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RESOLUTE International Evaluation of The Resolute Stent in a  ‘Real-World’ Patient Population J. Belardi, F-J. Neumann, P. Widimský,  A. Serra Peñaranda, on Behalf of the RESOLUTE International Investigators TCT 2010
Disclosures ,[object Object],[object Object],[object Object]
RESOLUTE International ,[object Object],[object Object],[object Object],Background
RESOLUTE Global Clinical Program In Follow Up / Enrolling 38 mm sub-study  Non-RCT vs. PG (Resolute=110-175) enroll plan RESOLUTE Asia Open Label Real World (Resolute= 249-411) enroll 2.5 – 3.5mm Non-RCT (Resolute=100) vs. Hx Control RESOLUTE Japan SVS 2.25 Non-RCT vs. Performance Goal (Resolute≈60) RESOLUTE Japan enroll 6 mo 6 mo 6 mo 6 mo 1  Meredith IT, et al.  EuroIntervention.  2010;5:692-7 2  Meredith IT, et al.  J Am Coll Cardiol Intv . 2009;2:977-85 3  Meredith IT, et al.  EuroIntervention . 2007;3:50-53 4   Serruys PW, et al.,  N Engl J Med.  2010;363:136-46 RESOLUTE 1,2,3 Non-RCT First-in-Human (Resolute=139) 4 yr RESOLUTE AC 4 1:1 RCT vs. Xience DES (Resolute=1150; Xience V=1150) 1 yr RESOLUTE Intl Open Label Real World (Resolute=2200) 1 yr 2.25 – 3.5mm Non-RCT vs. Hx Control (Resolute=1241) RESOLUTE US 2.25 – 3.5mm Angio/IVUS Non-RCT vs. Hx Control (R=100) 4.0mm Angio Non-RCT vs. Hx Control (Resolute=58)
RESOLUTE International PI: J. Belardi, F–J. Neumann, P. Widimský  Primary Endpoint: Composite of Cardiac Death & Target Vessel MI at 12mo Key Secondary Endpoint: ARC Definite and Probable Stent Thrombosis at 12mo Drug Therapy: ASA and clopidogrel/ticlopidine ≥ 6mo (per guidelines) All patients with symptomatic coronary artery disease eligible for DES implantation (no lesion/vessel limitations) 6mo 3yr 2yr 12mo Clinical endpoints 30d Prospective, Multicenter, Real World Study Resolute Stent N = 2200 ~100 sites International No angiographic follow-up 25% randomly assigned to 100% monitoring
RESOLUTE International ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Exclusion Criteria Pregnancy  Inability to comply with follow-up requirements  Participation in another trial Patient Eligibility
RESOLUTE International ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Study Methods and Quality Control 1  Academic Research Consortium definitions as defined in Cutlip DE, et al.  Circulation.  2007;115:2344-2351  2  Vranckx P, et al.  EuroIntervention.  2010;5:871-874
RESOLUTE International Patient  Enrollment   NOTE: Enrollment was capped at 60 patients per site. Full list of enrolling centers in Appendix.  Country Enrolling Centers Patients Spain 18 623 Germany 17 456 Netherlands 6 223 India 5 174 Switzerland 6 166 Austria 3 97 Portugal 3 91 United Kingdom 7 86 Belgium 7 78 Norway 2 70 Czech Republic 1 60 Estonia 1 60 Greece 4 60 South Africa 4 40 Finland 1 37 Argentina 2 17 Slovakia 1 11
RESOLUTE International Patient  Follow-up   2349 Patients Enrolled 6 Month  Clinical Follow-up 12 Month Clinical Follow-up 30 Day Clinical Follow-up n =   2332 99.3% n =   2287 97.4% n = 2342 99.7%
RESOLUTE International Baseline Characteristics % N = 2349 patients Age (yr) 63.5  ±  11.2 Male 77.8 Diabetes mellitus  30.5 IDDM 9.0 Hypertension 68.0 Hyperlipidemia 63.9 Current smoker 24.2 Family history 31.4 Prior MI 27.0 Prior PCI 29.6 Prior CABG 8.4 Cardiac status: Stable angina 37.4 Unstable angina 26.1 Acute myocardial infarction (<72h) 20.0   STEMI (<12h) 7.0
RESOLUTE International Lesion Characteristics  1 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 total occlusion (preprocedure TIMI = 0).  % N = 2349 patients,  3147 lesions Left anterior descending 51.1 Left circumflex 27.5 Right coronary artery 32.4 Left Main 2.6 Bypass graft 1.8 De Novo 92.4 B2/C 57.1 Chronic total occlusion 6.3 Thrombus (angiographically visible) 12.0 Bifurcation 18.2 Main branch stenting only 15.2 Complex patients 1   67.5
RESOLUTE International Procedure Characteristics  * Site reported angiographic measurements. N = 2349 patients,  3147 lesions Multiple vessels treated (%) 20.6 Multiple vessels treated with study stent (%) 14.0 Number of lesions treated per patient 1.3  ±  0.7 Number of stents per patient 1.6  ±  1.0 Total stent length per patient (mm) 30.9  ±  20.5 Direct stenting (%) 32.1 Lesion length* (mm) 18.8  ±  10.8 Reference Vessel Diameter* (mm) 2.9  ±  0.5 Minimum Lumen Diameter* (mm) 0.5  ±  0.4 ≥  1 Small vessel ( ≤ 2.75mm) (%) 45.4 ≥  1 Long lesion (>18mm) (%) 46.1
RESOLUTE International Dual Antiplatelet Therapy (DAPT) Usage Percent of patients on DAPT at: 30 Days 6 Months 12 Months Aspirin 98.2 97.5 97.0 Clopidogrel 97.8 97.3 93.2 Ticlopidine 0.5 0.3 0.3 DAPT 96.9 95.6 91.3
RESOLUTE International Primary Endpoint: Cardiac Death & Target Vessel MI 10% 9% 8% 7% 6% 5% 4% 3% 2% 1% 0% Cumulative Incidence Cardiac Death/TVMI 0 30 60 90 120 150 180 210 240 270 300 330 360 Time after Initial Procedure (days) Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula. Days 0 30 60 90 120 150 180 210 240 270 300 330 360 No. at risk 2349 2331 2271 2260 2255 2246 2244 2228 2212 2204 2198 2191 2167 %CI 0.7 2.8 2.9 3.1 3.3 3.3 3.4 3.5 3.7 3.9 3.9 3.9 4.1 4.1%
RESOLUTE International Clinical Outcomes to 12 Months %  30 Days n = 2342 patients 12 Months n = 2287 patients Death (all) 0.4 2.3 Cardiac 0.4 1.3 MI (target vessel) 2.6 3.1 Q Wave 0.5 0.5 Non Q wave 2.0 2.6 Cardiac death + target vessel MI 2.8 4.2 ST Def/Prob (all) 0.7 0.9 Acute (0-1 days) 0.1 0.1 Sub-acute (2-30 days) 0.6 0.6 Late (>30 days) -- 0.1 TLR 0.9 3.4 TVR 1.0 4.2 TLF (cardiac death, target vessel MI, clinically driven TLR) 3.2 6.9 MACE 3.3 8.0 TVF 3.3 7.6
RESOLUTE International Cardiac Death TV-MI TLF MACE CI-TLR TVF Death CD/TV-MI ARC ST Def/Prob Clinical Outcomes to 30 Days Percentage [%] N = 2349
RESOLUTE International Cardiac Death TV-MI MACE TVF Death CD/TV-MI ARC ST Def/Prob Clinical Outcomes to 12 Months Percentage [%] CI-TLR TLF N = 2349
RESOLUTE International Monitored vs. Unmonitored Clinical Outcomes at 12 Months %  Monitored n = 586 patients Unmonitored n = 1763 patients P-value Death (all) 2.1 2.4 0.75 Cardiac 1.2 1.3 1.00 MI (target vessel) 3.7 2.9 0.40 Q Wave 0.7 0.5 0.51 Non Q wave 3.0 2.5 0.54 Cardiac death + target vessel MI 4.5 4.0 0.63 ST Def/Prob (all) 1.0 0.8 0.61 Acute (0-1 days) 0 0.2 0.58 Sub-acute (2-30 days) 0.7 0.6 0.76 Late (>30 days) 0.3 0.1 0.16 TLR 4.0 3.2 0.36 TVR 4.7 4.0 0.47 TLF (cardiac death, target vessel MI, clinically driven TLR) 7.7 6.7 0.39 MACE 8.7 7.8 0.54 TVF 8.4 7.3 0.41
RESOLUTE International Events (%) N=1082 N=1067 N=2349 N=330 N=1586 N=716 Performance Across Subgroups at 12 Months  Cardiac death/TV-MI CI-TLR > 18 mm Lesions ≤  2.75 mm Vessels All MVD Complex 1 Diabetes 1 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 total occlusion (preprocedure TIMI = 0).
RESOLUTE International Comparison with RESOLUTE All Comers at 12 Months %  R-International All patients N = 2349 R-All Comers Resolute arm  N = 1140 Age 63.5  ±  11.2 64.4 ± 10.9 Male 77.8 76.7 Diabetics 30.5 23.5 ACS (Acute MI (<72h) or unstable angina) 46.1 48.3 Complex patients 67.5 67.0 Death (all) 2.3 1.6 Cardiac 1.3 1.3 MI (target vessel) 3.1 4.2 Cardiac death + target vessel MI 4.2 5.4 ST Def/Prob (all) 0.9 1.6 Early (0-30 days) 0.7 1.1 Late (>30 days) 0.1 0.6 TLR 3.4 3.9 TLF 6.9 8.2 MACE 8.0 8.7 TVF 7.6 9.0
RESOLUTE International ,[object Object],[object Object],[object Object],Conclusions
Appendix Participating Centers
RESOLUTE International Participating Centers I NOTE: Enrollment was capped at 60 patients per site.  Hospital Investigator Patients Faculty Hospital of Kralovske Vinohrady (CZ) Dr. T. Budešínsk ý 60 Herz-Zentrum Bad Krozingen (DE) Prof. F-J. Neumann 60 Hospital Gregorio Marañón (ES) Dr. J. Soriano 60 Klinikum Esslingen (DE) Prof. M. Leschke 60 Marienhospital Osnabrück (DE) Prof. T. Wichter 60 Stadtspital Triemli (CH) Prof. F. Eberli 60 Stavanger Universitetssykehus (NO) Prof. D. Nilsen 60 Tartu University Hospital (EE) Dr. T. Hermlin 60 The Heart Care Clinic (IN) Dr. M. Chag 60 UMC Utrecht (NL) Dr. P. Stella 60 Universitätsklinik Innsbruck (AT) Dr. N. Moes 60 Alysis Zorggroep (NL) Dr. M. Tjon Joe Gin 59 Hospital General Univ. de Guadalajara (ES) Dr. J. Balaguer 58 Kantonsspital St. Gallen (CH) Prof. H. Rickli 58 Ambulantes Herzzentrum Kassel (DE) Dr. K-F. Appel 55 Hospital del Mar (ES) Dr. A. Serra 54 Hospital Carlos Haya (ES) Dr. C. Urbano 53 Hospital 12 de Octubre (ES) Dr. F. Hernández 50
RESOLUTE International Participating Centers II Hospital Investigator Patients Hospital de Santa Cruz (PO) Dr. P. Gonçalves 50 Academisch Ziekenhuis Maastricht (NL) Prof. J. Waltenberger 49 Hospital Germans Trias i Pujol (ES) Dr. J. Mauri 48 Hospital de Jaen (ES) Dr. M. F. Guzmán 46 Hospital Universitario de Salamanca (ES) Dr. I. Santos 42 B.M. Birla Heart Research Centre (IN) Dr. A. Mishra 40 Madras Medical Mission – Institute of Cardiovascular Diseases (IN) Dr. A. Mullasari 38 Helsinki University Hospital (FI) Dr. M. Laine 37 Krankenhaus Landshut-Achdorf (DE) Dr. J. Dietl 35 St.-Marien-Hospital Lünen (DE) Prof. C. Perings 32 CHU Sart Tilman (BE) Prof. V. Legrand 30 Hospital San Juan de Alicante (ES) Dr. R. Lopez 30 Donauspital im SMZ-Ost (AT) Dr. C. Wolf 29 Errikos Dunant (GR) Dr. V. Tzifos 29 Hospital Univ. Virgen de la Victoria (ES) Dr. J.M. Hernández 29 Hull Royal Infirmary (UK) Dr. F. Alamgir 28 Hospital Joan XXIII (ES) Dr. L. Krsticevic 27 Academisch Medisch Centrum Amsterdam (NL) Dr. J.P. Henriques 26
RESOLUTE International Participating Centers III Hospital Investigator Patients Hospital San Pedro de Alcántara (ES) Dr. J. Fernández 26 Hospital Universitario Nuestra Señora  de Candelaria (ES) Dr. H. Pérez 25 Klinikum Leverkusen (DE) Prof. P. Schwimmbeck 25 Bombay Hospital & Medical Research Centre (IN) Dr. B. Goyal 24 Hospital General de Asturias (ES) Dr. I. Lozano 22 Hospital Santa Marta (PO) Dr. L. Patricio 22 Hospital Univ. Virgen de la Arrixaca (ES) Dr. M. Valdés 22 Agios Loukas (GR) Dr. D. Tsikaderis 21 Krankenhaus Bethanien für die Grafschaft Moers (DE) Dr. H-J. Mertens 21 Glenfield Hospital (UK) Dr. G. Richardson 20 Serviço de Saúde da Região Autónoma da Madeira, E.P.E. (PO) Dr. J. Araújo 19 Universitätsklinikum Rostock (DE) Prof. C. Nienaber 19 Etablissement hospitalier de Sion (CH) Dr. G. Girod 17 Hospital Universitario Infanta Christina (ES) Dr. J.R. López 17 CHU de Charleroi (BE) Dr. J. Lalmand 16 Medisch Centrum Alkmaar (NL) Dr. R. Hautvast 16 Schüchtermann-Klinik (DE) Dr. N. Franz 15
RESOLUTE International Participating Centers IV Hospital Investigator Patients Klinikum Oldenburg gGmbH (DE) Prof. A. Elsässer 14 Panorama Medi-Clinic (SA) Dr. J.P. Roux 14 Schwarzwald-Baar Klinikum Villingen-Schwenningen (DE) Prof. W. Jung 14 Instituto Cardiovascular de Buenos Aires (AR) Dr. J. Belardi 13 UMC St. Radboud (NL) Dr. M. Brouwer 13 All India Institute of Medical Science (IN) Prof. V. Bahl 12 Craigavon Area Hospital (UK) Dr. I. Menown 12 Hôpital de la Tour (CH) Dr. E. De Benedetti 12 Krankenhaus St. Franziskus (DE) Prof. J. vom Dahl 12 Vincent Pallotti Hospital (SA) Dr. A. Horak 12 OIK NÚSCH (SK) Prof. V. Fridrich 11 Virga Jesseziekenhuis (BE) Dr. E. Benit 11 Dorset General Hospital (UK) Dr. F. Witherow 10 Heilig Hart Ziekenhuis (BE) Dr. F. Stammen 10 Hôpital Fribourgeois (CH) Dr. S. Cook 10 Sörlandet Sykehus Arendal (NO) Dr. M. Uchto 10 Vivantes Klinikum Auguste Viktoria (DE) Prof. H. Schühlen 10 Clinique Cecil (CH) Prof. J-J. Goy 9
RESOLUTE International Participating Centers V Hospital Investigator Patients Unitas Hospital (SA) Dr. C. Badenhorst 9 CardioVasculäres Centrum Frankfurt Sankt Katharinen (DE) Prof. H. Sievert 8 Clinique St. Luc (BE) Dr. E. El-Khoury 8 Diakonissen Speyer-Mannheim (DE) Dr. H. Schwacke 8 Evangelisches Krankenhaus Düsseldorf (DE) Prof. E. Vester 8 Landeskrankenhaus Graz-West (AT) Dr. H.W. Schuchlenz 8 Athens Medical Center (GR) Dr. G. Papaioannou 7 Hospital General Yagüe (ES) Dr. J.M. Durán 7 Hospital Virgen de la Macarena (ES) Dr. R. Ruiz 7 St. Thomas Hospital (UK) Dr. S. Redwood 7 Hairmyres Hospital (UK) Dr. B. O’Rourke 5 Milpark Hospital (SA) Dr. G. Cassel 5 Royal Free Hospital (UK) Dr. R. Rakhit 4 Sanatorio Allende (AR) Dr. H. Londero 4 HYGEIA (GR) Dr. A. Dimas 3 Universitair Ziekenhuis Antwerpen (BE) Prof. C. Vrints 2 ULB - Hôpital Erasme (BE) Prof. E. Stoupel 1

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Resolute International 09.21

  • 1. RESOLUTE International Evaluation of The Resolute Stent in a ‘Real-World’ Patient Population J. Belardi, F-J. Neumann, P. Widimský, A. Serra Peñaranda, on Behalf of the RESOLUTE International Investigators TCT 2010
  • 2.
  • 3.
  • 4. RESOLUTE Global Clinical Program In Follow Up / Enrolling 38 mm sub-study Non-RCT vs. PG (Resolute=110-175) enroll plan RESOLUTE Asia Open Label Real World (Resolute= 249-411) enroll 2.5 – 3.5mm Non-RCT (Resolute=100) vs. Hx Control RESOLUTE Japan SVS 2.25 Non-RCT vs. Performance Goal (Resolute≈60) RESOLUTE Japan enroll 6 mo 6 mo 6 mo 6 mo 1 Meredith IT, et al. EuroIntervention. 2010;5:692-7 2 Meredith IT, et al. J Am Coll Cardiol Intv . 2009;2:977-85 3 Meredith IT, et al. EuroIntervention . 2007;3:50-53 4 Serruys PW, et al., N Engl J Med. 2010;363:136-46 RESOLUTE 1,2,3 Non-RCT First-in-Human (Resolute=139) 4 yr RESOLUTE AC 4 1:1 RCT vs. Xience DES (Resolute=1150; Xience V=1150) 1 yr RESOLUTE Intl Open Label Real World (Resolute=2200) 1 yr 2.25 – 3.5mm Non-RCT vs. Hx Control (Resolute=1241) RESOLUTE US 2.25 – 3.5mm Angio/IVUS Non-RCT vs. Hx Control (R=100) 4.0mm Angio Non-RCT vs. Hx Control (Resolute=58)
  • 5. RESOLUTE International PI: J. Belardi, F–J. Neumann, P. Widimský Primary Endpoint: Composite of Cardiac Death & Target Vessel MI at 12mo Key Secondary Endpoint: ARC Definite and Probable Stent Thrombosis at 12mo Drug Therapy: ASA and clopidogrel/ticlopidine ≥ 6mo (per guidelines) All patients with symptomatic coronary artery disease eligible for DES implantation (no lesion/vessel limitations) 6mo 3yr 2yr 12mo Clinical endpoints 30d Prospective, Multicenter, Real World Study Resolute Stent N = 2200 ~100 sites International No angiographic follow-up 25% randomly assigned to 100% monitoring
  • 6.
  • 7.
  • 8. RESOLUTE International Patient Enrollment NOTE: Enrollment was capped at 60 patients per site. Full list of enrolling centers in Appendix. Country Enrolling Centers Patients Spain 18 623 Germany 17 456 Netherlands 6 223 India 5 174 Switzerland 6 166 Austria 3 97 Portugal 3 91 United Kingdom 7 86 Belgium 7 78 Norway 2 70 Czech Republic 1 60 Estonia 1 60 Greece 4 60 South Africa 4 40 Finland 1 37 Argentina 2 17 Slovakia 1 11
  • 9. RESOLUTE International Patient Follow-up 2349 Patients Enrolled 6 Month Clinical Follow-up 12 Month Clinical Follow-up 30 Day Clinical Follow-up n = 2332 99.3% n = 2287 97.4% n = 2342 99.7%
  • 10. RESOLUTE International Baseline Characteristics % N = 2349 patients Age (yr) 63.5 ± 11.2 Male 77.8 Diabetes mellitus 30.5 IDDM 9.0 Hypertension 68.0 Hyperlipidemia 63.9 Current smoker 24.2 Family history 31.4 Prior MI 27.0 Prior PCI 29.6 Prior CABG 8.4 Cardiac status: Stable angina 37.4 Unstable angina 26.1 Acute myocardial infarction (<72h) 20.0 STEMI (<12h) 7.0
  • 11. RESOLUTE International Lesion Characteristics 1 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 total occlusion (preprocedure TIMI = 0). % N = 2349 patients, 3147 lesions Left anterior descending 51.1 Left circumflex 27.5 Right coronary artery 32.4 Left Main 2.6 Bypass graft 1.8 De Novo 92.4 B2/C 57.1 Chronic total occlusion 6.3 Thrombus (angiographically visible) 12.0 Bifurcation 18.2 Main branch stenting only 15.2 Complex patients 1 67.5
  • 12. RESOLUTE International Procedure Characteristics * Site reported angiographic measurements. N = 2349 patients, 3147 lesions Multiple vessels treated (%) 20.6 Multiple vessels treated with study stent (%) 14.0 Number of lesions treated per patient 1.3 ± 0.7 Number of stents per patient 1.6 ± 1.0 Total stent length per patient (mm) 30.9 ± 20.5 Direct stenting (%) 32.1 Lesion length* (mm) 18.8 ± 10.8 Reference Vessel Diameter* (mm) 2.9 ± 0.5 Minimum Lumen Diameter* (mm) 0.5 ± 0.4 ≥ 1 Small vessel ( ≤ 2.75mm) (%) 45.4 ≥ 1 Long lesion (>18mm) (%) 46.1
  • 13. RESOLUTE International Dual Antiplatelet Therapy (DAPT) Usage Percent of patients on DAPT at: 30 Days 6 Months 12 Months Aspirin 98.2 97.5 97.0 Clopidogrel 97.8 97.3 93.2 Ticlopidine 0.5 0.3 0.3 DAPT 96.9 95.6 91.3
  • 14. RESOLUTE International Primary Endpoint: Cardiac Death & Target Vessel MI 10% 9% 8% 7% 6% 5% 4% 3% 2% 1% 0% Cumulative Incidence Cardiac Death/TVMI 0 30 60 90 120 150 180 210 240 270 300 330 360 Time after Initial Procedure (days) Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula. Days 0 30 60 90 120 150 180 210 240 270 300 330 360 No. at risk 2349 2331 2271 2260 2255 2246 2244 2228 2212 2204 2198 2191 2167 %CI 0.7 2.8 2.9 3.1 3.3 3.3 3.4 3.5 3.7 3.9 3.9 3.9 4.1 4.1%
  • 15. RESOLUTE International Clinical Outcomes to 12 Months % 30 Days n = 2342 patients 12 Months n = 2287 patients Death (all) 0.4 2.3 Cardiac 0.4 1.3 MI (target vessel) 2.6 3.1 Q Wave 0.5 0.5 Non Q wave 2.0 2.6 Cardiac death + target vessel MI 2.8 4.2 ST Def/Prob (all) 0.7 0.9 Acute (0-1 days) 0.1 0.1 Sub-acute (2-30 days) 0.6 0.6 Late (>30 days) -- 0.1 TLR 0.9 3.4 TVR 1.0 4.2 TLF (cardiac death, target vessel MI, clinically driven TLR) 3.2 6.9 MACE 3.3 8.0 TVF 3.3 7.6
  • 16. RESOLUTE International Cardiac Death TV-MI TLF MACE CI-TLR TVF Death CD/TV-MI ARC ST Def/Prob Clinical Outcomes to 30 Days Percentage [%] N = 2349
  • 17. RESOLUTE International Cardiac Death TV-MI MACE TVF Death CD/TV-MI ARC ST Def/Prob Clinical Outcomes to 12 Months Percentage [%] CI-TLR TLF N = 2349
  • 18. RESOLUTE International Monitored vs. Unmonitored Clinical Outcomes at 12 Months % Monitored n = 586 patients Unmonitored n = 1763 patients P-value Death (all) 2.1 2.4 0.75 Cardiac 1.2 1.3 1.00 MI (target vessel) 3.7 2.9 0.40 Q Wave 0.7 0.5 0.51 Non Q wave 3.0 2.5 0.54 Cardiac death + target vessel MI 4.5 4.0 0.63 ST Def/Prob (all) 1.0 0.8 0.61 Acute (0-1 days) 0 0.2 0.58 Sub-acute (2-30 days) 0.7 0.6 0.76 Late (>30 days) 0.3 0.1 0.16 TLR 4.0 3.2 0.36 TVR 4.7 4.0 0.47 TLF (cardiac death, target vessel MI, clinically driven TLR) 7.7 6.7 0.39 MACE 8.7 7.8 0.54 TVF 8.4 7.3 0.41
  • 19. RESOLUTE International Events (%) N=1082 N=1067 N=2349 N=330 N=1586 N=716 Performance Across Subgroups at 12 Months Cardiac death/TV-MI CI-TLR > 18 mm Lesions ≤ 2.75 mm Vessels All MVD Complex 1 Diabetes 1 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 total occlusion (preprocedure TIMI = 0).
  • 20. RESOLUTE International Comparison with RESOLUTE All Comers at 12 Months % R-International All patients N = 2349 R-All Comers Resolute arm N = 1140 Age 63.5 ± 11.2 64.4 ± 10.9 Male 77.8 76.7 Diabetics 30.5 23.5 ACS (Acute MI (<72h) or unstable angina) 46.1 48.3 Complex patients 67.5 67.0 Death (all) 2.3 1.6 Cardiac 1.3 1.3 MI (target vessel) 3.1 4.2 Cardiac death + target vessel MI 4.2 5.4 ST Def/Prob (all) 0.9 1.6 Early (0-30 days) 0.7 1.1 Late (>30 days) 0.1 0.6 TLR 3.4 3.9 TLF 6.9 8.2 MACE 8.0 8.7 TVF 7.6 9.0
  • 21.
  • 23. RESOLUTE International Participating Centers I NOTE: Enrollment was capped at 60 patients per site. Hospital Investigator Patients Faculty Hospital of Kralovske Vinohrady (CZ) Dr. T. Budešínsk ý 60 Herz-Zentrum Bad Krozingen (DE) Prof. F-J. Neumann 60 Hospital Gregorio Marañón (ES) Dr. J. Soriano 60 Klinikum Esslingen (DE) Prof. M. Leschke 60 Marienhospital Osnabrück (DE) Prof. T. Wichter 60 Stadtspital Triemli (CH) Prof. F. Eberli 60 Stavanger Universitetssykehus (NO) Prof. D. Nilsen 60 Tartu University Hospital (EE) Dr. T. Hermlin 60 The Heart Care Clinic (IN) Dr. M. Chag 60 UMC Utrecht (NL) Dr. P. Stella 60 Universitätsklinik Innsbruck (AT) Dr. N. Moes 60 Alysis Zorggroep (NL) Dr. M. Tjon Joe Gin 59 Hospital General Univ. de Guadalajara (ES) Dr. J. Balaguer 58 Kantonsspital St. Gallen (CH) Prof. H. Rickli 58 Ambulantes Herzzentrum Kassel (DE) Dr. K-F. Appel 55 Hospital del Mar (ES) Dr. A. Serra 54 Hospital Carlos Haya (ES) Dr. C. Urbano 53 Hospital 12 de Octubre (ES) Dr. F. Hernández 50
  • 24. RESOLUTE International Participating Centers II Hospital Investigator Patients Hospital de Santa Cruz (PO) Dr. P. Gonçalves 50 Academisch Ziekenhuis Maastricht (NL) Prof. J. Waltenberger 49 Hospital Germans Trias i Pujol (ES) Dr. J. Mauri 48 Hospital de Jaen (ES) Dr. M. F. Guzmán 46 Hospital Universitario de Salamanca (ES) Dr. I. Santos 42 B.M. Birla Heart Research Centre (IN) Dr. A. Mishra 40 Madras Medical Mission – Institute of Cardiovascular Diseases (IN) Dr. A. Mullasari 38 Helsinki University Hospital (FI) Dr. M. Laine 37 Krankenhaus Landshut-Achdorf (DE) Dr. J. Dietl 35 St.-Marien-Hospital Lünen (DE) Prof. C. Perings 32 CHU Sart Tilman (BE) Prof. V. Legrand 30 Hospital San Juan de Alicante (ES) Dr. R. Lopez 30 Donauspital im SMZ-Ost (AT) Dr. C. Wolf 29 Errikos Dunant (GR) Dr. V. Tzifos 29 Hospital Univ. Virgen de la Victoria (ES) Dr. J.M. Hernández 29 Hull Royal Infirmary (UK) Dr. F. Alamgir 28 Hospital Joan XXIII (ES) Dr. L. Krsticevic 27 Academisch Medisch Centrum Amsterdam (NL) Dr. J.P. Henriques 26
  • 25. RESOLUTE International Participating Centers III Hospital Investigator Patients Hospital San Pedro de Alcántara (ES) Dr. J. Fernández 26 Hospital Universitario Nuestra Señora de Candelaria (ES) Dr. H. Pérez 25 Klinikum Leverkusen (DE) Prof. P. Schwimmbeck 25 Bombay Hospital & Medical Research Centre (IN) Dr. B. Goyal 24 Hospital General de Asturias (ES) Dr. I. Lozano 22 Hospital Santa Marta (PO) Dr. L. Patricio 22 Hospital Univ. Virgen de la Arrixaca (ES) Dr. M. Valdés 22 Agios Loukas (GR) Dr. D. Tsikaderis 21 Krankenhaus Bethanien für die Grafschaft Moers (DE) Dr. H-J. Mertens 21 Glenfield Hospital (UK) Dr. G. Richardson 20 Serviço de Saúde da Região Autónoma da Madeira, E.P.E. (PO) Dr. J. Araújo 19 Universitätsklinikum Rostock (DE) Prof. C. Nienaber 19 Etablissement hospitalier de Sion (CH) Dr. G. Girod 17 Hospital Universitario Infanta Christina (ES) Dr. J.R. López 17 CHU de Charleroi (BE) Dr. J. Lalmand 16 Medisch Centrum Alkmaar (NL) Dr. R. Hautvast 16 Schüchtermann-Klinik (DE) Dr. N. Franz 15
  • 26. RESOLUTE International Participating Centers IV Hospital Investigator Patients Klinikum Oldenburg gGmbH (DE) Prof. A. Elsässer 14 Panorama Medi-Clinic (SA) Dr. J.P. Roux 14 Schwarzwald-Baar Klinikum Villingen-Schwenningen (DE) Prof. W. Jung 14 Instituto Cardiovascular de Buenos Aires (AR) Dr. J. Belardi 13 UMC St. Radboud (NL) Dr. M. Brouwer 13 All India Institute of Medical Science (IN) Prof. V. Bahl 12 Craigavon Area Hospital (UK) Dr. I. Menown 12 Hôpital de la Tour (CH) Dr. E. De Benedetti 12 Krankenhaus St. Franziskus (DE) Prof. J. vom Dahl 12 Vincent Pallotti Hospital (SA) Dr. A. Horak 12 OIK NÚSCH (SK) Prof. V. Fridrich 11 Virga Jesseziekenhuis (BE) Dr. E. Benit 11 Dorset General Hospital (UK) Dr. F. Witherow 10 Heilig Hart Ziekenhuis (BE) Dr. F. Stammen 10 Hôpital Fribourgeois (CH) Dr. S. Cook 10 Sörlandet Sykehus Arendal (NO) Dr. M. Uchto 10 Vivantes Klinikum Auguste Viktoria (DE) Prof. H. Schühlen 10 Clinique Cecil (CH) Prof. J-J. Goy 9
  • 27. RESOLUTE International Participating Centers V Hospital Investigator Patients Unitas Hospital (SA) Dr. C. Badenhorst 9 CardioVasculäres Centrum Frankfurt Sankt Katharinen (DE) Prof. H. Sievert 8 Clinique St. Luc (BE) Dr. E. El-Khoury 8 Diakonissen Speyer-Mannheim (DE) Dr. H. Schwacke 8 Evangelisches Krankenhaus Düsseldorf (DE) Prof. E. Vester 8 Landeskrankenhaus Graz-West (AT) Dr. H.W. Schuchlenz 8 Athens Medical Center (GR) Dr. G. Papaioannou 7 Hospital General Yagüe (ES) Dr. J.M. Durán 7 Hospital Virgen de la Macarena (ES) Dr. R. Ruiz 7 St. Thomas Hospital (UK) Dr. S. Redwood 7 Hairmyres Hospital (UK) Dr. B. O’Rourke 5 Milpark Hospital (SA) Dr. G. Cassel 5 Royal Free Hospital (UK) Dr. R. Rakhit 4 Sanatorio Allende (AR) Dr. H. Londero 4 HYGEIA (GR) Dr. A. Dimas 3 Universitair Ziekenhuis Antwerpen (BE) Prof. C. Vrints 2 ULB - Hôpital Erasme (BE) Prof. E. Stoupel 1