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Fernando Alfonso MD, PhD, FESC Hospital Universitario “La Princesa ” Madrid. Spain

RIBS IV. A Prospective, Randomized Trial of Paclitaxel-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With Coronary In-Stent Restenosis of Drug-Eluting Stents: The RIBS IV Clinical Trial. Fernando Alfonso MD, PhD, FESC Hospital Universitario “La Princesa ” Madrid. Spain

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Fernando Alfonso MD, PhD, FESC Hospital Universitario “La Princesa ” Madrid. Spain

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  1. RIBS IV A Prospective, Randomized Trial of Paclitaxel-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With Coronary In-Stent Restenosis of Drug-Eluting Stents: The RIBS IV Clinical Trial Fernando Alfonso MD, PhD, FESC Hospital Universitario “La Princesa” Madrid. Spain On Behalf of the RIBS IV Investigators

  2. RIBS IV Background: • Treatment of patients with DES-ISR remains a challenge • In this setting, DES provide better results than classical coronary interventions. • Drug-eluting balloons (DEB) are also very effective in patients with BMS-ISR and DES-ISR, with results superior to those obtained by conventional BA and equivalent to those seen with 1st Generation DES • However, the value of DEB compared with 2nd Generation DES in patients with DES-ISR remains unknown

  3. RIBS IV 10 2 9 22 6 5 7 8 23 16 14 12 15 21 13 4 19 20 3 1 11 18 17 RIBS IV: (Restenosis Intra-stent: DEB vs EES) Multicenter, Prospective, Randomized 1.- ALICANTE H U General.2.- ASTURIAS H U Central Asturias. 3.- BADAJOZ H U Infanta Cristina.4.- BALEARES H U Son Espases. 5.- BARCELONA H U Bellvitge.6.- BARCELONA H U Clínico.7.- BARCELONA H U Santa Cruz y San Pablo.8.- BARCELONA H U Valle de Hebrón.9.- CANTABRIA H U Marqués de Valdecilla.10.- CORUÑA H U Juan Canalejo. 11.- GRANADA H U Virgen de las Nieves.12.- MADRID H U Doce de Octubre.13.- MADRID H U La Paz. 14.- MADRID H U La Princesa.15.- MADRID H U Puerta de Hierro. 16.- MADRID H U Clínico San Carlos.17.- MALAGA H U Carlos Haya.18.- MALAGA H U Virgen de la Victoria.19. TOLEDO H U Virgen de la Salud Toledo. 20.- VALENCIA H U Clínico.21.- VALENCIA H U General. 22.- VIGO H U Meixoeiro. 23.- ZARAGOZA H U Miguel Servet. Steering Committee. QCA & Clinical Events Committee Under the Auspices PCI WG Spanish Society of Cardiology Coordinator Center: HU Clínico San Carlos. Madrid. Investigators´ Driven Initiative Unrestricted Grants: B. Braun & Abbott Vascular

  4. RIBS IV Inclusion / Exclusion Criteria Inclusion: Exclusion: Stent Related: • Stent location undefined • ISR <1 Month • Thrombus • Vessel diameter < 2 mm • ISR length > 30 mm • ISR outside the Stent General: • Life expectancy < 1 y • Female in childbearing age • Problems FU angiography • Intolerance ASA/Clopidogrel • LVEF < 25% • Informed consent • Age 20 - 85 y • DES ISR (> 50% stenosis) • Angina or silent ischemia • ISR amenable for BA & Stent

  5. RIBS IV (Januray 2010 – August 2013) Rx Centralized Stratification: ISR Length & Edge 309 Pts DES-ISR Inclusion Criteria Informed Consent Randomization 155 Pts 154 Pts Xience Prime (Abbott Vascular) SeQuent Please (B. Braun) EES DEB 100% Angiographic Success 4 Died 18 Refused 3 Died 12 Refused 139 Pts 133 Pts QCA Primary End-point Angio FU Angio FU Mean: 279 days (Median: 248) Mean: 266 days (Median: 246) (272 Patients: 90% of Eligible)

  6. RIBS IV EES DEB QCA: In-Segment Analysis Reference Diameter Lesion Length (mm) (mm) 2.67+0.5 2.59+0.5 10.7+5 10.4+6 p = 0. 21 p = 0.56 CAAS II System

  7. RIBS IV EES DEB QCA: In-Segment Analysis MLD-FU (mm) p = 0.004 2.03 In-Segment (Primary Endpoint) 1.80 Seg Lesion MLD-FU (mm) p < 0.0001 2.20 1.89 In-Lesion

  8. RIBS IV __ EES __ DEB Cumulative Frequency Distribution Curves (%) RE 15 (11%) 27 (19%) p = 0.06 RR (95%CI)1.44 (0.94-2.20) POST PRE p < 0.001 FU p = 0.009 (%) Stenosis In-Segment Intention to Treat

  9. RIBS IV 0.18+0.6 vs 0.30+0.6 mm EES DEB In-Segment Analysis (QCA) Late Loss 30 20 10 (mm) 0 0.14 0.06 -1,00 0,00 1,00 2,00 3,00 4,00 4,00 (-0.20 – 0.40) (-0.18 – 0.65) 3,00 Kolmogorov-Smirnov <0.05 2,00 *p = 0.06 1,00 30 0,00 20 -1,00 10 0 * median (IQR); Mann-Whitney “U” -1,00 0,00 1,00 2,00 3,00 4,00

  10. RIBS IV MACE (Exclusive) EES: 10 (7%) p = 0.009 HR 0.39 (95%CI 0.19-0.83) DEB: 24 (16%) Events at Final FU (1 Year) 1 Year FU 309P (100%); FU Time 360+35 days MACE (Cardiac Death, MI, TLR):Non-exclusive 19 6 5 2 2 2 1 1 C Death (4) AMI (7)+ CABG TLR (2) PCI TLR (25) + 3 Definitive ST Thrombosis (1 EES y 2 DEB [all after re-PCI & stenting]) Intention to Treat

  11. RIBS IV __ EES __ DEB Clinical Follow-up: 1 Year FU 309P (100%); FU Time 360+35 days 96% % 100 87% 80 Breslow, p = 0.008 Log Rank, p = 0.008 60 40 20 Freedom from TLR 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Time (months)

  12. RIBS IV __ EES __ DEB Clinical Follow-up: 1 Year FU 309P (100%); FU Time 360+35 days % 90% 100 80 82% Breslow, p = 0.047 Log Rank, p = 0.044 60 40 20 Freedom from MACE (Cardiac Death, MI, TVR) 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Time (months)

  13. RIBS IV DEBvsBAin the RIBS Trials MLD FU Late Loss (mm) (mm) p < 0.01 p < 0.05 0.77+0.7 0.73+0.7 2.01+0.6 1.80+0.6 1.52+0.7 1.52+0.7 0.30+0.6 0.14+0.5 BA RIBS I BA RIBS II DEB RIBS V DEB RIBS IV BA RIBS I BA RIBS II DEB RIBS V DEB RIBS IV BMS-ISR DES-ISR BMS-ISR DES-ISR (QCA) In-Segment Analysis

  14. RIBS IV Conclusions: • In patients with DES-ISR EES provide superior late angiographic results than DEB (MLD 1ry end-point) • In these patients EES also provide better late clinical results, driven by a significant reduction in the rate of TLR • Treatment of DES-ISR remains challenging and associated with poorer clinical and angiographic results than treatment of BMS-ISR. Further studies (more patients & longer follow-up) are still warranted in this adverse setting.

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