Comparison of the Prognostic value of the New Risk Stratification Score and the Clinical

Syntax Score in outcome prediction in patients with three-vessel CAD who underwent
percutaneous catheter intervention at Chinese General Hospital

Author:
Reda A. So, MD
INTRODUCTION
Background of the Study
In the past decade, heart disease has been the number one cause of death among Filipinos.
Worldwide, it takes the lives of 17 million people per year. Coronary Artery Disease (CAD) is a serious
healthcare problem in today’s aging society. Despite significant advances in the treatment of coronary
CAD, the disease tends to follow a progressive course with high mortality and morbidity rates. Patients
with CAD are at significant risk for recurrent cardiovascular events such as arrhythmia, death, stroke, and
development of heart failure. Therefore, the secondary prevention of cardiovascular events is invaluable
for improving the prognostic outlook of CAD patients.
Several risk-prediction models have been developed to help health care professionals, patients
and their families comprehend the attendant risks of PCI, and thus provide an objective 1 basis for
decision-making. These risk stratification tools or risk scores have assisted cardiologists in decision
making and in accurately showing the periprocedural risk from PCI to the patient.
A novel risk stratification system would provide critical information that could result in more
aggressive therapy and lead to improved patient survival. The Synergy between Percutaneous Coronary
Intervention with TAXus and Cardiac Surgery (SYNTAX) score, a measure of coronary lesion complexity,
has been proposed for use in the risk stratification of patients with untreated left main trunk or 3-vessel
CAD.
Numerous different models have been developed for risk stratification. The SYNTAX score which
has shown to be an independent predictor of MACE in patients with triple vessel disease treated with
angioplasty. However it does not comprehensively incorporate clinical variables, hence it is compared
with novel scoring System NERS (New Risk Stratification) score which has clinical, procedural and
angiographic indices. This study was done to compare the SYNTAX and NERS scoring system in terms of
sensitivity and specificity in predicting outcome of patients who underwent PCI.

Review of Literature
Unprotected left main coronary artery (ULMCA) disease occurs in approximately 4% of
individuals who undergo angiography. Patients with LMCA disease are at high hazard for cardiovascular
events because occlusion of this vessel compromises flow to at least 75% of the left ventricle and 100%
in cases of the left dominant type. Severe LMCA disease reduces flow to a considerable segment of the
myocardium, placing the patient at high risk for life-threatening events such as left ventricular
dysfunction and arrhythmias (Fajadet and Chieffo, 2012; Kalbfleisch and Hort, 1977).
 A Study done by Chen et al in 2010, wherein they compared the predictive outcomes of NERS vs
Syntax scoring in patient with unprotected left main stenosis. The NERS score was derived from 260
patients with unprotected left main stenosis who underwent percutaneous coronary intervention and
tested in 337 patients in a consecutive left main registry undergoing percutaneous coronary intervention
in a prospective, multicenter trial. Six-month clinical and angiographic follow-up was obtained in 100%
and 88.9% of patients, respectively. The primary end point was major adverse cardiac events (MACE),
encompassing myocardial infarction, all-cause death, and target vessel revascularization.
Receiveroperator characteristic (ROC) curve was generated for the comparison of NERS versus SYNTAX
scores. Results The NERS score consisted of 54 variables (17 clinical, 4 procedural, and 33 angiographic).
At follow-up, myocardial infarction, cardiac death, and target vessel revascularization occurred in 3.0%,
5.6%, and 13.1% of patients, respectively, for a composite MACE of 26.0%. A NERS score 25 (hazard ratio:
1.13; 95% confidence interval [CI]: 1.11 to 1.16; p 0.001) was the only independent predictor of
cumulative MACE and stent thrombosis at follow-up (odds ratio: 31.04; 95% CI: 19.36 to 67.07; p 0.001).
The outcome was more predictive of MACE than the SYNTAX score was. Further study is needed to
address their relative roles in assessment for appropriateness of coronary artery bypass graft versus
percutaneous coronary intervention for unprotected left main coronary artery stenosis.

Another study at Philippine Heart Center by Daet et al, wherein all eligible patients
diagnosed with Coronary Artery Disease with triple vessel disease who underwent angioplasty
were included. Risk scoring system was done using SYNTAX and NERS score. Phone interviews
were conducted and at the end 6 months, to determine the occurrence of the major adverse
cardiac events (MACE), encompassing myocardial infarction, all cause death and target vessel
revascularization. The two scoring system was compared. The outcome was seventy eight
patients were included in the study. SYNTAX score was divided into low risk group (<34) and
high risk group (≥34). Ninety seven percent belong to low risk group while 3% belong to high
risk group. The NERS score was also divided into low risk group <25) and high risk group (≥25).
Ninety two percent belong to low risk group while 8% belongs to high risk group. In terms of
MACE (major adverse cardiac events ) encompassing myocardial infarction, all-cause death, and
target vessel revascularization, there was 6.4% on both scoring group. The SYNTAX score has 0%
sensitivity, 97.3% specificity, 0% positive predictive value, 93.4%negative predictive value, kappa
value of -0.038±0.101 and p value of 0.646. The NERS score has 20% sensitivity, 93.2%
specificity, 16.7% positive predictive value, 94.4%negative predictive value of 94.4%, kappa
value of 0.120±0.113with p value of 0.143. In conclusion, both SYNTAX scoring and NERS scoring
did not differ significantly in terms of prediction of MACE in patients with triple vessel disease
who underwent angioplasty. NERS score 19 showed better predictive value but larger
population and longer follow up is needed in order to confirm these findings.

Objectives:
General
This study aimed to compare the NERS (New Risk Stratification) and SYNTAX (Synergy between
Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) scores for prognostication
after stenting of unprotected left main stenosis.

METHODS and MATERIALS

• Study design: Prospective Cohort Study
• Study setting: East Avenue Medical Center, Hemodialysis Unit with 15 HD machines
catering around 20-30 patients per day
• Study Population
• Medical charts of patients at HD unit of East Avenue Medical Center from
January 2015 to August 2016 will be retrieved and reviewed.
• The following variables will be collected
- age (years), sex, dialytic vintage (months), time of death (months)
cardiovascular diseases (CVD) like hypertension, hypertensive
cardiovascular disease, heart failure, diabetes mellitus, duration of HD
(min), body weight (BW; kg), interdialytic weight gain (IWG, kg),
ultrafiltration rate (UFR: ml/h/kg BW), pre-HD systolic and diastolic blood
• For each patient, date of HD sessions, pre and post HD weight and weight gain
will be recorded. With these values we will be able to get the ultrafiltrate rate per
session of HD that will be used for data analysis.
 • Inclusion criteria were the following: (1) all adult (≥ 18 years old) ESRD patients at EAMC-
HD unit, (2) on maintenance HD for at least 3 months, (3) on HD frequency of 2x/week.
Since almost all of patients enrolled at our HD unit undergo 2x a week HD due financial
reasons.
• Exclusion criteria were the following: (1) less than 18 years old , (2) who missed HD
sessions in the last three months, (3) undergoing 3x/week HD or less than 2x/week, (4)
acute kidney injuries

Sample Size: A minimum sample size of 211 patients satisfying the inclusion/exclusion criteria
are needed in the study based on 5% level of significance, 80% power, observed hazard ratio of
1.22 of UFR with mortality and mortality rate of 52% 1, 0.8 anticipated overall probability of
event and 0.65 margin of error.

Plan of Data Analysis

All valid data from evaluable subjects satisfying the inclusion/exclusion criteria will be
included in the analysis. Missing values will not be replaced or estimated during the statistical
analysis of outcome variables. Checks for normality and homogeneity of sample population on
quantitative demographic and clinical characteristics will be done. Summary statistics will be
presented in summary tables or graphs and reported as mean ± SD or median (IQR=interquartile
range) for quantitative demographic and clinical characteristics and n (%) for qualitative
variables. T-test or Mann-Whitney test will be used to compare between groups of patients. Chi-
square test will be used to compare proportions. Univariate analysis will be done using mean of
log-rank test. Checks on the assumption of proportionality will also be performed. Independent
variables which satisfy the assumption of proportionality will be included in the multivariate Cox
proportional hazards regression model. Diagnostic checks on the model will be performed.
Hazard ratios and 95% confidence intervals will be estimated. Significance will be based on p-
values ≤ 0.05. SPSSv20 will be used in data processing and analysis.

1
 Ethical Issues:
Data will be anonymized and will not be used for any other purposes than intended.
This protocol will be submitted to the hospital ethics committee for review prior to
implementation.

Gantt Chart: Proposed Table of Activities

Activities January February March April May June July August September October November December

Making of
Research
Proposal and
Approval
Research: Chart
Review and
Analysis
Making Final
Paper
Presentation of
Final Research
Paper

Budget
Estimated Amount Allotted Money
Printing of Patient’s Data 1,050 1300
- Bond paper 4 reams –
(800)
- Ink black (250)
Printing of actual paper 500 700
- Bond paper 1 ream
(200)
 - Book binding (300)
Total 1,550 2,000
APPENDIX
Dummy Tables
Table 1 Clinical Characteristics
Parameter Group A Group B p-
(patients who (patients who value
survived) died)
n= n=
Age (years), mean ± SD
Sex (men/women), n (%)
Dialytic vintage (months), mean ± SD
Cardiovascular disease, n (%)
Diabetes Mellitus, n (%)
Duration of HD (minutes) , mean ± SD
Kt/v, mean ± SD
Body weight (kg), mean ± SD
Interdialytic body weight gain (kg) , mean
± SD
Pre-HD systolic pressure, median (IQR)
Pre-HD diastolic pressure, median (IQR)
Ultra-filtration rate ( ml/h/kg BW) , mean
± SD
* Significant at 5% level

Table 2 Results of Survival Analysis

Name of Date Pre Post Weight Ultrafiltrate
Patient Haemodialysis haemodialysis Gain rate
weight (kg) weight (kg)
st
1 session

2nd

3rd

4th

5th

6th

7th
 8th
Admitted
Yes or no?
If yes, what is the reason for admission?
Did the patient expired?
If yes, what is the final diagnosis?

Data from
Table 3 Results of Survival Analysis
Parameter Hazard Ratio 95% CI p-value
Age (years)
Sex (men/women)
Dialytic vintage (months)
Cardiovascular disease
Diabetes Mellitus
Duration of HD (minutes)
Kt/v
Body weight (kg)
Interdialytic body weight gain (kg)
Pre-HD systolic pressure
Pre-HD diastolic pressure
Ultra-filtration rate ( ml/h/kg BW)
Time of death (months)
* Significant at 5% level
Table 4 Sample Size Computation

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