Fernando Alfonso MD, PhD, FESC Hospital Universitario La Princesa Madrid. Spain. On Behalf of the RIBS VI Investigators
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1 : A Prospective, Multicenter, Registry of Bioresorbable Vascular Scaffolds in Patients With Coronary Artery Bare-Metal or Drug-Eluting In-Stent Restenosis Fernando Alfonso MD, PhD, FESC Hospital Universitario La Princesa Madrid. Spain. On Behalf of the RIBS VI Investigators Javier Cuesta MD, Fernando Rivero MD, María J. Pérez-Vizcayno MD, Bruno García MD, José R. Rumoroso MD, Francisco Bosa MD, Armando Pérez de Prado MD, Mónica Masotti MD, Raúl Moreno MD, Angel Cequier MD, Hipólito Gutiérrez MD, Arturo García-Touchard MD, José R López-Mínguez MD, Javier Zueco MD.
![Disclosure Statement of Financial Interest I, [Fernando Alfonso, MD, and the coauthors], DO NOT have a financial interest/arrangement or affiliation](/docs-images/73/68938861/images/2-1.jpg "with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation")
2 Disclosure Statement of Financial Interest I, [Fernando Alfonso, MD, and the coauthors], DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation
3 Background: Management of patients with in-stent restenosis (ISR) still remains a challenge. The role of bioresorbable vascular scaffolds (BVS) in these patients is unknown. However, the potencial benefits of their strong antiproliferative effects without the need of an additional permanent metal layer, make these devices an attractive strategy in this scenario.
4 Objective: To assess the efficacy of BVS in the treatment of patients with ISR. To compare BVS results with those obtained with drugeluting balloons (DEB) and everolimus-eluting stents (EES) in the RIBS IV and RIBS V RCT - Primary Endpoint: MLD at Follow-up - Clinical Endpoint: Combined (Cardiac D, MI,TVR/TLR) ClinicalTrials.gov ID: NCT
5 Multicenter, Prospective, Angiographic FU Asturias, HU Central Asturias. 2.-Badajoz, HU Infanta Cristina. 3.- Barcelona, HU Bellvitge. 4.- Barcelona, HU Clinic. 5.- Barcelona, HU Sant Pau. 6.- Barcelona, HU Vall D Hebrón. 7.- Canarias, HU de Canarias 8.- Cantabria, HU Marques de Valdecilla. 9.- Santiago Compostela, HU Santiago 1.-León, HU CA de León 11.-Madrid, HU 12 de Octubre. 12.-Madrid, HU La Paz. 13.-Madrid, HU LaPrincesa 14.- Madrid, HU Puerta de Hierro. 15.-Madrid, HU Ramón y Cajal Málaga, HU Virgen de la Victoria. 17.-Toledo, H U Virgen de la Salud Toledo 18.- Valladolid, HU Clínico de Valladolid 19.- Vizcaya HU Galdakao Research Promotor: Spanish Society of Cardiology (SSC) Auspices: Working Group on Interventional Cardiology of the SSC Coordinator Center: H. Universitario La Princesa Madrid. Investigators driven initiative Unrestricted research grants: Abbott Vascular (StJude y Terumo)
6 Study Organization Coordinating Center: Hospital Universitario La Princesa. Madrid. Steering Committee: F. Alfonso (Chairman and Principal Investigator), J. Zueco, A. Cequier, C. Morís. Clinical Events Committee: R. Hernández, M. Sabaté. Coronary Angiography Core Laboratory: (Hospital Universitario La Princesa, Madrid) J. Cuesta, M.J. Pérez-Vizcayno. Data Coordination, Safety Monitoring and Statistical Committee: J. Cuesta, M.J. Pérez-Vizcayno, Cristina Fernández. Intravascular Ultrasound and Optical Coherence Tomography Committee: F. Alfonso J. Cuesta. Sites and Investigators: In order of enrollment: 1 Hospital Universitario La Princesa, Madrid, (F. Alfonso, J. Cuesta, F. Rivero, T. Bastante, A. Benedicto, M. García- Guimaraes); 2 Hospital Universitario Vall d Hebron, Barcelona, (B. García del Blanco); 3 Hospital Universitario de Canarias (F. Bosa); 4 Hospital Galdakao, Vizcaya (J.R. Rumoroso); 5 Complejo Asistencial Universitario de León, León, (A. Pérez del Prado); 6 Hospital Universitario Clinic de Barcelona, Barcelona, (M. Masotti); 7 Hospital Universitario Infanta Cristina, Badajoz, (J.R. López-Mínguez); 8 Hospital Universitario de Valladolid, Valladolid (H. Gutierrez); 9 Hospital Universitario de Bellvitge, Barcelona, (A. Cequier); 1 Hospital Universitario Marqués de Valdecilla, Santander, (J. Zueco); 11 Hospital Universitario Puerta de Hierro, Majadahonda, (A. García-Touchard); 12 Hospital Universitario La Paz, Madrid, (R. Moreno); 13 Hospital Universitario 12 de Octubre, Madrid, (T. Velazquez); 14 Hospital Universitario Sant Pau, Barcelona, (V. Martí); 15 Hospitalario Universitario Central de Asturias, Oviedo, (C. Morís); 16 Hospital Ramón y Cajal, Madrid (R. Hernández); 17 Hospital Universitario Virgen de la Salud Toledo, Toledo, (J. Moreu); 18 Hospital Universitario Virgen de la Victoria, Málaga, (J.M. Hernández); 19 Complejo Hospitalario Universitario de Santiago, Santiago de Compostela (R. Trillo)
7 Inclusion: RIBS VI Inclusion / Exclusion Criteria Exclusion: Informed consent Age 2-85 y ISR (> 5% stenosis) Angina or silent ischemia ISR amenable for BVS Stent Related: Stent location undefined ISR <1 Month Thrombus Vessel diameter < 2.25 mm ISR outside the Stent General: Life expectancy < 1 y Female in childbearing age Problems FU angiography Intolerance DAT LVEF < 25%
8 Flow Diagram RIBS VI Prospective, Angio FU (BMS-ISR and DES-ISR) Same RIBS Centers Incl/Excl / Criteria Informed Consent 498 Pts ISR Randomization 39 Pts RIBS IV; 189 Pts RIBS V January 21 August Pts BVS Absorb (Abbott Vascular) April 214 December Pts DEB SeQuent Please (B. Braun) 249 Pts EES Xience Prime (Abbott Vascular) 1% Angio Success 1% Angio Success 134 Pts Angio FU QCA Primary End-point (95% of Eligible) 141 9Mo (1%); 124 (88%) 1Y (17 Pending) 223 Pts Angio FU Mean: 257 days QCA Primary End-point 442 Pts: 91% of Eligible 498 1Y Clinical FU (1%) 219 Pts Angio FU Mean: 27 days ClinicalTrials.gov Identifier: NCT & NCT123994
9 Clinical Characteristics BVS (141) DEB (249) EES (249) Age (years) Female 16 (11) 4 (16) 37 (15) - Diabetes 72 (51)* 15 (42) 85 (34) - Hyperlipidemia 113 (8) 179 (72) 183 (74) - Hypertension 16 (75) 178 (72) 189 (76) Unstable Angina 69 (49) 118 (47) 121 (49) Stable Angina / Isch 72 (51) 131 (53) 128 (51) Time to ISR (median days) 177*
10 Angiographic Data BVS (141) DEB (249) EES (249) - LAD 66 (47) 112 (45) 18 (43) - RCA 44 (31) 8 (32) 77 (31) - LCX 27 (19) 48 (19) 56 (23) DES-ISR 7 (51) 154 (62) 155 (62) Length ST (mm) 2±7 2±7 2±7 >1 Treatment of ISR 21 (15) 23 (9) 2 (8) LVEF (%) 56±13 58±12 59±11
11 Procedural Data BVS (141) DEB (249) EES (249) Device Length Max Pressure (atm) Inflation Time (sec) B/A Ratio Cross-over () 13 (5) 1 (.4) Success 141 (1) 249 (1) 249 (1)
12 QCA: In-Segment Analysis Reference Diameter Lesion Length (mm) 2.7±.5 2.6±.5 2.7± (mm) 12±6 12±7 12± p =. 29 BVS DEB EES p =.89 CAAS II System
13 QCA: MLD at FU 2.5 MLD-FU (mm) RIBS VI p < ± ± ±.7 Seg Lesion In-Segment (Primary Endpoint) p < ± ±.6 2.3± In-Lesion BVS DEB EES
14 QCA: In-Segment 2 Acute Gain p <.1 (mm).7 Late Loss p <.5 (mm) BVS DEB EES
15 (%) PRE p =.3 FU p <.1 POST p <.1 4 DEB 2 EES BVS MLD (mm)
16 (%) POST p <.1 FU p <.1 RE 35 (16%) 19 (9%) 15 (11%) p =.7 PRE p =.8 DEB 2 EES BVS (%) Stenosis
17 On multivariate analysis, after adjusting for all potential confounders: - MLD at FU was significantly smaller - % DS at FU was significantly larger after BVS compared with EES treatment
18 Events at Final FU (1 Year) 141 Pts (1%) 1 Mo FU; 1Y FU 124 Pts (88%) (17 Pts pending 1Y) 2 2 (%) (11.3) 19 (13.5) (2.8) () 1 (.7) Death Def/Pr ST AMI TLR TVR AMI: 1 periprocedural; 1 definitive BVS thrombosis 1 late SB closure; 1 definitive ST of a stent in another vessel segment
19 1 % 91% 8 6 Breslow, p =.12 Log Rank, p =.14 86% 85% 4 2 Freedom from Cardiac Death, MI, TVR DEB EES BVS Time (months)
20 1 % 94% 8 6 Breslow, p =.2 Log Rank, p =.3 87% 87% 4 2 Freedom from Cardiac Death, MI, TLR DEB EES BVS Time (months)
21 1 % 97% Breslow, p =.2 Log Rank, p =.2 Freedom from TLR 89% 89% DEB EES BVS Time (months)
22 Conclusions: BVS are safe and effective in the treatment of selected patients with ISR BVS provide favorable late angiographic (restenosis rate 11%) and clinical results (TLR 11%) in these patients The acute and late angiographic findings of BVS appear to be similar to those obtained with DEB ( leave nothing behind strategy ) but poorer than those seen after EES implantation (caution required as historical controls from RCT were used) Further studies with long-term follow-up will be required to elucidate the relative value of BVS vs other well-established therapeutic strategies in this challenging setting
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