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Presenter Dr Praveen Gupta
Moderator Dr Raja Selvaraj
MD(Ped) DNB(Card) Fellowship in Cardiac EP(Toronto)
Cardiac Electrophysiologist
Associate Professor of Cardiology
Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry | India 605006
Date 14/12/2016
Research roundUpdate of ongoing research projects
1
Title of the dissertion
Restenosis and its clinical and procedural determinants in patient with
drug eluting stent
2
Name, Designation & Address guide with mobile number, e-mail ID
DR. AJITH ANANTHAKRISHNA PILLAI
Associate Professor,
Department of Cardiology,
JIPMER
9488828946
Intradepartmental
3
Introduction Problem statement Plain old balloon angioplasty,” rates of acute and chronic vessel occlusion were
high
The advent of bare-metal stents (BMS) appeared to eliminate the issue of acute
and chronic recoil
Restenosis rates with BMS were between 16% and 44%
DES (Drug eluting stent) in restenosis rates reported at 0% to 16%
4
Introduction
In-stent restenosis (ISR) requiring target vessel revascularization (TVR), so-
called DES failure, to be ≈5% to 10%
In 2004, the first report of risk factors associated with DES restenosis in
patients with the unrestricted use of SES since approval of its CE mark was
made
Usual patient characteristics, lesion types, and procedural factors incriminated
with restenosis in BMS were equally responsible with DES, with diabetes
mellitus implicated as one of the strongest risk factors
5
Rationale
Better understanding of proportion (percentage), clinical and
procedural characteristics associated with In-stent restenosis of drug
eluting stents leads to measure to prevent DES restenosis
6
Novelty
This study is on restenosis and its clinical and procedural determinants
in patient with drug eluting stent.The proposed study is new in this
perspective for better understanding of proportion (percentage)of
restenosis along with clinical and procedural characteristics in our
population
7
Expected outcome & application
The above study will tell us about the proportion (percentage) of DES
restenosis in Indian patient along with the factor related to it. It will
help in preventing the rate of restenosis in Indian patient
8
Research hypothesis (es)
Clinical and procedural characteristics associated with the restenosis in
patient with Drug eluting stent
9
Research question(s)
What is the proportion (percentage) of restenosis,clinical and
procedural determinant associated with the restenosis in patient with
Drug eluting stent?
10
Objectives
1. To assess the proportion (percentage) of restenosis among the patient with Drug
eluting stent
2. To identify the association of clinical and procedural characteristics with
restenosis in patient with Drug eluting stent
3. Calculate and analyse time to restenosis
11
Methodology
Study design / type
Observational follow up study
Study participants
Inclusion criteria
Patient with Drug eluting stent attending cardiology OPD of JIPMER
Number of groups to be studied :
Patient with Drug eluting stent attending cardiology OPD of JIPMER
12
Sampling Sampling Population
Cardiovascular patient underwent Drug Eluting Stenting 3 months to 2 years back
Sampling calculation
Sample size in each group and sample size
550 (Sample size is estimated using the statistical formula for estimating a single
proportion. The expected percentage of restenosis among the patient with Drug
eluting stent was 15% and the sample size is estimated at 5% level of significance
and 3% absolute precision.
Sampling technique
Convenient sampling techniques
13
Study procedure
In this study patient who had drug eluting stent insertion over the last 3 months
to 2 years and attending the cardiology OPD will be assessed regarding the
status of restenosis. The details of above patient with regard to Age, gender
(Sex), sociodemographic, clinical, procedural character, and lesion character
will be collected. All of the above patient will be followed up for the minimum
one year of the period. Patients will be recruited only once after the
occurrence of restenosis.
14
List of variables and their measurement methods with standardization techniques
Independent variables characteristics Age,Gender ( sex )Socio-demographic (Domicile, Occupation, Income, Married, Education)Clinical characteristics, • Diabetes mellitus• Hypertension• Smoking• Dyslipidemia• Positive family history• Drug compliance• Presence of LV dysfunction (<50%)• Unstable/Stable CAD• Single/Multivessel disease
15
List of variables and their measurement methods with standardization techniques
Elective/Emergency PCI
Procedural characteristics,
Length of the stent
Treatment of multiple lesions
Type of DES
Periproceduralcomplication
Final lumen diameter
Lesion characteristics
Vessel involved
Length of disease
Chronic total occlusion
Vessel size
Lesion morphology- Calcified/Thrombosed
Proximal vs Distal lesion
Dependent Variable
Restenosis16
List variable wise statistical tests to be used for data analysis
The distribution of Categorical variable such as gender, sociodemographic characteristics, clinical
characteristics, sociodemographic characteristics, will be expressed in terms of frequency and percentage.
The distribution of continuous variable such as age, duration of diseases, chronic total occlusion, vessel
size, length of the stent etc. will be expressed in terms of mean with standard deviation or median with
range based on the distribution of data. The association of restenosis with Categorical Variable in the
clinical characteristics, procedural characteristics and lesion characteristics and also with the socio
demographics will be carried by using Chi-Square test or Fisher’s exact test. The association of restenosis
with the continuous variables mentioned above will be carried out by using Independent students
t-test/Mann Whitney U test or one way analysis of variance/kruskallwallis test based on the distribution of
data and number of groups. The Independent factor associated with restenosis will be examined by using
Binary Logistics regression analysis. All the statistical analysis will be carried out at 5% level of
significance with P valueless than 0.05 as statistically significant.
17
List risks and benefits of the study It’s a Observational follow up study so minimal risk is involved. Better
understanding of clinical and procedural characteristics associated with Instent
restenosis of drug eluting stents leads to measure to prevent DES restenosis
18
Major change advised by IEC
Procedure needs to be explained clearly stating that the patients will be
recruited only once after the occurrence of restenosis
Necessary change has been made and procedure is now explained
clearly stating that patient will be recruited only after the occurrence
of restenosis
19
DATA EXCLUDED=67 (INCOMPLETE FOLLOW UP/OLD)
IN-STENT STENOSIS=07
STENT THROMBOSIS=07
20
MALES (16/53)
FEMALES (37/53)
01020304050607080
30.2
69.8
% OF PATIENTS
% OF PATIENTS
21
DM (24/53) NO DM (29/53)
0102030405060
45.254.8
% OF PATIENTS
% OF PATIENTS
22
HTN (28/53) NO HTN (25/53)
40
44
48
52
56
60
52.8
47.2
% OF PATIENTS
% OF PATIENTS
23
ISR (7/53) NO ISR (46/53)
0
20
40
60
80
100
13.2
86.8
% OF PATIENTS
% OF PATIENTS
24
MALES (6/16) FEMALE (1/37)05
10152025303540
37.5
2.7
% OF MALES/FEMALE DE-VELOPING ISR
% OF MALES/FE-MALE DE-VELOPING ISR
25
MALES (6/7) FEMALES (1/7)
0102030405060708090
85.7
14.3
% OF PATIENTS WITH ISR
% OF PATIENTS WITH ISR
26
HTN (2
/7)
DM (4/7)
SMOKING (3
/7)0
102030405060
28.5
57.1442.8
% OF PATIENTS WITH ISR
% OF PATIENTS WITH ISR
27
SVD (1/7)
DVD (3/7)
TVD (3/7)
05
1015202530354045
14.2
42.8 42.8
% OF PATIENTS WITH ISR
% OF PATIENTS WITH ISR
28
SINGLE STENT (1/7)
DOUBLE STENT (6/7)
0
20
40
60
80
100
14.2
85.8
% OF PATIENTS WITH ISR
% OF PATIENTS WITH ISR
29
LAD (8/13)
RCA (3/13)
LCX (2/13)
010203040506070 61.5
2315.5
% OF VESSELS STENTED IN PATIENTS WITH ISR
% OF VESSELS STENTED
TOTAL STENTS PUT IN ISR PATIENTS=13
30
LAD (7/8)
RCA (2/3)
LCX (1/2)
020406080
10087.5
66.6650
% OF BLOCKED STENTS IN VESSELS IN PATIENTS WITH
ISR% OF BLOCKED STENTS IN VESSELS IN PATIENTS WITH ISR
31
LV Dys
(1/7)
CTO/CAL
CIFIED (2
/7)0
102030
14.2
28.5
% OF PATIENTS WITH ISR
% OF PATIENTS WITH ISR
32
ST (7/53) NO ST (46/53)
0
20
40
60
80
100
13.2
86.8
% OF PATIENTS
% OF PATIENTS
33
ACUTE (0/7)
SUB ACUTE (1/7)
LATE (2/7) VERY LATE (4/7)
0102030405060
0
14.2
28.5
57.1
% OF PATIENTS WITH ST
% OF PATIENTS WITH ST
34
ConclusionIndependent variables affecting ISR
Common in malesCommon in DM>HTN>SmokersCommon in DVD=TVD>SVDCommon in LAD>RCA>LCX
Stent thrombosisCommon presentation: Very late>Late>Sub
acute
35
DrawbacksInsuffient dataMarked sex disproportion in dataIncidence/prevalence cannot be calculated
36
37