1. Ms. Leonardo Roever Coronary Stents

2. Coronary Artery Disease Leading cause of death in United States for men and women Caused by buildup of plaque in arteries Heart tissue is deprived of nutrients Risk factors: – Age – Gender – Genes

3. Symptoms and Tests for Coronary Artery Disease Symptoms: – Vary in strength – Chest pain – Fatigue – Shortness of breath – Weakness Tests: – ECG – Exercise Stress Test – Nuclear Stress Test – CT Scan – Coronary Angiograph

4. Coronary Angioplasty with Stents Common treatment for Coronary Artery Disease Process: – Blockage is defined through coronary angiography – Incision is made – Cardiac catheter is guided to the heart through an artery of the groin or arm – Guide wire is manipulated to lie across the blockage – Heparin is a given to thin the blood and prevent clotting – Stent balloon catheter is transported along the guide wire and is positioned over the blockage – Saline is pumped into the balloon to inflate it – Balloon is inflated for 30 to 60 seconds to expand the stent

5. Stents Expandable Mesh-like tube Invented to overcome short comings of regular coronary angioplasty Stays in artery permanently

6. Kinds of Stents Uncoated Stents – Bare metal Drug-coated Stents – Coated with Sirolimus – Controlled release of medicine into tissue – Drug limits overgrowth of natural tissue – Anti-rejection-type medicine (10% vs 26%)

7. Types Bare metal stents: – Traditional method – May have an increased rate of re-narrowing due to growth of scar tissue in the stent, a condition called Restenosis. Drug-eluting stents: -Combat Restenosis - Coated with medications that are slowly released to block the body's ability to form scar tissue around the stent. The medication is delivered directly to the site of the artery blockage.

8. History Percutaneous transluminal coronary angioplasty (PTCA) by Gruntzig in 1977 Puel and Sigwart, in 1986, deployed the first coronary stent to act as a scaffold In 2001, drug-eluting stents (DES) were introduced as a strategy to minimize restenosis

10. Treatment of Bifurcation Lesion with two stents Baseline Treatment

11. Final Result

12. DES in Bifurcation Lesions (Milan experience April 2002 – March 2005) Total number of patients: 368 Total number bifurcations: 389 True bifurcational lesions: 60 % Bifurcations treated with Cypher stent: 54% Bifurcations treated with Taxus stent: 46% Type D Type FType G

13. DES in Bifurcation Lesions ( 389 de-novo bifurcations) Lesion location 51% 25% 18% 6%

14. DES in Bifurcation Lesions Stent technique 197 (50.4%) Stent on both branches 193 (49.6%) One stent on the MB 390 bifurcations

15. DES in Bifurcation Lesions Stent technique (one stent vs two stents) Left main (n=98) Other locations (n=292) 32% 68% 58% 42% = One stent only = Stent on both branches

16. DES in Bifurcation Lesions Stent technique (one stent vs two stents) True bifurcations (n=232) Other bifurcations (n=158) 59% 41% 63% 37% = One stent only = Stent on both branches

17. DES in Bifurcation Lesion in 292 lesions Two-stent techniques NO LMT lesions 83% 3% 7%

18. DES in Bifurcation Lesion in 292 lesions 54% 10% 27% 9% Two-stent techniques Left main lesions

19. DES in Bifurcation Lesion Milan Experience Baseline Clinical Characteristics (II) Group 1S (n = 155 patients) Group 2S Group 2S (n = 119 patients) P Value Diabetes mellitus, % 37 (24%) 24 (21%) 0.5 SYNTAX score 26.80±18.137.69±23.40.001 LVEF, % 54±953±90.2 Prior CABG, % 10 (7%) 10 (9%) 0.5 Prior MI, % 68 (54%) 41 (43%) 0.8 Unstable angina, % 49 (43%) 40 (35%) 0.7 GP 2b/3a inhibitors, % 17 (11%) 27 (23%) 0.009

20. DES in Bifurcation Lesion Milan Experience Clinical Follow-Up at 12 months (n=367) All patients Group 1S (n = 185 patients) Group 2S Group 2S (n = 183 patients) P Value Death 3 (1.7%) 5 (2.7%) 0.5 MI (after hospital discharge) 1 (0.6%) 4 (2.2%) 0.2 TLR 18 (5.0%) 40 (11.0%) 0.002 TVR 25 (6.9%) 52 (14.4%) 0.001 Cumulative MACE 28 (7.6%) 55 (15.0%) 0.001

21. DES in Bifurcation Lesion Milan Experience Clinical Follow-Up at 12 months NO left main (n=274) SES (n = 156 patients) PES PES (n = 118 patients) P Value Death 2 (1.3%) 1 (0.9%) 0.7 MI (after hospital discharge) 4 (2.6%) 00.08 TLR 25 (16%) 14 (12%) 0.3 TVR 33 (21%) 18 (16%) 0.2 Cumulative MACE 35 (22%) 19 (16%) 0.2

22. DES in Bifurcation Lesion Milan Experience Angiographic follow-up (performed in 85% of lesions) Restenosis rate (%) 10.0% 17.0% 6.6% 8.6% P=0.07

23. Angiographic follow-up 4.0% 12.0% 5.6% 4.6% 23%28% 7.3% 11% P=0.03P=0.04 restenosis rate (%) One stent only Stents on both branches = final kissing = No kissing

24. DES in Bifurcation Lesion Milan Experience Stent thrombosis 0% 0.5% 1C 0.5% 2.5% 0.5% 1.5% 1 C 4T 1C 2T 1C (%)

25. DES in Bifurcation Lesion Milan Experience Stent thrombosis 0% 0.5% 1C 0.5% 2.5% 0.5% 1.5% 1 C 4T 1C 2T 1C (%)

26. Provisional Balloon – T stenting of Bifurcation Lesions 1 2 Baseline Taxus 2.75/32: LAD (wire protection of Septal) 3 Balloon: D1

27. Provisional Balloon – T stenting of Bifurcation Lesions 4 6 5 Taxus 2.5/24: D1 Taxus 2.5/24: D1 Balloon: LAD Balloon: LAD Intermediate result RESULT 3 STEPS: -stent at 15-18atm. KISS -stent balloon down to 8 atm. -main branch balloon up to 20 atm.

28. Provisional Balloon – T stenting of Bifurcation Lesions (8) Additional Taxus at proximal LAD (wire protection of RIM) Final result (7)

29. Provisional Bifurcation Crush Stenting Provisional Bifurcation Crush Stenting with IVUS control Baseline: LAD/ Diagonal

30. Provisional Bifurcation Crush Stenting Rotablation prox/mid LAD burr 1.5mm After Rotablation

31. Result after LAD stent Stenting prox LAD, Cypher 3.5/33 Provisional Bifurcation Crush Stenting

32. Result of SB DilatationDilatation SBWiring SB

33. Provisional Bifurcation Crush Stenting Cypher stenting at side branch ostium: 2.5/18mm MB: Quantum Maverick 3.5 mm 3 STEPS: -stent at 15-18atm. KISS -stent balloon down to 8 atm. -main branch balloon up to 20 atm.

34. Provisional Bifurcation Crush Stenting FINAL RESULT

35. Provisional Bifurcation Crush Stenting Provisional Bifurcation Crush Stenting IVUS controlled (Main Branch) Post bifurcation stenting After Rotabltor at MB, before SB balloon dilatation

36. Provisional Bifurcation Crush Stenting Provisional Bifurcation Crush Stenting Final IVUS: from MB to SB diagonal

37. Provisional Bifurcation Crush Stenting Provisional Bifurcation Crush Stenting Final IVUS: from SB to MB Into the diagonal LAD

38. Provisional Bifurcation Crush Stenting Provisional Bifurcation Crush Stenting Final IVUS: from MB and from SB dia LAD dia LAD

39. Ostial disease: Type B, Type 4

40. HSR 39456 Baselin e V Stent-Balloon Technique For bifurcational ostial lesions (IIIB and IV)

41. Step 1 V Stent-Balloon Technique For bifurcational ostial lesions (IIIB and IV) HSR 39456

42. Step 2 V Stent-Balloon Technique For bifurcational ostial lesions (IIIB and IV) HSR 39456

43. Final Result V Stent-Balloon Technique For bifurcational ostial lesions (IIIB and IV) HSR 39456

44. CACTUS: A prospective randomized study n = 250 patients 6- month Angio.F/U Angio.F/U R Pre-dilatation de novo TRUE bifurcation lesions of the native coronary arteries “ Crushing” CYPHER™ SELECT n = 125 “ Crushing” CYPHER™ SELECT n = 125 Provisional T CYPHER™ SELECT n = 125 Provisional T CYPHER™ SELECT n = 125 12, 18, 24- month Clinical F/U 1- month Clinic.F/U Clinic.F/U

45. Most bifurcations need the SB to stay open at the end of the procedure, residual stenosis appears less relevant Most bifurcations need the SB to stay open at the end of the procedure, residual stenosis appears less relevant If optimal result on the side branch is important, in a true bifurcation 2 stents may be needed at least 50% of the time If optimal result on the side branch is important, in a true bifurcation 2 stents may be needed at least 50% of the time Conclusions for bifurcations 1 stent strategy Angio F-U only if clinically needed

46. Future Advancements The ReZolve™ stent integrates a proprietary drug-eluting polymer and a novel design to create a stent with metal-like performance out of a polymer material. The stent restores blood flow and supports the artery through healing, then completely dissolves from the body, leaving the patient free of a permanent implant.

47. Future Advancements Unlike permanent metal alloys, the REVA polymer dissolves from the body after healing of the artery has occurred, leaving additional treatment options available in the future. Another unique feature of the polymer is that it is visible under x-ray, allowing the stent to be visualized during the implant procedure and at follow up. Other bioresorbable polymer stents are invisible and require permanently attached radiopaque markers to aid in their placement.