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CEREA DES

CEREA DES. TCT 2009. Featured Clinical Trials CEREA DES A Prospective Randomized Trial of Corticosteroids in Patients Undergoing Stent Implantation Flavio Ribichini, MD Director Catheterization Laboratories University of Verona. CEREA DES. TCT 2009. No conflict of interest. CEREA

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CEREA DES

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  1. CEREA DES TCT 2009 Featured Clinical Trials CEREA DES A Prospective Randomized Trial of Corticosteroids in Patients Undergoing Stent Implantation Flavio Ribichini, MD Director Catheterization Laboratories University of Verona

  2. CEREA DES TCT 2009 • No conflict of interest

  3. CEREA DES Protocol • CEREA-DES is an Italian, spontaneous(NOT sponsored), multicenter, randomized study that enrolled375 patients with CAD: • BMS(control group) • DES(DES group, limited to Cypher and Taxus stents) • BMS followed by prednisone treatment (prednisone group) Ribichini et al. J Cardiovasc Med 2009;10:192

  4. Background

  5. CEREA DES Aim of the Study:comparison of the primary endpoint obtained in a control group of patients treated with BMS versus two study groups: DES or BMS plus oral prednisone Primary endpoint: event-free survival of death, MI and recurrence of ischemia needing TVR at one year. Secondary endpoints: event free survival at 2 and 3 years including major bleeding. Restenosis rate at 9 months by QCA, and cost-effectiveness at 1,2 and 3 years. Sample Size: the expected primary endpoint rates are 90% for DES and for prednisone-treated patients and 77% for BMS. A sample size of 120 patients per group provides a 80% power 125 pts per arm were included to obviate for drop-out Ribichini et al. J Cardiovasc Med 2009;10:192

  6. CAD Angina or ischemia Informed consent Single or multi-vessel CAD Native vessel or bypass conduits Successfully recanalized CTO Any BMS stent, only Cypher or Taxus DES, any technique. CEREA DES Inclusion Criteria Ribichini et al. J Cardiovasc Med 2009;10:192

  7. Diabetes Age >80 Recent QWMI (less than 2 weeks) Contraindication for steroid use Renal failure (plasma creatinine  2.5 mg/dl) Neoplasia Severe gastritis or active peptic ulcer Contraindications to dual AP therapy CEREA DES Exclusion Criteria Ribichini et al. J Cardiovasc Med 2009;10:192

  8. CEREA DES Study Flowchart 375 non diabetic pts with CAD BMS+PRED DES BMS 125 pts 125 pts ITT 125 pts - 1: DES -1: no stent +3 no pred -3 (only BMS) +1 DES 126 pts 126 pts 122 pts AT 12m FU 125 pts 125 pts 125 pts CEREA-DES ClinicalTrials.gov NCT00369356

  9. CEREA DES Prednisone Treatment 1mg/Kg orally during the first 15 days 15d 0.5mg/Kg orally from day 16 to 30 15d 40 days 0.25mg/Kg orally from day 30 to 40 10d At hospital discharge associate: Diuretics (25 to 50 mg of thiazidic diuretic) Anti-acids (20 to 40 mg of proton pump inhibitor) At 4 weeks Check blood cells count to rule out side effects of thienopyridines Assess treatment compliance and side effects Eventually, upgrade anti-hypertensive treatment Eventually withdraw diuretics, anti-acids and thienopyridine if not otherwise indicated Ferrero V, et al. Drugs 2007;67:1243-55

  10. CEREA DES CEREA-DES Participating centres European Hospital, Roma:F Tomai, L De Luca, PF Corvo, AS Ghini Università degli studi di Novara:G De Luca, P Marino, E Franchi Istituto Clinico Humanitas, Milano:P Presbitero, D Zavalloni, M Rossi Osp. S. Giovanni Bosco, Torino:G Boccuzzi, R Garbo, M Minelli Università degli Studi di Verona:G Pesarini, V Ferrero, F Ribichini CEREA-DES ClinicalTrials.gov NCT00369356

  11. CEREA DES Baseline Characteristics I

  12. CEREA DES Baseline Characteristics II

  13. CEREA DES Clinical Presentation

  14. CEREA DES Baseline Biochemical Characteristics

  15. CEREA DES Medical Treatment pre-PCI

  16. CEREA DES Medical Treatment at Discharge

  17. CEREA DES Vessels and Lesions Characteristics P=NS

  18. Vessels Treated LIMA

  19. CEREA DES Lesions Characteristics P=NS

  20. CEREA DES Stent Used in the Study

  21. Stent used in the study 18.45 16.79 P=0.003 16.08 BMS DES BMS+PRED Average final balloon diameter post stent 3.20 P=0.05 3.07 3.05 BMS DES BMS+PRED

  22. CEREA DES Medical Treatment at 12 Months

  23. MACE at 12 Months 15.2 12 10.4 Event rate (%) 2.4 0.8 0.8 0 0 0

  24. Combined MACE 18.4% Event rate (%) 12% 11.2%

  25. CEREA DES Primary Endpoint p=0.1 (log-rank)

  26. CEREA DES Kaplan-Meier and Log-Rank Survival Analysis p=0.07 (log-rank)

  27. Multivariate Cox Regression Analysis for the three groups

  28. Multivariate Cox Regression: BMS vs DES and PREDNISONE

  29. CEREA DES CEREA-DES CONCLUSIONS • The clinical results of DES treatment in an independent researchconfirm • the expected performance of Taxus and Cypher stents at one year 2. Previous results obtained with oral prednisione in small, single-centre experiences are replicated in this randomized, multi-centre, study. Oral prednisone after BMS yields good clinical results and can be an alternative to patients that may not receive DES 3. The outcome ofpatients treated with BMShas greatly improved over years with low rate of events compared to previous studies. Indeed, better stent designs and optimal medical treatment yielded better results than expected in the control group

  30. CEREA DES CEREA-DES CONCLUSIONS The main difference bewteen a DES and a systemic drug therapy study: After coronary intervetions, an adequete and effective systemic treatment, like prednisone, together with statins, RAS inhibitors, anti-platelet drugs, and beta blockers, puts THE PATIENT rather than THE ARTERY at the centre of our medical effort. Thank you

  31. CEREA DES BACK UP SLIDES Statistical note: “The study was designed as a superiority trial, to compare DES, and BMS plus prednisone, with BMS alone. The direct comparison of the two study groups (DES vs BMS plus prednisone) as a non-inferiority trial would be more appropriate and of greater interest. However, the sample size required for a pairwise comparison of the three groups, or even more, for a non-inferiority trial between DES and BMS plus prednisone, would be over 2507 patients even keeping the non-inferiority margin as high as 25%. CEREA-DES ClinicalTrials.gov NCT00369356

  32. CEREA DES BMS DES BMS+PREDNISONE RAVEL (12m) 29% 6% SIRIUS (9m) 21% 8.6% E - SIRIUS (9m) 22.6% 8% C - SIRIUS (9m) 18% 4% TAXUS IV (9m) 16% 8.5% TAXUS VI (9m) 22.5% 16.4% ENDEAVOR II (9m) 15.1% 7.8% Est.avg. 12m (linear extrap.) 23.5% 9.9% 9.9% Death, MI and TVR at 9 to 12 months in randomized trials BMS vs DES CEREA DES 18.4% 11.2% 12%

  33. CEREA DES CEREA-DES enrollment

  34. CEREA DES Dual Anti-Platelet Treatment at 6 Months

  35. In Hospital NQWMI (n) 1 1 0 CEREA DES In Hospital QWMI (n) 2* 0 0 30 days deaths (n) 0 0 0 30 days QWMI (n) 0 0 0 30 days NQWMI (n) 0 0 0 30 days TVR 1* 0 0 30 days TLR 1* 0 0 In hospital and 30-days events BMS DES BMS+PREDNISONE *Same patient

  36. Side-Effect N (%) Edema 9/125-7,2% Hyperglicemia 6/125-4,8% Cushing 3/125-2,4% Infectious disease 3/125- 2,4% Neutropenia 1/125-0,8% Agitazione psicomotoria 1/125-0,8% Side Effects of the Steroid Therapy

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