1. Northeast Georgia Heart Center State of the Art Review: Bypass graft Interventions J. Jeffrey Marshall, MD, FSCAI Past President SCAI, 2012-2013 Director Cardiac Cath Lab Northeast GA Heart Center SCAI Fellow’s Course Qingdao, CHINA August 22, 2014

2. Northeast Georgia Heart Center Disclosures None

3. Post-CABG Myocardial Ischemia Bypass Wrong Vessel Native Vessel Progression SVG Atheroma Diffuse Disease Early Graft Failure ?

4. Severe Ischemia Very Early After CABG – Anterior ST Elevation  SVG occlusion  Distal anastaomosis lesion  Asymptomatic >25 years

5. Ischemia Driven Coronary Angiography Early After Coronary Bypass Surgery % 45 3 0 50 53 6 10 12 20 Reifart et al 1 Cutlip et al 2 Rasmussen 3 Approximately 3.5% of CABG PTCARe-CABG Medical Therapy 1) Circulation 1996;94:I-86 2) Circulation 1996;94:I-249 3) Circulation 1996;94:I-413 145 patients from 3 experienced centers 75 0 % 30 No Explanation 56 Graft Failure 75 0 Findings Treatment

6. Northeast Georgia Heart Center What is the Frequency of Graft Failure at One Year ? Study1 Year (% per patient) 5 Years10 Years PRAGUE-441% (on pump) 51% (off pump) NA PREVENT IV41.7%NA RIGOR31%NA Halabi, et. al.39.3%NA ROOBY28.7% (on pump) 36.5% (off pump) NA Goldman et. al.20%31%39%

7. Northeast Georgia Heart Center What is the Frequency of Graft Failure at One Year ? Study1 Year (% per SVG) 5 Years10 Years PREVENT IV26.6%NA Fitzibbon et. al.19%25%40% RIGOR19%NA Khot et. al.30.1%NA

8. Vanderbilt Intra-operative Angiography After CABG Study 97 (12%) had significant defects 22 (2.8%) minor adjustments 48 (6%) required PCI (1.8 stents per pt. ; 84% DES) 27 (3.4%) surgical revision 796 Grafts ; 2005-2007 Zhao et al JACC 2009;53:232

9. Northeast Georgia Heart Center How Should Early Post-CABG Ischemia Be Managed? Coronary Angiography and PCI (or Re-Op ) If Appropriate - Class I indication ACC/AHA PCI

10. Northeast Georgia Heart Center Post Procedure Initial Angiogram Results of PCI and stent in 75 y/o male with recurrent angina 2 months following CABG

11. Straight LateralRight Anterior Oblique 66 y/o male with severe angina 4 months after 2 nd CABG Aorto-Ostial Stenosis of SVG to OM, Surgical Y Radial Artery to LAD

12. “Fluting” Proximal Stent 5.0 mm Balloon Final Result

13. SVG Atheromas – PCI vs CABG ?

14. Northeast Georgia Heart Center In Hospital Results of 2,256 Patients After SVG PCI at Emory University Hospital Angiographic Success 95% In Lab Complication 12% CK > 750 7% 7% Q wave MI 1% 1% In-Hospital Death 1% 1% Ashfaq, Ghazzal, Douglas et al J Invasive Cardiol 2006;18:100-105

15. Kaplan Meier Survival Curves Comparing Survival up to 5 years after SVG PCI in 2,256 Patients at Emory University Diabetes No Diabetes Survival Time in Years 0.5 0.6 0.7 0.8 0.9 1.0 Proportion Surviving 12345 P=0.0001 Ashfaq et al. J Am Cardiol 2003; 41: 47A

16. % 8.3 Death PTCA Stent Major Cardiac Events in the SAVED Trial (PS Stent vs PTCA in SVG) Savage, Douglas, Fischman et al NEJM 1997;337:740 6 Months 3.7 4.5 P=NS 26 38 Any Event 6.5 P=NS 11 5.6 12 7.4 16 13 P=.13 P=NS P=.05 Q Wave MINon Q MICABGPTCA 0 50

17. Northeast Georgia Heart Center PCI in SVG Disease is often Complicated by Myocardial Infarction 1 Circulation 1996;94:I-683 2 Circulation 1998;98:I-353 3 Circulation 1999;100:2400-2405 Creatine Kinase > 3 times normal % 0 30 RAVES 1 Two Centers 2 1995-1997 22% 17% Procedural AMI is the strongest predictor of late death 3

18. Options For Improved Outcomes in SVG PCI Embolic Protection Stent Issues ( Direct stenting, DES vs BMS, sizing ) Thrombus Management Vasodilators

19. Northeast Georgia Heart Center Distal Embolic Protection With Balloon Occlusion and Aspiration (PercuSurg)

20. SAFER Trial – Comparison of PercuSurge to Routine Stenting in SVG’s 801 Patients Randomized 30 Day MACE Reduced 42% P<0.001 Baim et al. Circulation 2002;105:1285. RoutineProtected % 0 20 16.5% 9.6%

21. FilterWire

22. Fire Trial: Randomized Filter Wire vs. GuardWire in SVG PCI 650 patients in 65 sites Conclusion: FW not inferior to GW Stone et al. J Am Coll Cardiol 2003; 41: 43AFWGW TIMI 3 Flow 95.7%97.7% Device Success 95.5%97.2% Death0.9%0.9% MI9.0%10.0% QMI0.9%0.6% 30 day MACE 9.9%11.6%

23. Northeast Georgia Heart Center Example of SVG Unsuitable for Distal Protection Best Strategy for Embolic Protection in this Patient is Proxis

24. Northeast Georgia Heart Center PROXIMAL Trial JACC.2007;50:1442-9.

25. PROXIMAL Trial.

26. Proximal Trial: Proxis vs. Filter or GuardWire in SVG PCI 594 randomized patients Conclusion: Proxis not inferior to GW or FW Rogers et al. TCT 2005ProxDistalDeath0.7%1.0% Non QMI 7.9%6.4% QMI0.7%1.7% 30 day MACE 9.2%10.0%

27. Embolic Protection Paradox Beneficial across all subsets in 6 randomized studies ; plaque volume and SVG degeneration strongest predictors of MACE Used in <25% of 19,546 SVG PCI in the ACC-NCDR Registry Circulation 2008;117:790 and AJC 2007;100:11

28. Northeast Georgia Heart Center Direct Stenting of SVGs Improves Acute Outcomes Less non-Q MI ( 11% vs 18%, P<0.02 ) Reduced CK-MB Lower maximal CK-MB Leborgne et al AHJ 2003;146:501

29. Northeast Georgia Heart Center Should Stents in SVGs Be Intentionally Undersized ? Less plaque extrusion through stent struts by IVUS Less MI ( CK-MB > 3 X Normal ) Similar TVR and TLR at 1 year Hong et al AJC 2010 ;105:179

30. Northeast Georgia Heart Center Drug Eluting or Covered Stents in SVGs ? ?

31. Northeast Georgia Heart Center Covered Stents for SVG Interventions Lee MS, Park SJ, Kandzari DE, et. al. Saphenous vein graft intervervention. J Am Coll Cardiol Intv. 2011;4:831-843.

32. Author Followup% MortalityP Value (months)BMSDES _______________________________________________________________ Lee (2005) 9 3 0.7 0.03 Chu (2006) 12 7 6 NS Minutello (2007) 20 12 7 NS Vignali (2008) 12 8 4 NS Baldwin (2008) 12 7 5.4 NS TOTAL 7 4 0.025 Observational Studies Comparing DES with BMS in SVG N= 804 patients Blankenship CCI 2008;762:23-24

33. Northeast Georgia Heart Center Outcomes of 148 Propensity Score Matched SVG PCI Patients by Stent Type Applegate et al CCI 2008;72:7-12

34. 112 lesions – median follow-up 1.5 years BMSPESP Value _____________________________________________ Restenosis51% 9% 0.0001 TLR 28% 5% 0.003 TVR31% 15% 0.08 Cardiac Death 2% 2% NS Randomized Comparison of BMS vs Paclitaxel- Eluting Stents (PES) in SVG [SOS Trial] Brilakis, et al. JACC 2009;53:919-928 Angiographic follow-up at 12 months N=80

35. Northeast Georgia Heart Center Randomized Comparison of BMS vs Paclitaxel- Eluting Stents (PES) in SVG [SOS Trial] Brilakis, et al. JACC 2009;53:919-928 Angiographic follow-up at 12 months N=80 Cumulative frequency distribution curves before and immediately after the intervention Cumulative frequency distribution curves immediately after the intervention and at 12 months post intervention Binary restenosis 51% vs 9% p < 0.0001

36. Northeast Georgia Heart Center Randomized Comparison of BMS and Paclitaxel – Eluting Stents (PES) in SVG [SOS Trial] Brilakis et al JACC 2009; 53: 919-928

37. Outcomes of DES and BMS at One year in ISAR - CABG DES reduced death, MI, TVR endpoint (15 % vs 22 %, p=0.02) DES reduced TLR and TVR at 1 year by 48% and 44% (p=0.03) No difference in death, MI, ST 303 DES vs 307 BMS Randomized Pts Mehilli J, Pache S, Abdel-Wahab M, et.al. Drug-eluting versus bare-metal stents in saphenous vein graft lesions (ISAR-CABG): a randomised controlled superiority trial. Lancet 2011;378:1071-1078.

38. Northeast Georgia Heart Center Outcomes of DES and BMS at One year in ISAR - CABG 303 DES vs 307 BMS Randomized Pts Composite Endpoint (death, MI, ischemia driven TLR) TLR Mehilli J, Pache S, Abdel-Wahab M, et.al. Drug-eluting versus bare-metal stents in saphenous vein graft lesions (ISAR-CABG): a randomised controlled superiority trial. Lancet 2011;378:1071-1078.

39. Northeast Georgia Heart Center Outcomes of DES and BMS at One year in ISAR - CABG 303 DES vs 307 BMS Randomized Pts Death or MI Death Mehilli J, Pache S, Abdel-Wahab M, et.al. Drug-eluting versus bare-metal stents in saphenous vein graft lesions (ISAR-CABG): a randomised controlled superiority trial. Lancet 2011;378:1071-1078.

40. Northeast Georgia Heart Center Mehilli J, Pache S, Abdel-Wahab M, et.al. Drug-eluting versus bare-metal stents in saphenous vein graft lesions (ISAR-CABG): a randomised controlled superiority trial. Lancet 2011;378:1071-1078. Outcomes of DES and BMS at One year in ISAR - CABG 303 DES vs 307 BMS Randomized Pts

41. Other Observations at Follow-up Angiography in ISAR - CABG 438 (72%) had routine follow-up angiogram (median 6.7 months) DES reduced restenosis (15% versus 29%, p<0.0001) and graft occlusion (6% versus 12% ) 303 DES vs 307 BMS Randomized Pts Mehilli et al Lancet 2011;378:1071-78

42. Northeast Georgia Heart Center DES vs BMS for SVG Interventions Lee MS, Park SJ, Kandzari DE, et. al. Saphenous vein graft intervervention. J Am Coll Cardiol Intv. 2011;4:831-843.

43. Northeast Georgia Heart Center Native Vessel vs SVG PCI With Drug- Eluting Stents Bundhoo et al CCI 2011;78:169

44. Northeast Georgia Heart Center Native Vessel vs SVG PCI With Drug- Eluting Stents Bundhoo et al CCI 2011;78:169

45. Conclusions: Post-CABG Revascularization SVGs have poor long term patency rates and recurrent ischemia is a common clinical problem Early PCI is frequently very durable Results of late SVG PCI are suboptimal compared to native PCI Distal protection should be used in ALL cases of SVG PCI (ACC/AHA/SCAI class I indication) – reduces risk of no reflow, distal embolization and peri- procedural MI

46. Northeast Georgia Heart Center Conclusions: Post-CABG Revascularization Distal protection devices are underutilized Covered stents do not reduce MACE in SVG PCI Direct stenting and slightly undersizing may improve outcomes DES treatment reduces angiographic and clinical restenosis but does not alter death or MI Native vessel PCI is preferred whenever possible as as an alternative therapy