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18 th EUROCHAP European Chapter Congress of the International Union of Angiology XIX MLAVS 2009 Annual Meeting of the Mediterranean League of Angiology.

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Presentation on theme: "18 th EUROCHAP European Chapter Congress of the International Union of Angiology XIX MLAVS 2009 Annual Meeting of the Mediterranean League of Angiology."— Presentation transcript:

1 18 th EUROCHAP European Chapter Congress of the International Union of Angiology XIX MLAVS 2009 Annual Meeting of the Mediterranean League of Angiology and Vascular Surgery

2 Ness J. J Am Geriatr Soc 1999;47:1255-6

3 % 3649 subjects (average age, 64 yrs) followed-up for 7.2 years Hooi JD. J Clin Epid 2004;57:294–300

4 Poldermans D. Eur Heart J 2009 Aug 27 [Epub] 30-day risk of cardiac death or myocardial infarction

5 McFalls EO. NEJM 2004;351:

6 To assess the benefit of prophylactic coronary artery revascularization before major vascular surgery in patients at increased risk for perioperative cardiac complications and with clinically stable, angiographically significant coronary artery disease To assess the benefit of prophylactic coronary artery revascularization before major vascular surgery in patients at increased risk for perioperative cardiac complications and with clinically stable, angiographically significant coronary artery disease McFalls EO. NEJM 2004;351:

7 All patients scheduled for vascular surgery were screened All patients scheduled for vascular surgery were screened Patients could be enrolled if: Patients could be enrolled if: 1. judged at high risk of cardiac complications 2. had >70% coronary stenosis at angiography 3. were amenable to PCI or CABG McFalls EO. NEJM 2004;351:

8 Only 8.7% of 5859 screened patients were enrolled!

9 No revasc 7.0% revasc 3.6% McFalls EO. NEJM 2004;351:

10 VariableRevascNo RevascP Value (N=258)(N=252) Age, yr 65.6± ± Previous MI (%) 111 (43.0) 103 (40.9) 0.62 Previous CHF (%) 31 (12.0) 19 (7.5) 0.09 Previous CVA (%) 54 (20.9) 47 (18.7) 0.50 Diabetes (%)97(37.6) 101(40.0) 0.84 Current smoker (%) 128 (49.6) 114 (45.2) 0.41 Left ventricular EF % 54±12 55± V disease (%) 91 (35.3)79 (31.3)0.69 Previous CABG (%) 38 (14.7) 39 (15.5) 0.83 VariableRevascNo RevascP Value (N=258)(N=252) Age, yr 65.6± ± Previous MI (%) 111 (43.0) 103 (40.9) 0.62 Previous CHF (%) 31 (12.0) 19 (7.5) 0.09 Previous CVA (%) 54 (20.9) 47 (18.7) 0.50 Diabetes (%)97(37.6) 101(40.0) 0.84 Current smoker (%) 128 (49.6) 114 (45.2) 0.41 Left ventricular EF % 54±12 55± V disease (%) 91 (35.3)79 (31.3)0.69 Previous CABG (%) 38 (14.7) 39 (15.5) 0.83 McFalls EO. NEJM 2004;351:

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12 § The criteria include ≥3 among: age >70, angina, Q waves on ECG, previous CHF, previous ventricular tachycardia, or diabetes mellitus

13 Coronary artery revascularization before elective vascular surgery does not significantly alter the long-term outcome Coronary artery revascularization before elective vascular surgery does not significantly alter the long-term outcome Thus, among patients with stable cardiac symptoms, preventive coronary artery revascularization cannot be recommended Thus, among patients with stable cardiac symptoms, preventive coronary artery revascularization cannot be recommended

14 Only 8.7% of screened patients were enrolled Only 8.7% of screened patients were enrolled Cardiac risk stratification was not uniform Cardiac risk stratification was not uniform Only 32% of the enrolled patients had 3-vessel disease Only 32% of the enrolled patients had 3-vessel disease CHF rate was almost double in “Revasc” arm CHF rate was almost double in “Revasc” arm Relevant crossover between randomization arms Relevant crossover between randomization arms Complete revasc with PCI in 61.9%; no use of DES Complete revasc with PCI in 61.9%; no use of DES Periprocedural mortality of PCI was 1.4% Periprocedural mortality of PCI was 1.4% 3.9% mortality after uncomplicated CABG or PCI before vascular surgery 3.9% mortality after uncomplicated CABG or PCI before vascular surgery

15 Garcia S. Am J Cardiol 2008;102:809-13

16 Survival 2.5 years after vascular surgery

17 Garcia S. Am J Cardiol 2008;102:809-13

18 CARP showed that prophylactic coronary revascularization does not improve postoperative outcome CARP showed that prophylactic coronary revascularization does not improve postoperative outcome Verify whether at least those patients with severe CAD benefit from this strategy Verify whether at least those patients with severe CAD benefit from this strategy Patients with ≥3 risk factors underwent stress imaging; those with extensive stress-induced ischemia (≥5 segments or ≥3 walls) were randomized Patients with ≥3 risk factors underwent stress imaging; those with extensive stress-induced ischemia (≥5 segments or ≥3 walls) were randomized All received beta-blockers, and antiplatelet therapy was continued during surgery All received beta-blockers, and antiplatelet therapy was continued during surgery Poldermans D. JACC 2007;49:1763–9

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20 All-Cause Death or Myocardial Infarction at 1 year Prophylactic revascularization Best medical therapy P>0.2 Prophylactic revascularization Best medical therapy

21 Poldermans D. JACC 2007;49:1763–9

22 CARP and DECREASE-V showed that prophylactic coronary revascularization does not improve postoperative outcome, but have many limitations CARP and DECREASE-V showed that prophylactic coronary revascularization does not improve postoperative outcome, but have many limitations 30-day cardiovascular complication rates of vascular surgery remain as high as 15-20% (mortality 3-5%) 30-day cardiovascular complication rates of vascular surgery remain as high as 15-20% (mortality 3-5%) Patients with Revised Cardiac Risk Index ≥2 were randomized to “systematic” or “selective” (after stress imaging) coronary angiography and consequent revascularization Patients with Revised Cardiac Risk Index ≥2 were randomized to “systematic” or “selective” (after stress imaging) coronary angiography and consequent revascularization All received beta-blockers, and aspirin therapy was continued during surgery All received beta-blockers, and aspirin therapy was continued during surgery Monaco M. JACC 2009;54:989–96

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24 Systematic angiography Selective angiography Systematic Selective

25 Landesberg G. Eur Heart J 2007;28:533-9

26 Hachamovitch R. Circulation 2003; 107:2900-6

27 20% Hachamovitch R. Circulation 2003; 107:2900-6

28 Boden WE et al. NEJM 2007;356:

29 COURAGE Trial The Revenge of the Clinical Cardiologist Interventionalists Vs. Clinical Cardiologists

30 Boden WE et al. NEJM 2007;356: Population: 2287 pts with objective evidence of myocardial ischemia and significant CAD Population: 2287 pts with objective evidence of myocardial ischemia and significant CAD Primary end point: death and non-fatal MI Primary end point: death and non-fatal MI Results: Results: PCI showed no benefit in the primary end point vs. medical therapy (19% vs. 18.5%, p=0.62) PCI showed no benefit in the primary end point vs. medical therapy (19% vs. 18.5%, p=0.62) PCI showed a significant benefit in angina relief at 1 and 3 years, that was not sustained at 5 years PCI showed a significant benefit in angina relief at 1 and 3 years, that was not sustained at 5 years

31 32,468 (91.4%) patients were excluded! -8,677 did not meet inclusion criteria  5,155 had undocumented ischemia  3,961 due to vessel anatomy -6,554 were excluded for logistic reasons -18,360 had one or more exclusions  4,513 had undergone recent (<6 mo) revascularization  4,939 had inadequate EF  2,987 had contraindication to PCI  2,542 had a serious coexisting illness  1,285 had concomitant valvular disease  1,203 had class IV angina  1,071 had a failure of medical therapy  947 had LM stenosis >50%  722 had only PCI restenosis (no new lesion)  528 had complications after MI 32,468 (91.4%) patients were excluded! -8,677 did not meet inclusion criteria  5,155 had undocumented ischemia  3,961 due to vessel anatomy -6,554 were excluded for logistic reasons -18,360 had one or more exclusions  4,513 had undergone recent (<6 mo) revascularization  4,939 had inadequate EF  2,987 had contraindication to PCI  2,542 had a serious coexisting illness  1,285 had concomitant valvular disease  1,203 had class IV angina  1,071 had a failure of medical therapy  947 had LM stenosis >50%  722 had only PCI restenosis (no new lesion)  528 had complications after MI Highly selected study population ! Boden WE et al. NEJM 2007;356:

32 All cause death was a wrong endpoint (it should have been cardiac death!) Boden WE et al. NEJM 2007;356:

33  15.7% of patients randomized to PCI were not treated or did not complete follow-up vs. 8.5% of the patients assigned to OMT who were lost to follow-up.  Trial design projection: no more than 10% of OMT patients would cross over to PCI. Reality: 25.5% of OMT crossed over to PCI but their outcome was evaluated as they were on drug therapy only (intention- to-treat principle).  For various reasons, 4% of the PCI patients were not treated with an intervention but their outcome was evaluated as they were (intention-to-treat principle) Critical point: crossover to PCI

34 1149 patients total 46 (4%) procedure not attempted 27 (2%) no lesions crossed 1077 patients (94%) had PCI attempted 1577/1688 lesions had PCI success (93%) 787 patients (69%) had 2 or 3 vessel ds. 590 pts (59%) received 1 stent 416 pts (41%) received ≥2 stents At least 371 of 787 pts (47%) with multivessel disease had incomplete revascularization 97% BMS 3% DES Boden WE et al. NEJM 2007;356:

35 Any cardiac biomarker elevation A 2.8% MI rate seems high for patients with stable angina Spontaneous MI PCI+OMT=108OMT=119 Periprocedural MI PCI+OMT=35OMT=9 GP IIb/IIIa inhib. and clopidogrel, which minimize periprocedural MIs, were rarely used Boden WE et al. NEJM 2007;356:

36 Hirsh A et al. Lancet 2007;369: ICTUS trial: periprocedural MI, defined as CK-MB>ULN, is mostly inconsequential. Only large MIs should be included in a meaningful clinical end point 4-Year Mortality (%) 7.9% 6.6% HR 0.88 ( ) p=0.75 YesNo In-hospital MI

37 LDL <85 mg/dl in ~ 70% of pts LDL <85 mg/dl in ~ 70% of pts SBP <130 mmHg in ~ 65% of pts SBP <130 mmHg in ~ 65% of pts DPB <85 mmHg in ~ 94% of pts DPB <85 mmHg in ~ 94% of pts HgBA1C <7.0% in ~ 45% of pts HgBA1C <7.0% in ~ 45% of pts

38 Duke Clinical Research Institute, AHA CRUSADE registry ( )

39 Improves symptoms from coronary lesions Improves symptoms from coronary lesions usually better than drugs usually better than drugs similar to bypass surgery (in most patients) similar to bypass surgery (in most patients) May reduce death and MIs in some patients May reduce death and MIs in some patients Improves symptoms from coronary lesions Improves symptoms from coronary lesions usually better than drugs usually better than drugs similar to bypass surgery (in most patients) similar to bypass surgery (in most patients) May reduce death and MIs in some patients May reduce death and MIs in some patients PCI in Chronic Stable Coronary Syndromes… PCI in Chronic Stable Coronary Syndromes…

40 Silber S. Eur Heart 2005;26:804–847

41 Poldermans D. Eur Heart J 2009 Aug 27 [Epub]

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43 Patients with PAD have a 4- to 10-fold increase in cardiac death and MI Patients with PAD have a 4- to 10-fold increase in cardiac death and MI Patients undergoing vascular surgery still have a high perioperative cardiac mortality and morbidity Patients undergoing vascular surgery still have a high perioperative cardiac mortality and morbidity CARP and DECREASE-V failed to prove a clinical benefit from prophylactic coronary revascularization before vascular surgery, even in patients with large myocardial ischemia CARP and DECREASE-V failed to prove a clinical benefit from prophylactic coronary revascularization before vascular surgery, even in patients with large myocardial ischemia … so why screening for CAD in PAD patients? … so why screening for CAD in PAD patients?

44 Even in patients with severe PAD, requiring vascular surgery, systematic screening is probably unnecessary, considering the lack of benefit of prophylactic coronary revascularization Even in patients with severe PAD, requiring vascular surgery, systematic screening is probably unnecessary, considering the lack of benefit of prophylactic coronary revascularization Patients with multiple clinical risk factors for increased cardiac risk probably deserve coronary angiography, particularly patients with CHF and insulin-dependent diabetes Patients with multiple clinical risk factors for increased cardiac risk probably deserve coronary angiography, particularly patients with CHF and insulin-dependent diabetes

45 Neither the presence of large myocardial ischemia at stress imaging nor the angiographic severity of coronary stenoses are efficient means to identify those patients with PAD who are at highest risk of acute coronary events Neither the presence of large myocardial ischemia at stress imaging nor the angiographic severity of coronary stenoses are efficient means to identify those patients with PAD who are at highest risk of acute coronary events There is still room for investigation! There is still room for investigation!

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48 To determine the impact of a strategy of systematic coronary angiography on immediate- and long-term outcome of patients at medium- high risk who were undergoing surgical treatment of peripheral arterial disease. AIM of TRIAL

49 208 PATIENTS were found to have a Revised Cardiac Risk Index (RCRI) ≥ 2 and were randomizated into 2 groups: The “selective strategy” group A consisted of 103 patients who eventually underwent coronary angiography at the time of peripheral angiography as a result of a positive stress test The “systematic strategy” group B consisted of 105 patients who underwent outright coronary angiography at the time of peripheral angiography, without a noninvasive test being performed.

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51 The primary end point was the MACE incidence at follow-up; The secondary end point was the occurrence of a MACE between the screening and 30 days after the surgical procedure. END POINT

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55 A strategy of routine coronary angiography positively impacted long- term outcome of peripheral arterial disease surgical patients at medium-high risk. This is the first such demonstration in a randomized, prospective trial.

56 McFalls EO. J Vasc Surg 2007;46: P<0.001 vs. other groups

57 McFalls EO. J Vasc Surg 2007;46:

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59 Primary end point: composite of all-cause death and nonfatal MI between screening and 30-days after the index surgical procedure composite of all-cause death and nonfatal MI between screening and 30-days after the index surgical procedure Secondary end point: composite of all-cause death and nonfatal MI at 1 year composite of all-cause death and nonfatal MI at 1 year Poldermans D. JACC 2007;49:1763–9

60 McFalls EO. EHJ 2008;29:394–401 P=0.03

61 McFalls EO. EHJ 2008;29:394–401

62 1.Angina pectoris 2.Prior MI 3.Heart failure 4.Stroke/TIA 5.Renal dysfunction (serum creatinine >2 mg/dL or a creatinine clearance of 2 mg/dL or a creatinine clearance of <60 mL/min) 6.Diabetes mellitus requiring insulin therapy Poldermans D. Eur Heart J 2009 Aug 27 [Epub]

63 Hachamovitch R. Circulation 2003; 107: % 85% 60% 40%

64 Primary end point: long-term mortality long-term mortality Secondary end points: myocardial infarction myocardial infarction stroke stroke limb loss limb loss dialysis dialysis McFalls EO. NEJM 2004;351:

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66 Garcia S. Am J Cardiol 2008;102: Survival in patients with left main disease

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