data

Randomized toRandomized to

Deferral of PTCA Performance of PTCA

N=167 N=158

Age, (yr) 629 6310

Female sex (%) 29 29

Ejection Fraction (%)6710 689


Defer study 5 year follow up

Randomized to Randomized to

Deferral of PTCA Performance of PTCA

N=167 N=158

Ref. diam. (mm) 2.96 ± 0.63 2.98 ± 0.57

1.42 ± 0.38

MLD (mm) 1.42 ± 0.40

52 ± 11

DS (%) 52 ± 10

0.730.19

FFR 0.720.19

The DEFER Study: Baseline QCA and FFR

All baseline characteristics were identical between both groups


Defer study 5 year follow up

The DEFER Study:

Diameter Stenosis versus FFR


Defer study 5 year follow up

event – free survival (%)

100

75

78.8

72.7

64.4

Defer

50

p=0.52

p=0.03

Perform

p=0.17

25

Reference

(FFR < 0.75)

0

0

1

2

3

4

5

Years of Follow-up


Defer study 5 year follow up

DEFER: Clinical Outcome at 5 Years

Non-TLR(%)

6 (6.7)

6 (6.8)

11 (8.2)

Patients ≥1 event (%)

24 (27 %)

52 (39 %)

19 (21 %)

FFR ≥0.75

FFR<0.75

Defer

Perform

Reference

Number of patients

91

90

144

Lost to follow-up 1 2 10

Cardiac Death(%)

3 (3.3)

2 (2.3)

8 (6.0)

4 (3.0)

Non Cardiac Death(%)

3 (3.3)

3 (3.4)

Q wave MI (%)

0

4 (4.5)

6 (4.5)

Non-Q wave MI(%)

0

1 (1.1)

7 (5.2)

CABG(%)

1 (1.1)

4 (4.5)

14 (10.4)

TLR(%)

8 (8.9)

8 (9.1)

18 (13.4)

Other (%)

0

1 (1.1)

2 (1.5)

Total events

21

29

70

Pts free of angina(%)

68 %

58 %

72 %


Cardiac death and acute mi after 5 years

Cardiac Death And Acute MI After 5 Years

P< 0.03

%

20

P< 0.005

15.7

15

P=0.20

10

7.9

5

3.3

0

DEFER PERFORM REFERENCE

FFR > 0.75 FFR < 0.75


Defer study 5 year follow up

Defer group

Perform group

Reference group

freedom from chest pain

100%

*

* *

* *

80%

* *

*

60%

40%

20%

0%

baseline

1month

1 year

2 year

5 year

FFR > 0.75 FFR > 0.75 FFR < 0.75


Defer study 5 year follow up

DEFER: Summary and Conclusions (1)

  • In patients with stable chest pain, the most important prognostic factor of a given coronary artery stenosis, is its ability of inducing myocardial ischemia (as reflected by FFR < 0.75)

  • In those patients, clinical outcome of such “ischemic” stenosis, even when treated by PCI, is much worse than that of a functionally “non-significant” stenosis.

  • 3. The prognosis of “non-ischemic” stenosis (FFR > 0.75) is excellent and the risk of such “non-significant” stenosis or plaque to cause death or AMI is < 1% per year, and not decreased by stenting


Defer study 5 year follow up

DEFER: Summary and Conclusions (2)

  • Conclusion

  • Stenting a “non-ischemic” stenosis does not benefit patients with stable chest pain, neither

  • in prognostic nor symptomatic respect.


  • Defer study 5 year follow up

    event – free survival (%)

    100

    75.8

    75

    64.4

    50

    ³

    FFR

    0.75

    p=0.03

    FFR < 0.75

    25

    0

    0

    1

    2

    3

    4

    5

    Years of Follow-up


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