Il Dr. Giampaolo Niccoli dichiara di non aver ricevuto negli ultimi due anni compensi o finanziamenti da Aziende Farmaceutiche e/o Diagnostiche:

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1 Il Dr. Giampaolo Niccoli dichiara di non aver ricevuto negli ultimi due anni compensi o finanziamenti da Aziende Farmaceutiche e/o Diagnostiche: Dichiara altresì il proprio impegno ad astenersi, nell ambito dell evento, dal nominare, in qualsivoglia modo o forma, aziende farmaceutiche e/o denominazione commerciale e di non fare pubblicità di qualsiasi tipo relativamente a specifici prodotti di interesse sanitario (farmaci, strumenti, dispositivi medico-chirurgici, ecc.).

2 Department of Cardiovascular Sciences Standards of care nel trattamento dell IMA Dr. Giampaolo Niccoli Department of Cardiovascular Medicine Catholic University of the Sacred Heart Rome

3 Glycemic disorders in cardiovascular diseases Lancet 2010;375:

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7 LA MALATTIA CORONARIOCA NEL DIABETICO E PIU SEVERA J Am Coll Cardiol 2004; 43:585-91

8 LA MALATTIA CORONARIOCA NEL DIABETICO E PIU ESTESA Niccoli G et al, EHJ, 2013

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10 LA MALATTIA CORONARIOCA NEL DIABETICO E PIU VULNERABILE Niccoli G et al, EHJ, 2013

11 Diabete: aumentato rischio di mortalità a lungo termine STEMI NSTEMI

12 Piccolo et Al - Effect of Diabetes Mellitus on Frequency of Adverse Events in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention Am J Cardiol 2016;118:345e352

13 Piccolo et Al - Effect of Diabetes Mellitus on Frequency of Adverse Events in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention Am J Cardiol 2016;118:345e352

14 Which are the therapeutic objectives in acute phase of ACS in diabetic patients? 1. Glycemic control 2. Antiaggregation 3. Revascularization

15 1. Glycemic control ESC Guidelines on STEMI 2017 ESC Guidelines for the management of acute myocardial infarction in patients presentingwithstsegmentelevation - European Heart Journal (2018) 39, doi: /eurheartj/ehx393

16 1. Glycemic control ESC Guidelines on NSTEMI and 2013 ESC guidelines on diabetes and CVD ESC guidelines on NSTEMI 2013 ESC guidelines on diabetes 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation - European Heart Journal (2016) 37, doi: /eurheartj/ehv320 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD - European Heart Journal (2013) 34, doi: /eurheartj/e ht108

17 Suscettibilita all ostruzione microvascolare Predisposizione acquisita Diabetes and acute hyper-glycaemia (Timmer et al, AJC, 2005) (Iwakura et al, JACC, 2003)

18 Which are the therapeutic objectives in acute phase of ACS in diabetic patients? 1. Glycemic control 2. Antiaggregation 3. Revascularization

19 2. Antiaggregation (and DM) Patti and al. -Antiplatelet Therapy in DM - Circulation Journal Vol.78, January 2014

20 18624 patients with ST-segment elevation or non-st-segment elevation ACS. Among them 4662 (25%) were reported as having DM by the investigators European Heart Journal (2010) 31, )

21 Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin [PEGASUS]; NCT ) (J Am Coll Cardiol 2016;67: )

22 subjects eligible for enrollment if they had moderate- to high-risk unstable angina (UA/NSTEMI), after medical treatment for STEMI with coronary anatomy known to be suitable for PCI, or before cardiac catheterization with planned primary PCI for STEMI Circulation. 2008;118:

23 Circulation. 2008;118:

24 Circulation. 2016;133: DOI: /CIRCULATIONAHA

25 Which are the therapeutic objectives in acute phase of ACS in diabetic patients? 1. Glycemic control 2. Antiaggregation 3. Revascularization

26 SYNTAX Trial: Death, Stroke and Myocardial infarction Kappetein et al. EJCTS 2013

27 Huang et al. CARDIOLOGY 2014, Harskamp et al. Cardior Ther. 2013

28 Optimal Choice of Stent Type in Diabetic Patients with Coronary Artery Disease BMS (bare metal stent) ZES (Zotarolimuseluting stent) PES (Paclitaxel-eluting stent) The probability of several DES and BMS producing the best outcomes in terms of efficacy and safety endpoints for patients with diabetes. SES (Sirolimus-eluting stent) EES (Everolimuseluting stent) Harskamp et al. Cardior Ther. 2013

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32 Conclusions - A large part of patients presenting with NSTEMI-ACS and STEMI is affected by diagnosed or undiagnosed diabetes mellitus. - A correct management of many factors in the acute phase of ACS, like correction of hyperglicemia, use of appropriate antiaggregation and a correct choice of revascularization can have an important impact on prognosis - Discharge tehrapy should be probably tailored in diabetics including prolonged DAPT and new antglycemic drugs with cardioprotective outcome data

33 Department of Cardiovascular Sciences Thanks for your attention

34 ESC guideline son myocardial revascularization: recommendations in diabetics EHJ 2014

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37 Current evidence for optimal revascularization strategy in the diabetes patients ; RCT Huang et al. CARDIOLOGY 2014, Harskamp et al. Cardior Ther. 2013

38 3. Revascularization 2013 ESC guidelines on diabetes,prediabetes and CVD ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD - European Heart Journal (2013) 34, doi: /eurheartj/eht108

39 3. Revascularization 2015 ESC guidelines on NSTEMI 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation - European Heart Journal (2016) 37, doi: /eurheartj/ehv32 0

40 Freedom Trial

41 Farkouh ME, et al. N Engl J Med Dec 20;367(25): CONCLUSION - In patients with diabetes and advanced coronary disease, CABG was of significant benefit as compared to PCI. MI & all cause mortality were independently decreased, while stroke was slightly increased - There was no significant interaction between the treatment effect of CABG on the primary endpoint according to SYNTAX score or any other prespecified subgroup. - CABG surgery is the preferred method of revascularization for patients with diabetes & multi-vessel CAD

42 J Am Coll Cardiol 2010;55:432 40

43 2. Antiaggregation ESC Guidelines on NSTEMI and 2017 ESC focused update on dual antiplatelet therapy 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation - European Heart Journal (2016) 37, doi: /eurheartj/ehv ESC focused update on dual antiplatelet therapy n coronary artery disease developed in collaboration with EACTS - European Heart Journal (2018) 39, doi: /eurheartj/ehx419

44 Circulation 2011; 123:

45 2. Antiaggregation (and DM) Patti and al. -Antiplatelet Therapy in DM - Circulation Journal Vol.78, January 2014

46 n engl j med 360;13 nejm.org march 26, 2009

47 Glycaemic control in acute coronary syndromes: prognostic value and therapeutic options De Caterina et al- European Heart Journal (2010) 31, doi: /eurheartj/ehq162 n engl j med 360;13 nejm.org march 26, 2009

48 1. Glycemic control DIGAMI 1 and DIGAMI 2 DIGAMI patients with DM and acute MI to a 24-h insulin glucose infusion, followed by multi-dose insulin, or to routine glucose- lowering therapy.326 Mortality after 3.4 years was 33% in the insulin group and 44% (P ) in the control group DIGAMI 2 failed to demonstrate prognostic benefits. Glycaemic control in acute coronary syndromes: prognostic value and therapeutic options De Caterina et al- European Heart Journal (2010) 31, doi: /eurheartj/ehq162

49 What about the prognosis of patients with diabetes after AMI? Donahoe Sean M. et al- Diabetes and Mortality Following Acute Coronary Syndromes - JAMA, August 15, 2007 Vol 298, No. 7

50 Donahoe Sean M. et al- Diabetes and Mortality Following Acute Coronary Syndromes - JAMA, August 15, 2007 Vol 298, No. 7 Cumulative Incidence of All- Cause Mortality Through 1 Year After ACS

51 Introduction (1) Acute coronary syndromes (NSTE-ACS and STE-ACS) represent the main manifestation of ischemic heart desease, the most frequent cause of morbidity and mortality in Europe and worldwide. However in Europe there has been an overall trend for a reduction in ischaemic heart disease mortality over the past three decade ischaemic heart disease now accounts for almost 1.8 million annual deaths, or 20% of all deaths in Europe. Female Male European Society of Cardiology: Cardiovascular Disease Statistics 2017 European Heart Journal (2017) 0, 1 72

52 Introduction (2) - Atherosclerotic cardiovascular disease is the leading cause of morbidity and mortality for individuals with diabetes and is the largest contributor to the direct and indirect costs of diabetes 1. - Myocardial infarction represents the most common diabetes-related complication 2. - About 20-30% of European patients with NSTEMI-ACS have known diabetes mellitus; but a similar proportion of people may have undiagnosed diabetes or impaired glucose tolerance Standards of Medical Care in Diabetes 2018 Diabetes Care 2018;41(Suppl. 1):S86 S Piccolo et Al - Effect of Diabetes Mellitus on Frequency of Adverse Events in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention Am J Cardiol 2016;118:345e ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation Web Addenda

53 Glycemic disorders in cardiovascular diseases State of the Art in Diabetes Management Lars Rydén Department of Medicine Karolinska Institutet Stockholm, Sweden World Diabetes Day 14 November 2017

54 Diabetes and pathogenesis of CVD ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD - European Heart Journal (2013) 34, doi: /eurheartj/eht108

55 Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: full text - European Heart Journal Supplements (2007) 9 (Supplement C), C3 C74 doi: /eurheartj/ehl261

56 Which are the therapeutic objectives after discharge in diabetic patients with recent ACS? 1. Risk factors control and CV therapy 2. Use of antidiabetic drugs with evidence of CV benefits

57 1. Risk factor control 2013 ESC guidelines on diabetes,prediabetes and CVD ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD - European Heart Journal (2013) 34, doi: /eurheartj/eht108

58 1. Risk factor control - Glycemic Control Impact of intensive vs. conventional glucose-lowering therapy Significant improvement in end-stage renal disease was observed but no other difference in other microvascular end points. Diabetes-related mortality ACCORD, Action to Control Cardiovascular Risk in Diabetes; ADVANCE, Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation; CV, cardiovascular; HbA 1c, glycosylated haemoglobin; N/R, not reported; UKPDS, UK Prospective Diabetes Study; VADT, Veteran s Affairs Diabetes Trial 1. UKPDS Group. Lancet 1998;352: ; 2. Holman et al. N Engl J Med 2008;359: ; 3. Gerstein et al. N Engl J Med 2008;358: ; 4. ACCORD study group Diabetes Care 2016;39: ; 5. Patel et al. N Engl J Med 2008;358: ; 6. Zoungas et al. N Engl J Med 2014;371: ; 7. Duckworth et al. N Engl J Med 2009;360: ; 8. Hayward et al. N Engl J Med 2015;372:

59 n engl j med 358;6 february 7, 2008

60 n engl j med 358;6 february 7, 2008

61 Gæde P et al Diabetologia 2016;59:

62 Cardiovascular therapy

63 Which are the therapeutic objectives after discharge in diabetic patients with recent ACS? 1. Risk factors control and CV therapy 2. Use of antidiabetic drugs with evidence of CV benefits

64 Conclusions Cardiovascular Disease and Risk anagement: Standards of Medical Care in Diabetesd2018 Diabetes Care 2018;41(Suppl. 1):S86 S104

65 n engl j med 373;22 nejm.org November 26, 2015

66 CANVAS/CANVAS-R HR and 95% CI were estimated using Cox regression models with stratification according to trial and history of CVD for all canagliflozin groups combined versus placebo. CI, confidence interval; CV, cardiovascular; CVD, cardiovascular disease; HF, heart failure; HR, hazard ratio; MI, myocardial infarction; PY, person-years; SGLT-2i, sodium-glucose cotransporter-2 inhibitor Neal B et al. N Engl J Med 2017; doi: /NEJMoa

67 n engl j med 375;4 nejm.org July 28, 2016

68 n engl j med 375;19 nejm.org November 10, 2016

69 CI, confidence interval; CV, cardiovascular; MACE, major adverse cardiac event; MI, myocardial infarction 1. Marso SP et al. N Engl J Med 2016;375: ; 2. Marso SP et al. N Engl J Med 2016;375: ; 3. Zinman B et al. Cardiovasc Diabetol 2014;13:102; 4. Neal B et al. N Engl J Med 2017; doi: /NEJMoa

70 2016 European Guidelines on cardiovascular disease prevention in clinical practice European Heart Journal (2016) 37,