Welcome to the 8 th European Bifurcation Club 12-13 October 2012 - Barcelona Safety and clinical efficacy of Sideguard stent for treatment of bifurcation lesions Interim results from European multicentre Sideguard Bifurcation Registry study
Dr. Sanjay Sastry Manchester Heart Centre Royal Bolton Hospital Royal Albert Edward Infirmary, Wigan
Trumpet Sideguard : Self Expanding Nitinol for Bifurcations Gimbal Anchor Trumpet Gimbal Anchor Flared end with 3 markers Easy crossing Ostial coverage Higher radial force Transition zone Axial flexibility Lower radial force. Spacer to improve anchoring. Distal markers
Sideguard Profile Sideguard Self-expanding Nitinol Stent Delivers like a PCI catheter Rx, low-profile (<3.2Fr), single wire, employs standard inflators Sheath prevents migration & allows accurate placement Split Sheath Technology
The Sideguard Coronary Sidebranch Registry A post market registry to observe the clinical outcomes of the Bare Metal Sideguard Coronary Sidebranch stent in de novo Bifurcation Lesions of Native Coronary Arteries
European Registry Summary Total Registry Patients Enrolled 419 Enrolment is on-going in Germany, Italy and the UK
European Registry Demographics Medical history of patients N= 419 Age profile 65 years (35 92) Male 77% Smokers/previous smokers 61% Diabetes 20% Family history of CV disease 49% Previous MI 33% Previous CABG 4% Previous PCI 32% Stroke/TIA 6% Hypertension 71% Hypercholesterolemia 63% Congestive Heart Failure 5%
85 Sites with 5+ enrolment
Lesion Morphology
Lesion Morphology
Procedural Details Item Average (n=419) Procedure time Contrast Volume Fluoroscopy time 78 minutes (Min: 20; Max:305) 252ml (Min:62ml; Max:1250ml) 20min47sec (Min:1.50; Max:140.40) Kissing Balloon 51%
Procedural Details Baseline Vessel & lesion characteristics (n=419) Mainbranch Sidebranch Mean Vessel Diameter Mean Vessel Diameter 3.25mm +/- 0.44 2.73mm +/- 0.32 Mean Lesion Length Mean Lesion Length 20.55mm +/- 10.83 9.23mm +/- 6.25 Mean Stent Length Mean Stent Length 22.54mm +/- 7.27 9.45mm +/- 2.56 2nd Stent (%, L+/-σ) 3rd Stent (%, L+/-σ) Second Stent used 30%, 17.73mm +/- 7.9 4.5%, 17.47mm +/- 7.73 12.3% Calcification present 31.5% Tortuous anatomy 24.9%
Device / Procedural Success details Device failures 11 Stent not deployed at intended site 8 Did not cross proximal lesion 2 SB occlusion caused when deploying MV stent 1 Lesion failures 27 Sidebranch lesion failures (DS 50+%) 7 Main vessel lesion failures (DS 50+%) 1 Both vessel lesion failures (DS 50+%) 2 Procedural failures 4 Myocardial infarction 2 Repeat revascularisation (1MB & 1SB) 2
European Registry Primary Endpoint MACE at 30 days MI 10/399 2.5% SB TLR MV TLR 3/399 1/399 0.75% 0.25% Death 1/399 0.25% Total 15/399 3.75% MACE at 12 Months MI 6/205 2.9% SB TLR MV TLR Both 5/205 3/205 5/205 2.4% 1.5% 2.4% Death 2/205 1% Total 21/205 10.2% MACE at 6 Months MI 12/322 3.7% SB TLR MV TLR Both 6/322 2/322 2/322 1.9% 0.6% 0.6 Death 1/322 0.3% Total 23/322 7.1% Stent Thrombosis Sub-acute (<30d) 5 1.2% Late (>30d, <1year) 1 0.3% Very late (> 1year) 0 0% Total 6/406 1.5%
Provisional Technique Comparison Questioning the Keep it Simple approach Published studies promote the keep it simple approach to bifurcation stenting strategies. We compare their results to the Sideguard data CACTUS (2009) BBC ONE (2010) DK Crush II (2011) Simple (n=173) Crush (n=177) Simple (n=250) Complex (n=250) Provisional (n=185) DK Crush (n=185) MACE 15.0 (6m) 15.8 (6m) 8.0 (9m) 15.2 (9m) 17.3 (12m) 10.3 (12m) CE Trial (n=83) 10.8 (6m) Sideguard Registry (n=310) 7.1 (6m) No penalty for using a dedicated second stent. CE Trial (n=83) 12.0 (12m) Sideguard Registry (n=189) 10.2 (12m)
Conclusion The Sideguard device offers a straight-forward bifurcation solution that provides full coverage at the ostium of the sidebranch while maintaining wire access to the main vessel at all times. Excellent safety profile obtained from the European Registry with MACE rates at 6 months of 7.1% with a sidebranch failure rate of 2.5% and a bifurcation failure rate of 3.1% Data continues to substantiate the view that there is no procedural or long-term penalty for placing a stent in the sidebranch while offering confidence by preserving and protecting the sidebranch due to plaque and carina shift.
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Sideguard Case example Positive re-modelling: IVUS sub study Post-Intervention Stent area=4.4 mm 2 Lumen area=4.4 mm 2 Follow-up Stent area=5.7 mm 2 Lumen area=5.7 mm 2 Main Vessel *IH area=0.0 mm 2 IVUS images Gary S. Mintz M.D. Cardiovascular Research Foundation, New York, NY,USA
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