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MINIMASTER CUORE e DIABETE La fase acuta dell’ IMA: la Strategia Interventistica “I DES nei soggetti diabetici: vantaggi

MINIMASTER CUORE e DIABETE La fase acuta dell’ IMA: la Strategia Interventistica “I DES nei soggetti diabetici: vantaggi e problemi” P. Ortolani Istituto di Cardiologia, Policlinico S.Orsola-Malpighi, Bologna. Diabetes: A Pro-Thrombotic State !!!. NO. Adhesion Aggregation Activation.

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MINIMASTER CUORE e DIABETE La fase acuta dell’ IMA: la Strategia Interventistica “I DES nei soggetti diabetici: vantaggi

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  1. MINIMASTER CUORE e DIABETE La fase acuta dell’ IMA: la Strategia Interventistica “I DES nei soggetti diabetici: vantaggi e problemi” P. Ortolani Istituto di Cardiologia, Policlinico S.Orsola-Malpighi, Bologna

  2. Diabetes: A Pro-Thrombotic State !!! NO Adhesion Aggregation Activation ET-1 Thrombin t-PA

  3. DIABETES Trial Primary End Point – Late Loss at 9 Months (149 pts) p=<0.0001 p=<0.0001 • In-stent and overall in-segment late lumen loss was significantly reduced in the drug eluting stent group. • No significant difference was seen in the degree of late loss reduction between insulin-dependent patients (99% reduction) and patients on oral agents (72 % reduction.) mm Sabatè M et al. Circulation 2005;112: 2175-83 Presented at ACC Scientific Sessions 2004

  4. Network Meta-Analysis: DES vs. BMS Target Lesion Revascularization Stettler C Lancet 2007, 370: 937-948

  5. Hazard Ratio 0.66 (95% CI: 0.46 – 0.96), p = 0.041 15.0 11.6 REAL Registry: 1648 Diabetic Patients (ACS 65%, Multivessel disease 80%) 2-year Adjusted Cumulative Survival: DES vs. BMS 1.5 0.7 TVR Stent Thrombosis Ortolani P et Al. Circulation 2008, 117: 923-930

  6. The EVASTENT Matched-Cohort Registry: Stent Thrombosis After SES Implantation Machecourt J J Am Coll Cardiol 2007; 50: 501

  7. Long-Term Clinical Impact of Diabetes Mellitus In Patients With STEMI Treated by PPCI • More extensive coronary artery disease • More comorbid conditions (advanced age, renal failure, peripheral vascular disease) • Basal and post-PPCI abnormal myocardial perfusion (endothelial dysfunction, diminished coronary flow reserve, impaired ischemic pre-conditioning) • Excessive delay from symptom onset to presentation • Post PPCI high rates of restenosis and coronary lesions progression No diabetes vs. NID: Chi-Square: 2.3, p = 0.131 50 46% No diabetes vs. ID: Chi-Square: 28.1, p = 0.000 ID vs. NID: Chi-Square: 11.1, p = 0.001 40 30 27% Mortality % 20 19% 10 Insulin-dependent diabetes (ID) (n=62) Non Insulin-dependent diabetes (NID) (n=198) Non insulin-dependent diabetes (NID) (n=198) 0 No diabetes (n=1061) 0 300 600 900 1200 Time (days) Ortolani P et Al. Submitted 2008

  8. Rationale for DES Use in Diabetic Patients with STEMI Target Vessel Revascularization After Primary Stenting (BMS) Stukey T, Am J Cardiol 2004; 95: 1-7 Dudek D, Kardiol Pol 2004;61: 232-241

  9. Why Should We Not Use DESs in All Diabetic Patients Undergoing Primary PCI ? • May not be effective • May not be safe ( risk of thrombosis) • May not be cost- effective)

  10. DESs use in Diabetics with Acute Myocardial InfarctionAre DESs a Safe Solution in This Peculiar Setting ? 1. Acute Coronary Syndrome as Predictor of DES Thrombosis ESTROFA Registry : 23.500 DES Treated Patients 2-Years FUP HR=6.9 (4-12) HR=5.2 (5.5-7.6) De la Torre JACC 2008; 51: 986-990

  11. DESs use in Diabetics with Acute Myocardial InfarctionAre DESs a Safe Solution in This Peculiar Setting ? 2. Premature Discontinuation of Antiplatelet Therapy as a Predictor of DES Thrombosis

  12. DESs use in Diabetics with Acute Myocardial InfarctionAre DESs a Safe Solution in This Peculiar Setting ? 2. Premature Discontinuation of Thienopyridine Therapy after DES Implantation in STEMI Patients Spertus JA Circulation 2006; 113: 2803-2809

  13. DESs use in Diabetics with Acute Myocardial InfarctionAre DESs a Safe Solution in This Peculiar Setting ? 3. Impact of Thrombus Burden on Risk of Stent Thrombosis with DES in STEMI Patients Sianos G J Am Coll Cardiol 2007; 50: 573-583

  14. TAPAS Trial: Mortality at 1-year Zijlstra F ACC 2008

  15. DESs use in Diabetics with Acute Myocardial InfarctionAre DESs a Safe Solution in This Peculiar Setting ? 4. Underlying Plaque Morphology Affects the Rate and Completeness of Healing and Endotelialization A. Finn TCT 2007

  16. DESs use in Diabetics with Acute Myocardial InfarctionAre DESs a Safe Solution in This Peculiar Setting ? 5. Incomplete Stent Apposition Primary PCI STEMI Elective PCI 9-Months 6-Months 9-Months

  17. NS NS NS NS NS RESEARCH and T-SEARCH Registries; n=505 GRACE Registry Landmark Post-Discharge Survival Analysis-STEMI All pts died in hospital were excluded, as well as the pts without FUP Three-Year Clinical Outcome of SES and PES vs. BMS in STEMI Courtesy of PG Steg ESC 2007 Daemen J Am J Cardiol 2007; 99: 1027-1032

  18. MASS Stent AMI Registry- 2-Year Outcome in MI Patients (5258 pts) A Propensity Matched Review of All PCI Procedures for STEMI – n-STEMI Patients Mauri L ACC 2008

  19. 11 DES vs. BMS RCTs in STEMI (n=3,605 patients) De Luca Int J Cardiol 2008; In Press

  20. DES vs. BMS RCTs in STEMI (n=3,605 patients) Diabetic Patients : 10–20% De Luca Int J Cardiol 2008; In Press

  21. DES vs. BMS RCTs in STEMI (n=2,357 patients) Diabetic Patients : 10–20% De Luca Int J Cardiol 2008; In Press

  22. Uncoated Stent Sirolimus Stent MULTISTRATEGY Trial (n=745 patients, 15% diabetics) ARC Stent Thrombosis P=0.45 6% P=0.31 P=0.65 4.5% 3% 1.5% 0% Definite/Probable Possible Definite/Probable Definite Valgimigli M JAMA 2008; 299: 1788-1799

  23. Outcomes After DES Implantation in STEMI: Diabetics (n= 56) vs. non Diabetics (n= 170) Zhang Q Chin Med J 2007; 120: 1862-1867

  24. EARLY ST LATE ST HR 0.29 [0.15-0.56] P=0.0001 HR 0.46 [0.22-0.97] P=0.04 CLOPIDOGREL PRASUGREL 1.44% % of Subjects 0.91% 71% 54% 0.42% 0.42% TRITON TIMI 38 13,608 ACS patients (STEMI, n-STEMI, UA) STENT AnalysisDefinite/Probable ST: DES Only (N=5743) Diabetic Subgroup N= 3146 Wiviott SD, et al NEJM2007 Wiviott SD, et al Lancet 2008

  25. Conclusions • Although the evidence showing efficacy and safety of DES in PPCI patients is growing, however due to safety issues, currently indiscriminate DES use in STEMI pts with diabetes may not be recommended • BEST INDICATIONS: • - Lesions at high risk for restenosis: long-lesions, small • vessels • - High probability of viable myocardium (early onset) • - No contraindications to dual antiplatelet therapy • - After thrombo-aspiration • - After proper assessment of the vessel size (nitrates injection)

  26. The End

  27. New York PCI Registry: Clinical Outcome of DES vs. BMS in STEMI (Up to 2 yrs FUP) NS P=0.004 P=0.007 NS Hannan E JACC Intv 2008; 1: 136-138

  28. Rationale for DES Use in Diabetic Patients with STEMI Balloon Angioplasty vs. BMS: The STENT PAMI Study Grines CL NEJM 1999; 341:1949-56

  29. Conclusions 2 Conclusions While awaiting the results of dedicated studies, considering the potential hazards, an indiscriminate DESs use in diabetic patients with STEMIat presentmay not be recommended.

  30. DESs use in Diabetics with Acute Myocardial InfarctionAre DESs a Safe Solution in This Peculiar Setting ? 5. IVUS Predictors of Early Stent Thrombosis With the Uses of SES: Stent Underexpansion and Residual Reference Segment Stenosis are Predictors of Early Stent Thrombosis P<0.001 P<0.001 P<0.001 Fujii K JACC 2005; 45: 995-998

  31. DESs use in Diabetics with Acute Myocardial InfarctionAre DESs a Safe Solution in This Peculiar Setting ? 7. Impact of Dual Antiplatelet Therapy Duration in Diabetics Overall Mortality in Diabetic Patients: Meta-Analisys of 3,853 Diabetic Patients Stettler C 2008, Submitted

  32. Secondary end points – Restenosis, TLR, MACE (149 pts) Angiographic restenosis, TLR, and overall MACE were significantly reduced. (Reduction in overall MACE was primarily due to the reduction in TLR – rates of cardiac death and MI were not significantly different between the two groups.) p =<0.001 p=<0.0001 p =<0.0001 % Sabatè M et al. Circulation 2005;112: 2175-83 TCT 2004

  33. The EVASTENT Matched-Cohort Registry: Stent Thrombosis After SES Implantation Machecourt J J Am Coll Cardiol 2007; 50: 501

  34. Diabetes as Predictor of Drug-Eluting Stent Thrombosis

  35. ACSwith persistent ST-segment elevation DESs use in Diabetics with Acute Myocardial InfarctionAre DESs a Safe Solution in This Peculiar Setting ?

  36. DESs use in Diabetics with Acute Myocardial InfarctionAre DESs a Safe Solution in This Peculiar Setting ? 7. Diabetes as Predictor of Drug-Eluting Stent Thrombosis

  37. DESs use in Diabetics with Acute Myocardial InfarctionAre DESs a Safe Solution in This Peculiar Setting ? 6. Incomplete Stent Apposition and Very Late Stent Thrombosis Cook S Circulation 2007; 115: 2426-2434

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