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FRONTIER Registry The Guidant MULTI-LINK FRONTIER ™ Coronary Stent System for the Treatment of Pts with Native De Novo or Restenotic Bifurcation Coronary Artery Lesions T. Lefèvre and W. Van der Giessen On Behalf the FRONTIER Investigators
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Objective To assess the safety, procedural success, performance and 6 month clinical outcome of bifurcation stenting To evaluate angiographic results and 6 month incidence of TSR With the use of the Guidant MULTI-LINK FRONTIER Coronary Stent System in patients with de novo or restenotic bifurcation lesions
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Study design Prospective, non randomized 100 patients Up to 2 lead in patients per site 13 sites - Europe, New Zealand Clinical Follow-up In-hospital, 30 days and 6 months Angiography Pre and Post-Procedure 6 months
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Specially designed dual lumen tip Main Branch (RX) Side Branch (OTW) Designed for preserving side branch access Integrated-tip design allows single tip delivery, avoiding wire wrap Stent deploys with simultaneous “kissing balloon inflation” Wire position is maintained in both branches throughout the procedure Guidant MUTI-LINK FRONTIER™ Coronary Bifurcation Stent System
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Guidant ML FRONTIER™ Coronary Bifurcation Stent System Sizes Stent length – 18mm (main branch) 7 Fr. GC Compatible Main Branch Balloon2.5mm3.0mm3.5mm4.0mm Side Branch Balloon2.0mm2.5mm
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Two balloons. Two wires. One very special stent. “Provisional T stenting” strategy Guidant MULTI-LINK FRONTIER™ Deployment Technique
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ML FRONTIER™ Deployment Sequence Guidant MULTI-LINK FRONTIER™ Deployment Technique Self rotation when out of phase
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Primary endpoints Incidence of MACE* at 6 months follow-up * Hierarchical occurrence of Death, Q-wave and non-Q-wave MI, Target Lesion Revascularization (main branch and/or side branch) including PTCA and CABG
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Secondary endpoints Incidence of MACE at 30 days follow up Angiographic binary restenosis rate at 6 months Access site complications TVF at one and six months follow up TVR at six months follow up Acute success of stent delivery, deployment, and post dilatation
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Key Inclusion Criteria Other lesions in different epicardial vessel successfully treated prior to bifurcation procedure Native or restenotic (no stent) vessel suitable to receive a 2.5 to 4.0 mm ML FRONTIER Stent Target main branch vessel is a major coronary artery with estimated stenosis > 50 and < 100% Angle of bifurcation < 75 Main branch lesion suitable for a total stent length of < 31mm by visual estimate Appropriate lesion morphology
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Key Exclusion Criteria Untreated lesion >50% proximal or distal to target lesion Target lesion contains thrombus Target lesion is aorto-ostial or left main stem location Target lesion or proximal vessel has excessive tortuosity unsuitable for stent delivery Heavy or severe calcification
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Enrolling Sites (n= 11) Patients enrolled Dr. van der GiessenRotterdamThe Netherlands16 Dr. OrmistonAucklandNew Zealand15 Prof. SchultheissBerlinGermany15 Dr. QuilletToursFrance12 Dr.ReimersMiranoItaly11 Dr. LefèvreMassyFrance10 Dr. GuagliumiBergamoItaly9 Dr. BrunelNantesFrance7 Dr. WijnsAalstBelgium6 Dr. BüttnerBad KrozingenGermany2 Dr. HartmannLübeckGermany2 Total105
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FRONTIER Trial Enrollment
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Baseline Demographics (Intent-to-treat patient population) n = 105 Age (years)62.4 (60.3 – 64.5) Number of men (%)77.1 Current smoker (%)27.9 Diabetes requiring treatment (%)17.1 Hypertension requiring treatment (%)46.2 Hypercholesterolemia requiring treatment (%)64.8 Prior MI (%)36.2 Stable angina: CCS III or IV (%)14.3 Unstable angina: Braunwald class 1-2 A-B (%)30.5 Prior CABG (%)1.0 LAD location (%)79.1
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Baseline QCA Analysis (Intent-to-treat patient population) Target vessel (n= 103 patients*) Main branch (%) Side branch (%) Moderate to heavy Calcification29.411.7 Thrombus1.90 Pre-procedural TIMI flow Grade 391.393.2 ACC / AHA lesion class A2.026.6 B120.860.9 B277.212.5 * Cardialysis, Rotterdam, The Netherlands
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Bifurcation Lesion Classification (Intent-to-treat patient population) Bifurcation angulation < 75 degrees70.9% 7.9%24.8% 13.9% 36.6% 5.9% 10.9% Prebranch Postbranch Parent Vessel Only Bifurcation Ostial Prebranch and ABC DEF Cardialysis, Rotterdam, The Netherlands
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Device success*92.2% Procedural success93.3% Use of GPIIb/IIIa inhibitors26.0% Additional stent implant - One only - More than one 37.1% 6.7% Reason why additional stent implanted - To cover target lesion - Inflow dissection - Outflow dissection 16.7% 66.7% 16.7% Stent used - Diameter (mm) - Length (mm) 3.03 ± 0.37 12.51 ± 5.57 Procedural data in Main Branch (Intent-to-treat patient population) * Stent did not cross (8/9), twisted wire (1/9)
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Device success*92.2% Procedural success93.3% Use of GPIIb/IIIa inhibitors26.0% Additional elective stent implant as allowed by protocol (n) 37.1% (39/105) More than one additional stent (n) ** -To cover target lesion (n) -Inflow dissection (n) - Outflow dissection (n) 6.7% (7/105) 1 4 1 Stent used - Diameter (mm) - Length (mm) 3.03 ± 0.37 12.51 ± 5.57 Procedural data in Main Branch (Intent-to-treat patient population) * Stent did not cross (8/9), twisted wire (1/9) ** 1 reason unknown Caution: Investigational device. Limited by Federal (US) law to investigational use only. Not available for sale
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Pre-procedure reference vessel diameter (mm)2.77 ± 0.51 Lesion length (mm)12.16 ± 5.83 Pre-dilatation performed (%) Maximum pre-dilatation balloon size: - Diameter (mm) - Length (mm) - Balloon pressure (atm) 100 2.68 ± 0.40 16.25 ± 3.77 10.36 ± 3.13 FRONTIER stent max. deployment pressure (atm)12.1 ± 2.3 Post stent implant dilatation performed (%) Maximum post-dilatation balloon size: - Diameter (mm) - Length (mm) - Balloon pressure (atm) 70.8 3.14 ± 0.45 13.43 ± 4.03 11.9 ± 3.80 Procedural data in Main Branch (Per protocol patient population) Cardialysis, Rotterdam, The Netherlands
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Lesion length (mm)4.03 ± 2.71 Pre-procedure reference side branch diameter (mm)2.10 ± 0.67 Side branch post treatment - None (%) - Balloon (%) - Stent (%) 19.8 37.5 42.7 Stent diameter (mm)2.64 ± 0.34 Stent length (mm)9.92 ± 2.81 Maximum balloon diameter (mm)2.53 ± 0.44 Maximum balloon length (mm)15.03 ± 4.59 Maximum balloon pressure (atm)10.15 ± 2.81 Kissing balloon technique performed (%)79.5 Procedural data in Side Branch (Per protocol patient population) Cardialysis, Rotterdam, The Netherlands
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Main Branch In-stent (n = 96) Pre-procedure ref. diameter (mm)2.77 ± 0.51 Pre-procedure DS (%)60.7 ± 12.2 Pre-procedure MLD (mm)1.07 ± 0.35 Post-procedure DS (%)15.1 ± 9.6 Post-procedure MLD (mm)2.43 ± 0.41 6-month DS (%)38.8 ± 19.1 6-month MLD (mm)1.59 ± 0.56 Binary restenosis (>50%)25.3 % Acute gain in-stent (mm)1.36 ± 0.46 Late loss in-stent (mm)0.84 ± 0.55 QCA Analysis (Per-protocol patient population) In-stent + 5 mm (n=96) - - - 24.5 ± 9.5 2.04 ± 0.40 40.3 ± 19.29 1.51 ± 0.54 27.6 % - - Cardialysis, Rotterdam, The Netherlands
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Side Branch In-segment Total (n = 96) Pre-procedure ref. diameter (mm)2.10 ± 0.67 Pre-procedure DS (%)39.1 ± 18.1 Pre-procedure MLD (mm)1.23 ± 0.45 Post-procedure DS (%)25.1 ± 12.7 Post-procedure MLD (mm)1.47 ± 0.40 6-month DS (%)39.4 ± 20.9 6-month MLD (mm)1.13 ± 0.47 Binary restenosis (>50%)29.1 % QCA Analysis (Per-protocol patient population) Stented (n = 39) Ballooned (n = 36) Non-treated (n = 21) 2.32 ± 0.792.01 ± 0.531.81 ± 0.54 46.7 ± 19.437.0 ± 13.927.4 ± 15.1 1.17 ± 0.461.27 ± 0.441.30 ± 0.43 23.8 ± 12.727.3 ±11.723.6 ± 14.6 1.59 ± 0.421.42 ± 0.371.30 ± 0.36 44.8 ± 26.233.9 ± 14.037.6 ± 15.2 1.02 ± 0.561.24 ± 0.351.19 ± 0.40 36.8 %18.8 %31.3 %
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MACE (intent-to-treat patient population) In-Hospital n=105 30 ± 5 days n=105 SAT (%) Q-wave MI (%) Non Q-wave MI (%) 01.0 1.0 TLR, CABG or PCI (%)1.0 TVR, CABG or PCI (%)1.0 Death (%) (Death, MI, TLR) 00 MACE (%)2.9 Target Vessel Failure (%) (Death, MI, TVR) 2.9 Hierarchical Ranking 180 ± 10 days n=105 01.9 13.4 19.1 0 17.1 22.9
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Sample calculation (MACE) Study Alpha Rate nLower Limit Upper Limit Finci et al0.0537.4% 91 27.4% 48.1% Yamashita et al0.0537.8% 37 22.5% 55.2% Finci et ali 0.0562.2% 45 46.5% 76.2% Yamashita et al0.0550.9% 53 36.8% 64.9% Lefèvre et al0.0529.1% 182 17.5% 36.3% Karvouni et al0.0548.4% 62 35.5% 61.4% Al Suwaidi et al 0.0526.8% 75 17.1% 38.1% Al Suwaidi et al0.0547.7% 51 32.9% 61.5% Wt. Avg 29.5%51.2 %
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Conclusion This new stent specifically designed for treating bifurcation lesions and preserving side branch access can be used with a high procedural success rate. Compared to previous studies with workhorse stents, the clinical outcome as well as acute angiographic and 6-months results are very encouraging.
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