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Transcript of XXXI Jornadas SOLACI. 10ª Región CONOSUR LIIIº...
Fernando Alfonso Departamento de Cardiología
Hospital Universitario de La Princesa
Universidad Autónoma de Madrid
Instituto Investigación Sanitaria (IIS-IP)
Madrid. ESPAÑA
Tratamiento de la
Reestenosis del Stent
Farmacoactivo
XXXI Jornadas SOLACI. 10ª Región CONOSUR
LIIIº Congreso Chileno de Cardiología y Cirugía Cardiovascular
Hotel Patagónico. Puerto Varas. Chile (30 Nov – 1 Dic 2016)
DES Restenosis
Neointimal Proliferation
Predominant Mechanism
Neointimal hyperplasia (SMC)
Curfman GDN. Egl J Med 2007;356(10):1059-60.
Neoatherogenesis
Fibroatheroma. Lipid-laden
Macrophages, calcium (Necrotic Core)
DES 30%, Earlier than BMS
Young, Unstable, Time, DES
Nakazawa G, Virmani R. J Am Coll Cardiol 2011;57:1314–22
Thrombus
DES Fracture
DES Gap
Geographic Miss
Uneven/Undelivered Drug
Non-uniform Strut Distribution
DES Damage
DES Underexpansion (***)
Hypersensitivity
Drug Resistance
Biological Factors
Focal
Diffuse
Mechanical Factors
IVUS / OCT
Treatment of DES ISR:
DES Restenosis
58% Rupture, 52% TCFA, 58% Thrombus
Kang SJ, Mintz GS. Circulation. 2011;123:2954-2963
Rupture
TCFA
TCFA
Thrombus
OCT in 50 Pts with DES ISR
Calcified DES ISR
A +
+
+
+
+
+
B
C
D
E *
*
*
Alfonso F. Calcified In-Stent Restenosis : A Rare Cause of Dilation Failure Requiring Rotational Atherectomy. Circ Cardiovasc Interv 2012;5;e1-e2.
Calcified DES ISR
+ +
+
*
A B
C
Alfonso F. Calcified In-Stent Restenosis : A Rare Cause of Dilation Failure Requiring Rotational Atherectomy. Circ Cardiovasc Interv 2012;5;e1-e2.
“The elusive link between very late ISR and ST”
Ruptured Neoatherosclerosis
B *
PRESTIGE (13/08/2012)
E
*
+
+
+
D
*
+
+
+
A
B C D
E *
T
C
DES Restenosis
Alfonso F, J Am Coll Cardiol 2013;61:155
ESC
Guidelines
I - A
Medical Management (including oral antiproliferative agents)
Repeated PCI:
Balloon angioplasty (BA)
Non-compliant balloons
Cutting /Scoring balloons (CB)
Drug-Eluting Balloons (DEB)
Brachytherapy (VBT)
Rotational atherectomy / Laser
Bare-Metal Stents (BMS)
Drug-Eluting Stents (DES)
Homo-DES
Hetero-DES (Switch)
Coronary Surgery
Treatment of DES ISR:
Meta-Analyses on ISR
Author Date Patients/Trials Network
Metaanalysis
Interventions 1ry End-Point Main Result
(Better>Worse)
OR (95%CI)
Radke et al16 2003 3012/28 VBTvsBA MACE VBT>BA -37.7+4.0%*
Costantini et al17 2003 133 VBTvsPlacebo BR VBT>placebo 0.06 (0.02- 0.17)(+)
Uchida et al18 2006 1310/5 VBTvsPlacebo MACE VBT > placebo 0.19 (0.09-0.29)
Dibra et al19 2007 1230/4 DESvsVBT TLR DES>VBT 0.35 (0.25-0.49)
Oliver et al20 2008 3103/14 DESvsVBTvsBA MACE DES=VBT>BA 0.72 (0.61-0.85)
Alfonso et al21 2008 300/2 DESvsBMS BR DES>BMS 0.11 (0.03-0.36)(+)
Lu et al22 2011 1942/12 DESvsVBT TVR DES>VBT 0.44 (0.23-0.81)
Yu et al23 2013 349/5 DCBvsDES/BA TLR DCB>DES/BA 0.17 (0.07-0.38)
Navarese et al24 2013 399/4 DCBvsDES/BA TLR DCB>DES/BA 0.20 (0.11-0.36)
Indermuehle et al25 2014 801/5 DCBvsPES/BA MACE DCB>PES/BA 0.46 (0.31-0.70)
Sun et al26 2014 6330/28 DESvsOther TLR DES>BMS>other 0.46 (0.34-0.62)
Vyas et al27 2014 1680/10 SameDESvsDifDES TLR DES>DES 0.73 (0.45-0.93)
Piccolo et al 28 2014 1586/7 X DCBvsDESvsBA %DS DCB=DES>BA -17.7 (-25- -11)**
Mamuti et al29 2014 864/5 DCBvsDES/BA MACE DCB>DES>BA 0.49
Mamuti et al30 2015 803/4 DCBvsDES MACE DCB=DES 1.04
Li et al31 2015 1448/9 DCBvsDESvsBA MACE DCB=DES>BA 0.21 (0.13-0.33)
Benjo et al32 2015 1375/5 VBTvsDES TLR DES>VBT 2.4 (1.5-3.6)
Siontis et al33 2015 5923/27 X Multiple %DS EES>DCB>other -9 (-15.8- -2.2)**
Lee et al6 2015 2059/11 X DCBvsDESvsBA TLR DCB=DES>BA 0.22 (0.10-0.42)
%DS: Percent diameter stenosis; EES: Everolimus Eluting Stent; DCB: Drug Coated Balloon; VBT: Vascular Brachytherapy; TLR: Target Lesion revascularization; DES: Drug Eluting Stent; MACE:
Mayor Adverse Cardiac Events;DifDES: different (hetero) DES; SameDES: Similar (homo) DES; TVR: Target Lesion Revascularization. (+) Simple pooled analysis of randomized clinical trials. Other :
more than 2 different interventions. ; (*): Probability of MACE (in %)
(**): %DS
Alfonso F, Rivero F. J Thorac Dis 2015;7(10):1678-1683.
DCB
Late Loss
(mm)
(%)
PEB
BA
Habara S. J Am Coll Cardiol Intv 2011;4:149 –54
RCT: 50 Pts SES ISR
25 PEB vs 25 BA
(%) TLR
DCB in SES ISR
Restenosis
PEB for ISR (Acute)
D E F * * *
A B C * *
*
2/6/2011 RIBS IV (DB #52323, #1838961) Sandoval J, Alfonso F. J Invasive Cardiol. 2012 Oct;24(10):E215-8.
PEB for DES ISR (Follow-up)
D E F
* * *
* * *
A B C
2/6/2011 RIBS IV (DB #52323, #1838961) Sandoval J, Alfonso F. J Invasive Cardiol. 2012 Oct;24(10):E215-8.
Primary Endpoint: Diameter Stenosis at FU
Diameter Stenosis at Follow-up Angiography (%)
Cu
mu
lati
ve
Fre
qu
en
cy
(%
)
0 20 40 60 80 100
0
20
40
60
80
100
Balloon Angioplasty (BA)
Paclitaxel-Eluting Balloon (PEB)
Paclitaxel-Eluting Stent (PES)
PEB versus PES
Pnon-inferiority =0.007
PEB versus BA
PES versus BA
Psuperiority <0.001
PEB 38.0%
PES 37.4%
BA 54.1%
ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents
for In-Stent Restenosis: 3 Treatment Approaches
ISAR-DESIRE 3
ISAR-DESIRE 4: Primary Endpoint Diameter Stenosis at Follow-up Angiography
ISAR-DESIRE 4: Intracoronary Stenting and Angiographic Results: Optimizing
Treatment of Drug Eluting Stent In-Stent Restenosis 4
0 20 40 60 80 100
0
20
40
60
80
100
Diameter Stenosis at Follow-up Angiography (%)
Cu
mu
lati
ve
Fre
qu
en
cy
(%
)
Scoring-balloon
Control
P= 0.047
40.4% ± 21.4
35.0% ± 16.8
“Implications of a Third Metal Layer in
Human Coronary Arteries”
21 consecutive Pts Stenting for recurrent ISR after stenting for ISR
Alfonso F, et al. J Am Coll Cardiol 2009;53:2053-60
High Pressures 20+4 atm
(p<0.05 as compared with 2nd ST)
Angiographic Restenosis 21%
2nd ISR BA 3rd ST FU
DES Restenosis
Second vs First Gen DES
RIBS III (Rx DES ISR). Hetero-DES (Switch) 363 Pts DES ISR from 12 Spanish sites. 274 (75%) Hetero-DES vs 89 (25%) No Hetero-DES
Time (Years)
MACE (Cardiac death, MI, TLR)
Restenosis: 2nd Gener DES:
Total: 16 vs 31%, p=0.009
Any DES: 16 vs 28%, p=0.04
Hetero-DES: 15 vs 26%, p=0.08
Alfonso F et al. TCT 2011 Presentation (Featured Research)
309 Pts DES-ISR
Randomization
Inclusion Criteria
Informed Consent
Rx Centralized
Stratification:
ISR Length & Edge
154 Pts
DEB
155 Pts
EES
3 Died
12 Refused
139 Pts Angio FU
4 Died
18 Refused
133 Pts Angio FU Mean: 279 days
(Median: 248) Mean: 266 days
(Median: 246) (272 Patients: 90% of Eligible)
QCA Primary
End-point
100% Angiographic Success
SeQuent Please (B. Braun)
Xience Prime
(Abbott Vascular)
RIBS IV (Januray 2010 – August 2013)
RIBS IV
QCA: MLD at FU
0
0,5
1
1,5
2
2,5
0
0,5
1
1,5
2
2,5
MLD-FU DEB EES
Seg
p = 0.004
2.03 1.80
Lesion p < 0.001 (mm)
1.89 2.20
MLD-FU
(mm)
In-Segment (Primary Endpoint)
In-Lesion
Clinical Follow-up:
0 1 2 3 4 5 6 7 8 9 10 11 12
0
20
40
60
80
100 %
Time (months)
Freedom from TLR
__
EES __ DEB
1 Year FU 309 P (100%); FU Time 360+35 days
Breslow, p = 0.008
Log Rank, p = 0.008
96%
87%
RIBS IV
BVS for DES ISR
A
B C D E
* *
* *
+
+ + +
+
+
^ ^
F G H I
*
* * *
Absorb for ISR Alfonso F, et al J Am Coll Cardiol 2014:63:2875
BVS for ISR
RIBS VI
BVS for ISR
Multicenter Prospective Study
Mandated Angio FU
141 Patients
2016
Alfonso F, et al TCT 2016
RIBS VI
TCT 2016
Flow Diagram
Same RIBS Centers
Incl/Excl / Criteria
Informed Consent
RIBS VI Prospective, Angio FU
(BMS-ISR and DES-ISR)
141 9Mo (100%); 124 (88%) 1Y (17 Pending)
QCA
(95% of Eligible)
Primary End-point
134 Pts Angio FU
498 Pts ISR
309 Pts RIBS IV; 189 Pts RIBS V
Randomization
249 Pts
EES
249 Pts
DEB
219 Pts Angio FU
223 Pts Angio FU Mean: 257 days
Mean: 270 days
100% Angio Success
SeQuent Please (B. Braun)
Xience Prime
(Abbott Vascular)
498 1Y Clinical FU (100%)
442 Pts: 91% of Eligible
QCA Primary End-point
January 2010
August 2013
141 Pts
BVS Absorb
(Abbott Vascular)
100% Angio Success
April 2014
December 2015
ClinicalTrials.gov Identifier: NCT01239953 & NCT01239940
Alfonso F, et al TCT 2016
Algorithm for DES ISR Treatment
DES ISR
Medical Rx
FFR (IVUS/OCT)
(-)
Asymptomatic
Severity ?
IVUS / OCT
Underlying Mechanism
DES
DES
DES
Focal
Gap
Fracture
Edge
Body
Diffuse
Underexpansion ?
Optimization
Pressure NC BA
Avoid Geo Miss
DES / DEB
Prefered DES: Hetero DES & 2nd G
Favor DEB: Multiple ST layers, major SB