• 12 Month Outcomes in Patients with Type 2 Diabetes Mellitus after Implantation of the Resolute Zotarolimus-eluting Stent: Insights into the initial Results from the RESOLUTE Global Clinical Program

    Prof. Dr. Sigmund Silber, FESC On behalf of the RESOLUTE Clinical Program Investigators RESOLUTE Global Clinical Program Type 2 Diabetic patients have an increased risk of restenosis and other major adverse cardiovascular events. The Resolute ZES has been shown to be safe and effective for the treatment of complex patients and lesions, in a randomized controlled trial and in 4 single arm studies – all studies included patients with diabetes mellitus. An analysis of outcomes in these diabetic patients was prospectively planned and therefore we evaluated the effectiveness of the Resolute ZES in these patients from all these 5 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% are considered “on label” diabetic patients. For this analysis only those patients with or without diabetes considered on label were included so as to more closely correlate with historical data on outcomes in diabetics. 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. N = 5130 Patients 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, saphenous vein graft (SVG), ISR, AMI (=72 hours), left ventricular ejection fraction (LVEF) <30%, an unprotected left main lesion, =3 vessels, renal impairment (creatinine = 140µmol/L), total lesion length per vessel >27 mm, =2 lesions per vessel , lesion with thrombus, or lesion with total occlusion. RESOLUTE Pooled – On Label DM vs On Label Non-DM Lesion and Procedure Characteristics RESOLUTE Pooled – On Label DM vs On Label Non-DM Dual Antiplatelet Therapy (DAPT) Usage 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% P value = 0.081 Hazard Ratio = 1.341 95% CI (0.96, 1.87) RESOLUTE Pooled – On Label DM vs On Label Non-DM 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% P value = 0.5702 Hazard Ratio = 1.134 95% CI (0.73, 1.75) RESOLUTE Pooled – On Label DM vs On Label Non-DM 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% P value = 0.0363 Hazard Ratio = 1.676 95% CI (1.03, 2.72) RESOLUTE Pooled – On Label DM vs On Label Non-DM 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% P value = 0.9075 Hazard Ratio = 1.086 95% CI (0.27, 4.34) RESOLUTE Pooled – On Label DM vs On Label Non-DM While the outcomes in the on label diabetic patient population are encouragingly low and relatively consistent with the events rates in non diabetics (on label) it is of interest to determine how the event rates compare between the more complex insulin dependent diabetic patient cohort with those seen in the non insulin dependent group. Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula. 5.0% 10.6% 0 Time after Initial Procedure (months) IDDM (N = 250) Non IDDM (N = 628) Cumulative Incidence of TLF 3 6 9 12 15% 10% 5% 0% RESOLUTE Pooled – On Label IDDM vs NIDDM Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula. 2.6% 6.1% 0 Time after Initial Procedure (months) IDDM (N = 250) Non IDDM (N = 628) Cumulative Incidence of Cardiac Death/TV MI 3 6 9 12 15% 10% 5% 0% RESOLUTE Pooled – On Label IDDM vs NIDDM 5.4% 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) IDDM (N = 250) Non IDDM (N = 628) Cumulative Incidence of TLR 3 6 9 12 15% 10% 5% 0% RESOLUTE Pooled – On Label IDDM vs NIDDM 0.8% 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. 0 Time after Initial Procedure (months) IDDM (N = 250) Non IDDM (N = 628) Cumulative Incidence of ARC Definite/Probable Stent Thrombosis 3 6 9 12 15% 10% 5% 0% RESOLUTE Pooled – On Label IDDM vs NIDDM

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