3 year clinical outcomes in patients

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3 year clinical outcomes in patients

  1. 1. For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2013 Medtronic, Inc. All rights reserved. 10092599_1A 04/20133 Year Clinical Outcomes inPatients with Diabetes Mellitusfrom the RESOLUTE US TrialKimberly A Skelding, MDon behalf of the RESOLUTE US InvestigatorsOrlando, FloridaSCAI 2013
  2. 2. For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2013 Medtronic, Inc. All rights reserved. 10092599_1A 04/2013Author Disclosure• Nothing to disclose
  3. 3. For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2013 Medtronic, Inc. All rights reserved. 10092599_1A 04/2013RESOLUTE US – Diabetics• Patients with diabetes have significantly higherevent rates because of:– Endothelial dysfunction– Impaired platelet function– Altered coagulation / fibrinolysis– Increased smooth muscle cell proliferation• The ResoluteTM ZES is the only DES with an FDAapproved indication for patients who have coronaryartery disease and diabetes• This post-hoc analysis reports the performance ofthe ResoluteTM stent in the RESOLUTE US trial inpatients with diabetes• Furthermore, these data are placed in context to thelarger dataset from the RESOLUTE Pooled clinicalprogramBackground
  4. 4. For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2013 Medtronic, Inc. All rights reserved. 10092599_1A 04/2013Enrollment Complete – In Follow-upRESOLUTE1 Non-RCT First-in-Human (R = 139) 5 yrRESOLUTE AC2,3 1:1 RCT vs Xience V (R = 1140; X = 1152) 3 yrNon-RCT Observational (R = 2349) 3 yr2.25–4.0 mm Non-RCT vs Hx Control (R = 1402) 3 yrRESOLUTE US52.5–3.5 mm Non-RCT (R = 100) vs Hx ControlRESOLUTE Japan 2 yrR Japan SVS 2.25 Non-RCT vs PG (R = 65) 1 yr38 mm Substudy Non-RCT vs PG (R = 114) 1 yrRESOLUTE Asia Non-RCT Observational (R = 312) 1 yrRI-US Registry Post-approval Study (R ≈ 230) EnrollingRESOLUTE USRESOLUTE Global Clinical ProgramEnrolling / Planning1:1 RCT vs Taxus (R = 200; T = 200)R-China RCT 1 yrRESOLUTE Int4R-China Registry Non-RCT Observational (R = 1800) 1 yr1Meredith IT, et al. EuroIntervention. 2010;5:692-7. 2Serruys PW, et al. N Engl J Med. 2010;363:136-46. 3Silber S, et al. Lancet.2011;377:1241-47. 4Neumann FJ, et al. EuroIntervention. 2012;7(10):1181-8. 5Yeung AC, et al. JACC. 2011;57:1778-83.
  5. 5. For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2013 Medtronic, Inc. All rights reserved. 10092599_1A 04/2013Hx ControlsPerformance GoalsResoluteTM ZES2.25–3.5 Clinical (n=1242)2.25–3.5 Angio/IVUS (n=100)4.0 Angio (n=60)38mm Clinical (n=110–175)RESOLUTE USPrimary Endpoints:• 2.25–3.5 Clinical → Target Lesion Failure at 12mo• 2.25–3.5 Angio/IVUS → In-Stent LLL at 8mo• 4.0 Angio → In-Segment LLL at 8mo• 38 mm Clinical → Target Lesion Failure at 12moDrug Therapy: ASA and clopidogrel/ticlopidine ≥ 6mo (per guidelines)De Novo Native Coronary LesionVessel Diameter: 2.25 – 4.2 mmLesion Length: ≤ 27 mm(≤ 35 mm lesions tx w/ 38 mm stent)Clinical endpointsAngio/IVUS endpoints6mo 4yr3yr2yr12mo 18mo8mo 5yr9mo30dN = max 1577 patientsUp to 135 US sitesClinical Study Design
  6. 6. For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2013 Medtronic, Inc. All rights reserved. 10092599_1A 04/2013Key Inclusion CriteriaClinical evidence of ischemiccoronary diseaseSingle or double de novo lesion innative coronary arteryTarget lesion ≤27mm inlength, diameter stenosis ≥50%<100%, and target RVD ≥2.25mm≤4.2mmTarget vessel TIMI flow ≥2Patient is able to take DAPT for atleast 6 monthsTreatment of up to two lesions, if thelesions are located in separatetarget vesselsKey Exclusion CriteriaAcute MI within 72 hours ofindex procedurePrevious PCI of target vessel within9 months pre-procedurePlanned PCI of any vessel within30 days post-procedureHx stroke or TIA within 6 monthsLVEF <30%RESOLUTE USKey Eligibility CriteriaMauri L, et al. Am Heart J. 2011;161:807-14.
  7. 7. For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2013 Medtronic, Inc. All rights reserved. 10092599_1A 04/2013RESOLUTE US – Diabetic PatientsBaseline Characteristics%Diabetic PatientsN = 482All PatientsN = 1402Age (yr) 64.5 ± 10.2 64.1 ± 10.7Male 62.2 68.3Diabetes mellitus 100.0 34.4IDDM 28.0 9.6Hypertension 92.9 84.2Hyperlipidemia 95.0 87.7Current smoker 18.0 20.9Prior MI 21.5 21.6Prior PCI 35.3 32.7Prior CABG 10.8 8.8Clinical status:Stable angina 56.3 56.1Unstable angina 41.5 41.9Myocardial infarction 2.2 2.1
  8. 8. For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2013 Medtronic, Inc. All rights reserved. 10092599_1A 04/2013%Non-DiabeticsN = 920Non-IDDMN = 347IDDMN = 135Age (yr) 63.9±10.9 64.9±10.3 63.5±10.1Male 71.4 66.0 51.1Diabetes mellitus 0.0 100.0 100.0IDDM 0.0 0.0 100.0Hypertension 79.6 92.2 94.8Hyperlipidemia 83.9 95.7 93.3Current smoker 22.4 18.4 17.0Prior MI 21.7 20.4 24.4Prior PCI 31.3 32.9 41.5Prior CABG 7.8 11.0 10.4Clinical status:Stable angina 42.9 40.9 44.4Unstable angina 32.3 30.5 31.9Myocardial infarction 1.5 1.4 2.2RESOLUTE US – Diabetic PatientsBaseline Characteristics
  9. 9. For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2013 Medtronic, Inc. All rights reserved. 10092599_1A 04/2013%DiabeticPatientsn = 465All Patientsn = 1402Death (all) 5.4 4.7Cardiac 3.0 2.1MI (target vessel) 1.5 2.1Q Wave 0.2 0.1Non Q wave 1.3 1.9Cardiac death or target vessel MI 4.3 3.9ST Def/Prob (all) 0.0 0.3Early (0-30 days) 0.0 0.1Late (31-360 days) 0.0 0.1Very late (>360 days) 0.0 0.1TLR (clinically driven) 6.7 4.9TVR (clinically driven) 12.5 9.7TLF (cardiac death, TV-MI, TLR) 10.8 8.5TVF (cardiac death, TV-MI, TVR) 15.5 12.7RESOLUTE US – Diabetic PatientsClinical Outcomes at 36 Months
  10. 10. For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2013 Medtronic, Inc. All rights reserved. 10092599_1A 04/201310.86.73.01.50.08.54.92.1 2.10.3RESOLUTE US – Diabetic PatientsSafety and Efficacy Outcomes at 36 MonthsDiabetic (n=465/482)Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR.TLR is ischemia driven. Data are not prespecified or powered for the analysis shown.Events[%]All Patients (n=1341/1402)TV-MITLR CardiacDeathST(ARC Def/Prob)TLF
  11. 11. For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2013 Medtronic, Inc. All rights reserved. 10092599_1A 04/2013%Non-DiabeticsN = 920Non-IDDMN = 347IDDMN = 135Death (all) 4.3 3.9 9.2Cardiac 1.6 2.7 3.8MI (target vessel) 2.4 1.2 2.3Q Wave 0.1 0.3 0.0Non Q wave 2.3 0.9 2.3Cardiac death or target vessel MI 3.7 3.6 6.1ST Def/Prob (all) 0.5 0.0 0.0Early (0-30 days) 0.1 0.0 0.0Late (31-360 days) 0.1 0.0 0.0Very late (>360 days) 0.2 0.0 0.0TLR (clinically driven) 4.0 6.0 8.4TVR (clinically driven) 8.2 11.4 15.3TLF (cardiac death, TV-MI, TLR) 7.3 9.6 13.7TVF (cardiac death, TV-MI, TVR) 11.2 13.8 19.8RESOLUTE US – Diabetic PatientsClinical Outcomes at 36 MonthsData are not prespecified or powered for the analysis shown.
  12. 12. For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2013 Medtronic, Inc. All rights reserved. 10092599_1A 04/20130 360 720CumulativeIncidenceofTLRIDDMNon-IDDMTime After Initial Procedure (days)0%10%15%20%5%IDDMNo. at risk 135 135 133 123 118 117 114 110 108 107% CI 0.00 0.75 3.87 7.00 7.00 7.00 7.84 7.84 7.84 8.70Non-IDDMNo. at risk 347 347 345 337 325 321 316 307 301 296% CI 0.00 0.29 1.46 3.51 4.40 4.70 5.00 5.00 5.32 6.02Non-DiabeticsNo. at risk 920 918 906 894 874 861 841 820 803 798% CI 0.22 0.66 1.21 2.09 2.54 3.00 3.58 3.82 3.94 3.94Non-Diabetics1080RESOLUTE US – Diabetic PatientsCumulative Incidence of TLR at 36 Months8.70%3.94%6.02%Data are not prespecified or powered for the analysis shown.
  13. 13. For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2013 Medtronic, Inc. All rights reserved. 10092599_1A 04/20130 360 720CumulativeIncidenceofCardiacDeathorTVMIIDDMNon-IDDMTime After Initial Procedure (days)0%10%15%5%IDDMNo. at risk 135 134 132 127 126 125 122 118 115 114% CI 0.74 1.49 2.99 2.99 2.99 3.78 4.57 5.38 6.20 6.20Non-IDDMNo. at risk 347 346 344 340 335 334 330 321 316 312% CI 0.29 0.58 1.44 1.73 1.73 2.03 2.92 2.92 3.23 3.54Non-DiabeticsNo. at risk 920 906 897 889 876 867 848 832 819 813% CI 1.52 1.63 1.85 1.96 2.30 2.86 3.10 3.10 3.45 3.57Non-Diabetics1080RESOLUTE US – Diabetic PatientsCumulative Incidence of Cardiac Death or TVMI at 36 Months6.20%3.54%3.57%Data are not prespecified or powered for the analysis shown.
  14. 14. For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2013 Medtronic, Inc. All rights reserved. 10092599_1A 04/20130 360 720 1080CumulativeIncidenceofARCDef/ProbStentThrombosisIDDMNon-IDDMTime After Initial Procedure (days)0%1.5%2.0%1.0%IDDMNo. at risk 135 135 134 128 127 126 123 120 117 116% CI 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00Non-IDDMNo. at risk 347 347 346 342 337 336 332 324 318 314% CI 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00Non-DiabeticsNo. at risk 920 920 911 903 890 881 865 848 833 828% CI 0.00 0.22 0.22 0.22 0.33 0.33 0.33 0.33 0.45 0.45Non-Diabetics0.5% 0.45%0.0%0.0%RESOLUTE US – Diabetic PatientsCumulative Incidence of ARC Def/Prob ST at 36 MonthsData are not prespecified or powered for the analysis shown.
  15. 15. For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2013 Medtronic, Inc. All rights reserved. 10092599_1A 04/2013RESOLUTE US & Pooled Diabetics• In this post-hoc analysis, the RESOLUTE US trialshowed very good outcomes in the diabeticsubgroup, despite the higher risk nature of thediabetic patient population• There was a low rate of TLF (10.8%) and TLR(6.7%)• No stent thrombosis out to 3 yearsConclusions

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