Cardiology Symposium

1. Cardiology Symposium James T. DeVries, MD Assistant Professor of Medicine Dartmouth Medical School Dartmouth-Hitchcock Medical Center

2. No disclosure or conflicts

3. Outline • What is new with revascularization? • Bypass surgery (CABG) versus coronary stents (PCI) • New technologies in the pipeline- ready for primetime? • Aortic valve replacement without opening the chest • Stroke therapy

4. Coronary Artery Disease • Heart disease is the #1 killer in the US • We 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 disease

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

9. P C I C A B G CABG & PCI: Historical Pro & Cons • Cost effective • Fast recovery • Reduced acute complications • Increased restenosis • Repeat revascularization • Angina relief • Reducedre-intervention • Completerevascularization • High costs • Invasive The pros and cons of CABG historically outweighed those of PCI

10. P C I C A B G Evolution of Revascularization ? • Improved technique • Improved stent design • DES • Off pump technique • Less invasive approach • Increased arterialrevascularization • Optimal perioperative monitoring • Increased restenosis • Repeat revascularization • High costs • Invasive • Recovery time Over the last decade, the standard of care for both CABG and PCI has continuously improved, leveling the playing field.

11. CABG vs PCI TrialsResults Summary No stents used Superior Treatment Modality PCI CABG No difference Stents used RepeatRevascularization Significant decrease of revascularization expected with DES

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

13. ARTS-II Trial 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

14. ARTS-II Trial 607 patients with multivessel coronary lesions 26.2% diabetic 54% 3 vessel disease 13.9% 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 Bare Metal Stent 2.8 stents per patient Avg total length: 48 mm n = 600 Sirolimus-eluting stent 3.7 stents per patient Avg total length: 73 mm n = 607 CABG n = 602 • 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

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

16. 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

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

18. 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. • 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.

19. allcomer study instead of highly selected patient population Syntax Overall Study Goal • To provide real-world answers to these questions in order to develop new guidelines for the beginning of the 21st century. This goal requires a novel study approach: 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

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

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

22. 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 PCI 750 pts CABG 750 pts Baseline data QOL & Costs Baseline to 5 years

23. SYNTAX Results- 1 Year

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

25. Communication is Important!

26. Future Tech-Coming to a cath lab near you!

27. Aortic Valve Replacement-Without Surgery!

28. Common cause of cardiovascular morbidity and mortality, particularly in the elderly Narrowing of aortic valve results in increased work load on the heart Symptoms include shortness of breath, chest pain, and passing out (syncope) Currently, only open heart surgery with valve replacement can correct this problem Aortic Stenosis

29. Aortic Valve Replacement

30. Percutaneous Aortic Valve

31. Percutaneous Aortic Valve

32. Technique for Insertion

33. Aortic Valvuloplasty

34. Stroke Therapy

35. Stroke Statistics • There are over 700,000 strokes per year in the US • Stroke is the leading cause of adult disability and the third most common cause of death • The vast majority of strokes result from blockage in the arteries of the brain • The risk factors for stroke are the same as the risk factors for coronary heart disease • Treatment of strokes is limited, consisting mostly of supportive care

36. Stroke Therapy • Intravenous thrombolytic (“clot buster”) is the only currently approved therapy for stroke • Must be given within 3 hours of onset of symptoms • Less effective in large strokes, risk of bleeding into the brain • Nationwide, it is used in less than 3% of strokes

37. Stroke Therapy • Increasing interest in catheter-based therapies for acute stroke • Mechanically “open” the artery with devices, pull out the clot • Stroke teams are integral part of this therapy, available 24/7 for rapid activation • Many similarities to treating heart attack

42. Case Example • 49 yo mother of three presents with ride sided paralysis, inability to speak, onset 1 hour prior • Given thrombolytic drugs and transferred • Remained with dense paralysis, inability to speak 2 hours later • Brought to angiography

46. Case • Immediately recovered partial use of right hand and foot • Talking the following day • Was discharged to home 3 days later with mild right sided weakness, but speech intact

47. Technology is not always easy…..

48. Summary • What we can do through catheters is increasing every day • Many trials ongoing to determine the best therapy for stroke and heart disease • Stay tuned!