The CONTRACT study Navvus FFR to Reduce CONTRAst, Cost and RadiaTion

insights form a single-centre clinical and economical evaluation with the RXi Rapid-Exchange FFR device

Joost Daemen, MD, PhD

Kaneshka Masdjedi, MD

Potential conflicts of interest

Speaker's name: Joost Daemen

I have the following potential conflicts of interest to report:

Consultanty fees: Astra Zeneca

Institutional grant/research support: Boston Scientific, Medtronic, Recor medical, St. Jude Medical

• Fractional Flow Reserve (FFR) is the mainstay of functional

hemodynamic assessment of coronary artery lesions

• The RXi Navvus system (ACIST Medical Systems, Eden Prairie, MN)

Background

Specific features

• Use a guidewire of first choice

• May facilitate negotiating complex

anatomies

• Multiple pullback measurements

while maintaining guidewire

position Diletti et al. EuroIntervention 2015

• This is an investigator-initiated, prospective,

observational cohort study

• a single-centre clinical and economical

evaluation with the RXi Rapid-Exchange FFR

device

• to assess if the use of the RXI Navvus system

reduces cost, contrast and radiation as

compared to conventional FFR systems

Objectives

Study population and enrollment:

• All consecutive patients referred for coronary angiography or

PCI and an indication to perform FFR

• Between September 1st, 2014 and February 28th 2015

• Odd dates (1,3,5,…) -> Conventional FFR system

• Even dates (2,4,6,...)-> Navvus FFR system

Methods

Study flow chart

238 pts

Navvus 97pts

15 pts ≥ 2 devices

- Doesn’t cross lesion: 3*

- Device defect: 8**

- Result questioned: 1

- Unclear: 3

82 pts Navvus only

Conventional FFR wire 141 pts

- St. Jude Medical Aeris/Certus: 120

- Radi Medical : 11

- Volcano Prime/Combowire: 10

5 pts ≥ 2 devices

- Connection problem sytem pressure: 1

- Device defect: 2

- Unsterile: 1

- Unclear: 1

136 pts Conventional FFR wire only

* 2/3 excessive tortuosity and calcification ** 5/6 manufacturing issue

Baseline

NAVVUS (n=82)

cFFR (n=136) p-value

Mean age (y±SD) 64,3±10,6 64,2±9,6 0,93

Male sex, (%) 69,5 67,6 0,77

Risk factors for CVD, (%)

Hypertension, (%) 61,3 55,6 0,49

Diabetes Mellitus, (%) 32,9 27,9 0,44

BMI, (±SD) 27,9±4,6 28,0±5,5 0,94

Hyperlipidemia, (%) 54,9 54,4 0,95

Smoker, n (%) 19,6 19,5 0,88

Co-morbidity

Previous MI, (%) 51,2 64,7 0,05

Previous PCI, (%) 43,9 57,8 0,05

Previous CABG, (%) 4,9 5,2 0,92

Renal Insufficiency, (%) 12,2 15,8 0,47

Hemoglobine (mmol/L) (±SD) 8,3±1,1 8,5±1,1 0,23

COPD, (%) 8,5 11,2 0,53

Procedural characteristics

NAVVUS (n=82)

cFFR (n=136) p-value

Multivessel disease, % 52,4 40,4 0,09

Multivessel FFR, % 22,0 24,2 0,70

OCT, % 13,4 19,1 0,28

IVUS, % 6,1 10,3 0,29

RCA 36,6 37,0 0,95

LAD 65,9 58,5 0,28

LCX 34,1 34,8 0,92

LM 4,9 5,2 0,92

Vessel diameter ≤2.5mm 45,1 30,9 0,034

Heavy calcification 9,8 11,8 0,60

Procedural characteristics

NAVVUS (n=82)

cFFR (n=136) p-value

Number of FFR measurement 1,57±0,84 1,52±0,77 0,69

Mean FFR value 0,82±0,08 0,83±0,10 0,42

Positive FFR, (%) 52 44 0,25

Material used, n (±SD)

Total number of wires* 2,5±1,2 3,0±1,8 0,02

Number of balloons used 1,5±1,7 1,2±1,6 0,27

Number of stents used 1,3±1,4 1,1±1,4 0,18

* Includes FFR wire

Total procedural costs Procedures in which only 1 device was used

€-

€500,00

€1 000,00

€1 500,00

€2 000,00

€2 500,00

€3 000,00

€3 500,00

€4 000,00

€4 500,00

Proceduralcosts

FFR > 0.80 FFR < 0.80 Multivesseldisease

MultivesselFFR

Navvus

ConventionalFFR

FFR device price set to €0,-

P-value=ns for all

Procedural costs were €2.180,- in the Navvus group as compared to €1.892,- in the cFFR group (p=0.32) in the total population.

Contrast volume (ml) Procedures in which only 1 device was used

150 144

174

147 156

180

0

20

40

60

80

100

120

140

160

180

200

Total cohort(n=218)

Multivessel FFR(n=50)

Multivesseldisease (n=98)

Navvus

ConventionalFFR

P-value=ns for all

Radiation use (centiG*cm2 ) Procedures in which only 1 device was used

6 200 6 198

7 203

5 076 4 888

6 609

0

2 000

4 000

6 000

8 000

Total cohort(n=218)

Multivessel FFR(n=50)

Multivesseldisease (n=98)

Navvus

ConventionalFFR

P-value=ns for all

Procedure time (min) Procedures in which only 1 device was used

72

77 72 73

88

79

0

10

20

30

40

50

60

70

80

90

100

Total cohort(n=218)

Multivesseldisease (n=96)

Multivessel FFR(n=50)

Navvus

ConventionalFFR

P-value=ns for all

Multivariable analyes Predictors of cost

Predictors Beta-value P-value Beta-value P-value

Multivessel disease 0,366 <0,001 0,043 0,10

Bifurcation 0,227 0,001 -0,098 0,001

Calcification 0,248 <0,001 0,040 0,12

Vessel diameter≤2,5mm 0,238 <0,001 0,001 0,98

Number of stents 0,886 <0,001 0,762 <0,001

Number of balloons 0,738 <0,001 0,186 <0,001

OCT 0,210 0,002 0,243 <0,001

Navvus 0,016 0,81 -0,010 0,68

Univariate Multivariate

Multivariable analyes Predictors of contrast

Predictors Beta-value P-value Beta-value P-value

Multivessel disease 0,338 <0,001 0,115 0,009

Bifurcation 0,221 0,001 -0,071 0,27

Calcification 0,171 0,012 0,003 0,96

Vessel diameter≤2,5mm 0,244 <0,001 0,040 0,5

Number of stents 0,525 <0,001 0,23 0,007

Number of balloons 0,549 <0,001 0,340 <0,001

OCT 0,308 <0,001 0,288 <0,001

Navvus 0,017 0,809 -0,039 0,47

Univariate Multivariate

Multivariable analyes Predictors of radiation (cumulative total area dose)

Predictors Beta-value P-value Beta-value P-value

BMI 0,223 0,001 0,22 <0,001

Multivessel disease 0,269 <0,001 0,090 0,15

Bifurcation 0,192 0,005 -0,203 0,003

Calcification 0,234 0,001 0,035 0,56

Vessel diameter≤2,5mm 0,181 0,008 0,040 0,52

Number of stents 0,477 <0,001 0,060 0,49

Number of balloons 0,573 <0,001 0,581 <0,001

Navvus 0,117 0,087 0,070 0,22

Univariate Multivariate

• The RXi Navvus FFR system as compared to conventional

pressure wire based FFR in daily clinical practice was

associated with comparable procedural costs, amount of

radiation and contrast used.

• A trend was seen to potential advantages in patients with

multivessel disease or positive FFR, in which the use of the

Navvus system was associated with lower costs, contrast and

a shorter procedure time.

Conclusion

• Single center non-randomized study with a limited number of

patients

• Final analyses only performed in procedures in which only 1

device was used

• Cost analyses based on local list prices

• Potential specific advantages of the system not assessed

Discussion

• Objective: determine the impact of FFR values post PCI on (long-

term) clinical outcome in an all-comer PCI setting.

• Intervention: FFR assessment using ACIST NAVVUS™ rapid

exchange FFR micro catheter system will be performed after PCI.

The FFR value distal to the (most distal) stent and a pull-back

evaluation will be performed.

• Outcome: A composite of MACE including all-cause death,

myocardial infarction and TVR @ 30-days, 1 year, 2 years and 5

years.

Ongoing projects FFR-SEARCH

• Inclusion status:

0 1000 500

March 2016 December 2016

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