Two Years Clinical Outcomes of Diabetic Patients Treated with a New - PowerPoint PPT Presentation

Two Years Clinical Outcomes of Diabetic Patients Treated with a New Generation Drug-Eluting Stent Francesco Saia Policlinico S.Orsola Malpighi, Bologna, Italy William Wijns, Ran Kornowski, Patrick Joly, Fraser Witherow, Enrique Novo Garcia, Dezsö Apró, Ismail Ates, Ernst G. Vester, Petr Kala, Sinan Dagdelen, Marcus Wiemer, Gian Battista Danzi On behalf of NOBORI 2 investigators

Disclosure Statement of Financial Interest The authors have no potential conflict of interests to report

Introduction • Patients with diabetes mellitus have poorer clinical outcomes after PCI, with higher incidence of death, restenosis and stent thrombosis as compared to non- diabetic patients. • We investigated the safety and efficacy of Nobori, a new generation DES, in a large cohort of 888 patients with diabetes mellitus (213 patients were insulin dependent - IDDM) enrolled in 125 centres worldwide.

Study Design Patients suitable for treatment with DES 125 sites (Europe, Asia, North-Africa) N = 3067 Pre-specified subgroup Patients with Diabetes Patients w/o Diabetes N = 888 N = 2179 213 IDDM 675 NIDDM Clinical Follow-Up up to 5 years Primary Endpoint : Target Lesion Failure at 12 months Composite of Death, MI Target vessel related and TLR 12 Months FU = 97% 24 Months FU = 95%

NOBORI DES Components BMS Platform • Excellent flexibility • Innovative delivery system • With hydrophilic M-coating Drug Carrier • Biodegradable Polymer : Poly Lactic Acid • Abluminal coating • 9 to 12 months degradation Biolimus A9™ • Powerful anti-proliferative & anti-inflammatory properties

Study Organization Steering Committee: Principal INVESTGATOR • • E. Stabile • Dr. G.B. Danzi K. E. Hauptmann • P. Kala • J. Koolen Executive Operational Committee: • • R. Koning B. Chevalier • • F. Fath-Ordoubadi P. Urban • • D. Carrie W. Wijns • • M. Wiemer • CEC – all events adjudicated J. Goicolea • • C. Hanet A. Serra • • G. Stankovic • J. Vos Monitoring • • A. Vogt • 100% monitoring on-line, 30% on-site • B. Rensing • C. Royaards • Study management EMCD -Terumo Europe • Angiographic Corelab: • MCR – Milan • Data management • CorExperts - Belgrade • Electronic data collection KIKA • Medical Sponsor – Terumo Europe • •

Baseline Demographics P-value IDDM NIDDM Total DM Non-DM DM vs n=213 n=676 n=888 n=2179 non-DM Age, years 66.1±10.1 66.6±10.1 66.5±10.12 63.5±11.2 <0.001 (mean ± SD) Male % 67.1 72.3 80.3 <0.001 74.0 Previous MI % 33.0 32.8 32.9 33.3 NS Previous PCI % 36.2 33.1 33.9 31.4 NS Previous CABG % 13.6 8.1 9.4 8.6 NS Current smoking % 16.9 18.1 17.9 28.7 <0.001 Hyperlipidemia % 78.6 76.3 76.9 68.7 <0.001 Hypertension % 86.4 79.7 81.3 64.0 <0.001 CCI (mean ± SD) 2.61 ± 1.67 2.1 ± 1.3 2.2 ± 1.4 0.8 ± 0.9 <0.001

Clinical Presentation P-value IDDM NIDDM Total DM Non-DM DM vs n=213 n=676 n=888 n=2179 non-DM (%) 20.3 17.4 14.1 0.026 Silent ischemia 16.5 46.2 44.7 45.0 46.1 NS Stable angina 33.5 38.9 37.6 39.7 NS Unstable angina 10.3 11.4 11.2 10.6 NS NSTEMI 4.2 8.4 7.4 8.4 NS STEMI 50.7 52.4 52.0 54.1 NS ACS ACS = Acute Coronary Syndrome

Procedural Characteristics P-value IDDM NIDDM Total DM Non-DM DM vs n=213 n=676 n=888 n=2179 non-DM (mean ± SD) Diseased 1.81±0.79 1.83±0.78 1.83±0.78 1.69±0.76 <0.001 vessels/pt 2.15±1.18 2.19±1.16 2.18±1.17 1.96±1.11 <0.001 Lesions/pt Lesions 1.43±0.65 1.45±0.70 1.44±0.69 1.39±0.69 0.005 treated/pt 1.73±1.06 1.80±1.17 1.79±1.14 1.71±1.07 NS Stents/pt

Lesion location/classification P-value IDDM NIDDM Total DM Non-DM DM vs non (%) n=321 n=1028 n=1349 n=3114 -DM Lesion location Graft 1.3 2.8 2.5 1.7 NS LAD 42.1 37.6 38.6 41.9 0.040 RCA 30.2 30.4 30.3 29.5 NS LCX 25.9 27.5 27.1 25.5 NS LM 0.6 1.8 1.5 1.4 NS Lesion AHA/ACC classification Type A 2.3 4.1 3.7 3.7 NS Type B1 20.9 25.9 24.8 23.1 NS Type B2 44.2 42.8 43.1 41.4 NS Type C 32.6 27.2 28.4 31.8 0.040

Lesion characteristics Total Non- P-value IDDM NIDDM DM DM DM vs n=321 n=1028 non-DM (%) n=1349 n=3114 10.8 11.0 NS Ostial 11.2 10.6 Calcification* 34.5 29.0 30.2 24.3 <0.001 Occlusion 8.6 8.8 8.8 10.9 0.054 Eccentricity 85.7 79.7 81.0 81.8 NS Thrombus 6.6 8.9 8.4 10.2 NS *moderate/severe *moderate/severe

Quantitative QCA data P-value IDDM NIDDM Total DM Non-DM DM vs n=321 n=1028 n=1349 n=3114 non-DM (mean±SD) RVD -pre, mm 2.55±0.64 2.57±0.58 <0.001 2.57±0.59 2.63±0.57 MLD -pre, mm 0.82±0.49 0.83±0.47 NS 0.83±0.48 0.83±0.51 DS -pre, % 67.7±17.3 67.8±16.7 NS 67.8±16.8 68.3±17.8 Lesion length, 15.48±8.56 14.82±8.80 14.97±8.75 15.86±9.92 0.017 mm MLD -post, mm 2.44±0.49 2.48±0.47 0.004 2.47±0.47 2.52±0.47 DS -post, % 13.1±7.4 12.8±6.7 NS 12.88±6.86 13.15±7.09 Acute gain, mm 1.62±0.59 1.65±0.56 1.64±0.57 1.69±0.58 0.025 Lesions analysed by QCA

Angina status and DAT at 2 years p-value Total DM IDDM NIDDM Non-DM DM vs (%) n= 888 non- n=213 n=676 n = 2179 DM Angina status No angina 82.4 88.9 87.3 88.26 NS Stable angina 15.9 9.0 10.7 9.5 NS Unstable angina 0.6 1.2 1.1 0.8 NS Dual Anti-Platelet Therapy 12 months 77.0 77.7 77.6 71.7 0.001 24 months 37.1 39.7 39.1 31.1 <0.001

2 year clinical outcomes P-value Total DM IDDM NIDDM Non-DM DM vs n= 888 n=213 n=676 n = 2179 (%) non-DM 4.2 2.1 2.6 1.2 0.007 Cardiac death 5.2 2.7 3.3 2.0 0.05 MI 1.9 0.6 0.9 0.4 NS TLR CABG TLR Re-PCI 6.6 2.7 3.6 2.2 NS TVR, non TL 3.3 1.3 1.8 1.3 0.3 TLF 11.7 5.8 7.2 4.2 <0.001 14.6 7.9 9.5 5.6 <0.001 MACE TLF = Target Lesion Failure = Cardiac death, MI Target vessel related , clinically driven TLR MACE = Cardiac death, any MI, TVR

Composite Endpoints – at 2 years P<0.001 for TLF, MACE and POCE at 2 years TLF = Cardiac death, MI (TV related), TLR MACE = Cardiac death, any MI, TVR POCE = Patient Oriented Composite Endpoint = All deaths, all MIs, All revascularizations

Stent Thrombosis at 2 Years 0.94 1.04 1.02 0.73 Total (%) 0.94 1.04 1.02 0.73 0.94 1.04 1.02 0.73 0.94 1.04 1.02 0.73 0.94 1.04 1.02 0.73

KM survival curve DM vs No DM - MACE at 2 years p<0.001

KM survival curve IDDM vs NIDDM-MACE at 2 years p=0.007

KM survival curve DM vs NO DM – TLF at 2 years p<0.001

KM survival curve IDDM vs NIDDM – TLF at 2 years p=0.006

CONCLUSIONS • Patients with diabetes were older, and presented more often with hypertension and dyslipidemia, and lesions in smaller vessels • Our results indicate good clinical performance of the Nobori DES in this high risk patient population • As expected and observed in other studies, there was a higher rate of target lesion failure in diabetic patients, mainly driven by higher rates of target lesion revascularization. The main contributor of this outcome was the group of insulin- dependent diabetes patients, who presented with smaller RVD, and longer and more complex lesions. • Particularly appealing was the absence of any late and very late stent thrombosis in IDDM patients and very low frequency in total cohort