• 12 Month Outcomes in Patients with Diabetes Mellitus Implanted with a Resolute Zotarolimus-eluting Stent: Initial Results from the RESOLUTE Global Clinical Program

    Stephan Windecker On behalf of the RESOLUTE Clinical Program Investigators Swiss Cardiovascular Center and Clinical Trials Unit Bern Bern University Hospital, Switzerland ? I have the following potential conflicts of interest to report- ? Research contracts ? Consulting ? Employment in industry ? Stockholder of a healthcare company ? Owner of a healthcare company ? Other(s) ? I do not have any potential conflict of interest Potential conflicts of interest While drug eluting stents (DES) are often used in complex patient and lesion cohorts the amount of data on current generation DES in this patient cohort is limited. Resolute All Comers is an unrestricted open label trial that provides the ability to assess the outcomes in both the more well studied simple patient cohort and the more complex, higher risk patient cohort. Resolute All Comers Complex Versus Simple Patients Stefanini G et al. J Am Coll Cardiol 2011, in press Death TV-MI CI-TLR Death CD/TV-MI ARC ST Def/Prob Percentage [%] RESOLUTE All Comers – Complex Patients Clinical Outcomes to 12 Months R-ZESEES (n=764)(n=756) P=0.02 P=0.24 P=0.90 P=0.58 P=0.26 P=0.80 Death TV-MI CI-TLR Death CD/TV-MI ARC ST Def/Prob Percentage [%] RESOLUTE All Comers – Simple Patients Clinical Outcomes to 12 Months R-ZESEES (n=376)(n=396) P=0.79 P=0.50 P=0.70 P=0.48 P=0.12 P=0.49 Stefanini G et al. J Am Coll Cardiol 2011, in press 0 Time after Initial Procedure (days) ZES Simple EES Simple 90 180 270 360 10% 6% 2% 0% ZES Complex EES Complex Cumulative Incidence Patient Oriented Composite 8% 4% 30 120 150 210 330 300 240 60 ZES Simple EES Simple ZES Complex EES Complex No. at Risk Target Lesion Failure 8.9 5.6 6.8 9.8 The ability to assess outcomes in broad patient populations such as simple or complex is possible from a single randomized trial such as Resolute All Comers, however for assessment of more specific sub-groups such as diabetics the prospective analysis from a broader pooled patient data set may allow for more clarity and confidence in reported outcomes. Patients with diabetes are of particular interest as outcomes in this sub group have not been as low as seen in the broader general patient population. Ischemia Driven MACE, 0 to 5 YEARS 0 Years after Index PCI Cumulative Incidence 1 3 4 5 40% 30% 20% 0% 10% 2 HR (95% Cl)- 1.45 (1.06-1.99), p=0.02 0 Years after Index PCI Cumulative Incidence 1 3 4 5 40% 30% 20% 0% 10% 2 HR (95% Cl)- 1.09 (0.73-1.64), p=0.67 0 Years after Index PCI Cumulative Incidence 1 3 4 5 40% 30% 20% 0% 10% 2 HR (95% Cl)- 1.74 (1.17-2.59), p=0.01 0 Years after Index PCI Cumulative Incidence 1 3 4 5 40% 30% 20% 0% 10% 2 HR (95% Cl)- 1.07 (0.52-2.24), p=0.85 Ischemia Driven TLR, 0 to 5 YEARS Cardiac Death or MI, 0 to 5 YEARS ARC Definite Stent Thrombosis, 0 to 5 YEARS Five Year Outcomes of Diabetic Patients Included into the SIRTAX Trial .1 10 .2 .5 2 5 1 Non Diabetes Diabetes Stettler C et al. Brit Med J 2008 Non-Diabetic Patients N=10,947 SES PES BMS 2851 60/2851 26/1845 10/1052 18/811 3585 63/3585 35/3080 21/1655 12/722 No. of Events/No. of Patients 2857 52/2857 25/2091 10/995 6/182 0 Years after Initial Procedure 1 3 4 20% 16% 12% 0% 8% 2 4% Cumulative Incidence of Death Overall 20% 16% 12% 0% 8% 4% 0 Years after Initial Procedure 1 3 4 2 904 37/904 15/632 7/358 10/224 1162 35/1162 40/1020 11/535 3/158 1078 39/1078 26/830 12/497 1/73 No. of Events/No. of Patients Diabetic Patients N=3,852 An analysis of outcomes in the diabetic patients fro the one randomized control trial and 4 single arm studies was prospectively planned and therefore we evaluated the effectiveness of the Resolute ZES in these patients from all these studies. Of the 5130 patients enrolled in the RESOLUTE Global Clinical Program, a significant proportion were considered high risk with complex lesions, 1535 had diabetes and of that 57.2% that are considered “on label” diabetic patients are included in this initial analysis. The analysis of this cohort was a pre specified analysis in the Global Resolute Clinical Program. Methods RESOLUTE1 Non-RCT First-in-Human (R=139) 4 yr RESOLUTE AC2,3 1-1 RCT vs. Xience V (R=1140; X=1152) 2 yr RESOLUTE Int Non-RCT Observational (R=2349) 1 yr 2.25 – 3.5mm Non-RCT vs. Hx Control (R=1242) 1 yr RESOLUTE US4 2.25 – 3.5mm Angio/IVUS Non-RCT vs. Hx Control (R=100) 1 yr 4.0mm Angio Non-RCT vs. Hx Control (R=60) 1 yr 2.5 – 3.5mm Non-RCT (R=100) vs. Hx Control RESOLUTE Japan 1 yr R Japan SVS 2.25 Non-RCT vs. PG (R=63) <1 yr 38 mm sub-study Non-RCT vs. PG (R=110-175) < 30d RESOLUTE Asia Non-RCT (R˜300) enroll R-China Registry Registry (R=1500 max) enroll RESOLUTE US 3-1 vs. Cypher (R=742; C=248) R-China RCT plan RESOLUTE Global Clinical Program Enrolling / Planning 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 Yeung AC, et al. JACC. 2011;57(17)-1778-1783. Diabetic Patient Analysis 5130 Patients Enrolled Total Diabetic Patient Population N = 1535 ‘On label’ Diabetic Population N = 878 57.2% of total diabetic population On label is defined as all enrolled subjects excluding subjects with bifurcation, bypass grafts, ISR, AMI = 72 hours, LVEF <30%, unprotected left main lesion, >2 vessels stented, renal insufficiency or failure (creatinine = 140µmol/L), total lesion length per vessel >27 mm, >1 lesion per vessel, lesion with thrombus, or total occlusion (preprocedure TIMI = 0). Baseline Characteristics Death TV-MI TLF MACE CI-TLR TVF Death CD/TV-MI ARC ST Def/Prob Percentage [%] n = 867 RESOLUTE Pooled – On Label Diabetics Clinical Outcomes to 12 Months Dual Antiplatelet Therapy (DAPT) Usage RESOLUTE Pooled – On Label Diabetics 4.9% Target Lesion Failure (cardiac death, TV MI and TLR) Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula. 0 Time after Initial Procedure (months) Diabetics (N = 878) Non Diabetics (N = 1903) Cumulative Incidence of TLF 3 6 9 12 15% 10% 5% 0% RESOLUTE Pooled – On Label DM vs Non-DM P value = 0.081 Hazard Ratio = 1.341 95% CI (0.96, 1.87) 2.0% Clinically Driven Target Lesion Revascularization Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula. 0 Time after Initial Procedure (months) Diabetics (N = 878) Non Diabetics (N = 1903) Cumulative Incidence of TLR 3 6 9 12 15% 10% 5% 0% RESOLUTE Pooled – On Label DM vs Non-DM P value = 0.0363 Hazard Ratio = 1.676 95% CI (1.03, 2.72) 3.1% Cardiac Death and Target Vessel MI Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula. 0 Time after Initial Procedure (months) Diabetics (N = 878) Non Diabetics (N = 1903) Cumulative Incidence of Cardiac Death/TV MI 3 6 9 12 15% 10% 5% 0% RESOLUTE Pooled – On Label DM vs Non-DM P value = 0.5702 Hazard Ratio = 1.134 95% CI (0.73, 1.75) 0.3% Definite/Probable Stent Thrombosis Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula. Cumulative Incidence of ARC Definite/Probable Stent Thrombosis 0 Time after Initial Procedure (months) Diabetics (N = 878) Non Diabetics (N = 1903) 3 6 9 12 15% 10% 5% 0% RESOLUTE Pooled – On Label DM vs Non-DM P value = 0.9075 Hazard Ratio = 1.086 95% CI (0.27, 4.34) Diabetics (N = 878) Non Diabetics (N = 1903) RESOLUTE Pooled – On Label DM vs Non-DM Time after Initial Procedure (months) 0 3 6 9 12 Cumulative Incidence 20% 10% 5% 0% 15% 11.2% 14.4% Log Rank P value = 0.023 Patient Oriented Endpoint Additional findings from the Resolute All Comers trial reinforces the lower events rates that are expected when treating “simple” patient and lesion cohorts R-ZES and EES have similar outcomes and are safe and effective among patients with c

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