Beispiel Kardiologie: Drug-eluting

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1 Umsetzung von Studienergebnissen in die klinische Praxis Beispiel Kardiologie: Drug-eluting Stents Wolfgang Rutsch Leiter des Bereichs Herzkatheterlabore Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie Klinik- und Zentrumsdirektor Prof. Dr. med. Gert Baumann Charité,, Universitätsmedizin tsmedizin Berlin, Campus Charité Mitte Rutsch Charité Aug 28 #1#

2 Entwicklung von PCI und koronarchirurgischen Eingriffen in Deutschland zwischen Jahr 2 Rev Rev PTCA gesamt ACVB CABG (17,6%) PCI PCI (82,4%) Revaskularisationen pro 1 Mill Einwohner: USA Deutschland Jahr Rutsch Charité Aug 28 #2#

3 Angiographic Restenosis in Clinical Trials Author Year n Treatment RR, % Raizner et al Prostacyclin 47 Schwartz et al Aspirin-dipyridamole 39 Ellis et al i.v. heparin 39 M-HEART Corticosteroid 43 Franzen et al Fish oil 35 Knudtson et al Prostacyclin 3 CCAT PTCA vs. DCA 43 CAVEAT PTCA vs. DCA 58 BENEENT I PTCA vs. stent 32 RESS PTCA vs. stent 42 Weintraub et al Lovastatin 41 M-HEART-II Thromboxane antagonist 45 MARCATOR Cilazapril 36 BOAT PTCA vs. DCA 4 BENEENT II PTCA vs. stent 21 TOTAL 38% Rutsch Charité Aug 28 #3#

4 Restenosis Rates in Randomized Trials of DES A hierarchical Bayesion meta-analysis analysis of randomised clinical trials of DES MN Babapulle,, et al. Lancet 24, 364: RAVEL SIRIUS C-SIRIUS E-SIRIUS Pooled Cypher TAXUS I TAXUS II TAXUS IV Pooled -83% TAXUS 6,2 DES -69% 7,1 Cypher BX Velocity BMS 36,9 TAXUS Express 23,5 Rutsch Charité Aug 28 #4#

5 Target Lesion Revascularization Rates in Randomized Trials Investigating DES A hierarchical Bayesion meta-analysis analysis of randomised trials of DES MN Babapulle,, et al. Lancet 24, 364: RAVEL RAVEL SIRIUS SIRIUS C-SIRIUS C-SIRIUS E-SIRIUS E-SIRIUS Pooled Pooled Cypher Cypher TAXUS TAXUS II TAXUS TAXUS II II TAXUS -8% TAXUS IV IV Pooled Pooled TAXUS TAXUS -73% 18,5 12,2 5 3,5 3,3 Cypher BX Velocity TAXUS Express DES BMS Rutsch Charité Aug 28 #5#

6 DES-Thrombose Firestorm ESC Barcelona 2 Camenzind E, ESC 2, Oral Presentation #992 Analyse aller damals verfügbaren, publizierten, randomisierten Studien, Analyse auf Studienebene! Rutsch Charité Aug 28 #6#

7 BASKET-LATE % 1,2 Cardiac death BMS DES 4,9 4,1 1,3 1,3 MI MI Cardiac death and MI MI 6,7 4,5 TVR Late major cardiac events (months 7 to 18). Cardiac death or nonfatal myocardial infarction (MI), was significantly greater in drug-eluting stent (blue) versus bare-metal stent (red) groups, which contrasts with a trend toward a lower restenosis-related related target vessel revascularization (TVR) rate after drug-eluting stents. Rutsch Charité Aug 28 #7#

8 9 Prospective, Double-Blind Blind, Randomized Trials Freedom From Cardiac Death Independent CRF patient-level meta-analysis analysis Rutsch Charité Aug 28 #8#

9 9 Prospective, Double-Blind Blind, Randomized Trials Freedom From Myocardial Infarction Independent CRF patient-level meta-analysis analysis Rutsch Charité Aug 28 #9#

10 9 Prospective, Double-Blind Blind, Randomized Trials Freedom From Ischemic TLR Independent CRF patient-level meta-analysis analysis Rutsch Charité Aug 28 #1#

11 SCAAR Swedish Coronary Angiography and Angioplasty Registry Lagerqvist B, et al, for the SCAAR Study Group, NEJM 27 6-month cumulative incidence of death and myocardial infarction of the cohort of the SCAAR registry. A A Landmark Trial Rutsch Charité Aug 28 #11#

12 SCAAR Swedish Coronary Angiography and Angioplasty Registry Lagerqvist B, et al, for the SCAAR Study Group, NEJM 27 25: 63% 2: 27% Rutsch Charité Aug 28 #12#

13 The SCAAR registry or the Swedish yo-yo Patrick W. Serruys*, MD PhD; ; Joost Daemen,, MD Department of Cardiology,, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands, EuroIntervention Nov 27 6-month cumulative incidence of death and myocardial infarction of the 25 cohort of the SCAAR registry. A A Landmark Blamage Percentage of DES and BMS use per year in Sweden (SCAAR registry) Rutsch Charité Aug 28 #13#

14 DES Penetration in the US Source: Millenium Research Group BASKET-LATE Sept 2 COURAGE-Trial March Jan 89, 87,9 87,8 88, 87,7 85,9 86,1 83,9 8,1 Feb Mar Apr May Jun Camenzind ESC Barcelona Sept 2 July Aug Sep Oct 76,9 72,8 7,4 7,2 68, 67,9 66,8 65,2 Nov SCAAR-Registry Feb 27 FDA-Panel Dez 2 Dec Jan 7 Feb 7 ACC April 27 64,8 62, Abnahme DES- Implantation Mar Apr May Jun um July3% Sep von 89% Jan 2 auf 62% Sept 27 Rutsch Charité Aug 28 #14#

15 Academic Research Consortium (ARC) Definitions of Stent Thrombosis Timing Acute stent thrombosis: : 24 h after stent implantation Subacute stent thrombosis: : 24 h 3 h d after stent implantation Late : 3 d 1 d 1 y after stent implantation Very late *: 1 y after stent implantation Three categories of evidence in defining stent thrombosis Definite stent thrombosis Probable stent thrombosis Possible Rutsch Charité Aug 28 #15#

16 Academic Research Consortium Definitions of in a Pooled Meta- Analysis of the Randomized RAVEL, SIRIUS, E-SIRIUS, E and C-SIRIUS C Trials Possible Possible Probable Probable Definite Definite Very Very late late (>1year) (>1year) Late Late (<1 (<1 year) year) Subacute Subacute (<3d) (<3d) Acute Acute (<24 (<24 h) h) ARC, ARC, any any thrombosis thrombosis 1,5 1,5 1,9 1,9,9,9,3,3 BMS BMS,8,8 SES 1,1 SES 1,1 1,6 1,6 2,6 2,6 1,3 1,3,3,3,3,3,5,5 3,2 3,2 3,4 3,4,5 1 1,5 2 2,5 3 3,5 4,5 1 1,5 2 2,5 3 3,5 4 Rutsch Charité Aug 28 #16# %

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