Abluminus DES+
The Diabetic Stent

OBJECTIVE
The en-ABL e-registry is a post marketing multicenter registry with an objective to evaluate clinical safety and efficacy outcomes in patients treated with Abluminus® DES+ Drug Eluting stent.

DESIGN
Prospective, Multi-center, post-market multicenter registry for evaluation of ABLUMINUS® DES+ in real world scenario.

ENPOINTS
Primary End Points:
–Registry device oriented Major Adverse Cardiac Events (MACE) @ 1 year
–Cardiac death,
–Target Vessel Myocardial Infarction (TV-MI) or
–Target Lesion/Vessel Revascularization (TLR/TVR).
Secondary End Points:
–Stent Thrombosis (ST) defined as definite and probable stent thrombosis according to the ARC definition
–Registry device-related MACE will be assessed at 3 months , 9 months, 1 year, 2 years and 3 years.

RESULTS

en-ABL e-REGISTRY Represents safety and efficacy outcomes in patients treated with Abluminus® DES+ Drug Eluting stent

Patients Status

2

Baseline characteristics

Demographics
Age (years) 56.30 ± 10.92
Male gender 79.53 %
Medical history/risk factors
Diabetes 36.72 %
Hypertension 44.84 %
Renal insufficiency 2.2 %
Prior MI 14.22 %
Prior PCI 5.32 %
Prior CABG 1.87 %
 3

Baseline Lesion & Procedural characteristics

1

 

Lesion Characteristics

No. of lesions=2150, No. of Device= 2361
Number of lesions per patient,% 1.18
Number of device per patient,% 1.3
Long lesions (≥28 mm) 51.21
Small vessels (RVD ≤2.75 mm) 48.88
DEVICE DETAILS
Mean stent diameter (mm) 2.91 ± 0.42
Mean stent length (mm) 26.35 ± 8.74

Primary and secondary end-points results at 1, 3, 9, 12 and 24-months

Events, n (%) 1 month 3 months 9 months 12 months 24 months
Underwent Follow-up 1813 (99.52) 1771 (97.20) 1573 (86.33) 1434 (78.70) 1010 (55.43)
MACE 10 (0.55) 15 (0.85) 31 (1.97) 36 (2.51) 37 (3.66)
Cardiac death 4 (0.22) 4 (0.23) 4 (0.25) 4 (0.27) 4 (0.39)
TV-MI 5 (0.27) 5 (0.28) 6 (0.38) 6 (0.42) 6 (0.59)
TLR/TVR 1 (0.06) 6 (0.34) 21 (1.34) 26 (1.81) 27 (2.67)
ST (ARC Def/Prob) 9 (0.50) 9 (0.51) 10 (0.63) 10 (0.69) 10 (0.99)
Sub-Groups in en-ABL e-registry

Patient Complexity

  Diabetics Acute Coronary Syndrome Small vessels
(≤ 2.75 mm)
Long Lesion
( ≥ 28mm)
Total patients enrolled 669 1109 937 977
Age (Years) 57.73 ± 9.61 56.14 ± 13.09 57.15± 12.92 57.31± 12.77
Male gender 77.58 80.07 77.80 80.25
History of hypertension 60.09 41.30 47.07 45.45
Prior MI 14.65 8.48 13.66 15.35
Prior PCI 6.73 3.88 6.40 5.38
Prior CABG 2.24 1.62 1.92 1.54
ACS clinical presentation 57.85 57.63 60.9
Number of Lesion per patient 1.2 1.16 1.27 1.22
Number of device per patient 1.3 1.27 1.45 1.39

Comparison of results at 12-months

  Diabetics Acute Coronary Syndrome Small vessels
(≤ 2.75 mm)
Long Lesion
( ≥ 28mm)
Underwent Follow-up 523 812 738 766
MACE 3.06 2.71 3.79 3.26
Cardiac Death 0.19 1.60 2.98 2.61
TV-MI 0.57 0.74 0.41 0.39
TLR/TVR 2.29 0.37 0.41 0.26
ST 0.76 1.11 0.81 0.65
Key Messages
  • At 1-year freedom from Major adverse Cardiac Event was achieved in 97.49% of patients.
  • Safety and efficacy have been proven in large number of complex CAD patients like Diabetics, ACS, Small vessel disease and long lesion.
  • Abluminus® DES+ application is a valuable treatment option for complex CAD patients.
Case Study

MID RCA

Patient History

59 year old Female
CAD
Diabetes Mellitus
ACS-STEMI <6-24 Hrs
Sever thrombotic Calcified lesion in Mid RCA
Type C lesion with 100% stenosis & TIMI grade 0

Treatment Summary

Successfully placed 3.5 x 40 mm Abluminus® DES+ stent at 16 ATM
Check angiography showed well deployed Mid RCA DES and TIMI grade 3 flow in the vessel

9 months angiographic follow-up Summary

Check angiography showed patency of the Mid RCA with TIMI grade 3 flow in the vessel

MID LCX

Patient History

54 year old Male
CAD
Diabetes Mellitus
Sever Thrombotic lesion with 100% stenosis in Mid LCX
Type C lesion with TIMI grade 0

Treatment Summary

Pre dilatation was performed with 2 ×15 mm balloon at 6-8 ATM
Successfully placed 2.5 x 32 mm Abluminus® DES+ stent at 16 ATM with post-dilation of 3 x 12 mm balloon at 16 ATM
Check angiography showed well deployed Mid LCX DES with TIMI grade 3 flow in the vessel

12 months angiographic follow-up Summary

Check angiography showed patency of the Mid LCX with TIMI grade 3 flow in the vessel

PROXIMAL LCX

Patient History

56 year old Female 
CAD
Diabetes Mellitus
Hypertension
Eccentric Sever Calcified lesion in Proximal LCX
Type B2 lesion with 99% stenosis & TIMI grade 2

Treatment Summary

Pre balloon dilatation was performed with 1.5×10 mm balloon at 10 ATM
Successfully placed 2.5 x 16 mm Abluminus® DES+ stent with post-dilation of 2.5  x 8 mm balloon at 16 ATM
Check angiography showed well deployed LCX DES and TIMI grade 3 flow in the vessel

9 months angiographic follow-up Summary

Check angiography showed patency of the Proximal LCX with TIMI grade 3 flow in the vessel

PROXIMAL RCA

Patient History

53 year old Male 
CAD
Previous MI
Diabetes Mellitus
Hypertension
Thrombotic lesion with 100% stenosis in Proximal RCA
Type B1 lesion with TIMI grade 0

Treatment Summary

Pre balloon dilatation was performed with 2.25×15 mm & 2.5×20 balloon at 14 ATM
Successfully placed 2.75 x 40 mm Abluminus® DES+ stent with post-dilation of 2.75x 40 mm balloon at 12 ATM
Check angiography showed well deployed Proximal RCA DES with TIMI grade 3 flow in the vessel

9 months angiographic follow-up Summary

Check angiography showed patency of the Proximal RCA with TIMI grade 3 flow in the vessel

DISTAL RCA

Patient History

50 year old Male 
CAD
Sever calcified Thrombotic lesion with 93% stenosis in Distal RCA
Type C lesion with TIMI grade 2
Sever Tortuosity

Treatment Summary

Pre balloon dilatation was performed with 2 ×15 mm & 2.5×10 balloon at 6-8 ATM
Successfully placed 3.5 x 24 mm Abluminus® DES+ stent at 12 ATM
Check angiography showed well deployed RCA DES with TIMI grade 3 flow in the vessel

9 months angiographic follow-up Summary

Check angiography showed patency of the Distal RCA with TIMI grade 3 flow in the vessel

MID LAD

Patient History

58 year old Male 
CAD
Diabetes Mellitus
Smoker
ACS- STEMI
Eccentric lesion with 79% stenosis in Mid LAD
Type C lesion with TIMI grade 2

Treatment Summary

Pre balloon dilatation was performed with 2.5×40 balloon at 10 ATM
Successfully placed 2.5 x 40 mm Abluminus® DES+ stent at 12 ATM
Check angiography showed well deployed Mid LAD DES with TIMI grade 3 flow in the vessel

9 months angiographic follow-up Summary

Check angiography showed patency of the Mid LAD with TIMI grade 3 flow in the vessel

  • Director and Head of Cardiology
    Life care Institute of Medical Sciences & Research & 
    Apollo Hospital International, Ahmedabad, Gujarat, India

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    Principal Investigator (en-ABL)

    Dr. Sameer Dani, MD, DM

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