New Generation Drug Eluting Stent Nobori: 2 Year Clinical Outcome of Patients with Chronic Total Occlusion Bernard Chevalier* Dragan Sagic, Carlo Trani, Damras Tresukosol, Peep Laanmets, Mario Lombardi, Enrique Novo Garcia, Stefan Hoffmann, Harald Schwacke, Werner Jung, David Hildick-Smith, Gian Battista Danzi On behalf of NOBORI 2 investigators *Institut Cardiovasculaire Paris Sud, Massy, France
Disclosure Statement of Financial Interest In the last five years I, Bernard Chevalier, received research grants or speaker fees or I am/was consultant for: Abbott Vascular, Asahi, Astra Zeneca, AVI, Boston Scientific, Biotronik, Cook, Cordis, Daichi-Sankyo, Eli-Lilly, Iroko, Medtronic, Terumo. I am currently minor shareholder & general mamager of CERC
Introduction • Successful recanalization of lesions totally occluded for more than 3 months (CTO) remains a challenging and controversial area of interventional cardiology. • We evaluated efficacy and long-term safety after treatment of CTO lesions with Nobori, a new generation drug eluting stent, coated only abluminally with a biodegradable polymer and Biolimus A9.
Nobori DES Components Nobori DES Stent Platform Excellent flexibility Innovative delivery system with hydrophilic M-coating Drug Carrier Biodegradable Poly Lactic Acid Abluminal coating 9 to 12 months degradation Biolimus A9™ Powerful anti-proliferative, anti-inflammatory properties
NOBORI – CTO Study 97 patients underwent treatment of a CTO lesion > 3 months old 59 patients underwent treatment of a TO lesion < 3 months old Primary endpoint: Target Lesion Failure (TLF) at 12 months: TLF- composite of cardiac death, myocardial infarction (TV related) and target lesion revascularisation (TLR) CTO = Chronic Total Occlusion > 3 months old with TIMI 0 TO= Total occlusion < 3 months old
NOBORI – CTO Study Multicentre, prospective, observational Design study # of patients per 97 in CTO / 59 in TO group # of lesions per 105 in CTO / 59 in TO group Follow-up 1m, 6m, 1y, 2y, 3y, 4y, 5y Inclusion/Exclusion All commers Criteria 2 years FUP = 95%
NOBORI – CTO Study Organization and Management PI: G.B. Danzi Steering Committee: Executive Operational Committee: • E. Stabile • B. Chevalier • K. E. Hauptmann • P. Urban • P. Kala • W. Wijns • J. Koolen • M. Wiemer • R. Koning • J. Goicolea • F. Fath-Ordoubadi • A. Serra • D. Carrie Monitoring: CEC: • • 100% monitoring on-line C. Hanet • • G. Stankovic 30% of patients on-site • J. Vos • EMCD and independent monitors • M.A. Vogt Study management: EMCD-Terumo • B. Rensing Data management: • C.J. Royaards • Electronic data collection KIKA Medical Angiographic Corelab: Sponsor: • MCR – Milan • • CorExperts - Belgrade Terumo Europe
NOBORI – CTO Study Baseline Demographics CTO TO >3 months <3 months N = 97 N=59 Age, years (Mean ± SD) 62 ± 11 61±14 Male (%) 85.6 (83 pts) 84.8 (50 pts) Previous MI (%) 37.1 (36 pts) 44.1 (26 pts) Prior PCI (%) 23.7 (23 pts) 23.7 (14 pts) Prior CABG (%) 10.3 (10 pts) 1.7 (1 pts) Diabetes Mellitus (%) 29.9 (29 pts) 15.3 (9 pts) Hyperlipidemia (%) 76.3 (74 pts) 61 (36 pts) Hypertension (%) 70.1 (68 pts) 66.1 (39 pts) Current smoker (%) 23.7 (23 pts) 28.8 (17 pts)
NOBORI – CTO Study Angina status pre-procedure CTO TO >3 months <3 months N = 97 N = 59 % % Unstable angina 16.5 47.5 Silent ischemia 19.6 15.3 Stable angina 63.9 37.3
NOBORI – CTO Study Lesion Location 0 1 19 23 9 1 1 15 8 4 0 1 0 16 2 0 0 0 0 0 0 3 TO 0 1 1 0 CTO 1 7 12 5 0 0 8 1 0 9 10 0 0 0 0 0 0 1 0 3 0 0 1 0 + 1 lesion in graft
NOBORI – CTO Study Study Procedure CTO TO >3 months <3 months N = 97 N=59 (n ± SD) (n ± SD) 1.88 ± 0.79 1.72 ± 0.77 No. of diseased vessels 2.19 ± 1.17 2.02 ± 1.13 No. of lesions detected pp* 1.53 ± 0.71 1.40 ± 0.69 No. of lesions treated pp* 2.62 ± 1.54 2.29 ± 1.38 No. of stents pp* All lesions in patient with at least 1 CTO lesion *per patient
NOBORI – CTO Study Study Procedure CTO TO >3 months <3 months N = 105 N=59 % STENTS PER LESION 44.8 % 1 52.5% 31.4% 2 30.5% 17.1% ≥3 13.6% 6.7% ONLY Balloon PTCA 3.4% 43.8% Post-dilatation 40.7%
NOBORI – CTO Study Procedural complications CTO TO >3 months <3 months N = 105 N = 59 Occlusion of small side branch, 1.1 % 3.0 % asymptomatic Dissections 9.5% 8.5 % None of the reported complications led to SAE during procedure
NOBORI – CTO Study Pre- and Post-Procedure TIMI flow TIMI pre-procedure TIMI post-procedure CTO TO CTO TO % % % % TIMI 0 91.6 81.8 1.9 0.0 TIMI 1 8.4 18.2 0.9 0.0 TIMI 2 0.0 0.0 3.8 1.7 TIMI 3 0.0 0.0 93.3 98.3
NOBORI – CTO Study Baseline QCA Data CTO TO (mean ± SD) <3 months >3 months N=48 N=86 2.16 ± 0.73 1.96 ± 0.47 RVD- pre, mm 2.85 ± 0.50 2.84 ± 0.46 RVD - post, mm 0.06 ± 0.22 0.10 ± 0.24 MLD pre, mm 2.01 ± 0.54 2.13 ± 0.47 MLD post, mm 97.4 ± 9.1 94.1 ± 13.9 DS – pre (%) 15.2 ± 6.2 15.2 ± 6.4 DS – post (%) 2.36 ± 0.44 2.30 ± 0.47 Acute gain in-stent, mm 1.95 ± 0.56 2.04 ± 0.59 Acute gain in-segment, mm
NOBORI – CTO Study Lesion Characteristics CTO TO <3 months >3 months N=48 N=86 % 8.1 12.5 Ostial 18.6 16.7 Bifurcation 38.4 35.4 Calcification* 58.1 54.2 Eccentricity* * Moderate / severe
OUTCOMES up to 2 YEARS
NOBORI – CTO Study Clinical outcomes up to 2 years CTO TO <3 months >3 months N= 97 N=59 % (No) % (No) Cardiac Death 3.1 (3 pts) 1.7 (1 pt) MI 1.0 (1 pt) 1.7 (1 pt) TLR - CABG 1.0 (1 pt) 0 (0 pt) TLR - PCI 2.1 (2 pts) 0 (0 pt) TVR-PCI, non TL 0.0 (0 pt) 3.4 (2 pt) TLF 5.2 (5 pts) 3.4 (2 pts) MACE 6.2 (6 pts) 5.1 (3 pts) NO Stent Thrombosis (early, late or very late ) TLF = Target Lesion Failure (Cardiac death, MI, clinically driven TLR); MACE = Cardiac death, any MI and TVR
NOBORI – CTO Study Clinical outcomes up to 2 years Total Cardiac MI TLR- TLR-PCI TVR-nTL MACE TLF ST CABG Death 3,1 1,7 1,0 1,7 1,0 0,0 2,1 0,0 0,0 3,4 6,2 5,1 5,2 3,4 0,0 0,0 0,0 0,0 CTO TO 2 years 1 year 0.0 0.0 0.0 0.0 0.0 Cardiac TLR- CABG MACE TLF ST MI TLR-PCI TVR-nTL Death TLF = Target Lesion Failure (Cardiac death, MI, clinically driven TLR); MACE = Cardiac death, any MI and TVR
NOBORI – CTO Study Conclusions Nobori stent proves to be safe and efficient when used to treat chronic total occlusions The absence of stent thrombosis up to 2 years despite multiple stent overlapping is particularly appealing and diserves further clincial investigation in the larger cohort of patients
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