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

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

Aug 03, 2023 357 likes •580 views

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,

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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

Two Years Clinical Outcomes of Diabetic Patients Treated with a New Generation Drug-Eluting Stent

Francesco Saia

Policlinico S.Orsola Malpighi, Bologna, Italy

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Disclosure Statement of Financial Interest

The authors have no potential conflict of interests to report

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  • Patients with diabetes mellitus have poorer clinical
  • utcomes 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.

Introduction

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Study Design

Clinical Follow-Up up to 5 years

Patients w/o Diabetes N = 2179 Patients suitable for treatment with DES 125 sites (Europe, Asia, North-Africa) N = 3067

12 Months FU = 97% 24 Months FU = 95%

Pre-specified subgroup Primary Endpoint : Target Lesion Failure at 12 months Composite of Death, MI Target vessel related and TLR

Patients with Diabetes N = 888 213 IDDM 675 NIDDM

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SLIDE 5

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

NOBORI DES Components

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SLIDE 6
  • Principal INVESTGATOR
  • Dr. G.B. Danzi
  • Executive Operational Committee:
  • B. Chevalier
  • P. Urban
  • W. Wijns
  • M. Wiemer
  • J. Goicolea
  • A. Serra
  • Monitoring
  • 100% monitoring on-line, 30% on-site
  • Study management EMCD-Terumo Europe
  • Data management
  • Electronic data collection KIKA
  • Medical
  • Steering Committee:
  • E. Stabile
  • K. E. Hauptmann
  • P. Kala
  • J. Koolen
  • R. Koning
  • F. Fath-Ordoubadi
  • D. Carrie
  • CEC – all events adjudicated
  • C. Hanet
  • G. Stankovic
  • J. Vos
  • A. Vogt
  • B. Rensing
  • C. Royaards
  • Angiographic Corelab:
  • MCR – Milan
  • CorExperts - Belgrade
  • Sponsor – Terumo Europe

Study Organization

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Baseline Demographics

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

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Clinical Presentation

(%)

Silent ischemia Stable angina Unstable angina NSTEMI STEMI ACS IDDM n=213

20.3 46.2 33.5 10.3 4.2 50.7

NIDDM n=676

16.5 44.7 38.9 11.4 8.4 52.4

Total DM n=888

17.4 45.0 37.6 11.2 7.4 52.0

Non-DM n=2179

14.1 46.1 39.7 10.6 8.4 54.1

P-value DM vs non-DM

0.026 NS NS NS NS NS

ACS = Acute Coronary Syndrome

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Procedural Characteristics

(mean±SD)

Diseased vessels/pt Lesions/pt Lesions treated/pt Stents/pt

IDDM n=213

1.81±0.79 2.15±1.18 1.43±0.65 1.73±1.06

NIDDM n=676

1.83±0.78 2.19±1.16 1.45±0.70 1.80±1.17

Total DM n=888

1.83±0.78 2.18±1.17 1.44±0.69 1.79±1.14

Non-DM n=2179

1.69±0.76 1.96±1.11 1.39±0.69 1.71±1.07

P-value DM vs non-DM

<0.001 <0.001 0.005 NS

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SLIDE 10

Lesion location/classification

(%) Lesion location

Graft LAD RCA LCX LM

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

  • DM

NS 0.040 NS NS NS NS NS NS 0.040

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Lesion characteristics

(%)

Ostial

Calcification* Occlusion Eccentricity Thrombus

IDDM n=321

11.2 34.5 8.6 85.7 6.6

NIDDM n=1028

10.6 29.0 8.8 79.7 8.9

Total DM n=1349

10.8 30.2 8.8 81.0 8.4

Non- DM n=3114

11.0 24.3 10.9 81.8 10.2

P-value DM vs non-DM

NS <0.001 0.054 NS NS

*moderate/severe

*moderate/severe

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Quantitative QCA data

Lesions analysed by QCA

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

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Angina status and DAT at 2 years

(%) Angina status No angina Stable angina Unstable angina Dual Anti-Platelet Therapy 12 months 24 months

IDDM n=213

82.4 15.9 0.6 77.0 37.1

NIDDM n=676

88.9 9.0 1.2 77.7 39.7

Total DM n= 888

87.3 10.7 1.1 77.6 39.1

Non-DM n = 2179

88.26 9.5 0.8 71.7 31.1

p-value DM vs non- DM

NS NS NS 0.001 <0.001

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2 year clinical outcomes

(%)

Cardiac death MI TLR CABG TLR Re-PCI TVR, non TL TLF MACE IDDM n=213

4.2 5.2 1.9 6.6 3.3 11.7 14.6

NIDDM n=676

2.1 2.7 0.6 2.7 1.3 5.8 7.9

Total DM n= 888

2.6 3.3 0.9 3.6 1.8 7.2 9.5

Non-DM n = 2179

1.2 2.0 0.4 2.2 1.3 4.2 5.6

P-value DM vs non-DM

0.007 0.05 NS NS 0.3 <0.001 <0.001

TLF = Target Lesion Failure = Cardiac death, MI Target vessel related , clinically driven TLR MACE = Cardiac death, any MI, TVR

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SLIDE 15

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

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SLIDE 16

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

0.94 1.04 1.02 0.73 Total (%)

Stent Thrombosis at 2 Years

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SLIDE 17

KM survival curve DM vs No DM - MACE

at 2 years

p<0.001

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SLIDE 18

KM survival curve IDDM vs NIDDM-MACE at 2 years

p=0.007

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SLIDE 19

KM survival curve DM vs NO DM – TLF at 2 years

p<0.001

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SLIDE 20

KM survival curve IDDM vs NIDDM – TLF at 2 years

p=0.006

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SLIDE 21

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