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RIBS VI: A Prospective, Multicenter, Registry of Bioresorbable Vascular Scaffolds

This multicenter, prospective registry aims to assess the efficacy of bioresorbable vascular scaffolds (BVS) in the treatment of in-stent restenosis (ISR) patients. The study will compare BVS results with those obtained with drug-eluting balloons and everolimus-eluting stents.

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RIBS VI: A Prospective, Multicenter, Registry of Bioresorbable Vascular Scaffolds

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  1. RIBS VI: 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, AngelCequier MD, Hipólito Gutiérrez MD, Arturo García-Touchard MD, • José R López-Mínguez MD, Javier Zueco MD.

  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. RIBS VI Background: Management of patientswith in-stentrestenosis(ISR) stillremains a challenge. Therole of bioresorbablevascular scaffolds(BVS) in thesepatientsisunknown. However, the potencial benefits of theirstrongantiproliferativeeffectswithouttheneed of anadditionalpermanentmetal layer, makethesedevicesanattractivestrategy in thisscenario.

  4. RIBS VI Objective: • To assesstheefficacy of BVS in thetreatment of patientswith ISR. • To compare BVS resultswiththoseobtainedwithdrug-elutingballoons (DEB) and everolimus-elutingstents (EES) • in the RIBS IV and RIBS V RCT • - PrimaryEndpoint: MLD at Follow-up • - ClinicalEndpoint: Combined (Cardiac D, MI,TVR/TLR) ClinicalTrials.gov ID: NCT02672878

  5. RIBS VI 1 8 9 19 4 5 3 6 11 12 15 14 2 16 Multicenter, Prospective, Angiographic FU 1.- 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 VallD’Hebrón.7.- Canarias, HU de Canarias 8.- Cantabria, HU Marques de Valdecilla.9.- Santiago Compostela, HU Santiago 10.- León, HU CA de León 11.- Madrid, HU 12 de Octubre.12.- Madrid, HU La Paz. 13.- Madrid, HU La Princesa 14.- Madrid, HU Puerta de Hierro. 15.- Madrid, HU Ramón y Cajal.16.- Málaga, HU Virgen de la Victoria.17.- Toledo, H U Virgen de la Salud Toledo18.- Valladolid, HU Clínico de Valladolid19.- Vizcaya HU Galdakao 10 13 18 17 7 Research Promotor: Spanish Society of Cardiology (SSC) Auspices: Working Group on Interventional Cardiology of the SSC Coordinator Center: H. Universitario La Princesa Madrid. Investigators´ driveninitiative Unrestrictedresearchgrants: Abbott Vascular (StJude y Terumo)

  6. RIBS VI StudyOrganization Coordinating Center: Hospital Universitario La Princesa. Madrid. Steering Committee: F. Alfonso (Chairman and Principal Investigator), J. Zueco, A. Cequier, C. Morís. ClinicalEventsCommittee: R. Hernández, M. Sabaté. CoronaryAngiography 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. Sitesand Investigators: In order of enrollment: 1Hospital Universitario La Princesa, Madrid, (F. Alfonso, J. Cuesta, F. Rivero, T. Bastante, A. Benedicto, M. García-Guimaraes); 2Hospital Universitario Valld’Hebron, Barcelona, (B. García del Blanco); 3Hospital Universitario de Canarias (F. Bosa); 4Hospital Galdakao, Vizcaya (J.R. Rumoroso); 5Complejo Asistencial Universitario de León, León, (A. Pérez del Prado); 6Hospital Universitario Clinic de Barcelona, Barcelona, (M. Masotti); 7Hospital Universitario Infanta Cristina, Badajoz, (J.R. López-Mínguez); 8Hospital Universitario de Valladolid, Valladolid (H. Gutierrez); 9Hospital Universitario de Bellvitge, Barcelona, (A. Cequier); 10Hospital Universitario Marqués de Valdecilla, Santander, (J. Zueco);11Hospital Universitario Puerta de Hierro, Majadahonda, (A. García-Touchard); 12Hospital Universitario La Paz, Madrid, (R. Moreno); 13Hospital Universitario 12 de Octubre, Madrid, (T. Velazquez); 14Hospital Universitario Sant Pau, Barcelona, (V. Martí); 15Hospitalario Universitario Central de Asturias, Oviedo, (C. Morís); 16Hospital Ramón y Cajal, Madrid (R. Hernández); 17Hospital Universitario Virgen de la Salud Toledo, Toledo, (J. Moreu); 18Hospital Universitario Virgen de la Victoria, Málaga, (J.M. Hernández); 19Complejo Hospitalario Universitario de Santiago, Santiago de Compostela (R. Trillo)

  7. RIBS VI Inclusion / ExclusionCriteria Inclusion: Exclusion: • Stent Related: • Stent location undefined • ISR <1 Month • Thrombus • Vesseldiameter < 2.25 mm • ISR outside the Stent • General: • Life expectancy < 1 y • Female in childbearing age • Problems FU angiography • Intolerance DAT • LVEF < 25% • Informed consent • Age 20 - 85 y • ISR (> 50% stenosis) • Angina or silent ischemia • ISR amenable for BVS

  8. RIBS VI FlowDiagram RIBS VI Prospective, Angio FU (BMS-ISR and DES-ISR) 498 Pts ISR 309 Pts RIBS IV; 189 Pts RIBS V Same RIBS Centers Incl/Excl / Criteria Informed Consent January 2010 August 2013 Randomization 249 Pts 249 Pts 141 Pts EES DEB BVS April 2014 December 2015 Xience Prime (Abbott Vascular) SeQuent Please (B. Braun) Absorb (Abbott Vascular) 100% AngioSuccess 100% AngioSuccess 219 Pts 223 Pts 134 Pts Angio FU Angio FU Angio FU Mean: 257 days Mean: 270 days QCA QCA Primary End-point Primary End-point (95% of Eligible) 442 Pts: 91% of Eligible 498 1Y Clinical FU (100%) 141 9Mo (100%); 124 (88%) 1Y (17 Pending) ClinicalTrials.gov Identifier: NCT01239953 & NCT01239940

  9. RIBS VI ClinicalCharacteristics

  10. RIBS VI AngiographicData

  11. RIBS VI Procedural Data

  12. RIBS VI QCA: In-SegmentAnalysis Reference Diameter LesionLength (mm) (mm) 2.7±0.5 2.6±0.5 2.7±0.5 12±6 12±7 12±6 p = 0. 29 p = 0.89 CAAS II System EES BVS DEB

  13. RIBS VI QCA: MLD at FU MLD-FU (mm) p < 0.001 In-Segment (PrimaryEndpoint) 1.87±0.5 1.88±0.6 2.16±0.7 Seg Lesion p < 0.001 1.94±0.5 1.94±0.6 2.30±0.7 In-Lesion BVS DEB EES

  14. RIBS VI QCA: In-Segment Late Loss AcuteGain p < 0.05 p < 0.001 (mm) (mm) 1.47 1.24 1.16 0.24 0.23 0.12 BVS DEB EES

  15. RIBS VI __ DEB (%) PRE POST FU p <0.001 p = 0.03 p <0.001 __ EES __ BVS MLD (mm)

  16. RIBS VI __ DEB (%) RE 35 (16%) 19 (9%) 15 (11%) p = 0.07 POST PRE p = 0.008 p < 0.001 FU p < 0.001 __ EES __ BVS (%) Stenosis

  17. RIBS VI Onmultivariateanalysis, afteradjustingforallpotentialconfounders: - MLD at FU wassignificantlysmaller - % DS at FU wassignificantlylarger after BVS comparedwith EES treatment

  18. RIBS VI Events at Final FU (1 Year) 141 Pts (100%) 10 Mo FU; 1Y FU 124 Pts (88%) (17 Ptspending 1Y) (%) 20 19 (13.5) 15 16 (11.3) 10 5 4 (2.8) 1 (0.7) 0 (0) TVR TLR Death AMI Def/Pr ST AMI: 1 periprocedural; 1 definitive BVS thrombosis 1 late SB closure; 1 definitive ST of a stent in anothervesselsegment

  19. RIBS VI __ EES __ __ BVS DEB 91% % 100 86% 80 Breslow, p = 0.12 Log Rank, p = 0.14 85% 60 40 20 Freedom from Cardiac Death, MI, TVR 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Time (months)

  20. RIBS VI __ EES __ __ BVS DEB % 94% 100 87% 80 87% Breslow, p = 0.02 Log Rank, p = 0.03 60 40 20 FreedomfromCardiacDeath, MI, TLR 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Time (months)

  21. RIBS VI __ EES __ __ BVS DEB % 97% 100 89% 80 89% Breslow, p = 0.002 Log Rank, p = 0.002 60 40 20 Freedomfrom TLR 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Time (months)

  22. RIBS VI Conclusions: BVS are safe and effective in thetreatment of selectedpatientswith ISR BVS provide favorable late angiographic (restenosisrate 11%) and clinicalresults (TLR 11%) in thesepatients Theacute and late angiographicfindings of BVS appear to be similar to thoseobtainedwith DEB (“leavenothingbehindstrategy”) butpoorerthan thoseseenafter EES implantation (cautionrequired as historicalcontrolsfrom RCT wereused) Furtherstudieswithlong-termfollow-up will be required to elucidatetherelativevalue of BVS vs otherwell-establishedtherapeuticstrategies in thischallengingsetting

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