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Resolute international 09 21 Resolute international 09 21 Presentation Transcript

  • RESOLUTE International Evaluation of The Resolute Stent in a ‘Real-World’ Patient PopulationJ. Belardi, F-J. Neumann, P. Widimský, A. Serra Peñaranda, on Behalf of the RESOLUTE International Investigators TCT 2010
  • Disclosures • Dr. Belardi is a consultant for Medtronic CardioVascular. • Dr. Serra is a consultant for Medtronic Spain. • Other authors have nothing to disclose.
  • RESOLUTE InternationalBackground• The RESOLUTE International study, as a complement to RESOLUTE All Comers, aims to further evaluate the Resolute stent – in a large number of real-world patients – in a wider variety of centers in various countries
  • RESOLUTE Global Clinical Program In Follow Up / Enrolling RESOLUTE1,2,3 Non-RCT First-in-Human (Resolute=139) Non-RCT First-in-Human (Resolute=139) 4 yr RESOLUTE AC4 1:1 RCT vs. Xience DES (Resolute=1150; Xience V=1150) 1:1 RCT vs. Xience DES (Resolute=1150; Xience V=1150) 1 yr RESOLUTE Intl Open Label Real World (Resolute=2200) Open Label Real World (Resolute=2200) 1 yr 2.25 – 3.5mm Non-RCT vs. Hx Control (Resolute=1241) 2.25 – 3.5mm Non-RCT vs. Hx Control (Resolute=1241) 6 mo RESOLUTE US 2.25 – 3.5mm Angio/IVUS Non-RCT vs. Hx Control (R=100) 2.25 – 3.5mm Angio/IVUS Non-RCT vs. Hx Control (R=100) 6 mo 4.0mm Angio Non-RCT vs. Hx Control (Resolute=58) 4.0mm Angio Non-RCT vs. Hx Control (Resolute=58) 6 mo 38 mm sub-study Non-RCT vs. PG (Resolute=110-175) 38 mm sub-study Non-RCT vs. PG (Resolute=110-175) enroll RESOLUTE Japan 2.5 – 3.5mm Non-RCT (Resolute=100) vs. Hx Control 2.5 – 3.5mm Non-RCT (Resolute=100) vs. Hx Control 6 moRESOLUTE Japan SVS 2.25 Non-RCT vs. Performance Goal (Resolute≈60) 2.25 Non-RCT vs. Performance Goal (Resolute≈60) enroll plan RESOLUTE Asia Open Label Real World (Resolute= 249-411) Open Label Real World (Resolute= 249-411) enroll 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 International Prospective, Multicenter, Real World Study PI: J. Belardi, F–J. Neumann, P. Widimský All patients with symptomatic coronary artery disease eligible for DES implantation (no lesion/vessel limitations) Resolute Stent ~100 sites International N = 2200 No angiographic follow-up 25% randomly assigned to 100% monitoringClinical endpoints 30d 6mo 12mo 2yr 3yr 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)
  • RESOLUTE International Patient Eligibility Inclusion Criteria Exclusion CriteriaCoronary artery disease Pregnancy• Stable angina• Silent ischemia• Acute coronary syndrome including Inability to comply with follow-up UA, NSTEMI and STEMI requirementsIntention to electively implant at least one Resolute stent Participation in another trialLesion characteristics• Number of lesions: no limitation• Number of vessels: no limitation• Lesion length: no limitationWritten informed consent
  • RESOLUTE InternationalStudy Methods and Quality Control High quality standards: • Independent Clinical Event Committee – Cardiovascular Research Foundation (NY) – Independent adjudication of all death, MI, ST and target vessel revascularization events – Events defined according to ARC definitions1 and historical2 definitions • Data Monitoring & Site Visits – At enrollment, 25% of patients were randomly assigned to 100% data monitoring – Regular site visits for study training, initiation and monitoring – Remote data monitoring through on-line system1 Academic Research Consortium definitions as defined in Cutlip DE, et al. Circulation. 2007;115:2344-23512 Vranckx P, et al. EuroIntervention. 2010;5:871-874
  • RESOLUTE International Patient EnrollmentCountry Enrolling Centers PatientsSpain 18 623Germany 17 456Netherlands 6 223India 5 174Switzerland 6 166Austria 3 97Portugal 3 91United Kingdom 7 86Belgium 7 78Norway 2 70Czech Republic 1 60Estonia 1 60Greece 4 60South Africa 4 40Finland 1 37Argentina 2 17Slovakia 1 11NOTE: Enrollment was capped at 60 patients per site.Full list of enrolling centers in Appendix.
  • RESOLUTE InternationalPatient Follow-up 2349 Patients Enrolled 30 Day 6 Month 12 Month Clinical Clinical Clinical Follow-up Follow-up Follow-up n = 2342 n = 2332 n = 2287 99.7% 99.3% 97.4%
  • RESOLUTE InternationalBaseline Characteristics% N = 2349 patientsAge (yr) 63.5 ± 11.2Male 77.8Diabetes mellitus 30.5 IDDM 9.0Hypertension 68.0Hyperlipidemia 63.9Current smoker 24.2Family history 31.4Prior MI 27.0Prior PCI 29.6Prior CABG 8.4Cardiac status: Stable angina 37.4 Unstable angina 26.1 Acute myocardial infarction (<72h) 20.0 STEMI (<12h) 7.0
  • RESOLUTE InternationalLesion Characteristics N = 2349 patients,% 3147 lesionsLeft anterior descending 51.1Left circumflex 27.5Right coronary artery 32.4Left Main 2.6Bypass graft 1.8De Novo 92.4B2/C 57.1Chronic total occlusion 6.3Thrombus (angiographically visible) 12.0Bifurcation 18.2 Main branch stenting only 15.2Complex patients1 67.51 Complex patient definition: bifurcation, bypass grafts, ISR, AMI <72 hr, LVEF <30%, unprotected LM, >2 vessels stented, renalinsufficiency or failure (creatinine >140 µmol/L), lesion length >27 mm, >1 lesion per vessel, lesion with thrombus or totalocclusion (preprocedure TIMI = 0).
  • RESOLUTE International Procedure Characteristics N = 2349 patients, 3147 lesionsMultiple vessels treated (%) 20.6Multiple vessels treated with study stent (%) 14.0Number of lesions treated per patient 1.3 ± 0.7Number of stents per patient 1.6 ± 1.0Total stent length per patient (mm) 30.9 ± 20.5Direct stenting (%) 32.1Lesion length* (mm) 18.8 ± 10.8Reference Vessel Diameter* (mm) 2.9 ± 0.5Minimum Lumen Diameter* (mm) 0.5 ± 0.4≥ 1 Small vessel (≤2.75mm) (%) 45.4≥ 1 Long lesion (>18mm) (%) 46.1* Site reported angiographic measurements.
  • RESOLUTE InternationalDual Antiplatelet Therapy (DAPT) UsagePercent of patients on DAPT 30 Days 6 Months 12 Monthsat:Aspirin 98.2 97.5 97.0Clopidogrel 97.8 97.3 93.2Ticlopidine 0.5 0.3 0.3DAPT 96.9 95.6 91.3
  • RESOLUTE International Primary Endpoint: Cardiac Death & Target Vessel MI Cumulative Incidence Cardiac Death/TVMI 10% 9% 8% 7% 6% 5% 4% 4.1% 3% 2% 1% 0% 0 30 60 90 120 150 180 210 240 270 300 330 360 Time after Initial Procedure (days)Days 0 30 60 90 120 150 180 210 240 270 300 330 360No. 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 Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula.
  • RESOLUTE InternationalClinical Outcomes to 12 Months % 30 Days 12 Months n = 2342 patients 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, 3.2 6.9 clinically driven TLR) MACE 3.3 8.0 TVF 3.3 7.6
  • RESOLUTE International Clinical Outcomes to 12 Months N = 2349 8.0 7.6 6.9Percentage [%] 4.2 3.4 3.1 2.3 1.3 0.9 Death Cardiac TV-MI CD/TV-MI ARC ST CI-TLR TLF TVF MACE Death Def/Prob
  • RESOLUTE InternationalMonitored vs. Unmonitored Clinical Outcomes at 12 Months % Monitored Unmonitored P-value n = 586 patients n = 1763 patients 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, 7.7 6.7 0.39 clinically driven TLR) MACE 8.7 7.8 0.54 TVF 8.4 7.3 0.41
  • RESOLUTE International Performance Across Subgroups at 12 Months Cardiac death/TV-MI CI-TLR 5.2Events (%) 4.3 4.2 4.0 3.8 4.0 3.5 3.7 3.7 3.4 3.4 3.0 MVD Diabetes ≤ 2.75 mm > 18 mm Complex1 All Vessels Lesions N=330 N=716 N=1067 N=1082 N=1586 N=2349 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 InternationalComparison with RESOLUTE All Comers at 12 Months% R-International R-All Comers All patients Resolute arm N = 2349 N = 1140Age 63.5 ± 11.2 64.4 ± 10.9Male 77.8 76.7Diabetics 30.5 23.5ACS (Acute MI (<72h) or unstable angina) 46.1 48.3Complex patients 67.5 67.0Death (all) 2.3 1.6 Cardiac 1.3 1.3MI (target vessel) 3.1 4.2Cardiac death + target vessel MI 4.2 5.4ST Def/Prob (all) 0.9 1.6 Early (0-30 days) 0.7 1.1 Late (>30 days) 0.1 0.6TLR 3.4 3.9TLF 6.9 8.2MACE 8.0 8.7TVF 7.6 9.0
  • RESOLUTE InternationalConclusions• In this real-world study the use of the Resolute stent was associated with a low clinical event rate, across all lesion and patient subgroups.• The data are robust as reflected by consistencies between monitored vs. unmonitored patients.• The results of RESOLUTE International support the generalizability of the RESOLUTE All Comers study results.
  • AppendixParticipating Centers
  • RESOLUTE International Participating Centers IHospital Investigator PatientsFaculty Hospital of Kralovske Vinohrady (CZ) Dr. T. Budešínský 60Herz-Zentrum Bad Krozingen (DE) Prof. F-J. Neumann 60Hospital Gregorio Marañón (ES) Dr. J. Soriano 60Klinikum Esslingen (DE) Prof. M. Leschke 60Marienhospital Osnabrück (DE) Prof. T. Wichter 60Stadtspital Triemli (CH) Prof. F. Eberli 60Stavanger Universitetssykehus (NO) Prof. D. Nilsen 60Tartu University Hospital (EE) Dr. T. Hermlin 60The Heart Care Clinic (IN) Dr. M. Chag 60UMC Utrecht (NL) Dr. P. Stella 60Universitätsklinik Innsbruck (AT) Dr. N. Moes 60Alysis Zorggroep (NL) Dr. M. Tjon Joe Gin 59Hospital General Univ. de Guadalajara (ES) Dr. J. Balaguer 58Kantonsspital St. Gallen (CH) Prof. H. Rickli 58Ambulantes Herzzentrum Kassel (DE) Dr. K-F. Appel 55Hospital del Mar (ES) Dr. A. Serra 54Hospital Carlos Haya (ES) Dr. C. Urbano 53Hospital 12 de Octubre (ES) Dr. F. Hernández 50NOTE: Enrollment was capped at 60 patients per site.
  • RESOLUTE InternationalParticipating Centers IIHospital Investigator PatientsHospital de Santa Cruz (PO) Dr. P. Gonçalves 50Academisch Ziekenhuis Maastricht (NL) Prof. J. Waltenberger 49Hospital Germans Trias i Pujol (ES) Dr. J. Mauri 48Hospital de Jaen (ES) Dr. M. F. Guzmán 46Hospital Universitario de Salamanca (ES) Dr. I. Santos 42B.M. Birla Heart Research Centre (IN) Dr. A. Mishra 40Madras Medical Mission – Institute of Dr. A. Mullasari 38Cardiovascular Diseases (IN)Helsinki University Hospital (FI) Dr. M. Laine 37Krankenhaus Landshut-Achdorf (DE) Dr. J. Dietl 35St.-Marien-Hospital Lünen (DE) Prof. C. Perings 32CHU Sart Tilman (BE) Prof. V. Legrand 30Hospital San Juan de Alicante (ES) Dr. R. Lopez 30Donauspital im SMZ-Ost (AT) Dr. C. Wolf 29Errikos Dunant (GR) Dr. V. Tzifos 29Hospital Univ. Virgen de la Victoria (ES) Dr. J.M. Hernández 29Hull Royal Infirmary (UK) Dr. F. Alamgir 28Hospital Joan XXIII (ES) Dr. L. Krsticevic 27Academisch Medisch Centrum Amsterdam (NL) Dr. J.P. Henriques 26
  • RESOLUTE InternationalParticipating Centers IIIHospital Investigator PatientsHospital San Pedro de Alcántara (ES) Dr. J. Fernández 26Hospital Universitario Nuestra Señora Dr. H. Pérez 25de Candelaria (ES)Klinikum Leverkusen (DE) Prof. P. Schwimmbeck 25Bombay Hospital & Medical Research Centre (IN) Dr. B. Goyal 24Hospital General de Asturias (ES) Dr. I. Lozano 22Hospital Santa Marta (PO) Dr. L. Patricio 22Hospital Univ. Virgen de la Arrixaca (ES) Dr. M. Valdés 22Agios Loukas (GR) Dr. D. Tsikaderis 21Krankenhaus Bethanien für die Grafschaft Moers Dr. H-J. Mertens 21(DE)Glenfield Hospital (UK) Dr. G. Richardson 20Serviço de Saúde da Região Autónoma da Dr. J. Araújo 19Madeira, E.P.E. (PO)Universitätsklinikum Rostock (DE) Prof. C. Nienaber 19Etablissement hospitalier de Sion (CH) Dr. G. Girod 17Hospital Universitario Infanta Christina (ES) Dr. J.R. López 17CHU de Charleroi (BE) Dr. J. Lalmand 16Medisch Centrum Alkmaar (NL) Dr. R. Hautvast 16Schüchtermann-Klinik (DE) Dr. N. Franz 15
  • RESOLUTE InternationalParticipating Centers IVHospital Investigator PatientsKlinikum Oldenburg gGmbH (DE) Prof. A. Elsässer 14Panorama Medi-Clinic (SA) Dr. J.P. Roux 14Schwarzwald-Baar Klinikum Villingen- Prof. W. Jung 14Schwenningen (DE)Instituto Cardiovascular de Buenos Aires (AR) Dr. J. Belardi 13UMC St. Radboud (NL) Dr. M. Brouwer 13All India Institute of Medical Science (IN) Prof. V. Bahl 12Craigavon Area Hospital (UK) Dr. I. Menown 12Hôpital de la Tour (CH) Dr. E. De Benedetti 12Krankenhaus St. Franziskus (DE) Prof. J. vom Dahl 12Vincent Pallotti Hospital (SA) Dr. A. Horak 12OIK NÚSCH (SK) Prof. V. Fridrich 11Virga Jesseziekenhuis (BE) Dr. E. Benit 11Dorset General Hospital (UK) Dr. F. Witherow 10Heilig Hart Ziekenhuis (BE) Dr. F. Stammen 10Hôpital Fribourgeois (CH) Dr. S. Cook 10Sörlandet Sykehus Arendal (NO) Dr. M. Uchto 10Vivantes Klinikum Auguste Viktoria (DE) Prof. H. Schühlen 10Clinique Cecil (CH) Prof. J-J. Goy 9
  • RESOLUTE InternationalParticipating Centers VHospital Investigator PatientsUnitas Hospital (SA) Dr. C. Badenhorst 9CardioVasculäres Centrum Frankfurt Sankt Prof. H. Sievert 8Katharinen (DE)Clinique St. Luc (BE) Dr. E. El-Khoury 8Diakonissen Speyer-Mannheim (DE) Dr. H. Schwacke 8Evangelisches Krankenhaus Düsseldorf (DE) Prof. E. Vester 8Landeskrankenhaus Graz-West (AT) Dr. H.W. Schuchlenz 8Athens Medical Center (GR) Dr. G. Papaioannou 7Hospital General Yagüe (ES) Dr. J.M. Durán 7Hospital Virgen de la Macarena (ES) Dr. R. Ruiz 7St. Thomas Hospital (UK) Dr. S. Redwood 7Hairmyres Hospital (UK) Dr. B. O’Rourke 5Milpark Hospital (SA) Dr. G. Cassel 5Royal Free Hospital (UK) Dr. R. Rakhit 4Sanatorio Allende (AR) Dr. H. Londero 4HYGEIA (GR) Dr. A. Dimas 3Universitair Ziekenhuis Antwerpen (BE) Prof. C. Vrints 2ULB - Hôpital Erasme (BE) Prof. E. Stoupel 1