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Invasiv behandling af hjertepatienten med diabetes AstraZenecas 32. kardiovaskulære årsmøde Kolding 23.-24. januar 2009 Hans Erik Bøtker.

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Presentation on theme: "Invasiv behandling af hjertepatienten med diabetes AstraZenecas 32. kardiovaskulære årsmøde Kolding 23.-24. januar 2009 Hans Erik Bøtker."— Presentation transcript:

1 Invasiv behandling af hjertepatienten med diabetes AstraZenecas 32. kardiovaskulære årsmøde Kolding januar 2009 Hans Erik Bøtker

2 Is outcome of percutaneous coronary intervention (PCI) inferior to bypass surgery (CABG) in diabetic compared to non-diabetics patients ? A persistent controversy!! Guidelines ESC 2007 – DCS 2008 PCI in diabetic patients has been improved during the last years - so has CABG Nielsen & Bøtker. Horm Metab Res 2005;37 Suppl.,83-89

3 PTCA vs. CABG in DM: randomized studies Mortality (%) 8 yr7 yr4 yr1 yr p=0.23 P<0.003 NS

4 PCI vs. CABG in DM: Registry studies Mortality (%)

5 By pass surgery versus PCI The BARI randomized trial comparing CABG and PTCA Patients with diabetes (and more unfavourable baseline characteristics that patients without diabetes) (n=353) The Bari Investigators Circulation 1997; 96: CABG LIMA CABG SVG PTCA Adjusted RR Five year mortality by type of intervention Mortality (%)

6 By pass surgery versus PCI (BMS) Stenting vs. CABG in multivessel disease. Subgroup analysis from ARTS Multivessel disease n = Diabetes n = 208 (17%) CABG Stented PCI Eventfree survival (%) Diabetes No Yes No Yes Follow up (days) Three year survival free from stroke, MI and revascularization Legrand et al Circulation 2004;109:

7 PCI with BMS vs. CABG (%) -DM+DM P<0.01 Death,MI, stroke Death,MI, stroke Legrand et al. ARTS 3-year FUP. Circulation 2004; 109: P<0.01 NS P<0.04

8 Syntax: DES vs. CABG MACCE to 12 Months all patients P= * Months Since Allocation Cumulative Event Rate (%) (death+CVA+MI+repeat revasc.) ITT population 12.1% 17.8% Event Rate ± 1.5 SE. * Fishers Exact Test TAXUS (N=903) CABG (N=897)

9 Syntax: DES vs. CABG MACCE to 12 Months all patients

10 Syntax: Outcome according to Diabetic Status (subgroup ) Diabetes (Medical Treatment) N=452 Non-Diabetic N=1.348 TAXUS CABG Death/CVA/MI MACCE Death/CVA/MI MACCE P=0.96 P= P=0.08 P=0.97 Death/CVA/MI MACCE



13 Cardia trial: endpoints

14 Cardia Styrker Stor (n=510), randomiseret, sammenlignende, nordeuropæisk interventionsundersøgelse på diabetes patienter Minimal cross over Svagheder 1 års follow up Screenings log uoplyst Stop for inklusion af nødvendige antal patt. Iht. styrkeberegning underpowered mhp. at afkræfte non-inferiority Mange små centre (14 af 24 centre randomiserede < 3 ptt./år) Få DES (drug eluting stents) (71%) Få LIMA grafter (89%) LM stenoser ekslusionskriterium Højere forekomst af hyperlipidæmi i PCI armen (93 vs 87%) Flere 3-kar-syge i PCI armen (65 vs 58%)

15 CABG/PCI anbefaling Treatment decisions regarding revascularization in patients with diabetes should favour coronary artery bypass surgery over percutaneous intervention IIa, A. Revaskularisering vha. CABG eller PCI beror på individuel vurdering (koronaranatomi, operationsrisici m.m.)

16 Individual treatment There is 3 Vessel Disease and 3 Vessel Disease

17 Influence of Syntax score

18 PCI vs. CABG in surgical risk patients AWESOME ptt.s Prior CABG AMI < 7 days EF < 0.35 Age > 70 years IABP to stabilize Total / DM 2,431 / 758 (31%) Randomized: 454/144 (32%) Physician directed registry: 1650/525 (32%) Patient directed registry: 327/89 (27%) AWESOME, JACC, 2002; 40:

19 PCI in surgical risk patients with DM AWESOME, JACC, 2002; 40: Randomized Register: Patient-choice Register: Physician-directed Survival

20 Outcome by individual evaluation Tarantini et al. Catheter Cardiovasc Interv 2009;73:50–58 A clinical judgment- based revascularization by DES-PCI is not associated with worse 2-year outcome compared with CABG. (n=93) (n=127)

21 Modern PCI Drug eluting stents Optimal anti-thrombotic and other medication

22 Bare metal vs. drug eluting stents Sabaté et al. Circulation 2005; 112:2175 RCT in patients with diabetes Sirolimus (n = 80; 111 lesions) Bare metal (n = 80; 110 lesions) End-point: in segment late lumen loss by QCA after 9 months Late lumen loss 0.06±0.4 mm Late lumen loss 0.47 ±0.5 Variable DES BMS % % % % Target lesion revasc Major CV event p<0.001 p<0.001

23 Differences between DES? Billinger, M. et al. Eur Heart J :

24 Clinical outcome for three trial directly comparing SES and PES: ISAR-DIABETES, REALITY, SIRTAX Major adverse cardiac events Target lesion revasculari zation Billinger, M. et al. Eur Heart J :

25 DES Penetration in Scandinavia Something is rotten in the state of Denmark? DK S

26 Definite Stent Thrombosis at months after index PCI DES 0.09% BMS 0.009% Adjusted RR = 10.9 (1.27 to 93.76) p=0.029 Jensen LO et al. J Am Coll Cardiol 2007;50:

27 DES and stent thrombosis in DM Spaulding et al. NEJM 2007;356: DM+ DM

28 Combined Definite, Probable or Possible Stent Thrombosis in DM Adjusted RR=0.70 ( ) ns Maeng et al. Am J Cardiol 2008;102:

29 DES long term effect in DM Stettler et al. BMJ 2008; 337:a1331 >6 mo clopidogrel treatment

30 DES When PCI with stent implantation is performed in a diabetic patient, drug eluting stents should be used - IIa, B Ved PCI anbefales brug af medicinafgivende stents efterfulgt af 12 måneders behandling med 75 mg clopidogrel

31 1 Year Mortality in Diabetics by PCI Strategy With and Without Abciximab EPIC, EPILOG, and EPISTENT Meta-Analysis PTCAStentMulti-Vessel PCI JACC 2000; 35: p = % p = % n=614n=343n=230n=197 % of Patients p = % n=108n=65 PlaceboAbciximab


33 ISAR SWEET: pretreatment with clopidogrel 600 mg

34 DM: indication for intensive anti- thrombotic therapy during PCI? Bivalirudin: REPLACE-2, ACUITY, HORIZONS TRITON-TIMI-38: Prasugrel

35 Antithrombotic treatment Glycoprotein IIb/III inhibitors are indicated in elective PCI in patients with diabetes I, B. Brug af glycoprotein IIb/IIIa-hæmmere anbefales i forbindelse med PCI proceduren

36 Revascularization of patients with DM Patients with DM can (probably) be revascularized as patients without DM CABG with LIMA in 3-vessel disease and lesions not suitable of PCI PCI in 1- and 2-vessel disease without need of LIMA PCI first choice in surgical high risk patients with multivessel disease when possible

37 Unresolved issues Incomplete revascularization New lesions Co-morbidity Metabolic dysregulation

38 Glucometabolic dysfunction Corpus et al. J Am Coll Cardiol 2004; 43: 8-14

39 Unresolved issues Important ongoing trials FREEDOM Diabetes mellitus type 2 Randomised to CABG or PCI (+DES) Death, MI or repeat revascularization Follow up 5 years BARI IID Diabetes mellitus type 2 Early revascularization or optimal medical therapy Glucose lowering randomised Follow up 6 years

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