avio: a prospective, randomized trial of intravascular-ultrasound guided compared to angiography...

AVIO: A Prospective, Randomized Trial of AVIO: A Prospective, Randomized Trial of

Intravascular-Ultrasound Guided Compared Intravascular-Ultrasound Guided Compared

to Angiography Guided Stent Implantation to Angiography Guided Stent Implantation

in Complex Coronary Lesionsin Complex Coronary Lesions

Antonio Colombo, MDAntonio Colombo, MDSan Raffaele Hospital Milan, ItalySan Raffaele Hospital Milan, Italy

On behalf of the AVIO Investigators

12:15pm-12:25pm12:15pm-12:25pm12:15pm-12:25pm12:15pm-12:25pm

Late Breaking Trial/First Report InvestigationLate Breaking Trial/First Report Investigation Washington DC, September 25th 2010Washington DC, September 25th 2010

Late Breaking Trial/First Report InvestigationLate Breaking Trial/First Report Investigation Washington DC, September 25th 2010Washington DC, September 25th 2010

Presenter Disclosure Information

Antonio Colombo, MDAntonio Colombo, MD

Co-founder & minor shareholder: Co-founder & minor shareholder: Cappella Inc.Cappella Inc.

Co-founder & minor shareholder: Co-founder & minor shareholder: Cappella Inc.Cappella Inc.

PRINCIPAL INVESTIGATORS/ PARTICIPATING CENTERS/NUMBER (N) OF PATIENTS ENROLLED PER CENTER

Antonio Colombo San Raffaele, Milan ItalyN=50

Christophe Caussin Hopital Marie Lannelongue, France N=42Patrizia Presbitero Istituto Clinico Humanitas, Milan, Italy N=24Stefano Galli, Centro Cardiologico Monzino N=23 Alberto Menozzi Azienda Ospedaliera Universitaria, Parma, Italy N=21 Ferdinando Varbella Ospedale degli Infermi, Rivoli, Italy N=17Fina Mauri Germans Trias i Pujol, Badalona, Spain N=15 Marco Valgimigli Azienda Ospedaliera Universitaria Ferrara, Italy N=15Chourmouzios Arampatzis Interbalkan Medical Center, Thessaloniki, Greece

N=13 Manuel Sabate Hospital Santa Creu i Sant Pau, Barcelona, Spain

N=12Andrejs Erglis P. Stradins Clinical University Hospital, Riga, Latvia

N=11 Bernhard Reimers Ospedale Civile, Mirano, Italy N=11 Flavio Airoldi Multimedica Hospital, Milan, Italy

N=8Mikko Syvanne Helsinki University Central Hospital, Finland N=6Ramon Lopez Palop Hospital Universitario San Juan, Alicante, Spain

N=5Ghada Mikhail St Mary's Hospital, London, United Kingdom N=4Philippe Mc Carthy King's College Hospital, London, United Kingdom

N=4 Francesco Romeo Tor Vergata University, Rome, Italy N=4

AVIO trialAVIO trialAngiography Vs IVUS Optimization Angiography Vs IVUS Optimization

CEC Cosmo Godino, MD

Gloria Melzi, MD

Marta Bande, MD

Project coordinators Alaide Chieffo, MD

Azeem Latib, MD

Project Management

Data Management Corelab & Statistics

MCR, Mediolanum Cardio Reasearch

M.Privitera/M.Repetto/M. C.Jori

M. A. Bonardi, F. D’Ambrosi

Statistics Prof. Bruno Mario Cesana

Sponsor Fondazione Evidence

AVIO trialAVIO trialAngiography Vs IVUS OptimizationAngiography Vs IVUS Optimization

n = 284 patients

6 month6 monthClinic.Clinic.

F/UF/U

6 month6 monthClinic.Clinic.

F/UF/URR PostdilatationPostdilatationComplex Lesions*Complex Lesions*Complex Lesions*Complex Lesions*

IVUS guidedIVUS guided(n= 142)(n= 142)

IVUS guidedIVUS guided(n= 142)(n= 142)

Angio guidedAngio guided(n= 142)(n= 142)

Angio guidedAngio guided(n= 142)(n= 142)

9, 12, 24 9, 12, 24 month month

Clinical F/UClinical F/U

9, 12, 24 9, 12, 24 month month

Clinical F/UClinical F/U

11 monthmonthClinic.Clinic.

F/UF/U

11 monthmonthClinic.Clinic.

F/UF/U

Study Design and Time FrameStudy Design and Time Frame

R = randomization


*Complex lesions were defined as Long lesions (>28mm), CTO, Bifurcations, Small vessels and Patients requiring 4 or more stents

49 pts were randomized to a final IVUS 49 pts were randomized to a final IVUS

AVIO Criteria for optimal stent expansion:

70%±10% of the cross sectional area of the inflated balloon used to post-dilate

the stentThe size of the NC balloon selected to

post-dilate the stent is the average of the media to media diameters of the stented area measured proximally, medially and

distally inside the stent. The value is rounded to the lower .00 or 0.50 mm. For values 3.5 mm or above the operator can

downsize as per judgment

Flow chart and Measurements Performed For IVUS Optimisation

Deploy Stent and Perform IVUS

Distal Stent

A in RED = Stent CSA 3.6 mm2

D1 = Max vessel Diameter (3.3mm)

D2 = Min vessel Diameter (3.1mm)

Optimal balloon size 3mm, target 70%

Proximal Stent

A

D1D2

STENTStent

Underexpansion

Study endpointsStudy endpoints

Primary Endpoint: was post-procedure in lesion minimal lumen diameter (MLD) evaluated by corelab QCA

Secondary endpoints: TLR and composite of MACE (death, MI, TVR) at 9 months

Study hypothesis: MLD 2.9±0.4 for IVUS vs. 2.7±0.5 mm for angio guided DES post-dilatation .


Clinical CharacteristicsClinical CharacteristicsIVUS (n=142) Angio (n=142)

Age (years) 63.9±10.1 63.6±11.0

Gender (M/F) 117/25 109/33

Diabetes (%) 23.9 26.8

Hypercholesterolemia (%) 70.4 76.8

Hypertension (%) 70.4 66.9

Current smokers (%) 34.5 31.0

Unstable Angina (%) 29.6 26.1

LVEF (%) 55.3±8.5 55.9±8.6


Lesion CharacteristicsLesion Characteristics

IVUS (n=182)

Angio (n=179)

CTO (%) 13.6 17.8Bifurcations (%) 23.1 27.2Long lesions (%) 62.1 58.0Small Vessels (%) 21.9 23.7LAD location (%) 53.3 48.6


1.28 lesions /patient were treated in IVUS vs 1.26 in Angio guided1.28 lesions /patient were treated in IVUS vs 1.26 in Angio guided

QCA measurementsQCA measurementsIVUS Angio P value

Baseline

RVD (mm) 2.67 ± 0.46

2.62 ± 0.41

Lesion length (mm) 27.4 ± 15.9

25.5 ± 15.0

Baseline MLD (mm) 0.76 ± 0.46

0.65 ± 0.45 0.01

Baseline stenosis (%) 71.6 ± 15.8

75.5 ± 16.1

In Lesion

Final RVD (mm) 2.94 ± 0.42

2.81 ± 0.45 0.004

Final stenosis (%) 8.4 ± 7.9 10.5 ± 9.0 0.02

Final MLD (mm) 2.70 ± 0.46

2.51 ± 0.46 0.0002

In stent

Final RVD (mm) 2.96 ± 0.46

2.83 ± 0.43 0.005

Final stenosis (%) 13.9± 7.3 15.5 ± 7.9 0.05

Final MLD (mm) 2.55 ± 0.46

2.39 ± 0.42 0.0006


Primary Study End Point In lesion MLD

Final MLD in Angio Group

2.51±0.46mm

Final MLD in Angio Group

2.51±0.46mm

Final MLD in IVUS Group

2.70±0.46mm

Final MLD in IVUS Group

2.70±0.46mm

P=0.0002P=0.0002

Cu

mula

tive F

requ

en

cy %

Cu

mula

tive F

requ

en

cy %

MLD (mm) MLD (mm)

In lesion Acute Gain In lesion Acute Gain

1.87±0.63mm

1.87±0.63mm

1.93±0.59mm

1.93±0.59mm

P=0.31P=0.31

QCA measurements in IVUS-optimized subgroupQCA measurements in IVUS-optimized subgroup

IVUS-AVIO criteria met

Angio P value

Baseline N-75 lesions N-179 lesions

MLD (mm) 0.79 ± 0.50 0.65 ± 0.45 0.03

Final In Lesion (Obstruction)

MLD (mm) 2.86 ± 0.46* 2.51 ± 0.46 <0.0001

Acute gain 2.07 ± 0.59* 1.87 ± 0.63 0.02

Final In Stent

MLD (mm) 2.68 ± 0.50* 2.39 ± 0.42 <0.0001

IVUS-AVIO criteria not met

Angio P value

Baseline N-81 N-179

MLD (mm) 0.76 ± 0.43 0.65 ± 0.45 0.054

Final In Lesion (Obstruction)

MLD (mm) 2.6 ± 0.38* 2.51 ± 0.46 0.15

Acute gain 1.84 ± 0.52* 1.87 ± 0.63 0.7

Final In Stent

MLD (mm) 2.51 ± 0.40* 2.39 ± 0.42 0.03


**p≤0.05 for comparison of IVUS lesions

meeting AVIO criteria vs. lesions not meeting criteria

**p≤0.05 for comparison of IVUS lesions

meeting AVIO criteria vs. lesions not meeting criteria

Primary Study End Point In lesion MLD

0 1 2 3 40

20

40

60

80

100

Angio_PRE

Angio_POST

IVUS_PRE

IVUS_POST

Final MLD inAngio Group

2.51 0.46mm

Final MLD inIVUS Group

2.86 0.46mm

IVUS subgroup meeting AVIO criteria

P<0.0001

MLD (mm)

Cu

mu

lati

ve

Fre

qu

en

cy

%

0 1 2 3 40

20

40

60

80

100

Angio_PRE

Angio_POST

Final MLD inAngio Group

2.51 0.46mm

Final MLD inIVUS Group

2.60 0.38mm

IVUS subgroup NOT meeting AVIO criteria

P=0.15

IVUS_PRE

IVUS_POST

MLD (mm)C

um

ula

tive

Fre

qu

en

cy %

N= 75N= 75 N= 81N= 81

In lesion Acute Gain In lesion Acute Gain

0 1 2 3 40

20

40

60

80

100

1.87 0.63mm 2.07 0.59mm

IVUS subgroup meeting AVIO criteria

P=0.02

Angio

IVUS

MLD (mm)

Cu

mu

lati

ve

Fre

qu

en

cy

%

0 1 2 3 40

20

40

60

80

100

1.87 0.63mm 1.84 0.52mm

IVUS subgroup NOT meeting AVIO criteria

P=0.7

AngioIVUS

MLD (mm)C

um

ula

tiv

e F

req

ue

nc

y %

N= 75N= 75 N= 81N= 81

QCA measurements at FU (9 months)QCA measurements at FU (9 months)

IVUS Angio P value

FU Lesions=82

Patients=75

Lesions=67

Patients=52

In Lesion (Obstruction)

RVD (mm) 2.70 ± 0.46 2.65 ± 0.39 0.51

Stenosis (%) 13.0 ± 17.5 17.6 ± 20 0.14

MLD (mm) 2.56 ± 0.75 2.30 ± 0.68 0.03

Late loss 0.19 ± 0.58 0.30 ± 0.54 0.27

*Angiographic Restenosis

-In-stent

-In-segment

7 (8.5%)

16 (19.3%)

6 (9.0%)

13 (18.8%)

0.93

0.95


QCA measurements at FU (9 months)QCA measurements at FU (9 months)

IVUS-AVIO criteria met

Angio P value

FU N-42 N-69


RVD (mm) 2.84 ± 0.51 2.65 ± 0.39 0.04

Stenosis (%) 11.5 ± 12.8 17.6 ± 20 0.08

MLD (mm) 2.72 ± 0.57 2.30 ± 0.68 0.001

Late loss 0.18 ± 0.34 0.30 ± 0.54 0.23

Angiographic Restenosis: in-segment

11 (26.2%) 13 (18.8%) 0.36

IVUS-AVIO criteria not

met

Angio P value

FU N-33 N-67


RVD (mm) 2.61 ± 0.32 2.65 ± 0.39 0.56

Stenosis (%) 14.6 ± 22.8 17.6 ± 20 0.50

MLD (mm) 2.39 ± 0.88 2.30 ± 0.68 0.57

Late loss 0.22 ± 0.78 0.30 ± 0.54 0.56

Angiographic Restenosis: in-segment

4 (12.1%) 13 (18.8%) 0.39


IVUS

(n= 142)

Angio*

(n= 142)

30 days MACE (days 0-30)Q wave MI 0 (0%) 0 (0%)

Non-Q wave MI 10 (7.0%) 10 (7.0%)TLR 1 (0.7%) 0 (0%)

TVR (including TLR) 1 (0.7%) 0 (0%)Cardiac Death 0 1 (0.7%)

Cumulative at 9-month MACE (days 0-270) MI 10 (7.0%) 12 (8.5%)TLR 10 (7.0%) 7 (5.0%)

TVR (including TLR) 11 (7.8%) 10 (7.8%)Cardiac Death 0 2 (1.4%)


*One pt in the angio group was lost to follow-up at 9 months*One pt in the angio group was lost to follow-up at 9 months

Freedom from Cumulative MACE at 9 Months

DaysDays

P= 0.47P= 0.47

83.1%83.1%

85.9%85.9%

IVUSAngioIVUSAngio

Stent Thrombosis (ARC Stent Thrombosis (ARC Definition)Definition)

IVUS (n=142)

Angio (n=142)

Definite 1 0Probable 0 0Possible 0 0


ConclusionsConclusions

- Our study demonstrated that a larger final MLD in

lesion was obtained with IVUS guided DES

postdilatation (Primary Study End-Point)

- IVUS guided postdilatation is safe procedure (no

difference in 30 days MACE)

-No difference in cumulative 9-months MACE

between IVUS and angio guided procedures


•Back Up slides

Primary Study End Point: In lesion MLD in the 2 Top Enroller Centers

MLD (mm) MLD (mm)

Cum

ula

tive F

requ

ency

%C

um

ula

tive F

requ

ency

%

Center 8Center 8 Center 2Center 2

Procedural CharacteristicsProcedural CharacteristicsIVUS (n=182) Angio

(n=182)Stent diameter (%) 2.95±0.38 2.86±0.36Stent length 23.9±6.74 23.2±6.51Stent pressure 15.6±3.1 15.3 ±2.6Postdilatation !! 58.8 88.5Postdilatation Balloon Diameter, mm

3.39±0.47 3.15±0.40

Postdilatation Max pressure, atm

20.3±4.82 19.6±4.0


DES TypesDES Types

IVUS (n=318)

Angio (n=325)

Promus /Xience % 57.9 59.7Taxus % 31.1 22.1Cypher % 6.0 10Endeavor % 4.4 7.4Other DES % 0.6 0.8


TLR per lesionTLR per lesion


avio: a prospective, randomized trial of intravascular-ultrasound guided compared to angiography...

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