Concept Medical Inc. - Best Heart Care Institute in Surat
MagicTouch - Concept Medical Inc. - Best Heart Care Institute in Surat
Clinical Data

NANOLUTE INDIA

OBJECTIVE:

The purpose of the registry is to observe and evaluate performance of Sirolimus Coated Balloon Catheter system for the treatment of lesions in native coronary arteries.

METHODS:

This multicenter registry will enroll real world, all comer patients (Having the target of 1000 patients) from the routine clinical practice at various interventional cardiology sites in India. The inclusion criteria were kept comprehensive to reflect routine clinical practice of treatment of coronary artery disease conditions (Real World scenario – All comer patients).Patients will be followed up clinically at 1 month, 6 month and 1 year.

To date, 359 patients were enrolled in this registry. Among these patients, three sub-groups will be created.

SUB GROUP 1: ISR Sub-group, patients with coronary In-stent Restenosis.

SUB GROUP 2: Small vessel Sub-group, patients with small vessel disease.

SUB GROUP 3: Bifurcation Sub-group, patients with bifurcation lesions.

END POINTS:

Primary End Point:

– MACE (Major Adverse Cardiac Event is a composite of cardiac death, myocardial infarction (MI) and target lesion/vessel revascularization (TLR/TVR)) at 6 months.
– Procedural success which is defined as technical and angiographic success in the absence of a Major adverse cardiac event (MACE) at hospital discharge.

Secondary End Point:

– MACE (Major Adverse Cardiac Event is a composite of cardiac death, myocardial infarction (MI) and target lesion/vessel revascularization (TLR/TVR)) at 1 year.

RESULTS

Baseline Characteristics

PATIENTS, N=393 Value
Age, years ± SD 59.72± 10.47
Male (%) 81.42
Female (%) 18.58
CARDIOVASCULAR RISK FACTORS (%)
Diabetes 44.78
Hypertension 45.80
Family history of CAD 3.56
PREVIOUS CV HISTORY (%)
Myocardial Infarction 31.04
Percutaneous Coronary Intervention 52.67
Coronary Artery Bypass Graft 6.36
ADDITIONAL RISK FACTORS (%)
Peripheral vascular disease 0.51
Renal Insufficiency 3.56
Left ventricular dysfunction 5.09
Multi-vessel CAD 39.69
CLINICAL PRESENTATION (%)
Stable angina 48.35
Acute Coronary Syndrome 47.84
Unstable angina 30.79
Non-ST elevation Myocardial Infarction 5.85
ST-elevation Myocardial Infarction 11.20

Lesion & Procedure Characteristics

N=393, No. of lesions (n) =419 , No. of devices=465
Target Vessel (%) Value
Left anterior descending 36.75
Diagonal 10.50
Circumflex 14.32
OM 9.79
Ramus 3.58
PDA 2.86
PLB 1.43
Right Coronary Artery 19.81
Left main 0.24
Graft 0.72
Indication
In-Stent Restenosis 45.11
Small Vessel 44.39
De-Novo lesion 9.07
Bifurcation 1.43
Procedure Characteristics (%)
Additional treatment 7.12
SCB Alone therapy 92.88
Procedure success 99.49
SCB Characteristics (mm ± SD)
Length, mm 22.18 ± 7.22
Diameter, mm 2.68 ± 0.45
Inflation pressure, bar 11.26 ± 5.27
Inflation time, s 51.55 ± 21.60
Device per patient 1.18

Clinical outcomes at 1 year:

85.24 % clinical follow-up completed at 1 Year

MACE rate at 1 year
MACE 4.78%
TLR / TVR 4.18%
Cardiac Death 0.301%
MI 0.30%
SUBGROUPS

ISR SUB GROUP

Baseline Characteristics, N=177

Characteristics Value
Age, years ± SD 60.24 ± 9.08
Male (%) 79.68
Female (%) 20.34
CARDIOVASCULAR RISK FACTORS (%)
Diabetes 53.11
Hypertension 50.28
Family history of CAD 4.52
PREVIOUS CV HISTORY (%)
MI 55.93
PCI 96.61
CABG 7.91
ADDITIONAL RISK FACTORS (%)
Peripheral vascular disease 1.13
Renal Insufficiency 5.65
Left ventricular dysfunction 6.21
Multi-vessel CAD 33.33
CLINICAL PRESENTATION (%)
Stable angina 50.85
ACS 46.33
Unstable angina 36.16
Non-ST elevation MI 4.52
ST-elevation MI 5.65

Lesion & Procedure characteristics

N=177 patients, n=189 lesions, no. of devices=216
Target vessel (%) Value
Left anterior descending 46.03
Diagonal 1.59
Circumflex 15.87
OM 5.82
Ramus 1.06
Right Coronary Artery 28.04
Graft 1.59
CLASSIFICATION OF IN-STENT RESTENOSIS (%)
I (FOCAL) 60.32
II (DIFFUSE- INTRA-STENT) 18.52
III (DIFFUSE- PROLIFERATIVE) 8.99
IV (DIFFUSE- TOTAL OCCLUSION) 9.52
Unknown 2.65
TYPE OF STENT WITH RESTENOSIS (%)
BMS 11.11
DES 79.86
CABG 1.59
BVS 1.06
Unknown 6.35
Procedure Characteristics (%)
SCB alone therapy 92.06
Additional stenting 7.91
Device per patient 1.22
SCB Characteristics (mm ± SD)
Length, mm 22.54 ± 7.12
Diameter, mm 2.88 ± 0.38

Clinical outcomes at 1 year:

87.01 % clinical follow-up completed at 1 Year

MACE rate at 1 year
MACE 6.49%
TLR / TVR 5.84%
Cardiac Death 0.0%
MI 0.65%

SMALL VESSEL SUB-GROUP

Baseline Characteristics, N=178

Characteristics Value 
Age, years ± SD 58.54 ± 11.50
Male (%) 82.02
Female (%) 17.98
CARDIOVASCULAR RISK FACTORS (%)
Diabetes 39.33
Hypertension 42.13
Family history of CAD 2.25
PREVIOUS CV HISTORY (%)
MI 8.99
PCI 14.61
CABG 4.49
ADDITIONAL RISK FACTORS (%)
Renal Insufficiency 2.25
Left ventricular dysfunction 4.49
Multi-vessel CAD 43.82
CLINICAL PRESENTATION (%)
Stable angina 43.82
ACS 50.56
Unstable angina 25.28
Non-ST elevation MI 7.87
ST elevation MI 17.42

Lesion & Procedure Characteristics

N=178 patients , n=185 lesions, no of devices=196
Target vessel (%) Value
Left anterior descending 30.27
Diagonal 19.46
Left Circumflex 11.89
Obtuse marginal 12.97
Ramus 5.41
PDA 6.49
PLB 3.24
Right Coronary Artery 10.27
Procedure Characteristics (%)
SCB alone therapy 94.94
Additional treatment 5.06
Device per patient 1.10
SCB Characteristics (mm ± SD)
Length, mm 21.66 ± 7.28
Diameter, mm 2.33 ± 0.26

Clinical outcomes at 1 year 

81.46 % clinical follow-up completed at 1 Year

MACE rate at 1 year
MACE 4.14%
TLR / TVR 3.45%
Cardiac Death 0.69%
MI 0.0%

 

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