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DRUG ELUTING STENTS IN DISEASED SAPHENOUS VEIN GRAFTS: Reappraisal of the evidence

DRUG ELUTING STENTS IN DISEASED SAPHENOUS VEIN GRAFTS: Reappraisal of the evidence. Frank Van den Branden, MD Antwerp Cardiovascular Institute Middelheim Antwerp, Belgium. Incidence of SVG Disease. Autologous saphenous vein graft remains the most frequently used conduit during CABG.

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DRUG ELUTING STENTS IN DISEASED SAPHENOUS VEIN GRAFTS: Reappraisal of the evidence

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  1. DRUG ELUTING STENTS IN DISEASED SAPHENOUS VEIN GRAFTS:Reappraisal of the evidence Frank Van den Branden, MD Antwerp Cardiovascular Institute Middelheim Antwerp, Belgium

  2. Incidence of SVG Disease • Autologous saphenous vein graft remains the most frequently used conduit during CABG. • The long term patency of vein grafts is limited. • Neointimal hyperplasia leading to accelerated atherosclerosis and thrombosis is the proposed mechanism of vein graft failure. Campeau L. et al. Circulation 1979

  3. Saphenous Vein Graft Disease • Morphology : • Diffuse, large, soft & friable atheroma • Poorly developed or absent fibrous cap • Little or no calcification • Thrombus in 70% of old SVG • Percutaneous coronaryintervention is consideredthe preferred modalitybecause of high morbidityand mortality ofredo-CABG

  4. SVG intervention Percutaneous coronary intervention as a treatment of diseased vein grafts (6-15% of PCI volume) is associated with: a poor immediate outcome: • distal embolization a poor long term outcome: • Restenosis (35-60 %)1,2 • Progression of disease of the non-treated segments (native and vein graft)3 Protection devices DES !? 1 Savage et al, NEJM 1997 2 Choussat et al, J Am Coll Cardiol 2000 3 Ellis et al, Am J Cardiol 1997

  5. BMS vs. PTCA in SVG Vermeersch, Agostoni. JIntervC 2005

  6. Drug Eluting Stents • In all randomized trials SVG lesions were excluded. • Mechanisms of in-stent restenosis are different in SVGs compared to native arteries. • Problem of higher local prothrombotic conditions in the vein graft and the expected delay in endothelial healing after DES are claimed as possible drawbacks , as they can lead to a higher risk of acute, subacute and late thrombosis.

  7. Currently Available Data • Several single arm registries: • Relatively small numbers • Encouraging • No safety issues • 3 published studies with historical BMS-control: • No safety issues • Conflicting data

  8. 1.09 0.37 The Milan Experience Treatment of saphenous vein graft lesions with drug-eluting stents Ge, et al. JACC 2005

  9. The Los Angeles Experience • Since april 2003 : 223 consecutive patients • 139 DES, 84 BMS • Single center, non- randomized • Baseline characteristics and angiographical data were comparable Drug eluting stenting is superior to bare metal stenting in saphenous vein grafts.Lee, et al. CCI 2005

  10. The Washington Experience Efficacy of sirolimus-eluting stents compared with bare metal stents for saphenous vein graft intervention Chu, et al. AJC 2006

  11. RRISC TrialReduction of Restenosis In Saphenous vein grafts with Cypher stent • Prospective, randomized, double-blind, non industry sponsored, single center, trial comparing SES vs. BMS in SVG lesions • 75 patients with 96 lesions localized in 80 diseased SVG were included • Enrollment: September 2003-November 2004 • Primary endpoint : 6-month in-stent late loss • Secondary endpoints (all at 6 months follow up): • Binary angiographic restenosis (in-stent/in-segment) • Clinical events (death, MI, TLR, TVR) Vermeersch, Agostoni et al. JACC 2006

  12. RRISC TrialReduction of Restenosis In Saphenous vein grafts with Cypher stent • Major Inclusion Criteria • De novo lesion (stenosis >50%) in a diseased SVG • Diameter ranging between 2.5 and 4.0 mm • Diagnosis of angina pectoris Osial stenoses & thrombotic/calcific stenoses were allowed No maximum lesion length prespecified • Major Exclusion Criteria • Impaired renal function • Prior stent within 5 mm of target lesion • Totally occluded vein grafts • Documented LVEjection Fraction <25% • Distal anastomotic stenosis • Prior brachytherapy in the index vessel • Recent MI (<7 days) Vermeersch, Agostoni et al. JACC 2006

  13. 204 patients screened (September 2003-November 2004) Patients excluded (reason): 2 patients (age >85 years) 18 patients (acute MI) 7 patients (MI within the last 7 days) 3 patients (creatinine >3 mg/dL) 40 patients (vein graft with RVD >4.0 mm) 12 patients (distal anastomotic disease) 38 patients (restenotic lesions) 8 patients (enrolled in other trials) 1 patient (no informed consent) 75 patients (with 96 lesions) meeting the inclusion criteria randomization 37 patients (49 lesions) randomized to BMS 38 patients (47 lesions) randomized to SES 1 patient died 2 patients refused angio follow up 37 patients (49 lesions) available for 6-month angiographic follow up 35 patients (44 lesions) available for 6-month angiographic follow up No patient was lost to follow up. All patients, but 1 (dead) available for 6-month clinical follow up. Vermeersch, Agostoni et al. JACC 2006

  14. Baseline characteristics Vermeersch, Agostoni et al. JACC 2006

  15. Vermeersch, Agostoni et al. JACC 2006

  16. BMS SES p=0.01 p=0.001 1.00 0.80 0.60 p=0.6 p=0.9 0.40 0.20 0.17 0.17 0.79 0.38 0.24 0.19 0.41 0.70 Prox edge In-stent Dist edge In-segment Late Loss Analysis Vermeersch, Agostoni et al. JACC 2006

  17. BMS SES 40 p=0.031 p=0.024 30 Δ=19.2% RRR=0.63 Δ=19.1% RRR=0.58 20 10 30.6% 11.4% 32.7% 13.6% In-stent In-segment Binary Restenosis Vermeersch, Agostoni et al. JACC 2006

  18. BMS SES 20 34 SES lesions 39 BMS lesions 15 Median: 24 mm3 [8-34] Median: 1 mm3 [0-13] 10 Number of lesions P<0.001 5 0 0 30 60 90 120 0 30 60 90 120 Neointimal Volume (mm3) IVUS analysis Agostoni et al. AJC 2007

  19. 6-month MACE • - Due to safety issues recently raised with DES • (ESC/WCC 2006), we decided to further follow up • our patients, in order to analyze long-term events. • In September 2006, a new approval was obtained • from the local Ethics Committee to extend the follow-up. • A new informed consent was obtained from • all the patients. • All patients were contacted between September • and December 2006 (no lost to follow up). • Blinding was maintained for patients and • referring physicians/cardiologists. Vermeersch, Agostoni et al. JACC 2006

  20. MACE after 6-monthup to 32 months (median f.u.) Vermeersch, Agostoni et al. JACC 2007

  21. Kaplan-Meyer Curves Vermeersch, Agostoni et al. JACC 2007

  22. Cumulative MACE Vermeersch, Agostoni et al. JACC 2007

  23. Stent Thrombosis(ARC criteria) Vermeersch, Agostoni et al. JACC 2007

  24. Causes of Death Vermeersch, Agostoni et al. JACC 2007

  25. Conclusions • The use of BMS was associated with lower long-term mortality than the use of SES for SVG disease. • Also the 6-month reduction in repeated revascularization procedures shown with the use of SES was lost at longer-term follow-up. • However: • this is secondary post-hoc analysis, • the play of chance should be strongly considered, • “hidden” factors unrelated to stent type could have influenced the final results. • Further studies are required before conclusions can be made about the safety or harm of using SES for SVG lesions.

  26. For further slides on these topics please feel free to visit the metcardio.org website:http://www.metcardio.org/slides.html

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