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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 round Update of ongoing research projects 1

In-stent restenosis with Drug eluting stent, on going research

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Page 1: In-stent restenosis with Drug eluting stent, on going research

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

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Page 2: In-stent restenosis with Drug eluting stent, on going research

Title of the dissertion

Restenosis and its clinical and procedural determinants in patient with

drug eluting stent

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Page 3: In-stent restenosis with Drug eluting stent, on going research

Name, Designation & Address guide with mobile number, e-mail ID

DR. AJITH ANANTHAKRISHNA PILLAI

Associate Professor,

Department of Cardiology,

JIPMER

9488828946

[email protected]

Intradepartmental

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Page 4: In-stent restenosis with Drug eluting stent, on going research

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%

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Page 5: In-stent restenosis with Drug eluting stent, on going research

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

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Page 6: In-stent restenosis with Drug eluting stent, on going research

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

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Page 7: In-stent restenosis with Drug eluting stent, on going research

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

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Page 8: In-stent restenosis with Drug eluting stent, on going research

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

 

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Page 9: In-stent restenosis with Drug eluting stent, on going research

Research hypothesis (es)

Clinical and procedural characteristics associated with the restenosis in

patient with Drug eluting stent

 

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Page 10: In-stent restenosis with Drug eluting stent, on going research

Research question(s)

What is the proportion (percentage) of restenosis,clinical and

procedural determinant associated with the restenosis in patient with

Drug eluting stent?

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Page 11: In-stent restenosis with Drug eluting stent, on going research

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

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Page 12: In-stent restenosis with Drug eluting stent, on going research

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

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Page 13: In-stent restenosis with Drug eluting stent, on going research

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

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Page 14: In-stent restenosis with Drug eluting stent, on going research

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.

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Page 15: In-stent restenosis with Drug eluting stent, on going research

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 

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Page 16: In-stent restenosis with Drug eluting stent, on going research

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

Page 17: In-stent restenosis with Drug eluting stent, on going research

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.

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Page 18: In-stent restenosis with Drug eluting stent, on going research

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

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Page 19: In-stent restenosis with Drug eluting stent, on going research

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

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Page 20: In-stent restenosis with Drug eluting stent, on going research

DATA EXCLUDED=67 (INCOMPLETE FOLLOW UP/OLD)

IN-STENT STENOSIS=07

STENT THROMBOSIS=07

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Page 21: In-stent restenosis with Drug eluting stent, on going research

MALES (16/53)

FEMALES (37/53)

01020304050607080

30.2

69.8

% OF PATIENTS

% OF PATIENTS

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Page 22: In-stent restenosis with Drug eluting stent, on going research

DM (24/53) NO DM (29/53)

0102030405060

45.254.8

% OF PATIENTS

% OF PATIENTS

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Page 23: In-stent restenosis with Drug eluting stent, on going research

HTN (28/53) NO HTN (25/53)

40

44

48

52

56

60

52.8

47.2

% OF PATIENTS

% OF PATIENTS

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Page 24: In-stent restenosis with Drug eluting stent, on going research

ISR (7/53) NO ISR (46/53)

0

20

40

60

80

100

13.2

86.8

% OF PATIENTS

% OF PATIENTS

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Page 25: In-stent restenosis with Drug eluting stent, on going research

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

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Page 26: In-stent restenosis with Drug eluting stent, on going research

MALES (6/7) FEMALES (1/7)

0102030405060708090

85.7

14.3

% OF PATIENTS WITH ISR

% OF PATIENTS WITH ISR

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Page 27: In-stent restenosis with Drug eluting stent, on going research

HTN (2

/7)

DM (4/7)

SMOKING (3

/7)0

102030405060

28.5

57.1442.8

% OF PATIENTS WITH ISR

% OF PATIENTS WITH ISR

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Page 28: In-stent restenosis with Drug eluting stent, on going research

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

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Page 29: In-stent restenosis with Drug eluting stent, on going research

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

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Page 30: In-stent restenosis with Drug eluting stent, on going research

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

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Page 31: In-stent restenosis with Drug eluting stent, on going research

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

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Page 32: In-stent restenosis with Drug eluting stent, on going research

LV Dys

(1/7)

CTO/CAL

CIFIED (2

/7)0

102030

14.2

28.5

% OF PATIENTS WITH ISR

% OF PATIENTS WITH ISR

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Page 33: In-stent restenosis with Drug eluting stent, on going research

ST (7/53) NO ST (46/53)

0

20

40

60

80

100

13.2

86.8

% OF PATIENTS

% OF PATIENTS

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Page 34: In-stent restenosis with Drug eluting stent, on going research

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

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Page 35: In-stent restenosis with Drug eluting stent, on going research

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

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Page 36: In-stent restenosis with Drug eluting stent, on going research

DrawbacksInsuffient dataMarked sex disproportion in dataIncidence/prevalence cannot be calculated

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Page 37: In-stent restenosis with Drug eluting stent, on going research

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