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Francesco Burzotta
Institute of Cardiology, Catholic University of the Sacred
Heart, Rome - Italy
Provisional stenting: can we improve outcomes?
RESOLUTE INTEGRITY: CLINICAL EXPERIENCE
How to (theoretically) improve provisional stenting?
DES with best response to different
technical steps
Improved sequence of
technical interventions
IMPROVED PROCEDURAL OUTCOME IN BIFURCATION PCI
IMPROVED LATE CLINICAL OUTCOME IN BIFURCATION PCI
How to (theoretically) improve provisional stenting?
DES with best response to different
technical steps
Improved sequence of
technical interventions
IMPROVED PROCEDURAL OUTCOME IN BIFURCATION PCI
IMPROVED LATE CLINICAL OUTCOME IN BIFURCATION PCI
Procedural key points in the interaction between provisional
technique and stent
STENT CONFORMABILTY INTO THE MAIN VESSEL (MV)
-MISS-MATCH BETWEEN PROXIMAL AND DISTAL MV
-MV BENDINGS (OR PROXIMAL MV TO SIDE BRANCH BENDING)
SIDE BRANCH (SB) ACCESIBILITY AFTER MV STENTING
-EASINESS OF SB REWIRING/DILATION
-SB SCAFFOLDING AFTER DISTAL REWIRING AND KISSING
-SB CELLS DILATION AFTER DISTAL REWIRING AND KISSING
STENT CONFORMABILTY INTO THE MAIN VESSEL (MV)
-MISS-MATCH BETWEEN PROXIMAL AND DISTAL MV
-MV BENDINGS (OR PROXIMAL MV TO SIDE BRANCH BENDING)
Procedural key points in the interaction between provisional
technique and stent
SIDE BRANCH (SB) ACCESIBILITY AFTER MV STENTING
-EASINESS OF SB REWIRING/DILATION
-SB SCAFFOLDING AFTER DISTAL REWIRING AND KISSING
-SB CELLS DILATION AFTER DISTAL REWIRING AND KISSING
STENT CONFORMABILTY INTO THE MAIN VESSEL
*Burzotta, Trani (unpublished data)
Bench testing*: 3.5mm stent dilation with 7x20 mm balloon
0
2
4
6
8
Cypher Xience Endeavor Resolute
Taxus
MAX diameter (mm)
STENT CONFORMABILTY INTO THE MAIN VESSEL (MV)
-MISS-MATCH BETWEEN PROXIMAL AND DISTAL MV
-MV BENDINGS (OR PROXIMAL MV TO SIDE BRANCH BENDING)
Procedural key points in the interaction between provisional
technique and stent
SIDE BRANCH (SB) ACCESIBILITY AFTER MV STENTING
-EASINESS OF SB REWIRING/DILATION
-SB SCAFFOLDING AFTER DISTAL REWIRING AND KISSING
-SB CELLS DILATION AFTER DISTAL REWIRING AND KISSING
RESOLUTE PLATFORM*
COMPARATIVE OVERVIEW
EASINESS OF SIDE BRANCH REWIRING/DILATION
*Basalus et al. EuroIntervent 2011
*Burzotta, Mortier et al. unpublished
SIDE BRANCH SCAFFOLDING AFTER POT, DISTAL REWIRING AND KISSING
Bench testing and virtual simulation of POT and kissing
SIDE BRANCH SCAFFOLDING AFTER POT, DISTAL REWIRING AND KISSING
*Burzotta, Mortier et al. unpublished
SIDE BRANCH SCAFFOLDING AFTER POT, DISTAL REWIRING AND KISSING
*Burzotta, Mortier et al. unpublished
How to (theoretically) improve provisional stenting?
DES with best response to different
technical steps
Improved sequence of
technical interventions
IMPROVED PROCEDURAL OUTCOME IN BIFURCATION PCI
IMPROVED LATE CLINICAL OUTCOME IN BIFURCATION PCI
Z-SEA-SIDE study
ACRONYM: Z-SEA-SIDE, Sirolimus vs Everolimus –eluting
stent randomized Assessment in bifurcated lesions and
clinical SIgnificance of residual siDE-branch stenosis
REGISTRATION: www.clinicaltrials.org (NCT00697372)
DESIGN: single centre, non sponsored, open label
prospective study comparing Resolute vs Cypher and
Xience in unselected bifurcated lesions
CO-INVESTIGATORS: Trani, Todaro, Mariani, Talarico,
Mongiardo, Mazzari, Porto, Niccoli, Leone, Tommasino,
Schiavoni, Crea
STUDY FLOW-CHART
225 CONSECUTIVE UNSELECTED PATIENTS WITH BIFURCATED LESION
UNDERGOING DES IMPLANTATION (only exclusion criteria:
contraindication to prolonged double antiplatelet therapy, STEMI, TIMI<3)
PERIOD 1 (150 PTS)
1:1 RANDOMIZATION TO
PROSPECTIVE EVALUATION OF PROCEDURAL PERFORMANCE
OFF-LINE, BLIND, 3DQCA ANALYSIS OF PROCEDURAL RESULTS WITH A
BIFURCATION-DEDICATED SOFTWARE
PERIOD 2 (75 PTS)
SYSTEMATIC IMPLANTATION OF
SES EES R-ZES
PCI with Provisional TAP-stenting strategy
RESULTS: PROCEDURAL
PERFORMANCE
STEPS OF PROVISIONAL-TAP
Need of guidewires different from
BMW for SB re-wiring
MV Stent according to
randomization / intention
SB re-wiring attempted (BMW)
SB stent implantation
followed by final kissing (TAP)
Kissing inflation performed
ANY SB “TROUBLE”
(composite of green items)
Failure of SB dilation
Failure of SB re-wiring
SB flow <3 after MV stent
P
6 (8.0%) 3 (4.0%) 1(1.3%)
52 (69.3%) 55 (73.3%) 58 (77.3%)
12 (16.0%) 8 (10.7%) 3 (4.0%)
1 (1.3%) 1 (1.3%) 0
2 (2.7%) 3 (4.0%) 0
7 (9.3%) 8 (10.7%) 3 (4.0%)
75 (100%) 75 (100%) 75 (100%) ns
0.11
ns
ns
ns
50 (66.7%) 51 (68.0%) 55 (73.3%)
6 (8.0%) 6 (8.0%) 10 (13.3%)
ns
ns
0.01
0.05
<0.01
RESULTS: 3DQCA
ANGIOGRAPHIC RESULTS
P
BE
FO
RE
PC
I M
AIN
VE
SS
EL
PO
ST
-PC
I
SID
E B
RA
NC
H
PO
ST
PC
I SB area stenosis
SB MLD at ostium*
Angle modification
SB Min. Lum area
* pre-defined end-point
MV area stenosis
SB Min. Lum area
MV Min. Lum. Area
SB area stenosis
Bifurcation angle
80.0% 75.8% 75.5%
1.0 mm2 1.2 mm2 1.2 mm2
50.2% 54.6% 50.5%
1.7 mm2 2.0 mm2 2.1 mm2
65° 67° 64°
ns
ns
ns
ns
ns
MV area stenosis
MV MLD prox to bif
MV MLD distal to bif
MV Min. Lum area
29.3% 30.7% 31.4%
5.2 mm2 5.8 mm2 5.7 mm2
2.9 mm 3.1 mm 3.0 mm
2.8 mm 3.0 mm 2.9 mm
ns
ns
ns
ns
0.07
0.01
43.9% 39.5% 36.3%
2.4 mm2 3.3 mm2 3.5 mm2
1.8 mm 2.7 mm 2.7 mm
-5.3° -4.4° -3.2° ns
How to (theoretically) improve provisional stenting?
DES with best response to different
technical steps
Improved sequence of
technical interventions
IMPROVED PROCEDURAL OUTCOME IN BIFURCATION PCI
IMPROVED LATE CLINICAL OUTCOME IN BIFURCATION PCI
LATE CLINICAL OUTCOME IN BIFURCATION PCI WITH RESOLUTE
RESULTS DERIVED FROM RESOLUTE TRIALS
RESULTS FROM A LARGE “REAL-WORLD” REGISTRY
LATE CLINICAL OUTCOME IN BIFURCATION PCI WITH RESOLUTE
RESULTS DERIVED FROM RESOLUTE TRIALS
RESULTS FROM A LARGE “REAL-WORLD” REGISTRY
For OMA distribution only. © 2012 Medtronic, Inc. All rights reserved. 10051776DOC_1A 05/12
Enrollment Complete - In Follow Up
RESOLUTE1 Non-RCT First-in-Human (R=139) 5 yr
RESOLUTE AC2,3 1:1 RCT vs. Xience V (R=1140; X=1152) 3 yr
Non-RCT Observational (R=2349) 2 yr
2.25 – 4.0 mm Non-RCT vs. Hx Control (R=1402) 2 yr RESOLUTE US5
2.5 – 3.5 mm Non-RCT (R=100) vs. Hx Control RESOLUTE Japan 2 yr
R Japan SVS 2.25 Non-RCT vs. PG (R=65) < 1yr
38 mm sub-study Non-RCT vs. PG (R=114) < 1yr
RESOLUTE Asia Non-RCT Observational (R=312) < 1yr
RI-US Registry Post-approval study (R=230) plan
RESOLUTE US
RESOLUTE Global Clinical Program
Enrolling / Planning
1:1 RCT vs. Taxus (R=200; T=200) R-China RCT < 1yr
RESOLUTE Int4
R-China Registry Non-RCT Observational (R=1800) < 1yr
2 All-comer Trials Allowed Enrollment of Bifurcation Lesions
1Meredith IT, et al. EuroIntervention. 2010;5:692-7. 2Serruys PW, et al. N Engl J Med. 2010;363:136-46. 3Silber S, et al. Lancet. 2011;377:1241-47. 4Neumann FJ, et al. EuroIntervention. 2012;7(10):1181-8. 5Yeung AC, et al. JACC. 2011;57:1778-83.
For OMA distribution only. © 2012 Medtronic, Inc. All rights reserved. 10051776DOC_1A 05/12
RESOLUTE All Comers
N = 1140 (R-ZES arm)
Bifurcations
N = 190
Bifurcations
N = 512
RESOLUTE International
N = 2349
Bifurcations N = 702
1 Year Follow-up n = 695 (99.0%)
2 Year Follow-up n = 688 (98.0%)
Patient Flowchart
RESOLUTE Pooled – Bifurcation Subset
For OMA distribution only. © 2012 Medtronic, Inc. All rights reserved. 10051776DOC_1A 05/12
% N = 702 patients,
1087 lesions
Lesion location
LAD 64.8
LCX 33.5
RCA 21.9
Left main 6.4
De novo 97.3
B2/C 73.2
Thrombus (angiographically visible) 9.4
Total occlusions (TIMI 0) 10.9
Lesion Characteristics
RESOLUTE Pooled – Bifurcation Subset
For OMA distribution only. © 2012 Medtronic, Inc. All rights reserved. 10051776DOC_1A 05/12
(1,1,1)
29.4%
(1,1,0)
8.4%
(1,0,1)
3.7%
(0,1,1)
7.1%
(1,0,0)
4.1%
(0,1,0)
9.1%
(0,0,1)
3.0%
Medina Classification*
RESOLUTE Bifurcation Subset
*Medina classification only available in RESOLUTE All Comers (R-AC) trial; n = 296 lesions
For OMA distribution only. © 2012 Medtronic, Inc. All rights reserved. 10051776DOC_1A 05/12
% N = 702 patients,
1087 lesions
Double guidewires 63.9
Main vessel stented 98.0
Side branch stenting 19.1
Bifurcation technique
Culotte 5.4
Mini-crush\Crush 25.9
T 38.8
Simultaneous Kissing Stent 7.5
V 9.5
Other 12.9
Kissing balloon post-dilatation (R-INT only) 78.4
Procedure Characteristics II
RESOLUTE Pooled – Bifurcation Subset
For OMA distribution only. © 2012 Medtronic, Inc. All rights reserved. 10051776DOC_1A 05/12
0
Time After Initial Procedure (months)
Cu
mu
lati
ve
In
cid
en
ce
of
TL
F
6 12 18 24
20%
16%
12%
0%
8%
4%
9.4%
Patients with Bifurcation
Patients without Bifurcation
12.6%
Patients at risk
Bifur 702 683 637 614 596
%CI 2.6% 7.7% 10.3% 11.8% 12.6%
No Bifur 2773 2745 2622 2547 2458
%CI 1.0% 4.5% 6.4% 8.2% 9.4%
Target Lesion Failure (Cardiac Death, TV-MI, TLR) to 2 Years
RESOLUTE Pooled – Bifurcation Subset
For OMA distribution only. © 2012 Medtronic, Inc. All rights reserved. 10051776DOC_1A 05/12
6.2%
0 6 12 18 24
Patients at risk
TLR 702 701 663 641 623
%CI 0% 3.0% 4.9% 5.9% 6.2%
TLR
Time After Initial Procedure (months)
20%
16%
12%
0%
8%
4%
Target Lesion Revascularization to 2 Years
RESOLUTE Pooled – Bifurcation Subset C
um
ula
tive
Incid
enc
e o
f
Reva
scula
riza
tion
TLR is ischemia driven.
4.9%
For OMA distribution only. © 2012 Medtronic, Inc. All rights reserved. 10051776DOC_1A 05/12
% 1 Year n = 695
2 Years n = 688
Death (all) 2.3 4.1
Cardiac death 1.6 2.6
Target vessel MI 5.9 6.4
Q Wave 1.3 1.6
Non Q wave 4.6 4.8
Cardiac death + target vessel MI 7.1 8.4
ARC Def/Prob ST (all) 2.0 2.3
Early (≤ 30 days) 2.0 2.0
Late (31-360 days) 0.1 0.1
Very Late (>360 days) -- 0.3
TLR 4.9 6.1
TVR 6.2 8.3
TLF (cardiac death, target vessel MI, TLR) 10.4 12.6
TVF (cardiac death, target vessel MI, TVR) 11.5 14.5
MACE (death, MI, TLR, emergent CABG) 11.4 14.4
Clinical Outcomes at 1 and 2 Years
RESOLUTE Pooled – Bifurcation Subset
For OMA distribution only. © 2012 Medtronic, Inc. All rights reserved. 10051776DOC_1A 05/12
Cu
mu
lati
ve
In
cid
en
ce
of
T
LR
5.7%
7.6%
Patients at risk
1 Stent 539 538 510 494 479
%CI 0% 3.0% 4.5% 5.3% 5.7%
>1 Stent 163 163 153 147 144
%CI 0% 3.1% 6.3% 7.6% 7.6%
Time After Initial Procedure (months)
0% 0 6 12 18 24
Patients with 1 Stent Implanted
Patients with >1 Stent Implanted
20%
16%
12%
0%
8%
4%
TLR by Number of Stents to 2 Years
RESOLUTE Pooled – Bifurcation Subset
TLR is ischemia driven.
LATE CLINICAL OUTCOME IN BIFURCATION PCI WITH RESOLUTE
RESULTS DERIVED FROM RESOLUTE TRIALS
RESULTS FROM A LARGE “REAL-WORLD” REGISTRY
EFFICACY OF RESOLUTE STENT FOR THE TREATMENT OF BIFURCATED CORONARY STENOSIS OF DIFFERENT COMPLEXITY: A REAL-WORLD ITALIAN MULTICENTRE
REGISTRY
F Burzottaa, A Tommasinoa, F Summariab, R Patrizib,
A Colomboc, A Latibc, M De Vitad, F Della Roveree, M Turturof, A Manzolig, Ielasi Ah, C Larosai, C Trania.
a Cardiology Department, Catholic University of Sacred Heart, Rome Italy, b Cardiology Department, Policlinico Casilino, Rome Italy, c San Raffaele Scientific Institute, Milan Italy, d Cardiology Department, Morgagni Hospital, Forlì Italy, e Cardiology Department, Ospedale Galliera, Genova Italy f Cardiology Department, di Venere Hospital, Bari Italy, g Cardiology Department, San Giovanni Addolorata Hospital, Rome Italy h Cardiology Department, Multimedica Hospital, Castellanza Italy i Cardiology Department, Lorenzo Bonomo Hospital, Andria Italy
• From August 2008 to March 2012, 9 Italian Centers prospectively collected data on pts with coronary artery disease treated by PCI with implantation of at least one R-ZRS.
• Patients receiving ZRS to treat a bifurcated lesion entered the present study.
• Pts were prospectively followed by phone contact at 1, 6, 12, 24, 36 and 48 months:
– to assess the occurrence of major adverse cardiac events (MACE; cardiac death, non-fatal myocardial infarction, TLR , TVR and ST defined according to the ARC criteria).
Methods
Italian ClinicalService® project:
• A national medical care project aimed at evaluating and improving the use of implantable cardiac devices in clinical practice
• The project consists of a shared environment for the collection, management, analysis and reporting of data from patients wearing Medtronic implantable devices
• An independent physician steering committee prospectively identifies key clinical questions on a yearly basis for analysis and publication
• A charter assigns the ownership of data to the centers and governs the conduct and relationship of the steering committee and Medtronic
• ClinicalTrials.gov identifier: NCT01007474
Methods
Patients with bifurcations 527
Maximum FU lenght (months) 48.5
Mean FU lenght (months) 20.2
Study population
Silent Ischemia
16%
Stable Angina
38%
ACS
46%
PCI Indication
Baseline Clinical Characteristics
Characteristics All (n=527)
Age (years) 66.1 (11)
Male 407 (77.2%)
Diabetes 152 (28.9%)
Current smoker 108 (20.5%)
Hypertension 410 (78%)
Previous AMI 140 (27%)
Previous PCI-CABG 166 (31.5%)
PCI
CABG
PCI+CABG
122 (23.1%)
31 (5.9%)
13 (2.5%)
Angio Characteristics
LM 17.3%
LAD-Diag 47.0%
LCx-OM 24.2%
RCA 8.4%
Medina – 001 4.3%
Medina – 010 18.8%
Medina – 100 8.0%
Medina – 011 8.3%
Medina – 101 Medina - 110
7.8%
22.7%
Medina – 111
30.3%
Angiographic Characteristics
SIMPLE
INTERMEDIATE
COMPLEX
BIFURCATION COMPLEXITY
Procedural Characteristics: stenting technique
88%
64%
5.9%
2.2%
1.2%
1.5%
1.0%
Single stent 88%
Double stent 12%
Cardiac death 1.9%
MI 3.6%
TLR 5.1%
TVR 6.1%
Stent thrombosis 1.0%
MACE 12.0%
Adverse events during (average 20 months) follow-up
MACE-FREE SURVIVAL
Free
do
m f
rom
MA
CE
(%)
0
25
50
75
100
Months since stent implant
0 3 6 9 12 15 18 21 24 27 30 33 36
No. at Risk 527 499 448 410 383 295 259 256 222 114 95 90 65
88.0%
By stenting technique
By bifurcation complexity
Fre
ed
om
fro
m M
AC
E (
%)
0
25
50
75
100
Months since stent implant
0 3 6 9 12 15 18 21 24 27
ComplessaIntermediaSemplice
P = 0.19
No. at Risk
Complessa
Intermedia
Semplice
0 0 0 0 0 0 0 0 0 0
162 155 147 138 130 101 87 86 74 40
188 177 154 141 131 98 89 87 76 40
143 139 125 112 105 85 76 76 67 32
Complex Intermediate Simple
91.1% 94%
88.9%
P = 0.19
Overall population
MACE-FREE SURVIVAL
Overall population
Free
do
m f
rom
MA
CE
(%)
0
25
50
75
100
Months since stent implant
0 3 6 9 12 15 18 21 24 27 30 33 36
No. at Risk 527 499 448 410 383 295 259 256 222 114 95 90 65
88.0%
Fre
ed
om
fro
m M
AC
E (%
)
0
25
50
75
100
Months since stent implant
0 3 6 9 12 15 18 21 24 27
SingleDouble
P = 0.011
No. at Risk
.
Single
Double
0 0 0 0 0 0 0 0 0 0
452 434 387 353 328 250 218 216 184 94
68 58 54 51 49 39 38 37 35 18
By stenting technique
91.8%
82.8%
P = 0.01
TLR-FREE SURVIVAL
Overall population
By stenting technique
By bifurcation complexity
Fre
ed
om
fro
m T
LR_
Eve
nt
(%)
0
25
50
75
100
Months since stent implant
0 3 6 9 12 15 18 21 24 27
ComplessaIntermediaSemplice
P = 0.29
No. at Risk
Complessa
Intermedia
Semplice
0 0 0 0 0 0 0 0 0 0
162 156 148 139 131 102 88 87 75 41
188 178 156 142 132 99 90 88 77 40
143 140 126 114 107 86 77 77 68 33
Complex Intermediate Simple
93%
92.5%
97.1%
Free
do
m f
rom
TLR
_Eve
nt
(%)
0
25
50
75
100
Months since stent implant
0 3 6 9 12 15 18 21 24 27 30 33 36
No. at Risk 527 502 452 414 387 298 262 259 225 116 97 93 67
92.7%
P = 0.29
Free
do
m f
rom
TLR
_Eve
nt
(%)
0
25
50
75
100
Months since stent implant
0 3 6 9 12 15 18 21 24 27
SingleDouble
P = 0.0095
No. at Risk
.
Single
Double
0 0 0 0 0 0 0 0 0 0
452 436 390 356 331 253 221 219 187 96
68 59 55 52 50 39 38 37 35 18
By stenting technique
94.5%
87.1%
TLR-FREE SURVIVAL
Overall population
Free
do
m f
rom
TLR
_Eve
nt
(%)
0
25
50
75
100
Months since stent implant
0 3 6 9 12 15 18 21 24 27 30 33 36
No. at Risk 527 502 452 414 387 298 262 259 225 116 97 93 67
92.7%
P <0.01
STENT THROMBOSIS-FREE SURVIVAL
Overall population By bifurcation complexity
Free
do
m f
rom
Tro
m (
%)
0
25
50
75
100
Months since stent implant
0 3 6 9 12 15 18 21 24 27
ComplessaIntermediaSemplice
P = 0.77
No. at Risk
Complessa
Intermedia
Semplice
0 0 0 0 0 0 0 0 0 0
162 157 149 142 134 106 93 92 78 44
188 181 163 150 140 106 98 96 82 42
143 140 127 115 108 86 78 78 69 33
98.8%
99.1%
99.5%
Complex Intermediate Simple
Free
do
m f
rom
Tro
m (
%)
0
25
50
75
100
Months since stent implant
0 3 6 9 12 15 18 21 24 27 30 33 36
No. at Risk 527 506 461 426 399 309 276 273 234 121 103 98 70
99%
P =NS
STENT THROMBOSIS-FREE SURVIVAL
Overall population By stenting technique
Free
do
m f
rom
Tro
m (
%)
0
25
50
75
100
Months since stent implant
0 3 6 9 12 15 18 21 24 27
SingleDouble
P = 0.64
No. at Risk
.
Single
Double
0 0 0 0 0 0 0 0 0 0
452 437 395 363 338 260 232 230 194 101
68 62 59 57 55 43 41 40 37 18
99.1%
98.5%
Free
do
m f
rom
Tro
m (
%)
0
25
50
75
100
Months since stent implant
0 3 6 9 12 15 18 21 24 27 30 33 36
No. at Risk 527 506 461 426 399 309 276 273 234 121 103 98 70
99%
P =NS
Simple
MACE BY BIFURCATION COMPLEXITY AND STENTING TECHNIQUE
Intermediate Complex
5%
10%
15%
20%
single stent double stent
MACE rate RR 6.5
RR 2.1
RR 2.4
CONCLUSIONS
the use of last generation ZRS is associated with excellent performance in provisional stenting procedures and with promising clinical outcome in a wide spectrum of bifurcated lesions complexity