2. DR. JAMSHID MOHAJERI MOGHADAM Interventional Cardiologist PCI &CABG

3. Coronary Artery Disease Heart disease is the #1 killer in the USHeart disease is the #1 killer in the US We are diagnosing heart disease more frequently due to better testing, improved sensitivity and increased awarenessWe are diagnosing heart disease more frequently due to better testing, improved sensitivity and increased awareness As a nation, we have too much obesity and lack of physical activity, risk factors for the development of coronary artery diseaseAs a nation, we have too much obesity and lack of physical activity, risk factors for the development of coronary artery disease

7. How do we best treat heart disease? Medical therapy?Medical therapy? Coronary stents (PCI)?Coronary stents (PCI)? Bypass surgery (CABG)?Bypass surgery (CABG)?

8. The goal of treatment S/A 1.Symptom relive 2.Survival increase 3.Complication control 4.Quality of life

9. Medical therapy & Revascularization COUREGE COUREGE No significant different or primary event rate (death or non fatal MI ) No significant different or primary event rate (death or non fatal MI ) PCI PCI improve symptom improve symptom

10. PCI and Medical therapy RCT comparing PCI with medical therapy are few in number and < 5000 patients, enrolled patients with SVD and prior stenting and enhanced adjunctive pharmaco therapy. RCT comparing PCI with medical therapy are few in number and < 5000 patients, enrolled patients with SVD and prior stenting and enhanced adjunctive pharmaco therapy. * Results : * Results : Better control of angina Better control of angina Functional capacity Functional capacity Quality of life Quality of life

11.  RITA – 2 showel excess of death and MI  62% Patients multivessed disease  COURAGE TRIAL : 2287 patients 2287 patients PCI did not reduce the risk of death or MI over a medium 4.6 years follow up. PCI did not reduce the risk of death or MI over a medium 4.6 years follow up.  TIMe Trial : similar results in elderly patients. PCI and Medical therapy PCI VS CABG

12. Most patients with chronic stable angina and class I – II symptoms Medical treatment. Most patients with chronic stable angina and class I – II symptoms Medical treatment. PCI for patients with severe symptoms despite medical PCI for patients with severe symptoms despite medical therapy or patients with high risk criteria on Noninvasive therapy or patients with high risk criteria on Noninvasive tests. tests. PCI and Medical therapy Conclusion PCI VS CABG

13. Risk stratification 1)clinical evaluation patient 2)response to stent testing 3)LV function 4)Coronary Anatomy

14. Clinical Evaluation of PTS DM DM HTN HTN Renal impairment Renal impairment Hyper CHL Hyper CHL Severe Angaina Severe Angaina Smoking Smoking PVD PVD LV dysfunction LV dysfunction ECG abnormality ECG abnormality

15. Non invasive test Ex.testEx.test ECHOECHO Stress ECHOStress ECHO SCANSCAN

16. LV Function  EF <35%  Mortality >3% per year

17. Coronary Anatomy SeveritySeverity LocationLocation ExtensionExtension NumberNumber 12 y survival 12 y survival 91% Normal 91% Normal 74% SVD 74% SVD 59% 2VD 59% 2VD 50% 3VD 50% 3VD LM Revascularization the best treatmentLM Revascularization the best treatment

18. Coronary Artery Bypass Grafting (CABG)

19. PCI Procedural refinements: Stents Expandable metal mesh tubes that buttresses the dilated segment, limit restenosis. Drug eluting stents: further reduce cellular proliferation in response to the injury of dilatation.

20. Which procedure is best?

21. Percutaneous Coronary Interventions (PCI) 1977: 1 st Coronary angioplasty by Gruntzig Limitation: restenosis 1939-1985

22. Ideal cases of PCI  Significant symptoms despite intensive medical therapy  Low risk for complications  Technical success rate  No history of CHF  EF > 40% PCI VS CABG

23. Patients with increased risk for PCI Advanced age Advanced age Female gender Female gender Unstable angina Unstable angina CHF CHF LM equivalent disease LM equivalent disease Multivessel disease Multivessel disease DM DM Renal failure Renal failure PCI VS CABG

24. + Angina relief + Reduced re-intervention + Complete revascularization ­ High costs ­ Invasive + Cost effective + Fast recovery + Reduced acute complications - Increased restenosis - Repeat revascularization PCI CABG The pros and cons of CABG historically outweighed those of PCI CABG & PCI: Historical Pro & Cons

25. Evolution of Revascularization + Off pump technique + Less invasive approach + Increased arterial revascularization + Optimal perioperative monitoring + Improved technique + Improved stent design + DES PCI CABG ­ High costs ­ Invasive ­ Recovery time - Increased restenosis - Repeat revascularization ? Over the last decade, the standard of care for both CABG and PCI has continuously improved, leveling the playing field.

26. CABG  Garrett, Dennis, DeBakey : Bailoat CABG in 1964  Fovoloro : late 1960 s  Kolessov : use of IMA 1967  Green : 1970  % 26 in CABG since 1997  In 2004 : 20% off – PUMP CABG  Minimally Invasive  Hybrid procedure PCI VS CABG

27. Surgical outcomes CABG  Patient population of CABG Higher risk ( older, 3VD, History of Revascularization, LV dysfunction Diabetes, Peripheral vascular disease ) ( older, 3VD, History of Revascularization, LV dysfunction Diabetes, Peripheral vascular disease )  Out comes with CABG Remain stable or improved PCI VS CABG

28. Operative Mortality Mortaliy of 503, 478 CABG - only in the s td data base 1997 – 1999: 3.05 % base 1997 – 1999: 3.05 % 2005 : 2. 2 % CABG PCI VS CABG

29. CABG Complications Mojor morbidity ( death, stroke, Renal failure sternal Mojor morbidity ( death, stroke, Renal failure sternal infection : 13.4% in 30 days infection : 13.4% in 30 days MI : 3.9% MI : 3.9% Respiratory complications Respiratory complications Bleeding : 2-6 % reparation for bleeding Bleeding : 2-6 % reparation for bleeding Wound infection Wound infection Post operative HTN Post operative HTN Cerebrovascular complication Cerebrovascular complication Stroke 2.6% Stroke 2.6% PCI VS CABG

30. CABG Complications AF : One of the most frequent complications of CABG AF : One of the most frequent complications of CABG up to 40% up to 40% Risk of stroke Risk of stroke Use of beta blockers reoluces post operative AF Use of beta blockers reoluces post operative AF Brady arrhythmia : 0.8% need for permanent pacemaker Brady arrhythmia : 0.8% need for permanent pacemaker Renal dysfunction Renal dysfunction PCI VS CABG

31. Return to Employment 80% who were employed prior to CABG Return to work 80% who were employed prior to CABG Return to work Patient undergoing CABG return to work 6 W later than PCI Patient undergoing CABG return to work 6 W later than PCI But long term employment is similar. But long term employment is similar. PCI VS CABG

32. SVG Patency Early occlusion : 8 – 12 % 1 year occlusion : 15 – 30 % occlusion 1 – 6 y occlusion : 2% Annually 6 – 10 occlusion : 4% Annually At 10 y :50% SVG occlusion and 20 -40% significant stenosis in Remaining PCI VS CABG

33. Arterial graft patency IMA graft patency rate 95% 1 y 88% 5 y, IMA graft patency rate 95% 1 y 88% 5 y, 83% 10 y. 83% 10 y. PCI VS CABG

34. Indications for Revascularization CABG :  Significant left main disease : Regardless of the severity of symptoms or LV dysfunction  Patients with 3 VD that Includes LAD proximal lesion & LV dysfunction  Patients with 2 VD with LAD proximal lesion & LV dysfunction or high risk non invasive tests PCI VS CABG

35. CABG vs PCI Trials Results Summary TrialTrial Clinical ParametersClinical Parameters Angiographi c Endpoints Cost Assessment Mortality & MI Angina Relief Repeat Revasculariza tion GABI PCIPCICABG No difference n/a EAST CABGCABGCABGPCI RITA CABGCABGn/an/a ERACI CABGCABGn/aPCI CABRI CABGCABGn/an/a BARI n/aCABGn/an/a MASS-2 CABG (MI) n/aCABGn/a No differenc e AWESOME CABGn/an/a ERACI-2 PCIn/aCABGCABG SoS CABG (Mortality) CABGCABGn/an/a ARTS No difference n/aCABGn/aPCI Superior Treatment Modality No stents used Stents used CABG No difference PCI Significant decrease of revascularization expected with DES Repeat Revascularization

36. TAXUS I TAXUS II Mean stent length [mm] E-SIRIUS SIRIUS TAXUS IV C-SIRIUS Lesion Complexity [% C Type] RAVEL Complex Lesions Long Stented lengths TAXUS VI TAXUS V QCA long lesion breakdown pending Drug Eluting Stent Trials … expanding lesion & procedural complexity with randomized trials

37. Arterial Revascularization Therapies Part II: a non-randomized comparison of contemporary PCI and coronary artery bypass grafting (CABG) in patients with multi-vessel coronary artery lesions ARTS-II Trial

38. Sirolimus-eluting stent 3.7 stents per patient Avg total length: 73 mm n = 607 Sirolimus-eluting stent 3.7 stents per patient Avg total length: 73 mm n = 607 ARTS-II Trial Historical Controls from ARTS I: 1202 patients with multivessel coronary lesions 18.2% diabetic 28% 3 vessel disease 7.5% type C lesions Historical Controls from ARTS I: 1202 patients with multivessel coronary lesions 18.2% diabetic 28% 3 vessel disease 7.5% type C lesions 607 patients with multivessel coronary lesions 26.2% diabetic 54% 3 vessel disease 13.9% type C lesions 607 patients with multivessel coronary lesions 26.2% diabetic 54% 3 vessel disease 13.9% type C lesions CABG n = 602 CABG n = 602 Bare Metal Stent 2.8 stents per patient Avg total length: 48 mm n = 600 Bare Metal Stent 2.8 stents per patient Avg total length: 48 mm n = 600 Endpoints:   Primary – Major adverse cardiac and cerebrovascular events (MACCE), including death, cerebrovascular event, myocardial infarction, and revascularization, at 1 year for the comparison of CABG treated patients in the ARTS I trial with sirolimus-eluting stent patients in the ARTS II trial   Secondary – MACCE at 30 days, 6 months, 3 and 5 years. – Total cost at 30 days – Cost, cost effectiveness, quality of life at six mo, and 1, 3, and 5 years Endpoints:   Primary – Major adverse cardiac and cerebrovascular events (MACCE), including death, cerebrovascular event, myocardial infarction, and revascularization, at 1 year for the comparison of CABG treated patients in the ARTS I trial with sirolimus-eluting stent patients in the ARTS II trial   Secondary – MACCE at 30 days, 6 months, 3 and 5 years. – Total cost at 30 days – Cost, cost effectiveness, quality of life at six mo, and 1, 3, and 5 years

39. ARTS II: Event free survival p = <0.001 p = 0.003 p = 0.46

40. ARTS II: MACCE at one year Overall MACCE at 1 year At 1 year, there was no difference in the incidence of MACCE between the ARTS II SES group and the ARTS I CABG group. The ARTS I bare metal stent group was associated with a significantly higher rate of 1 year MACCE compared to the other groups

41. ARTS II: components of MACCE % ACC 2005 p=NS

42. ARTS II: Summary Among patients with multivessel coronary lesions, patients treated with sirolimus-eluting stents had significantly lower rates of MACCE compared with a historical registry of similar patients treated with bare metal stents and rates of MACCE statistically equivalent to patients from the same registry treated with CABG. Among patients with multivessel coronary lesions, patients treated with sirolimus-eluting stents had significantly lower rates of MACCE compared with a historical registry of similar patients treated with bare metal stents and rates of MACCE statistically equivalent to patients from the same registry treated with CABG. The majority of the difference in MACCE between the ARTS II and ARTS I BMS groups was driven by the increased need for repeat revascularization in the bare metal stent group. The ARTS II group had equal rates of revascularization to the ARTS I CABG group, despite having increased length and complexity of lesions. The majority of the difference in MACCE between the ARTS II and ARTS I BMS groups was driven by the increased need for repeat revascularization in the bare metal stent group. The ARTS II group had equal rates of revascularization to the ARTS I CABG group, despite having increased length and complexity of lesions. Among patients with multivessel coronary lesions, patients treated with sirolimus-eluting stents had significantly lower rates of MACCE compared with a historical registry of similar patients treated with bare metal stents and rates of MACCE statistically equivalent to patients from the same registry treated with CABG. Among patients with multivessel coronary lesions, patients treated with sirolimus-eluting stents had significantly lower rates of MACCE compared with a historical registry of similar patients treated with bare metal stents and rates of MACCE statistically equivalent to patients from the same registry treated with CABG. The majority of the difference in MACCE between the ARTS II and ARTS I BMS groups was driven by the increased need for repeat revascularization in the bare metal stent group. The ARTS II group had equal rates of revascularization to the ARTS I CABG group, despite having increased length and complexity of lesions. The majority of the difference in MACCE between the ARTS II and ARTS I BMS groups was driven by the increased need for repeat revascularization in the bare metal stent group. The ARTS II group had equal rates of revascularization to the ARTS I CABG group, despite having increased length and complexity of lesions.

43. Syntax Overall Study Goal To provide real-world answers to these questions in order to develop new guidelines for the beginning of the 21 st century. This goal requires a novel study approach:To provide real-world answers to these questions in order to develop new guidelines for the beginning of the 21 st century. This goal requires a novel study approach: allcomer study instead of highly selected patient population consensus physician decision (surgeon & cardiologist) instead of inclusion & exclusion criteria nested registry for CABG only and PCI only patients to capture patient characteristics and outcomes

44. Eligible Study Population left main + 1-vessel disease left main + 2-vessel disease 3-vessel disease left main + 3-vessel disease Question of optimal treatment approach? new disease Isolated left main Previous interventions (PCI or CABG) excluded Acute MI with CK>2x Concomitant valve surgery Revascularization in all 3 vascular territories

45. Patient Flow define CABG only population (2750 pts) define PCI only population (50 pts) Establish profiles of non randomizable patients and their outcomes amenable for ≤1 interventional treatment TAXUSCABG vs Patients with de novo 3-vessel-disease and / or left main disease screening Local Heart Team (surgeon and interventionalist) registration Randomize 1500 pts Registries amenable for both treatments options Multi-center randomized controlled trial TAXUS DES non inferior to CABG for 12 months binary MACCE rate

46. MACCE Post-allocation/procedure to 5 years Follow Up and Data Collection Multi-center randomized controlled trial Registries CABG only 750 pts Randomly selected out of approx.>2750 pts PCI only <50 pts Baseline data QOL & Costs Baseline to 5 years PCI 750 pts CABG 750 pts

47. SYNTAX Results- 1 Year End Point CABGStent p value Revascularization5.9%13.7%0.001 Death/MI/Stroke7.6%7.7%NS Stroke2.2%0.6%0.001 MI3.2%4.8%NS

48. The Bottom Line Choice between CABG and PCI is complex, and depends on patient factors as well as technical considerationsChoice between CABG and PCI is complex, and depends on patient factors as well as technical considerations CABG tends to have less revascularizationCABG tends to have less revascularization There is no “one size fits all” approachThere is no “one size fits all” approach Discussion regarding the pro’s and cons of each approach is importantDiscussion regarding the pro’s and cons of each approach is important

49. PCI or CABG ? – my view PCI will increasePCI will increase PCI will take CABG casesPCI will take CABG cases Because of Drug Eluting StentsBecause of Drug Eluting Stents Because of improving skill and equipmentBecause of improving skill and equipment CABG will decreaseCABG will decrease The CABG we ask for will be more complexThe CABG we ask for will be more complex But the surgeons will be less experiencedBut the surgeons will be less experienced We need to participate in the development of PCI, not be lead by NSF – BCIS lead activityWe need to participate in the development of PCI, not be lead by NSF – BCIS lead activity Centres need to develop strategy for increasing volumeCentres need to develop strategy for increasing volume Less operators doing moreLess operators doing more More operators doing lessMore operators doing less Both…. BCIS lead activityBoth…. BCIS lead activity We need to address AMI – BCIS lead activityWe need to address AMI – BCIS lead activity We must hope for an improved thrombolytic strategy that evolves quickly!We must hope for an improved thrombolytic strategy that evolves quickly! PCI will increasePCI will increase PCI will take CABG casesPCI will take CABG cases Because of Drug Eluting StentsBecause of Drug Eluting Stents Because of improving skill and equipmentBecause of improving skill and equipment CABG will decreaseCABG will decrease The CABG we ask for will be more complexThe CABG we ask for will be more complex But the surgeons will be less experiencedBut the surgeons will be less experienced We need to participate in the development of PCI, not be lead by NSF – BCIS lead activityWe need to participate in the development of PCI, not be lead by NSF – BCIS lead activity Centres need to develop strategy for increasing volumeCentres need to develop strategy for increasing volume Less operators doing moreLess operators doing more More operators doing lessMore operators doing less Both…. BCIS lead activityBoth…. BCIS lead activity We need to address AMI – BCIS lead activityWe need to address AMI – BCIS lead activity We must hope for an improved thrombolytic strategy that evolves quickly!We must hope for an improved thrombolytic strategy that evolves quickly!

50. 95.4%95.4%82.5%82.5% UK Cardiac Surgical Register British Cardiovascular Intervention Society UK Cardiac Surgical Register British Cardiovascular Intervention Society 80%80% Single v Multi-vessel disease CABG & PCI !! HEALTH WARNING !! Some of the numbers and all of the opinions that follow are mine!! !! HEALTH WARNING !! Some of the numbers and all of the opinions that follow are mine!! Martin T Rothman BCIS 2002

51. Single v Multi-vessel disease CABG & PCI 95.4%95.4% 82.5%82.5% UK Cardiac Surgical Register British Cardiovascular Intervention Society UK Cardiac Surgical Register British Cardiovascular Intervention Society

52. CABG PCI Diffuse MVD SVD Complex MVD LMS MVD + Complex LMS + MVD CTO

53. CABG PCI Diffuse MVD SVD Complex MVD LMS MVD + Complex LMS + MVD CTO

54. PCI or CABG ? – my view PCI will increasePCI will increase PCI will take CABG casesPCI will take CABG cases Because of Drug Eluting StentsBecause of Drug Eluting Stents Because of improving skill and equipmentBecause of improving skill and equipment CABG will decreaseCABG will decrease The CABG we ask for will be more complexThe CABG we ask for will be more complex But the surgeons will be less experiencedBut the surgeons will be less experienced We need to participate in the development of PCI, not be lead by NSF – BCIS lead activityWe need to participate in the development of PCI, not be lead by NSF – BCIS lead activity Centres need to develop strategy for increasing volumeCentres need to develop strategy for increasing volume Less operators doing moreLess operators doing more More operators doing lessMore operators doing less Both…. BCIS lead activityBoth…. BCIS lead activity We need to address AMI – BCIS lead activityWe need to address AMI – BCIS lead activity We must hope for an improved thrombolytic strategy that evolves quickly!We must hope for an improved thrombolytic strategy that evolves quickly!

55. Conclusions Freedom from angina and repeat revascularization strongly favored CABG over PCI.Freedom from angina and repeat revascularization strongly favored CABG over PCI. The overall survival advantage of CABG over PCI among patients with DM was not statistically significant, averaging 0.8% in absolute terms at 5-yrs.The overall survival advantage of CABG over PCI among patients with DM was not statistically significant, averaging 0.8% in absolute terms at 5-yrs. Only a few trials specifically reported outcomes by number of diseased vessels—these suggest that CABG reduces mortality compared with PCI to a greater extent in patients with 3-vsl disease than in patients with 2-vsl disease.Only a few trials specifically reported outcomes by number of diseased vessels—these suggest that CABG reduces mortality compared with PCI to a greater extent in patients with 3-vsl disease than in patients with 2-vsl disease.

56. Lesion Subtotal 1.Single –vessel disease 2.Bifurcation lesion 3.CTO

57. PCI or CABG ? – my view PCI will increasePCI will increase PCI will take CABG casesPCI will take CABG cases Because of Drug Eluting StentsBecause of Drug Eluting Stents Because of improving skill and equipmentBecause of improving skill and equipment CABG will decreaseCABG will decrease The CABG we ask for will be more complexThe CABG we ask for will be more complex But the surgeons will be less experiencedBut the surgeons will be less experienced We need to participate in the development of PCI, not be lead by NSF – BCIS lead activityWe need to participate in the development of PCI, not be lead by NSF – BCIS lead activity Centres need to develop strategy for increasing volumeCentres need to develop strategy for increasing volume Less operators doing moreLess operators doing more More operators doing lessMore operators doing less Both…. BCIS lead activityBoth…. BCIS lead activity We need to address AMI – BCIS lead activityWe need to address AMI – BCIS lead activity We must hope for an improved thrombolytic strategy that evolves quickly!We must hope for an improved thrombolytic strategy that evolves quickly!

58. PCI or CABG witch strategy ? PCI or CABG witch strategy ? SVD : PCI SVD : PCI 2VD 2VD Multivessel disease : PCI as initial strategy especially in patients with good LV function, suitable anatomy and patient preference. CABG : Severe LAD proximal lesion, DM LV dysfunction, LM lesion, Diffuse disease. Advanced age and comorbidity : PCI is better Younger patient < 50 y : PCI is initial strategy CASS Registry : Impaired survivial in young patients PCI VS CABG

59. Other Condition 1-Diabets2-CRF3-BMI 4-Cost benefit

60. BARI Diabetic patients with CABG had better Diabetic patients with CABG had better survival at two years. survival at two years. PCI VS CABG

61. TAKE HOME MESSAGES

62. ARE THEY ENEMIES OR FRIENDS?

63. MY SURGICAL MUST DOs Concomitant compelling indication to cardiothoracic surgery (eg severe MR)Concomitant compelling indication to cardiothoracic surgery (eg severe MR) Absolute contraindications to antiplatelet therapyAbsolute contraindications to antiplatelet therapy Previous failed PCI attempts (especially LAD)Previous failed PCI attempts (especially LAD) Multivessel CTO or CTOMultivessel CTO or CTO involving proximal-mid LAD Very high SYNTAX scoreVery high SYNTAX score

64. CAN WE CAN DO WHATEVER THE SURGEON DOES?