12 Valgimigli aimradial20170921 MATRIX program

Results From The Minimizing
Adverse Haemorrhagic Events By
Transradial Access Site And
Systemic Implementation
of Angiox-
The MATRIX Program
M. Valgimigli, MD, PhD
Bern University Hospital,
Switzerland,
on behalf of the MATRIX Group
NCT01433627

Disclosure
• I have no conflict of interest related to
this presentation to declare

1:11:1
1:11:1
NSTEACS or STEMI with invasive management
Aspirin+P2Y12 blocker
Trans-Femoral
Access
Heparin
±GPI
Bivalirudin
Mono-Tx
Stop
Infusion
Prolong≥ 6 hs
infusion
1:11:1
Trans-Radial
Access
MATRIX Access
MATRIX Program registered at
ClinicalTrials.gov, number NCT01433627
Am Heart J. 2014 Dec;168(6):838-45.e6.

Study Organization and Sites
Sponsor
Clinical Event
Committee
P. Vranckx, Chair
S. Leonardi Co-Chair
P. Tricoci
Italian Society of Interventional Cardiology
Grant suppliers: The Medicines Company and Terumo
Principal Investigator: Marco Valgimigli, MD, PhD
Study Director: Maria Salomone. MD, PhD
78 Sites across 4 EU countries recruited patients
Statistical
Committee (CTU)
P.Jüni, MD, Chair
M. Rothenbühler
Dik Heg
National Coordinating Investigators and CROs
Paolo Calabrò, MD, PhD, Italy; Trial Form Support
Arnoud W J van‘t Hof, MD, The Netherlands; Trial Form Support
Manel Sabate’, MD, PhD, Spain; FLS-Research Support
Elmir Omerovic, MD, PhD, Sweden; Gothia Forum
Data Mng
E. Frigoli, Eustrategy
Project Leader

MATRIX Access
Cumulative enrollment by month
8,404
8,404
8,404 patients with ACS undergoing coronary angiography ± PCI
from 11th
Oct 2011 to 7th
Nov 2014
Operator Eligibility Criteria: Interventional cardiologist
expertise in TRI and TFI including at least 75 transradial
coronary interventions and at least 50% of interventions
performed via radial route in the year preceding site
initiation
Complete follow-up to 30 days available in
4183 (99.7%) of radial and 4191 (99·6%) of
femoral cohorts
Am Heart J. 2014 Dec;168(6):838-45.e6.

Let’s speak about money
• A Bayer sponsored study costs 26,000
euro per patient*
*: Personal Communication

euro per patient*
• A Novartis sponsored study costs 18,000
euro per patient*

euro per patient*
• A Novartis sponsored study costs 18,000
euro per patient*
• In MATRIX each patient costed less than
300 Euros

Radial (N=4,197) Femoral (N=4,207)
Age (years) 67±12 67±12
Age ≥ 75 ys (%) 28.3 29.3
Male (%) 74.5 72.4
BMI (kg/m2
) 27.1±4.1 27.1±4.1
Previous CVA (%) 4.6 5.5
PAD (%) 8.1 8.8
Renal failure (%) 1.1 1.4
Previous PCI (%) 13.9 14.7
Previous radial access (%) 2.8 2.0
Killip > 1 (%) 9.6 9.7
STEMI (%) 47.7 47.8
NSTEMI (%) 46.5 45.9
UA (%) 5.8 6.4
Enoxaparin (%) 16.3 17.5
Fondaparinux (%) 10.2 11.1
UFH (%) 29.5 29.4
Baseline Characteristics

Primary EPs:
MACE and NACE
RR: 0·85
p=0.031
RR: 0·83
p=0.009
Lancet. 2015 Jun 20;385(9986):2465-76

MI and CVA endpoints:
Any MI, STEMI, NSTEMI, unclassified*, stroke, TIA
P=1.00
P=0.059
P=0.20
*: LBBB, paced rhythm or unavailability of interpretable ECG
% %
Lancet. 2015 Jun 20;385(9986):2465-76

Fatal and ST EPs:
All-Cause, Cardiovascular, non-CV mortality, type of stent thrombosis
%
RR:0.72
(0.53-0.99)
P=0.045
RR: 0.75
(0.54-1.04)
P=0.08
P=0.69
P=0.66
%
Mortality Stent Thrombosis
NNTB: 167
Lancet. 2015 Jun 20;385(9986):2465-76

Bleeding endpoints:
BARC, TIMI, GUSTO, access vs non-access related
1.4%
2.5%
%
P=0.013
RR: 0.67
0.49-0.92
P=0.0004
RR: 0.37
0.21-0.66
BARC 3 or 5
P=0.0098
RR: 0.64
0.45-0.90
P=0.08
RR: 0.72
0.50-1.04 P=0.20
RR: 0.78
0.53-1.14
Major
or minor
moderate
or severe
P=0.82
P=0.68
Lancet. 2015 Jun 20;385(9986):2465-76

Rardial Better Femoral Better
1
HAZARD RATIO (95% CI)
P-VALUES
Superiority Interaction
0.89Intermediate (548-991)
0.75 (0.60-0.94)
1.04 (0.82-1.32) 0.76
0.011
Centre’s annual
volume of PCI
Low (247-544)
Intermediate (65.4-79.0%)
Centre’s
Proportion of
radial PCI
Low (14.9-64.4%)
NSTE-ACS (tp–)ACS type
STEMI
<75
Age
≥75 0.230.88 (0.70-1.09)
0.82 (0.68-0.97) 0.023 0.62
NACE: Subgroup Analysis
High (1000-1950)
High (80.0-98.0%)
NSTE-ACS (tp+)
Men
Sex
Women
<25
BMI
≥25
No
Ticagrelor or
prasugrel
Yes
No
Diabetes
Yes
<60
GFR
≥60
No
History of
PVD
Yes
20.25 0.50
0.75 (0.58-0.97) 0.025
0.0048
1.01 (0.79-1.29)
0.95 (0.75 -1.22) 0.71
0.95
0.64 (0.51-0.80) <0.001
0.44
0.86 (0.68-1.08)
0.58 (0.33-1.03) 0.059
0.19
0.85 (0.71-1.02) 0.07
0.0120.72 (0.56-0.93)
0.89 (0.76-1.05) 0.16 0.18
0.090.86 (0.73-1.02)
0.79 (0.63-0.99) 0.038 0.53
0.070.83 (0.68-1.02)
0.84 (0.70-1.01) 0.06 0.94
0.450.91 (0.71-1.17)
0.80 (0.68-0.94) 0.08 0.43
0.010.78 (0.65-0.94)
0.86 (0.70-1.07) 0.18 0.51
0.600.91 (0.64-1.30)
0.83 (0.71-0.96) 0.012
0.64

Radial Better Femoral Better
1
P-VALUES
Centre’s
Proportion
of radial PCI
Low (14.9-64.4%)
STEMI
Subgroup Analysis
High (80.0-98.0%)
NSTE-ACS (tp+)
2
0.0157
1.28 (0.71-2.32)
0.69 (0.40 -1.19) 0.18
0.41
0.48 (0.28-0.81) 0.006
0.10
0.87 (0.59-1.29) 0.49
0.49 (0.28-0.87) 0.012
Centre’s
Proportion
of radial PCI
Low (14.9-64.4%)
STEMI
High (80.0-98.0%)
NSTE-ACS (tp+)
0.20
0.90 (0.54-1.50)
0.57 (0.31 -1.03) 0.06
0.68
0.56 (0.32-0.97) 0.035
0.54
0.62 (0.41-0.94)
1.66 (0.28-10.0) 0.58
0.022
0.70 (0.42-1.17) 0.17
Mortality
Bleeding
40.500.25
1 20.500.25

MATRIX-Access:
STEMI and NSTE-ACS Subgroups
Vranckx P et al. Eur Heart J. 2017 Apr 7;38(14):1069-1080
RA compared with FA provided consistent benefit across the
whole spectrum of patients with ACS

MATRIX-Access:
STEMI and NSTE-ACS Subgroups
Vranckx P et al. Eur Heart J. 2017 Apr 7;38(14):1069-1080
All-cause death: Interaction between Center/Operator volume
and Radial benefits is present in STEMI but not NSTE-ACS
STEMI
NSTE-
ACS

P-VALUES
0.89Intermediate (548-991)
0.75 (0.60-0.94)
1.04 (0.82-1.32) 0.76
0.011
Centre’s annual
volume of PCI
Low (247-544)
Centre’s
Proportion of
radial PCI
Low (14.9-64.4%)
NACE: Subgroup Analysis
High (1000-1950)
High (80.0-98.0%)
0.75 (0.58-0.97) 0.025
0.0048
1.01 (0.79-1.29)
0.95 (0.75 -1.22) 0.71
0.95
0.64 (0.51-0.80) <0.001
MATRIX-MATCH
Is the Radial or the Operator that matters?
Radial Better Femoral Better
1 20.25 0.50
Lancet Letter 1: “The study’s positive outcomes in favour of radial access are probably
driven by excess events after femoral access in centres that manage a low proportion of
cases via the femoral approach”.
Lancet Letter 2: “…in MATRIX, the high radial volume centres were low-volume centres
for femoral access. This issue could lead to increased incidence of complications in the
femoral group, introducing potential bias favouring the radial group”.
JACC Interv. View-Point: “…centers performing PCI almost exclusively by TRA have
limited contemporary experience with TFA and consequently have more complications”.

MATRIX-Access: Sex Subgroups
Gargiulo G et al. JACC Interv 2017 In press
Coprimary composite endpoint of
all-cause mortality, MI or stroke
Female
Male
Coprimary composite endpoint of
all-cause mortality, MI, stroke, BARC 3 or 5
Female
Male
All-Cause Mortality
Female
Male
Myocardial Infarction
Female
Male
Stroke
Female
Male
Bleeding BARC 3 or 5
Female
Male
Outcome
0.73 (0.56, 0.95)
0.92 (0.77, 1.09)
0.89 (0.76, 1.05)
0.70 (0.43, 1.15)
0.76 (0.50, 1.15)
0.77 (0.56, 1.05)
0.95 (0.79, 1.15)
0.54 (0.16, 1.78)
1.46 (0.60, 3.57)
0.58 (0.34, 0.98)
0.74 (0.50, 1.11)
Rate Ratio
(95% CI)
0.15
0.18
0.79
0.25
0.18
0.45
P for
interaction
0.73 (0.56, 0.93)
Radial access better Femoral access better
10.25 0.5 2
 There was no
significant
interaction for all
outcomes
confirming
MATRIX-Access
results
(superiority of RA
vs FA)
irrespective of sex
 Females showed
significant benefit
from RA in
reducing MACE
and NACE
(p<0.025)

MATRIX-AKI
8,404
Ando G et al. JACC 2017; May; pii: S0735-1097(17)36897-3
15.43
17.36
5.18
6.05
3.41 3.73
1.10 1.19
0.68
1.12
OR 0.87
(0.77-0.98)
P=0.018
OR 0.85
(0.70-1.03)
P=0.090
OR 0.91
(0.72-1.15)
P=0.430
OR 0.92
(0.61-1.38)
P=0.671
OR 0.60
(0.38-0.97)
P=0.037
RA was associated with a reduced
risk of AKI compared with FA

MATRIX-AKI
Radial Access Femoral Access Odds Ratio (95% CI) p Value
All patients receiving an angiography and/or PCI (N=4109) (N=4101)
AKI according to primary endpoint definition 634 (15.43) 712 (17.36) 0.87 (0.77-0.98) 0.0181
AKI 25% relative increase 633 (15.41) 710 (17.31) 0.87 (0.77-0.98) 0.0195
AKI 0.5 absolute increase 175 (4.26) 223 (5.44) 0.77 (0.63-0.95) 0.0131
After index procedure only 605 (14.72) 670 (16.34) 0.88 (0.78-1.00) 0.0436
After staged procedure only 75 (1.83) 95 (2.32) 0.78 (0.58-1.06) 0.1189
AKI according to the KDIGO classification 213 (5.18) 248 (6.05) 0.85 (0.70-1.03) 0.0900
Stage 1 140 (3.41) 153 (3.73) 0.91 (0.72-1.15) 0.4295
Stage 2 45 (1.10) 49 (1.19) 0.92 (0.61-1.38) 0.6713
Stage 3 28 (0.68) 46 (1.12) 0.60 (0.38-0.97) 0.0367
Dialysis during hospitalization 6 (0.15) 14 (0.34) 0.43 (0.16-1.11) 0.0814
Patients without cross-over during PCI (N=3765) (N=3840)
Only pts index PCI (excluding angiography only) (N=3317) (N=3299)

MATRIX-AKI

MATRIX-Access
WHAT NEXT?
Work in progress...
Pooled IPD analysis of MATRIX, RIVAL, SAFE PCI, RIFLE-STEACS and Radial STEMI

Why does radial access
reduce mortality?

12 Valgimigli aimradial20170921 MATRIX program

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