• Final Five-year Outcomes from the Randomized Comparison of Zotarolimus-eluting Stents With Everolimus-eluting Stents in the RESOLUTE All Comers Trial

    Stephan Windecker Swiss Cardiovascular Center and Clinical Trials Unit Bern Bern University Hospital, Switzerland on behalf of the RESOLUTE All Comers Investigators PCR2014 Speaker's name- to be completed ? I have the following potential conflicts of interest to report- Consultant- … State the different companies concerned Employment in industry- … Honorarium- … Institutional grant/research support- Research grants to the institution from Biotronik and St Jude Owner of a healthcare company- … Stockholder of a healthcare company- … Longer-term follow-up for new generation DES remains incomplete and may provide additional information especially in patients with complex coronary artery disease. The RESOLUTE All Comers trial was the first randomized trial comparing the Resolute zotarolimus-eluting stent (R-ZES) with the XIENCE V everolimus-eluting stent (EES) in an all-comers patient population. We evaluated 5-year outcomes to determine whether clinical equivalence between the two stent types were maintained at longer follow-up. Background RESOLUTE All Comers RESOLUTE Global Clinical Program 1 Meredith IT, et al. EuroIntervention. 2010;5-692-7. 2 Serruys PW, et al. N Engl J Med. 2010;363-136-46. 3 Silber S, et al. Lancet. 2011;377-1241-47. 4 Neumann FJ, et al. EuroIntervention. 2012;7(10)-1181-8. 5Belardi JA, et al. J Interv Cardiol. 2013;26(5)-515-23. 6Yeung AC, et al. JACC. 2011;57-1778-83. 7Lee M, et al. Am J Cardiol. 2013;112(9)-1335-41. 8Xu B, et al. JACC Cardiovasc Interv. 2013;6(7)-664-70. 9Qiao S, et al. Am J Cardiol. 2013. doi- 10.1016/j.amjcard.2013.10.042. [Epub ahead of print] Enrollment Complete - In Follow Up RESOLUTE1 Non-RCT First-in-Human (R=139) 5 yr RESOLUTE AC2,3 1-1 RCT vs. Xience V™ EES (R=1140; X=1152) 5 yr Non-RCT Observational (R=2349) 3 yr 2.25 – 4.0 mm Non-RCT vs. Hx Control (R=1402) 4 yr RESOLUTE US6 2.5 – 3.5 mm Non-RCT (R=100) vs. Hx Control RESOLUTE Japan 3 yr RESOLUTE Asia7 Non-RCT Observational (R=312) 1 yr RI-US Registry Post-approval study (RI˜230) enrolling Enrolling / Planning 1-1 RCT vs. Taxus™ PES (R=200; T=200) R-China RCT8 1 yr RESOLUTE Int4,5 R-China Registry9 Non-RCT Observational (R=1800) 1 yr R-Japan SVS 2.25 Non-RCT vs. PG (R=65) 2 yr 38 mm sub-study Non-RCT vs. PG (R=114) 1 yr RESOLUTE US7 PROPEL Post-approval study (RI=1200) vs. Hx Control enrolling 17 European sites 2300 patients randomized 1-1 Subsets- QCA 460 pts (20%); OCT 50 pts (2%) 100% monitoring Clinical endpoints Angio/OCT endpoints Co-PIs- Profs. Serruys, Silber, Windecker Clinical Trial Design Open label, non-inferiority trial Any patient with symptomatic coronary arterydisease eligible for DES implantation (no lesion/vessel limitations) Resolute™ Stent n = 1150 Xience V™ Stent n = 1150 Primary Endpoint- 12-month target lesion failure (TLF), composite of cardiac death, target vessel MI & clinically driven TLR Secondary Endpoints- Clinical- Patient composite of any death, any MI, & any repeat revascularisation QCA (powered)- 13-month in-stent % diameter stenosis QCA- % diameter stenosis, late loss, and binary restenosis Drug Therapy- ASA and clopidogrel/ticlopidine > 6mo (per guidelines) Serruys PW, et al., N Engl J Med. 2010;363(2)-136-46 30d 6mo 4yr 3yr 2yr 12mo 13mo 5yr RESOLUTE All Comers Randomized 1-1 Resolute™ (R-ZES) N = 1140 n = 1132 99.3% n = 1128 98.9% Patients Enrolled N = 2292 Xience V™ (EES) N = 1152 n = 1142 99.1% n = 1139 98.9% n = 1128 98.9% n = 1137 98.7% 1 Yr Follow-up 2 Yr Follow-up 3 Yr Follow-up n = 1127 98.9% 4 Yr Follow-up n = 1135 98.5% n = 1123 98.5% 5 Yr Follow-up n = 1133 98.4% Baseline Characteristics Serruys PW, et al., N Engl J Med. 2010;363(2)-136-46. RESOLUTE All Comers Procedure Characteristics Serruys PW, et al., N Engl J Med. 2010;363(2)-136-46. Target Lesion Failure to 5 Years RESOLUTE All Comers Time After Initial Procedure (years) 0 1 3 2 Cumulative Incidence of TLF (%) 0 10 30 16.3% 17.1% Log rank P = 0.65 40 20 5 4 RESOLUTE All Comers Target Lesion Failure Components at 5 Years Time After Initial Procedure (months) RESOLUTE All Comers DAPT* Usage over 5 Years * Aspirin and (Clopidogrel or Ticlopidine or Prasugrel or Ticagrelor) P-value is not significant at all time points. Resolute™ ZES (N = 1140) Xience V™ EES (N = 1152) 11.3% 12.3% Stent Thrombosis to 5 Years- Definite Time After Initial Procedure (years) 0 1 3 2 Cumulative Incidence of ARC Definite ST (%) 0 6 0.82% 1.62% 10 8 2 4 4 RESOLUTE All Comers Log rank P = 0.08 5 Very Late Stent Thrombosis- Definite Time After Initial Procedure (years) 1 3 2 Cumulative Incidence of Very Late ARC Definite ST (%) 0 3 0.56% 0.47% 5 4 1 2 5 4 RESOLUTE All Comers Log rank P = 0.76 Stent Thrombosis to 5 Years- Definite / Probable Time After Initial Procedure (years) 0 1 3 2 Cumulative Incidence of ARC Definite/Probable ST (%) 0 6 1.7% 2.4% 10 8 2 4 5 4 RESOLUTE All Comers Log rank P = 0.22 Very Late Stent Thrombosis- Definite / Probable Time After Initial Procedure (years) 1 3 2 Cumulative Incidence of Very Late ARC Definite/Probable ST (%) 0 3 1.03% 0.84% 5 4 1 2 5 4 RESOLUTE All Comers Log rank P = 0.66 TLF Subset Analysis at 5 Years Complex patient definition- bifurcation, bypass grafts, ISR, AMI <72 hr, LVEF <30%, unprotected LM, >2 vessels stented, renal insufficiency or failure (creatinine >140 µmol/L), lesion length >27 mm, >1 lesion per vessel, lesion with thrombus or TO (preprocedure TIMI = 0). Favors R-ZES Favors EES 0.1 1.0 10.0

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