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

in outcome prediction in patients with unprotected left main stenosis 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 todays 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. 1

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). 2
 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
-0.0380.101 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 0.1200.113with 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 patients who
underwent PCI of unprotected left main stenosis.
Specific
1. To describe the demographic profile of patient who underwent percutaneous coronary
intervention
2. To determine the clinical, procedural and angiographic features of patients who underwent
percutaneous coronary intervention

METHODS and MATERIALS

Study design: Prospective Cohort Study
Study Population
Patients who underwent PCI at the Chinese General Hospital during the period of
January 1, 2018 to December 31, 2018, age 18 years.
The data gathered will be based on NERS score and Syntax score. The SYNTAX score was
generated and classified as lower (0 to 22), intermediate (23 to 32), higher (>/=33), and
high-risk (>/=23) scores. The NERS scoring system consisted of 54 variables that are
defined and listed in Tables 1 and 2.

Sample Size: A minimum of 169 patients who underwent percutaneous coronary intervention with
unprotected left main stenosis based on a level of significance of 5%, with a desired width of confidence
interval of 5%.

Plan of Data Analysis

 Descriptive statistics will be used to summarize the clinical characteristics of the patients.
Frequency and proportion will be used for nominal variables, median and IQR for ordinal variables, and
mean and SD for interval/ratio variables. All valid data will be included in the analysis. Missing variables
will be neither replaced nor estimated. STATA 12.0 will be used for data analysis.

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

MONTHS
ACTIVITIES
Jan Feb Mar Apr May Jun Jul Aug Sept Oct

Protocol preparation
Consultation with statistician
Meeting with co-authors
Protocol revisions
Drafting of questionnaires
Completing requirements for IRB
review
Translation/validation
IRB protocol review

Protocol revisions
Questionnaire revisions
Consultation with statistician
IRB review of revised protocol

Recruitment and data collection

Data analysis

Manuscript preparation
 Submission of research paper

Budget

EXPENDITURE AMOUNT UNIT COST TOTAL COST IN PHP

1. Statistician Fee 5,000 5,000

2. Stationaries 2,000 2,000

TOTAL 7,000 php 7,000 php

Dummy Tables

Baseline Characteristics of Overall Patients

Indexes Values
Age, yrs
Men
AMI
STEMI
NSTEMI
Previous MI
Diabetes mellitus
Hypertension
Current smoker
Abnormal lipidemia
LVEF
IABP
Temporary cardiac pacemaking
Emergency procedure for left main disease
Data are presented as n (%) or mean _ SD.

REFERENCES
1. Wu C, Hannan EL, Walford G, Faxon DP. Utilization and outcomes of unprotected left main
coronary artery stenting and coronary artery bypass graft surgery. Ann Thorac Surg
2008;86:11539.
2. Valgimigli M, Malagutti P, Rodriguez-Granillo GA, et al. Distal left main coronary disease is a
major predictor of outcome in patient undergoing percutaneous intervention in the drug-eluting
stent era: an integrated clinical and angiographic analysis based on the Rapamycin- Eluting Stent
Evaluation at Rotterdam Cardiology Hospital (RESEARCH) and Taxus-Stent Evaluated at
Rotterdam CardiologyHospital (T-SEARCH) registries. J Am Coll Cardiol 2006;47:1530 7.
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