Management of cardiovascular disease - coronary interventions -

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1 Master Classes in Preventive Cardiology I Management of diabetes in patients with CVD European Heart House Management of cardiovascular disease - coronary interventions - Francesco Cosentino MD, PhD, FESC Division of Cardiology 2 nd Faculty of Medicine University "Sapienza" Rome, Italy

2 Revascularisation: which is better PCI or CABG?

3 Coronary interventions Patients with diabetes have: higher complication rate higher long-term mortality/morbidity following revascularization both after bypass surgery and PCI, even in the era of DES greater incidence of 3-vessel, more diffuse disease in proximal and distal segments (NHLBI PCI registry) Most outcome information is derived from registries and sub-group analyses (selection bias)

4 Comparison of CABG with PTCA in pts with CAD Bypass Angioplasty Revascularisation Investigation (BARI) 1289 pts with multivessel disease of whom 353 had diabetes. Survival advantage in the CABG compared to the PCI cohort NEJM 1996; 335: 217

5 BARI Trial 10-Year Follow-Up Results BARI Investigators, JACC 2007

6 2009 Collaborative meta-analysis of 10 RCT PCI vs. CABG in multivessel CAD Mortality % PCI diabetes 1223 diabetic patients enrolled in 10 PCI vs CABG trials (6 PTCA and 4 BMS) median FU 5.9 years Long-term survival benefit of CABG among 1223 diabetic patients Interaction between diabetes status and treatment effect undertaken CABG diabetes PCI/CABG no diabetes Hlatky MA et al, Lancet 2009 Years of follow-up

7 Arterial Revascularization Therapy Study A subgroup analysis of the ARTS-I trial BMS vs CABG in pts with multivessel CAD Abizaid et al Circulation 2001

8 Has the use of DES in diabetic patients changed results first seen in the pre-des trials favouring CABG?

9 ARTS II Trial SES-PCI in Diabetes with multivessel CAD (single-arm study) 3-year clinical outcomes for ARTS-I and -II diabetic patients ARTS-I: PCI with BMS vs CABG ARTS-II: PCI with SES Incidence of MACCE (efficacy) Death/CVA/AMI (safety) Daemen et al. JACC 2008

10 Collaborative Network Meta-analysis All Cause Mortality 35 studies non-diabetic and 3852 diabetic patients Stettler C et al. BMJ 2008;337:a1331

11 Collaborative Network Meta-analysis Target Lesion Revascularization Both DES were associated with a decrease in revascularization rates compared with BMS in pts with and w/out diabetes DES seem same and effective Stettler C et al. BMJ 2008;337:a1331

12 Massachussets Registry DM - 3-Years Mortality Analysis including all patients undergoing PCI in non-federal hospital in Massachussets between April 2003 and September DM patients Unadjusted 3-year mortality 14.4% DES group and 22.2 BMS group (P<0.001)* Propensity matched diabetic cohorts Garg P et al. Circulation 2008;118:

13 Massachussets Registry DM 3-Years TVR Risk-adjusted 3-year revasc rate 18.4% DES group and 23.7 BMS group (P<0.001) Propensity matched diabetic cohorts Garg P et al. Circulation 2008;118:

14 Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX Trial) 1800 pts with LM or triple vessel CAD the primary outcome occured more often in the PCI group Serruys et al. NEJM 2009;360:961-72

15 Coronary Artery Revascularization in Diabetes (CARDia) DM and triple-vessel CAD Preliminary results at 1 year 10.5% 13.0% Primary endpoint: death, non fatal MI, non fatal stroke p =0.63 N=510

16 Coronary Artery Revascularization in Diabetes (CARDia) Higher rate of repeat revasc in the PCI group p= % 19.3 % N=510

17 Revascularization or Medical Management? Unstable CAD Stable CAD

18 Diabetic pts with non-st ACS have higher 30-day mortality meta-analysis of the diabetic populations within IIb-IIIa inhibitor trials Adjusted Odds Ratio & 95% CI Total, N = Diabetes, N = 6458 Diabetes p < Better Worse Roffi et al.,circulation 2001;

19 Early Invasive or Conservative Strategy in UA and NSTEMI 6 Months Death, MI, Rehosp ACS, (%) 27.7 p = P<0.05 RRR 27% ARR 7.6% 20.1 Conservative Invasive p = P=NS RRR 13% ARR 2.2% 0 Diabetes No Diabetes N=613 N=1607 Cannon et al. NEJM 2001;344: ejt

20 ESC ACS Guidelines 2007 Recommendations for Diabetes Early invasive strategy is recommended for diabetic patients with NSTE-ACS (I A). ESC Guidelines for the Management of NSTE-ACS

21 Impact of revascularization vs med therapy alone on mortality in stable CAD Meta-Analysis of Randomized Trials 28 trials, published pts (~470 patients/trial) Median FU 3 years No diabetes data Jeremias A et al. Am J Med 2009;122:152-61

22 Coronary revascularization decreases mortality in diabetics with stable multivessel disease A retrospective analysis of MASS II study N=190 Diabetics 611 patients with stable multivessel CAD Randomized to PCI, CABG or medical Tx 190 diabetic patients 5 yrs follow up Soares, P. R. et al. Circulation 2006;114:I-420-I-424

23 Impact of Revascularization: Euro-Heart Survey Freedom from MACE No DM, Revasc No DM, No Revasc DM, Revasc DM, No Revasc Anselmino et al. Eur J Cardiovasc Prev Rehabil 2008;15:216-23

24 Impact of EBM: Euro-Heart Survey Freedom from MACE No DM DM, EBM DM, No EBM Anselmino et al. Eur J Cardiovasc Prev Rehabil 2008;15:216-23

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26 Stable CAD and Diabetes PCI, CABG or medical management? QuickTime e un decompressore sono necessari per visualizzare quest'immagine. confront treatment decisions in practice

27 2368 diabetic pts with T2DM and stable CAD 2x2 design BARI 2D: study design revascularization (CABG or PCI) + intensive medical tx vs. intensive medical tx alone insulin sensitization (metformin/tzd) vs. insulin provision (sulfonylureas/insulin) Randomization to PCI or CABG prespecified by the physician as the more appropriate therapy for each patient 22 parallel strategies for for death long and term CVE death and CVE The BARI 2D study group NEJM 2009

28 BARI 2D little difference with respect to rates of survival and MACE 1º endpoint: death 2º: death/mi/stroke Follow-up 5 yrs The BARI study group NEJM 2009

29 Outcomes in the CABG Subgroup of BARI 2D Trial prespecified analyses of secondary end point reduction of death/nonfatal MI/stroke only among pts who were selected to undergo CABG. Ins sens associated with fewer CVE. Sobel BE, Coron Artery Dis 2010 The BARI study group NEJM 2009

30 BARI 2D: Patients Characteristics Low risk population for major CVE on the basis of angina symptoms, extent of CAD and VF

31 Conclusions (I) Diabetic patients at higher risk of CV events with both PCI and CABG Improvements in techniques for both PCI and CABG DES-PCI and CABG At 1 year similar death/mi/stroke rates PCI more revascularization CABG more stroke Choice of revascularization strategy based on diffuseness of atherosclerosis, clinical presentation, type of diabetes, comorbidities, pattern of coronary involvement, LV function. Interventional (Syntax) and surgical scores (Euroscore) should be taken into account Threshold for surgery should be lower in diabetic patients than in non-diabetic counterparts (especially in IDDM) Longer FU of the presented trials and results of ongoing controlled randomized trials in pts with diabetes (CARDia, FREEDOM) will further help in decision making

32 Conclusions (II) Optimal medical management is crucial, independently of revascularization strategy Initial conservative strategy is a valuable option In the presence of optimal compliance to medical management in low-risk diabetic patients (stable symptoms, moderate CAD on coronary angiogram, normal LV and renal function) Results of BARI 2 D cannot be extrapolated to unstable or in other respect higher risk diabetic patients to diabetic patients with unknown coronary anatomy

33 Diabetes with CAD a moving target against which the effectiveness of evolving treatments must be repeatedly assessed

34 ESC/EASD Guidelines 2007 Mechanical reperfusion by means of primary PCI is the revascularization mode of choice in diabetic patients with AMI (I A) When PCI with stent implantation is performed in patients with diabetes, DES should be used (IIa - B) Glycoprotein IIb/IIIa inhibitors are indicated in

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