Tratamiento de la Reestenosis del Stent Farmacoactivo
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1 XXXI Jornadas SOLACI. 10ª Región CONOSUR LIIIº Congreso Chileno de Cardiología y Cirugía Cardiovascular Hotel Patagónico. Puerto Varas. Chile (30 Nov 1 Dic 2016) Tratamiento de la Reestenosis del Stent Farmacoactivo Fernando Alfonso Departamento de Cardiología Hospital Universitario de La Princesa Universidad Autónoma de Madrid Instituto Investigación Sanitaria (IIS-IP) Madrid. ESPAÑA
2 DES Restenosis Neointimal Proliferation Curfman GDN. Egl J Med 2007;356(10): Predominant Mechanism Neointimal hyperplasia (SMC) Neoatherogenesis Nakazawa G, Virmani R. J Am Coll Cardiol 2011;57: Fibroatheroma. Lipid-laden Macrophages, calcium (Necrotic Core) DES 30%, Earlier than BMS Young, Unstable, Time, DES Thrombus
3 Treatment of DES ISR: Focal DES Fracture DES Gap Mechanical Factors Geographic Miss Uneven/Undelivered Drug Non-uniform Strut Distribution DES Damage DES Underexpansion () Hypersensitivity IVUS / OCT Diffuse Drug Resistance Biological Factors
4 DES Restenosis OCT in 50 Pts with DES ISR 58% Rupture, 52% TCFA, 58% Thrombus Rupture TCFA Thrombus TCFA Kang SJ, Mintz GS. Circulation. 2011;123:
5 DES Restenosis Layered DES ISR VCP DB # (9M FU RIBS 4)
6 Calcified DES ISR B A E C D Alfonso F. Calcified In-Stent Restenosis : A Rare Cause of Dilation Failure Requiring Rotational Atherectomy. Circ Cardiovasc Interv 2012;5;e1-e2.
7 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.
8 A DES Restenosis Ruptured Neoatherosclerosis The elusive link between very late ISR and ST B C T E D C B D E Alfonso F, J Am Coll Cardiol 2013;61:155 PRESTIGE (13/08/2012)
9 Treatment of DES ISR: 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 ESC Guidelines I - A
10 Meta-Analyses on ISR Author Date Patients/Trials Network Interventions 1ry End-Point Main Result OR (95%CI) Metaanalysis (Better>Worse) Radke et al /28 VBTvsBA MACE VBT>BA % Costantini et al VBTvsPlacebo BR VBT>placebo 0.06 ( )() Uchida et al /5 VBTvsPlacebo MACE VBT > placebo 0.19 ( ) Dibra et al /4 DESvsVBT TLR DES>VBT 0.35 ( ) Oliver et al /14 DESvsVBTvsBA MACE DES=VBT>BA 0.72 ( ) Alfonso et al /2 DESvsBMS BR DES>BMS 0.11 ( )() Lu et al /12 DESvsVBT TVR DES>VBT 0.44 ( ) Yu et al /5 DCBvsDES/BA TLR DCB>DES/BA 0.17 ( ) Navarese et al /4 DCBvsDES/BA TLR DCB>DES/BA 0.20 ( ) DCB Indermuehle et al /5 DCBvsPES/BA MACE DCB>PES/BA 0.46 ( ) Sun et al /28 DESvsOther TLR DES>BMS>other 0.46 ( ) Vyas et al /10 SameDESvsDifDES TLR DES>DES 0.73 ( ) Piccolo et al /7 X DCBvsDESvsBA %DS DCB=DES>BA ( ) Mamuti et al /5 DCBvsDES/BA MACE DCB>DES>BA 0.49 Mamuti et al /4 DCBvsDES MACE DCB=DES 1.04 Li et al /9 DCBvsDESvsBA MACE DCB=DES>BA 0.21 ( ) Benjo et al /5 VBTvsDES TLR DES>VBT 2.4 ( ) Siontis et al /27 X Multiple %DS EES>DCB>other -9 ( ) Lee et al /11 X DCBvsDESvsBA TLR DCB=DES>BA 0.22 ( ) %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):
11 DCB in SES ISR (%) Restenosis RCT: 50 Pts SES ISR 25 PEB vs 25 BA (mm) (%) TLR Late Loss PEB Habara S. J Am Coll Cardiol Intv 2011;4: BA
12 PEB for ISR (Acute) A B C D E F Sandoval J, Alfonso F. J Invasive Cardiol Oct;24(10):E /6/2011 RIBS IV (DB #52323, # )
13 PEB for DES ISR (Follow-up) A B C D E F Sandoval J, Alfonso F. J Invasive Cardiol Oct;24(10):E /6/2011 RIBS IV (DB #52323, # )
14 Cumulative Frequency (%) ISAR-DESIRE 3 Primary Endpoint: Diameter Stenosis at FU Paclitaxel-Eluting Balloon (PEB) Paclitaxel-Eluting Stent (PES) Balloon Angioplasty (BA) PEB 38.0% PES 37.4% PEB versus BA PES versus BA P superiority < PEB versus PES P non-inferiority =0.007 BA 54.1% Diameter Stenosis at Follow-up Angiography (%) ISAR-DESIRE 3: Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis: 3 Treatment Approaches
15 Cumulative Frequency (%) ISAR-DESIRE 4: Primary Endpoint Diameter Stenosis at Follow-up Angiography P= Scoring-balloon Control % ± % ± Diameter Stenosis at Follow-up Angiography (%) ISAR-DESIRE 4: Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4
16 DES Restenosis Implications of a Third Metal Layer in Human Coronary Arteries 21 consecutive Pts Stenting for recurrent ISR after stenting for ISR 2nd ISR BA 3rd ST FU High Pressures 204 atm (p<0.05 as compared with 2nd ST) Angiographic Restenosis 21% Alfonso F, et al. J Am Coll Cardiol 2009;53:
17 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 MACE (Cardiac death, MI, TLR) Restenosis: 2 nd 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 Time (Years) Alfonso F et al. TCT 2011 Presentation (Featured Research)
18 Inclusion Criteria Informed Consent RIBS IV (Januray 2010 August 2013) 309 Pts DES-ISR Randomization Rx Centralized Stratification: ISR Length & Edge Xience Prime (Abbott Vascular) 4 Died 18 Refused Mean: 279 days (Median: 248) 155 Pts EES 133 Pts Angio FU 100% Angiographic Success QCA Primary End-point 154 Pts DEB 139 Pts Angio FU (272 Patients: 90% of Eligible) SeQuent Please (B. Braun) 3 Died 12 Refused Mean: 266 days (Median: 246)
19 RIBS IV QCA: MLD at FU 2,5 MLD-FU (mm) EES DEB p = Seg Lesion 2 1,5 1 0,5 0 2, In-Segment (Primary Endpoint) MLD-FU (mm) p < , ,5 In-Lesion 0
20 RIBS IV Clinical Follow-up: 1 Year FU 309 P (100%); FU Time days 100 % 96% Breslow, p = Log Rank, p = EES DEB 87% 20 Freedom from TLR Time (months)
21 BVS for DES ISR A B C D E F G H I ^ ^ Alfonso F, et al J Am Coll Cardiol 2014:63:2875 Absorb for ISR
22 BVS for ISR 2016 RIBS VI BVS for ISR Multicenter Prospective Study Mandated Angio FU 141 Patients Alfonso F, et al TCT 2016
23 RIBS VI TCT 2016 Flow Diagram RIBS VI Prospective, Angio FU (BMS-ISR and DES-ISR) Same RIBS Centers Incl/Excl / Criteria Informed Consent 498 Pts ISR Randomization 309 Pts RIBS IV; 189 Pts RIBS V January 2010 August Pts BVS Absorb (Abbott Vascular) April 2014 December Pts DEB SeQuent Please (B. Braun) 249 Pts EES Xience Prime (Abbott Vascular) 100% Angio Success 100% Angio Success 134 Pts Angio FU QCA Primary End-point (95% of Eligible) 141 9Mo (100%); 124 (88%) 1Y (17 Pending) Alfonso F, et al TCT Pts Angio FU Mean: 257 days QCA Primary End-point 442 Pts: 91% of Eligible 498 1Y Clinical FU (100%) 219 Pts Angio FU Mean: 270 days ClinicalTrials.gov Identifier: NCT & NCT
24 Algorithm for DES ISR Treatment FFR (IVUS/OCT) (-) Medical Rx Asymptomatic Severity? DES ISR IVUS / OCT Underlying Mechanism Focal Diffuse Gap Fracture Edge Body DES DES DES Underexpansion? Avoid Geo Miss Pressure NC BA Optimization Prefered DES: Hetero DES & 2nd G Favor DEB: Multiple ST layers, major SB DES / DEB
25 XXXI Jornadas SOLACI. 10ª Región CONOSUR LIIIº Congreso Chileno de Cardiología y Cirugía Cardiovascular Muchas Gracias Fernando Alfonso MD, PhD, FESC Department of Cardiology Hospital Universitario de La Princesa. Madrid. Spain
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