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Pierfrancesco Agostoni, MD

Increased Late Mortality After Sirolimus-Eluting Stents Versus Bare Metal Stents in Diseased Saphenous Vein Grafts: Results from the Randomized DELAYED RRISC Trial. Pierfrancesco Agostoni, MD

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Pierfrancesco Agostoni, MD

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  1. Increased Late Mortality After Sirolimus-Eluting Stents Versus Bare Metal Stentsin Diseased Saphenous Vein Grafts: Results from the Randomized DELAYED RRISC Trial Pierfrancesco Agostoni, MD On behalf of the DELAYED-RRISC (Death and Events at Long-term follow up AnalYsis: Extended Duration of the Reduction of Restenosis In Saphenous vein grafts with Cypher stent) Investigators Antwerp Cardiovascular Institute Middelheim Antwerp, Belgium

  2. 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

  3. 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

  4. 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

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

  6. Vermeersch, Agostoni et al. JACC 2006

  7. 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

  8. BMS SES 40 p=0.031 p=0.024 30 AD=19.2% RRR=0.63 AD=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

  9. 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

  10. MACE after 6-monthup to 32 months (median f.u.)

  11. Kaplan-Meyer Curves

  12. Cumulative MACE

  13. Stent Thrombosis(ARC criteria)

  14. Causes of Death

  15. 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.

  16. Did David (BMS) defeat Goliath (SES) ??? Caravaggio, David with the head of Goliath, 1610

  17. However... Secondarypost-hoc analysis “Chance” could have played a majorrole Hieronymus Bosch, The magician, 1475-80

  18. Moreover... The sample size was small, thus prone to type I and II statistical errors Caspar David Friedrich, The wanderer above the sea of fog, 1818

  19. Thus... Additional larger studies are needed to finally determine if SES are really harmful in SVG Vittore Carpaccio, St.Agostino in his studio, 1502

  20. DELAYED-RRISC Investigators Steering Committee: Pierfrancesco Agostoni, MD Paul Vermeersch, MD Other Investigators: Stefan Verheye, MD, PhD Glenn Van Langenhove, MD, PhD Frank Van den Branden, MD Paul Van den Heuvel, MD Carl Convens, MD Data Monitoring: Christine Jacobs, RN Nancy Aerts, RN Anne-Rose Gustin (Incubate, Cardiac Solutions) CEC Committee: Giuseppe M. Sangiorgi, MD Giuseppe G.L. Biondi-Zoccai, MD Statistical Analysis: Pierfrancesco Agostoni, MD

  21. 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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