Careers
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.
Safety and efficacy outcomes in patients treated with Abluminus® DES+ Drug Eluting stent
Baseline characteristics
| Demographics | |
|---|---|
| Age (years) | 57.3 ± 12.64 |
| Male gender | 78.92 % |
| Medical history/risk factors | |
| Diabetes | 34.36 % |
| Hypertension | 42.24 % |
| Renal insufficiency | 2.04 % |
| Prior MI | 11.84 % |
| Prior PCI | 5.92 % |
| Prior CABG | 2.04 % |
Baseline Lesion Morphology |
| No. of lesions=2969, No. of Device= 3287 | |
| Number of lesions per patient | 1.19 |
| Number of device per patient | 1.31 |
| Extent of coronary artery disease | |
| 1 Lesion | 83.24 % |
| 2 Lesions | 14.8 % |
| 3 Lesions | 1.9 % |
| Lesion Details | |
| Diameter stenosis, mm | 87.02 ± 9.99 |
| Long lesions (≥28 mm) | 55.24 % |
| Small vessels (RVD ≤2.75 mm) | 47.15 % |
| Device Details | |
| Mean stent diameter (mm) | 2.95 ± 0.44 |
| Mean stent length (mm) | 26.79 ± 8.77 |
Safety & Efficacy end-points at 1 year & 2 years
Safety & Efficacy in Complex Patients
|
Diabetes sub-group N=859 |
AMI sub-group N=999 |
Small vessel (≤ 2.75 mm) sub-group N=1253 |
Long Lesion (≥28mm) sub-group N=1479 |
Long Lesion (≥ 28mm) in small vessel (≤ 2.75 mm) sub-group N=764 |
|
|---|---|---|---|---|---|
| Underwent Follow-up∗,n(%) | 855 (99.5%) | 999 (100%) | 1248 (99.6%) | 1475 (99.7%) | 760 (99.5%) |
| MACE | 3.6 % | 2.2 % | 3.6 % | 3.3 % | 4.5 % |
| Cardiac Death | 1.4 % | 0.8 % | 1.2 % | 1.2 % | 1.4 % |
| TV-MI | 0.5 % | 0.7 % | 0.4 % | 0.3 % | 0.4 % |
| TLR/TVR | 1.8 % | 0.7 % | 2.0 % | 1.8 % | 2.6 % |
| ST | 0.8 % | 1.0 % | 0.7 % | 0.6 % | 0.8 % |
*Patients underwent 1 year follow-up till September 2017. Clinical Follow-up ongoing for remaining patients.
- At 1-year freedom from Major adverse Cardiac Event was achieved in 97.33% of patients.
- The very low rate of events in patients treated with Abluminus DES+, ensures sustained safety and efficacy of this newer generation stent and it is a valuable option for daily treatment of complex patients such as patients with Diabetes, AMI, Small vessel, Long lesion and Long lesion in small vessel.
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
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Director and Head of Cardiology
Life care Institute of Medical Sciences & Research &
Apollo Hospital International, Ahmedabad, Gujarat, India
Principal Investigator (en-ABL)
Dr. Sameer Dani, MD, DM