AMIRI-CABG: Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG
Conditions: Ischemic Heart Disease, Coronary Artery Disease, Ischemic Reperfusion Injury, CABG
Sponsor: St. Petersburg State Pavlov Medical University

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
 
 
 
 
 
Statistical Analysis 
 
St. Petersburg State Pavlov Medical University 
 
Department of Cardiac Surgery #2 
 
Corresponding author 
Bunenkov Nikolay 
Bunenkov2006@gmail.com 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2021 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
 
STATISTICAL ANALYSIS .................................................................................................................................. 1 
ABBREVIATIONS ............................................................................................................................................ 6 
INTRODUCTION ............................................................................................................................................. 6 
STUDY DESIGN ............................................................................................................................................... 8 
ENROLLMENT ........................................................................................................................................... 8 
ALLOCATION ............................................................................................................................................ 8 
FOLLOW-UP .............................................................................................................................................. 8 
ASSESSMENT ............................................................................................................................................ 8 
PATIENTS ALLOCATION ........................................................................................................................... 10 
STUDY OBJECTIVES .................................................................................................................................. 10 
PRIMARY OBJECTIVE ............................................................................................................................... 10 
SECONDARY OBJECTIVES ......................................................................................................................... 10 
STUDY POPULATION ................................................................................................................................ 11 
INCLUSION CRITERIA ............................................................................................................................... 11 
EXCLUSION CRITERIA ............................................................................................................................... 12 
STUDY TIMEPOINTS ................................................................................................................................. 12 
MYELOPEROXIDASE TEST ........................................................................................................................ 12 
SAFETY ANALYSIS..................................................................................................................................... 13 
STUDY DURATION ................................................................................................................................... 13 
DEFINITIONS ............................................................................................................................................ 13 
ISCHEMIC-REPERFUSION INJURY ............................................................................................................ 13 
MYOCARDIAL INFARCTION 5 TYPE .......................................................................................................... 13 
ADVERSE EVENTS .................................................................................................................................... 13 
SERIOUS ADVERSE EVENTS...................................................................................................................... 14 
NONSERIOUS ADVERSE EVENTS .............................................................................................................. 14 
LABORATORY TEST ABNORMALITIES ...................................................................................................... 14 
COLLECTION AND REPORTING .................................................................................................................... 14 
NONSERIOUS ADVERSE EVENT COLLECTION AND REPORTING .............................................................. 14 
SERIOUS ADVERSE EVENT COLLECTION AND REPORTING ...................................................................... 14 
PREGNANCY ............................................................................................................................................ 15 
OTHER SAFETY CONSIDERATIONS ........................................................................................................... 15 
ETHICAL CONSIDERATIONS. INFORMED CONSENT ..................................................................................... 15 
DATA ANALYSIS ........................................................................................................................................... 15 
SAMPLE SIZE JUSTIFICATION ................................................................................................................... 15 
BASELINE CHARACTERISTICS ................................................................................................................... 15 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
HYPOTHESIS: BASELINE CHARACTERISTICS ARE COMPARABLE BETWEEN GROUPS. ............................. 15 
PRIMARY ENDPOINT ANALYSIS ............................................................................................................... 18 
ISCHEMIC – REPERFUSION INJURY ANALYSIS (MPO LEVEL) .................................................................... 19 
ISCHEMIC – REPERFUSION INJURY ANALYSIS (TNI LEVEL 1ST DAY AFTER CABG)..................................... 20 
ISCHEMIC – REPERFUSION INJURY ANALYSIS (TNI LEVEL 1ST DAY AFTER ON – PUMP CABG)................. 21 
ISCHEMIC – REPERFUSION INJURY ANALYSIS (TNI LEVEL 1ST DAY AFTER OFF – PUMP CABG) ............... 22 
ISCHEMIC – REPERFUSION INJURY ANALYSIS (TNI LEVEL 1ST DAY AFTER PUMP – ASSISTED CABG) ....... 23 
MISSING DATA ANALYSIS ........................................................................................................................ 25 
MECHANISM OF MISSINGNESS DETECTING ............................................................................................ 25 
SECONDARY ENDPOINT ANALYSIS .......................................................................................................... 27 
REFERENCES ............................................................................................................................................ 34 
 
CONSORT 2010 checklist of information to include when reporting a pilot or feasibility 
randomized trial in a journal or conference abstract 
 
Table 1 CONSORT 2010 checklist of information to include when reporting a pilot or feasibility 
randomized trial in a journal or conference abstract 
Item 
Description 
Reported on 
line number 
Title  
Assessment of Myocardial Ischemic-Reperfusion 
Injury During Off- and On- Pump CABG (AMIRI-CABG) 
ClinicalTrials.gov Identifier: NCT03050489 
 
Authors * 
Bunenkov N. S. 
 
Trial design 
Prospective non-randomized single center 
 
Methods 
 
 
Participants 
Eligibility criteria: multivessel coronary artery 
disease with indications for elective coronary artery 
bypass grafting 
 
Interventions 
Group 1: off-pump CABG  
Group 2: on-pump CABG 
Group 3: pump-assisted CABG (on-pump CABG 
without aortic cross-clamping) 
 
Objective 
To compare level of MPO between three groups of 
intervention 
 
Primary 
objective 
To compare ischemic-reperfusion injury between 
three groups of intervention 
 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Secondary 
objective 
To assess ability of MPO to predict worse outcome 
(death) 
To assess relation between MPO and TnI 
 
Outcome 
MPO level after CABG, death after CABG 
 
Randomization 
Non-randomized allocation. Heart Team decision. 
 
Blinding 
(masking) 
None 
 
Results 
 
 
Numbers 
randomized 
Number of participants screened n=500 
Allocated (non-randomized): off-pump CABG 
(n=181), on-pump CABG (n=128), pump-assisted 
CABG (n=27) 
 
Recruitment 
Complete 
 
Numbers 
analyzed 
Off-pump CABG: 181 
On-pump CABG: 128 
Pump-assisted CABG: 27 
 
Outcome 
Could MPO predict death during 30 days after CABG 
 
Harms 
Important adverse events or side effects 
 
Conclusions 
CPB activates leucocytes that cause myocardial 
damage 
Preoperative MPO level could evaluated as a 
predictor of myocardial damage and worse outcome 
after CABG 
 
Trial registration 
ClinicalTrials.gov Identifier: NCT03050489 
 
Funding 
Assessment of regenerative ability after cardiac 
surgery 
 
Table 2 Statistical analysis synopsis 
Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
ClinicalTrials.gov Identifier: NCT03050489 
Hypothesis 
Ischemic 
– 
reperfusion 
injury 
are 
comparable between groups 
Primary objective 
To compare ischemic-reperfusion injury 
during off-pump, on-pump and pump – 
assisted CABG 
Secondary objective 
To assess ability of myeloperoxidase to 
predict worse outcome after CABG 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Type of trial 
Prospective 
non-randomised 
single-
centre 
Type of research 
Explarotory 
Timeline 
2015-2019 
Groups 
Off-pump 
On – pump 
Pump-assisted (on-pump without aortic 
cross-clamping) 
Sample size estimation 
> 300 patients  
Planned sample size 
Averall: 300 
Off-pump: 100 
On-pump: 100 
Pump-assissted: 100 
Actual sample size 
Averall: 336 
Off-pump: 181 (conversion 6) 
On-pump: 128 
Pump-assissted: 27 
Baseline charachteristics comparing 
Testing for type of distribution of baseline 
characteristics: 
ANOVA for normal distribution 
Kruskal-Wallis test with multiple groups 
comparison adjustment for non-normal 
distribution 
Chi-squared test or exact Fisher’s test for 
nominal data 
Statistics hypothesis testing 
ANOVA/ANCOVA for MPO level, troponin 
I level 
Missing Data Handling 
Drop observations with missing data 
Evaluating of reason of missingness  
Hypothesis: Missing data depend on 
severity of complications 
Hypothesis testing with logistic regression 
model: Missingness = complications 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Abbreviations 
AEs – Adverse events  
CABG – coronary artery bypass grafting 
CPB – cardiopulmonary bypass grafting 
ECG – elecrocardiogram  
IL-8 - interleukin 8 
IQR – interquartile range 
LCx – left circumflex artery 
LDL - low-density lipoprotein 
MPO – myeloperoxidase 
Nmiss – number of missing values 
RCA – right coronary artery 
Rpm – rate per minute 
SAE - Serious Adverse Event 
URL – upper reference limit 
Introduction 
Coronary artery bypass grafting (CABG) is worldwide performed procedure. This 
procedure could be performed with cardiopulmonary bypass with aortic cross-clamping, 
without aortic cross-clamping (pump-assissted on beating heart with mechanical support 
of circulation) and off-pump. Some authors reported better outcomes for off-pump 
CABG, but others prefered on-pump CABG due to comfortable circumstances for 
coronary artery suture and pointed out on the risk of incomlete revascularization for off-
pump CABG. Pump-assissted CABG could be favorable for myocardial tissue due to 
maintaining coronary flow as well as stable hemodynamics. There were a lot of clinical 
trials comparing short- and long-term outcomes of on-pump and off-pump CABG. But 
there is litle evidence about comparison of myocardial damage during on-pump CABG, 
off-pump CABG and pump-assissted CABG. Most common timepoints for cardiac troponin 
level were within 2 days postoperatively. A few clinical trials monitored cardiac troponin 
level after second day postoperatively and lack thereof, of precise data about cardiac 
troponin dynamic after different types of CABG. Another important issue is inflammation 
response during CABG, wich is lower in off-pump CABG. But latest trials reported that 
CPB-mediated inflammation response play a less important role than surgical wound-
mediated inflammation response. It has been reported that myeloperoxidase(MPO) 
involved in ischemic-reperfusion myocardial damage [1]. Some clinical trials evaluated 
prognostic value of MPO for acute coronary syndrome [2 , 9]. The goal of current clinical 
trial is to evaluate MPO-level during off-pump, on-pump and pump-assisted CABG as well 
as myocardial damage and outcomes. Serum level of MPO as it has been reported raise 
fast during minutes after ischemia-reperfusion and could be measured during surgical 
procedure and served as a predictor major adverse cardiac events [1]. 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Cardiaс troponin is a specific and sensitive marker of myocardial necrosis and has found 
wide application in clinical practice. Nevertheless, the links of the pathogenesis that 
precede its release into the systemic circulation have not been sufficiently studied [7]. As 
early and specific markers of myocardial damage, MPO activated by ischemia-reperfusion 
of leukocytes, which are released into circulation and participate in myocardial damage, 
can act [7]. By measuring the concentration of inflammatory mediator MPO that 
degranulate the white blood cells and which can damage cardiomyocytes, it is possible to 
predict the extent of myocardial damage [6].  
Inflammation plays a crucial role in plaque destabilization and rupture. MPO belong to 
the marker of plaque instability and degranulated by leukocytes and produces active 
forms of halogens that is an important in antibacterial protection [12].  An important 
advantage of MPO in comparison with other markers is the presence of intrinsic activity, 
which, in the presence of fluorogenic substrates, allows to shorten the time of 
performance of enzyme-linked immunosorbent assays to two stages - sorption of the 
enzyme from the sample and detection of its activity, which is especially important for 
emergency diagnosis . Mediators of inflammation, secreted by the activation of 
leukocytes after ischemia-reperfusion, contribute to myocardial damage, accelerate the 
development of atherosclerosis and destabilize atherosclerotic plaques[12].  
At present, a large number of works are devoted to the problem of ischemic-reperfusion injury, 
however, the molecular-biological aspects have not been fully elucidated. A number of clinical 
studies of the diagnostic value of myeloperoxidase  in relation to acute coronary syndrome was 
conducted, and the prognostic value for cardiovascular complications in patients after PCI of 
was studied [3 , 5]. There are also studies evaluating the concentration of MPO in the coronary 
sinus after restoration of blood flow in aorto-coronary bypass surgery. Modern ideas about the 
mechanisms of MPO-dependent modification of low-density lipoprotein (LDL), their role in 
initiating inflammation and destabilization of atherosclerotic plaque are presented in the 
following reviews [8]. In brief, the meaning of the participation of modified LDL in 
atherogenesis is reduced to the following. Activation of monocytes and neutrophils leads to 
their degranulation and release of MPO into the extracellular space. Due to its polycationic 
properties (pI> 9), MPO binds to the negatively charged surface of LDL, as well as the cells of 
the vascular wall. As a result of activation of NADPH oxidase on the surface of leukocytes and 
endotheliocytes, the production of superoxide anion radical is enhanced. Spontaneous or 
catalyzed by the enzyme superoxide dismutase dismutation of the latter leads to the formation 
of hydrogen peroxide. Conditions are created for MPO-dependent synthesis of HOCl, which 
modifies LDL, and also causes endothelial dysfunction. Modified LDLs penetrate the damaged 
endothelium into the subendothelial space, where they are captured by macrophages. The 
accumulation of modified LDL leads to the transformation of macrophages into foam cells and 
the accumulation of lipids in the arterial intima. In addition, native LDL can also penetrate 
through the endothelium, where they undergo oxidative / halogen modifications from the 
active forms of halogens formed with the participation of MPO. Finally, modified LDLs activate 
endotheliocytes and monocytes, which results in the secretion of interleukin 8 (IL-8) and tumor 
necrosis factor (TNFα), respectively. In turn, IL-8 and TNFα activate monocytes and endothelial 
cells, closing the vicious circle of LDL modification. Also, modified LDL, interacting with the 
endothelium, inhibit the fibrinolysis process, contributing to the formation and subsequent 
destabilization of atherosclerotic plaque. Recently, we have shown that MPO are secreted by 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
neutrophils in response to LDL-modified oxidants . Thus, there is reason to assume the 
diagnostic significance of identifying active leukocyte enzymes in cardiovascular diseases [10]. 
 
 
 
Study Design 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Assessed for eligibility (n=500) 
Excluded  (n=164) 
   Not meeting inclusion criteria (n=164) 
valve disease or urgent intervention 
   Declined to participate (n=0) 
   Other reasons (n=0) 
Assessed for objective (n=175) 
Lost to follow-up (death) (n=4) 
Allocated to off-pump CABG (n=181) 
 Received allocated intervention 
(n=175) 
 Did not receive allocated intervention 
(conversion) (n=6) 
Lost to follow-up (n=0) 
Allocated to intervention (n=27) 
 Received allocated 
intervention (n=33) 
 Did not receive allocated 
intervention (n=0) 
Assessed for objective (n=33) 
Enrollment 
Allocated to on-pump CABG (n=128) 
 Received allocated intervention 
(n=128) 
 Did not receive allocated 
intervention (n=0) 
Lost to follow-up (death) (n=7) 
Assessed for objective (n=128) 
Allocation 
Follow-Up 
Assessment 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
 
 
 
 
 
 
Prospective single cente non-randomized clinical trial. 
Study Centers: First Saint Petersburg State Medical University. 
Number of groups: 3 
Intervention: 
 
Group 1: off-pump CABG  
 
Group 2: on-pump CABG 
 
Group 3: pump-assisted CABG (on-pump CABG without aortic cross-clamping) 
Sample size: >300. 
Table 3 Number of patients 
Intervention 
Number of patients 
Planned 
Actual 
off-pump CABG 
100 
181 (175) 
on-pump CABG 
100 
128 (127) 
pump-assisted CABG  
100 
27 (33) 
Total 
300 
336 
Conversion 
N/A 
6 
181 patient planned for elective CABG. There were 6 conversions to pump – assisted CABG (on-
pump CABG without aortic cross-clamping). 175 recived off-pump-CABG. 27 patient planned for 
elective pump – assisted CABG (on-pump CABG without aortic cross-clamping). 33 pump – 
assisted CABG were performed.  
Primary Endpoint: MPO level after operation. 
Secondary Endpoints: low output syndrome, length of stay in intensive care unit, length of stay 
in hospital, inotrope and vasopressor agents demand, duration of pulmonary ventilation, end 
systolic volume, end dyastolic volume, ejection fraction, reoperation, renal dysfunction, atrial 
fibrillation, death during 30 days after CABG, stroke during 30-days after CABG.  

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Patients allocation 
Patients were allocated into one of three groups of treatment by Heart Team. Patients 
consecutively admitted in the Department of Cardiac Surgery #1 and #2. All patients who 
admitted in the Department of Cardiac Surgery #1 allocated into off-pump CABG group. Patients 
who admitted in the Department of Cardiac Surgery #2 allocated into off-pump CABG group, on-
pump CABG group (when have proximal lesions of RCA or LCx), off-pump CABG group (when have 
more distal lesion of coronary arteries) or pump-asssisted CABG group (when have difusse 
coronary artery lesions). Heart Team includes three or more cardiac surgeons who performes off-
pump, on-pump or pump-assisted CABG more than 10 years, two or more interventional 
cardiologists, one neurologist, two ore more anesthesiologist, two ore more reanimatologist, one 
perfusiologist and two cardiologist. After debating patients were alocatted into one of threу 
groups for elective CABG.  
 
Study objectives 
• To compare ischemic-reperfusion injury after off-pump, on-pump and pump-
assisted - CABG  
Primary objective 
• To compare MPO level before and just after performing coronary anastomosis 
during off-pump CABG, on-pump CABG and pump-assisted CABG (with 
cardiopulmonary bypass without aortic cross-clamping) 
• To compare TnI level between groups 
Secondary objectives 
• To compare incidence of low output syndrome after off-pump CABG, on-pump CABG 
and pump-assisted CABG (with cardiopulmonary bypass without aortic cross-
clamping) 
• To compare length of stay in intensive care unit after off-pump CABG, on-pump 
CABG and pump-assisted CABG (with cardiopulmonary bypass without aortic cross-
clamping) 
• To compare length of stay in hospital care unit after off-pump CABG, on-pump CABG 
and pump-assisted CABG (with cardiopulmonary bypass without aortic cross-
clamping) 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
• To compare inotrope and vasopressor agents demand after off-pump CABG, on-
pump CABG and pump-assisted CABG (with cardiopulmonary bypass without aortic 
cross-clamping) 
• To compare duration of pulmonary ventilation after off-pump CABG, on-pump CABG 
and pump-assisted CABG (with cardiopulmonary bypass without aortic cross-
clamping) 
• To compare end systolic volume, end dyastolic volume, ejection fraction after off-
pump CABG, on-pump CABG and pump-assisted CABG (with cardiopulmonary 
bypass without aortic cross-clamping) 
• To investigate whether MPO level could predict outcomes after CABG 
• To compare incidence of reoperation after off-pump CABG, on-pump CABG and 
pump-assisted CABG (with cardiopulmonary bypass without aortic cross-clamping) 
• To compare incidence of renal dysfunction after off-pump CABG, on-pump CABG 
and pump-assisted CABG (with cardiopulmonary bypass without aortic cross-
clamping) 
• To compare incidence of atrial fibrillation after off-pump CABG, on-pump CABG and 
pump-assisted CABG (with cardiopulmonary bypass without aortic cross-clamping) 
• To compare incidence of death during 30 days after off-pump CABG, on-pump CABG 
and pump-assisted CABG (with cardiopulmonary bypass without aortic cross-
clamping) 
• To compare incidence of stroke during 30-days after off-pump CABG, on-pump 
CABG and pump-assisted CABG (with cardiopulmonary bypass without aortic cross-
clamping)  
Study population 
• Patients with mutivessel coronary artery lesions with indications for elective CABG 
Inclusion criteria 
• Multivessel coronary artery disease with indications for CABG 
• Single CABG procedure 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Exclusion criteria 
• Valve disease  
• Acute coronary syndrome or urgent CABG 
Study timepoints 
• During 30 days after CABG 
Myeloperoxidase Test 
Biomaterial production protocol: 
1st test before surgery. Blood is obtained from a central venous catheter in a volume of 4 ml into 
a violet tube. Within 7 minutes, centrifugation at 3000 rpm at 4 ° C is carried out. The plasma is 
then collected into an eppendorf-type tube of 1 ml and frozen at -40 or below. 
The 2nd test immediately after performing coronary artery suture. Blood is obtained from a 
central venous catheter in a volume of 4 ml into a violet tube. Within 7 minutes, centrifugation 
at 3000 rpm at 4 ° C is carried out. The plasma is then collected into an eppendorf-type tube of 1 
ml and frozen at -40 or below. Samples, they are delivered to the laboratory of biochemical 
genetics of the Institute of Experimental Medicine, where molecular and biological studies are 
performed.  The receipt of the material was approved by the ethical committee of the First State 
Medical University after I.P.Pavlov, protocol 03 / 17-11. 
Earlier we worked out methods for isolating homogeneous preparations of myeloperoxidase 
(MPO) [11]. The preparations of MPO (M ~ 145 kDa, RZ ~ 0.85) obtained with the help of original 
approaches do not contain impurities of leukocyte proteinases and differ in the specific activity 
that exceeds commercially available analogs. For the quantitative determination of MPO, 
previously used solid-phase enzyme-linked immunosorbent assays will be used, which are 
characterized by high sensitivity and specificity due to the independent production of 
monovalent antibodies against the proteins. 
The activity of MPO in the samples is estimated from the fluorescence of resorufin, which is 
formed by oxidation of 10-acetyl-3,7-dihydroxyphenoxazine with brominating MPO, which binds 
when the samples are incubated in plates with adsorbed on the surface of the wells with affinity 
antibodies against MPO obtained from rats [4]. Antibodies (5 μg / ml) dissolved in 40 mM 
Na2CO3, 80 mM NaHCO3, pH 9.4, are adsorbed in 96-well polystyrene plates overnight at 4 ° C. 
After 3 washes of PBS containing 0.05% Tween 20, the purified MPO was placed in the wells at 0 
concentrations; 0.625; 1.25; 2.5; 5; 10; 20; 40 ng / ml and samples diluted 10 to 80 times with 
PBS containing 0.05% Tween 20. After 60 min incubation in a thermoshaker at 37 ° C and 270 
rpm, the wells of the plate are washed 3 times with PBS containing 0.05% Tween 20. A solution 
containing 1 μM 10-acetyl-3,7-dihydroxyphenoxazine, 10 μM H2O2, 20 mM NaBr, 200 mM (NH4) 
2SO4, 24 mM sodium citrate buffer, pH 6.0 is placed in the wells. After 30 minutes of incubation 
in a thermoshaker at 37 ° C and 270 rpm, the fluorescence of the resorufin at 580-620 nm (535-
555 nm excitation) was measured using a flatbed monochromator fluorimeter-luminometer 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
spectrophotometer ("CLARIOstar", BMG LABTECH, Germany). The calibration plot of the 
fluorescence intensity I from [MPO] is processed in the MS Excel 2002 program as the binomial 
function I = a [MPO] 2 + b [MPO] + c (the coefficient of determinism R2 normalized from 0 to 1). 
The activity of MPO in the samples was calculated taking into account the dilution of the sample 
and expressed as ng / ml of purified MPO. 
In order to optimize the methods for determining the activity of these enzyme, the conditions of 
sorption from plasma of blood on solid-phase immobilized antibodies, dissociation conditions of 
inhibitors will be studied when their activity is detected. The results obtained will be compared 
with the results of the determination using traditional methods of enzyme immunoassay. As a 
result, optimal protocols will be obtained for rapid tests to detect the activity of myeloperoxidase 
in blood plasma after immunosorption. 
Safety Analysis 
Adverse events (AEs)/serious AEs. 
Study Duration 
The date of the first subject inclusion – 15 September 2015. 
Estimated date of the last subject inclusion – May 2019 . 
Expected date of database closing – October 2019. 
Study report ready –2020 
Definitions 
Ischemic-Reperfusion Injury 
Myocardial ischemic – reperfusion injury defined as troponin I elevation after CABG hihgher than 
upper reference limit (URL) in patients who does not met current criteria for myocardial 
infarction 5 type diagnosis. 
Myocardial Infarction 5 Type 
Myocardial Infarction 5 type defined as a troponin I elevation heigher than 10 time 99th 
percentile URL with new Q-vawe onset (ECG) or new regional wall motion abnormality 
(echocardiography) or graft/new coronary artery occlusion (angioangiography). 
 Adverse Events 
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a 
preexisting medical condition in a clinical investigation of procedure and not necessarily have a 
causal relationship with this treatment. An AE can therefore be any unfavorable and unintended 
sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with 
the use of investigational procedure, whether or not considered related to the investigational 
procedure. 
The causal relationship to study drug is determined by a physician and should be used to assess 
all adverse events (AE). The casual relationship can be one of the following: 
Related: There is a reasonable causal relationship between study procedure and the AE. 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Not related: There is not a reasonable causal relationship between study procedure and the AE.  
The term "reasonable causal relationship" means there is evidence to suggest a causal 
relationship.  
Adverse events can be spontaneously reported or elicited during open-ended questioning, 
examination, or evaluation of a subject. (In order to prevent reporting bias, subjects should not 
be questioned regarding the specific occurrence of one or more AEs.) 
Serious Adverse Events 
A Serious Adverse Event (SAE):  
results in death is life-threatening (defined as an event in which the subject was at risk of death 
at the time of the event; it does not refer to an event which hypothetically might have caused 
death if it were more severe) requires inpatient hospitalization or causes prolongation of existing 
hospitalization (see NOTE below) results in persistent or significant disability/incapacity is a 
congenital anomaly/birth defect is an important medical event (defined as a medical event(s) 
that may not be immediately life-threatening or result in death or hospitalization but, based upon 
appropriate medical and scientific judgment, may jeopardize the subject or may require 
intervention [eg, medical, surgical] to prevent one of the other serious outcomes listed in the 
definition above.) Examples of such events include, but are not limited to, intensive treatment in 
an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that 
do not result in hospitalization.)  
Nonserious Adverse Events 
A nonserious adverse event is an AE not classified as serious. 
Laboratory Test Abnormalities 
All laboratory test results captured as part of the study should be recorded following institutional 
procedures. Test results that constitute SAEs should be documented and reported as such. 
Collection and reporting 
Nonserious Adverse Event Collection and Reporting 
The collection of nonserious AE information will begin at initiation of study. 
All nonserious adverse events (not only those deemed to be treatment-related) should be 
collected during the treatment period for a minimum of 365 days following the procedure.  
Serious Adverse Event Collection and Reporting 
Following the subject’s written consent to participate in the study, all SAEs, whether related or 
not related to study drug, must be collected. All SAEs must be collected that occur within 365 
days after procedure.  
SAEs, whether related or not related to study procedure, and pregnancies must be reported. SAEs 
must be recorded an approved form; SAE report should be sent within 24 hours. 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Pregnancy 
There will be no pregnancy cases.  
Other Safety Considerations 
Any 
significant 
worsening 
noted 
during 
interim 
or 
final 
physical 
examinations, 
electrocardiograms, x-rays, and any other potential safety assessments, whether or not these 
procedures are required by the protocol, should also be recorded as a nonserious or serious AE, 
as appropriate, and reported accordingly. 
ETHICAL CONSIDERATIONS. INFORMED CONSENT 
This study will be conducted in accordance with International Society for Pharmacoepidemiology 
(ISPE) Guidelines for Good Pharmacoepidemiology Practices (GPP), in accordance with Good 
Clinical Practice (GCP), as defined by the International Conference on Harmonisation (ICH) and in 
accordance with the ethical principles the Declaration of Helsinki of 2000, Russian version – 
September 20, 2002.  
The study will also be carried out in keeping with federal, state, and local laws, rules and 
regulations. 
The study will be conducted in compliance with the protocol. The protocol, any amendments, 
and the subject informed consent will receive Institutional Review Board/Independent Ethics 
Committee (IRB/IEC) approval/favorable opinion before initiation of the study. 
Investigators must ensure that subjects are clearly and fully informed about the purpose of the 
study in which they participate. Freely given written informed consent must be obtained from 
every subject before participation in the study and the Informed Consent Form (APPENDIX 1) 
should be signed. Two copies of the Informed Consent Form will be signed by the patient. One 
copy of the Informed Consent Form will be taken by the patient; another remains with the 
investigator and is placed in the records. The rights, safety, and well-being of the study subjects 
are the most important considerations and should prevail over interests of science and society. 
All subject names will be kept confidential. Subjects will be identified throughout documentation 
and evaluation by the Individual Identification code allotted to them during the study. The 
subjects will be told that all study findings will be handled in strictest confidence.  
DATA ANALYSIS 
Sample Size Justification  
Since it is exploratory study and no statistical hypotheses will be tested, sample size calculation 
was not conducted for this study. Thus, about 300 patients is planned to be included in the 
analysis.  
Baseline Characteristics 
Hypothesis: baseline characteristics are comparable between groups. 
Hypothesis testing: 
- 
Normality test (Kolmogorov-Smirnov test, Shapiro-Wilk test) 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Group comparing: 
 
Continuous variables 
- 
Non-normal distribution: Kruskal-Wallis test with adjustment for multiple 
comparisons 
- 
Normal distribution: t-test with multiple comparison adjustment  
Nominal variables 
- 
Chi-squared test/ Fisher’s exact test 
Baseline characteristics: 
Table 4 Baseline characteristics specification 
Characteristic 
Variable name in database Test 
Age 
Age 
t-test 
Gender 
Sex 
Chi-squared test/ exact 
Fisher’s test 
Syntax Score I  
SS1 
Kruskal-Wallis test 
Syntax Score II  
SS2 
Kruskal-Wallis test 
Euroscore II      
EII 
Kruskal-Wallis test 
Charlson/ Deyo Index 
ICD 
Kruskal-Wallis test 
Ejection Fraction  
EFPreOp 
Kruskal-Wallis test 
End diastolic volume 
EDVPreOp 
Kruskal-Wallis test 
End systolic volume 
ESVPreOp 
Kruskal-Wallis test 
Table 5 Baseline characteristics 
Variables 
off-pump CABG 
(N=181) 
on-pump CABG 
(N=128) 
pump-
assisted CABG 
(N=27) 
P Value 
Age in years 
 
 
 
0.7836* 
      Mean±SD 
63.5±7.3 
63.6±7.1 
64.3±8.9 
 
      Min–Max 
43.0–79.0 
33.0–80.0 
46.0–80.0 
 
      Median (IQR) 
63.0 (59.0–68.0) 64.0 (59.0–68.0) 
66.0 (58.0–
69.0) 
 
Syntax Score I 
 
 
 
0.3667** 
      Nmiss (%) 
1 (0.6) 
2 (1.6) 
1 (3.7) 
 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Variables 
off-pump CABG 
(N=181) 
on-pump CABG 
(N=128) 
pump-
assisted CABG 
(N=27) 
P Value 
      Mean±SD 
26.2±9.4 
27.4±7.7 
27.8±6.7 
 
      Min–Max 
2.0–61.0 
10.0–52.5 
14.0–43.5 
 
      Median (IQR) 
24.4 (22.0–31.8) 25.8 (22.0–31.5) 
27.0 (22.0–
33.0) 
 
Syntax Score II 
 
 
 
0.6002 
      Nmiss (%) 
1 (0.6) 
2 (1.6) 
1 (3.7) 
 
      Mean±SD 
41.7±11.6 
40.9±12.5 
43.5±11.6 
 
      Min–Max 
8.1–68.0 
3.7–68.3 
24.6–67.6 
 
      Median (IQR) 
41.4 (32.7–50.8) 42.3 (31.1–49.9) 
43.5 (34.5–
53.6) 
 
EuroScore I 
 
 
 
0.3137 
      Mean±SD 
1.4±1.3 
1.3±1.0 
1.4±1.4 
 
      Min–Max 
0.5–10.8 
0.5–5.5 
0.5–6.7 
 
      Median (IQR) 
1.0 (0.7–1.5) 
1.0 (0.6–1.5) 
0.8 (0.6–1.4) 
 
Index Charlson/Deyo 
 
 
 
0.1141 
      Nmiss (%) 
1 (0.6) 
 
 
 
      Mean±SD 
5.4±2.0 
5.0±1.8 
4.9±2.0 
 
      Min–Max 
1.0–11.0 
0.0–10.0 
2.0–10.0 
 
      Median (IQR) 
5.0 (4.0–7.0) 
5.0 (4.0–6.0) 
5.0 (4.0–6.0) 
 
Ejection Fraction before 
operation 
 
 
 
0.9090 
      Nmiss (%) 
1 (0.6) 
2 (1.6) 
 
 
      Mean±SD 
60.2±10.4 
60.9±8.5 
58.4±11.7 
 
      Min–Max 
30.0–85.0 
28.0–85.0 
30.0–72.0 
 
      Median (IQR) 
62.0 (55.0–67.0) 62.0 (59.0–66.0) 
63.0 (55.0–
65.0) 
 
End diastolic volume 
 
 
 
0.2187 
      Nmiss (%) 
5 (2.8) 
5 (3.9) 
 
 
      Mean±SD 
115.7±41.5 
115.7±34.8 
131.1±53.6 
 
      Min–Max 
11.0–270.0 
44.0–224.0 
81.0–367.0 
 
      Median (IQR) 
109.0 (91.0–
131.5) 
114.0 (90.0–
139.0) 
121.0 (101.0–
141.0) 
 
End Systolic Volume 
 
 
 
0.4178 
      Nmiss (%) 
5 (2.8) 
5 (3.9) 
 
 
      Mean±SD 
48.0±28.0 
46.8±23.0 
50.5±20.7 
 
      Min–Max 
11.0–178.0 
12.0–138.0 
23.0–107.0 
 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Variables 
off-pump CABG 
(N=181) 
on-pump CABG 
(N=128) 
pump-
assisted CABG 
(N=27) 
P Value 
      Median (IQR) 
40.5 (31.0–55.0) 43.0 (32.0–54.0) 
44.0 (38.0–
55.0) 
 
Gender 
 
 
 
0.6268*** 
                Male 
142 (78.5) 
95 (74.2) 
20 (74.1) 
 
                Female 
39 (21.5) 
33 (25.8) 
7 (25.9) 
 
 * ANOVA, ** Kruskal-Wallis test, Nmiss – number of missing values, SD – standard deviation, IQR 
– interquartile range, *** - Chi-squared test, CABG – coronary artery bypass grafting 
Primary endpoint analysis 
Hypothesis: MPO levels after procedure are different between groups. 
Hypothesis testing: 
- 
Normality test (Kolmogorov-Smirnov test, Shapiro-Wilk test) 
Group comparing: 
 
Continuous variables 
- 
Non-normal distribution: Kruskal-Wallis test with adjustment for multiple 
comparisons 
 
Table 6 Myeloperoxidase variables specifications 
Characteristic 
Variable name in database Test 
MPO level before 
procedure 
MPOPreOp 
Kruskal-Wallis test 
 
MPO level after 
procedure 
MPOPostOp 
Kruskal-Wallis test 
Table 7 Myeloperoxidase before and during coronary artery bypass grafting (CABG) 
Variables 
off-pump CABG 
(N=181) 
on-pump CABG 
(N=128) 
pump-assisted 
CABG 
(N=27) 
P 
Value* 
MPO before CABG 
 
 
 
0.2904 
      Nmiss (%) 
34 (18.8) 
21 (16.4) 
9 (33.3) 
 
      Mean±SD 
35.8±32.1 
39.9±30.6 
29.2±14.8 
 
      Min–Max 
2.8–237.8 
4.0–168.9 
5.6–65.4 
 
      Median (IQR) 
27.7 (17.0–41.0) 
31.0 (19.0–48.7) 
29.0 (18.7–34.0) 
 
MPO after CABG 
 
 
 
<.0001 
      Nmiss (%) 
28 (15.5) 
26 (20.3) 
13 (48.1) 
 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Variables 
off-pump CABG 
(N=181) 
on-pump CABG 
(N=128) 
pump-assisted 
CABG 
(N=27) 
P 
Value* 
      Mean±SD 
96.2±75.3 
210.9±138.7 
175.0±102.6 
 
      Min–Max 
9.1–410.3 
16.7–824.6 
63.4–374.5 
 
      Median (IQR) 
66.5 (41.3–135.8) 184.3 (135.0–250.0) 
144.7 (95.0–
284.9) 
 
* Kruskal-Wallis test, Nmiss – number of missing values, SD – standard deviation, IQR – 
interquartile range, CABG – coronary artery bypass grafting 
Ischemic – reperfusion injury analysis (MPO level) 
Hypothesis: MPO level after suture performing depends on length of operation, length of 
cardiopulmonary bypass, MPO level before procedure and associated with complications 
Method of hypothesis testing: ANCOVA 
ANCOVA model: LGMPOPostOp = LGMPOPreOp CPBTYPE LGMPOPreOp*CPBTYPE 
COMPLICATION AoClamp CPBTime OpTime 
Table 8 Variables description 
Variable 
Description 
Note 
LGMPOPostOp 
Logarithm of MPO level during 
CABG (after suture performing) 
Log – transformation for normal 
distribution 
LGMPOPreOp   
Logarithm of MPO level before 
CABG (after suture performing) 
Log – transformation for normal 
distribution 
CPBTYPE 
Group of intervention 
1 – off-pump CABG 
2 – on – pump CABG 
3 – pump-assisted CABG 
COMPLICATION Cumulative number of 
complications 
Ordinal variable 
AoClamp 
Length of aortic cross-clamping, 
min 
Continuous variable 
CPBTime 
Length of cardiopulmonary bypass, 
min  
Continuous variable 
OpTime 
Length of procedure, min 
Continuous variable 
* 
Interaction effect 
 
Table 9 Characteristics of model 
Source 
Sum of 
Squares  
df 
Mean 
Square 
F 
p 
Eta 
Square 
Model 
51.9 
9 
5.77 
12.13 
0.0001 
0.34 
 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Table 10 General linear model LGMPOPostOp = LGMPOPreOp CPBTYPE LGMPOPreOp*CPBTYPE 
COMPLICATION AoClamp CPBTime OpTime 
Source 
Sum of 
Squares 
(Type III) 
df 
Mean 
Square 
F 
p 
Partial Eta 
Squared 
LGMPOPreOp 
0.9 
1 
0.9 
0.2 
0.0001 
0.009 
CPBType 
6.2 
2 
3.1 
6.6 
0.0001 
0.06 
LGMPOPreOp*CPBTYPE 
3.5 
2 
1.7 
3.6 
0.0499 
0.03 
Complication 
0.02 
1 
0.02 
0.04 
0.6 
0.0002 
AoClamp 
0.03 
1 
0.03 
0.05 
0.3 
0.0002 
CPBTime 
0.05 
1 
0.05 
0.1 
0.1 
0.0004 
OpTime 
1.3 
1 
1.3 
2.8 
0.1 
0.01 
Ischemic – reperfusion injury analysis (TnI level 1st day after CABG) 
Hypothesis: TnI level 1st after CABG depends on length of operation, length of cardiopulmonary 
bypass, MPO level before procedure and just after suture performing 
Method of hypothesis testing: ANCOVA 
ANCOVA model: LGTnI1 = LGMPOPostOp LGMPOPreOp CPBTYPE LGMPOPreOp*CPBTYPE 
AoClamp CPBTime AoClamp*CPBTime OpTime CPBTime* OpTime AoClamp*OpTime 
Table 11 Variables descriptions 
Variable 
Description 
Note 
TnI1 
Troponin I level 1st day after 
procedure 
Continuous variable 
LGMPOPostOp 
Logarithm of MPO level during 
CABG (after suture performing) 
Log – transformation for normal 
distribution 
LGMPOPreOp   Logarithm of MPO level before 
CABG (after suture performing) 
Log – transformation for normal 
distribution 
CPBTYPE 
Group of intervention 
1 – off-pump CABG 
2 – on – pump CABG 
3 – pump-assisted CABG 
AoClamp 
Length of aortic cross-clamping, 
min 
Continuous variable 
CPBTime 
Length of cardiopulmonary bypass, 
min  
Continuous variable 
OpTime 
Length of procedure, min 
Continuous variable 
* 
Interaction effect 
 
 
 
Table 12 Characteristics of model 
Source 
Sum of 
Squares  
df 
Mean 
Square 
F 
p 
Eta 
Square 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Model 
249.3 
14 
17.8 
10.4 
0.0001 
0.44 
Table 13 General linear model characteristics LGTnI1 = LGMPOPostOp LGMPOPreOp CPBTYPE 
LGMPOPreOp*CPBTYPE AoClamp CPBTime AoClamp*CPBTime OpTime CPBTime* OpTime 
AoClamp*OpTime 
Source 
Sum of 
Squares 
(Type III) 
df 
Mean 
Square 
F 
p 
Partial Eta 
Squared 
LGMPOPostOp 
2.0 
1 
2.6 
1.2 
0.3 
0.006 
LGMPOPreOp 
0.8 
1 
0.8 
0.5 
0.5 
0.002 
AoClamp 
2.3 
1 
2.3 
1.4 
0.2 
0.007 
CPBTime 
2.2 
1 
2.2 
1.3 
0.3 
0.007 
OpTime 
23.3 
1 
23.3 
13.6 
0.0003 
0.07 
CPBType 
3.9 
2 
1.9 
1.1 
0.3 
0.01 
CPBTime*OpTime 
0.7 
1 
0.7 
0.4 
0.5 
0.002 
AoClamp*CPBTime 
0.4 
1 
0.4 
0.22 
0.6 
0.001 
AoClamp*OpTime 
3.5 
1 
3.5 
2.1 
0.2 
0.01 
LGMPOPostOp*CPBTYPE 
4.1 
2 
2.1 
1.2 
0.3 
0.01 
LGMPOPreOp*CPBTYPE 
0.4 
2 
0.2 
0.1 
0.9 
0.001 
Summary: troponin I level 1st day postoperatively depends on length of operation 
Ischemic – reperfusion injury analysis (TnI level 1st day after on – pump CABG) 
Hypothesis: TnI level 1st day after on-pump CABG depends on length of operation, length of 
cardiopulmonary bypass, MPO level before procedure and after suture performing 
Method of hypothesis testing: ANCOVA 
ANCOVA model: LGTnI1 = LGMPOPostOp LGMPOPreOp CPBTYPE LGMPOPreOp*CPBTYPE 
AoClamp CPBTime AoClamp*CPBTime OpTime CPBTime* OpTime AoClamp*OpTime 
Table 14 Variables description 
Variable 
Description 
Note 
TnI1 
Troponin I level 1st day after 
procedure 
Continuous variable 
LGMPOPostOp 
Logarithm of MPO level during 
CABG (after suture performing) 
Log – transformation for normal 
distribution 
LGMPOPreOp   Logarithm of MPO level before 
CABG (after suture performing) 
Log – transformation for normal 
distribution 
CPBTYPE 
Group of intervention 
1 – off-pump CABG 
2 – on – pump CABG 
3 – pump-assisted CABG 
AoClamp 
Length of aortic cross-clamping, 
min 
Continuous variable 
CPBTime 
Length of cardiopulmonary bypass, 
min  
Continuous variable 
OpTime 
Length of procedure, min 
Continuous variable 
* 
Interaction effect 
 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Table 15 Characteristics of model 
Source 
Sum of 
Squares  
df 
Mean 
Square 
F 
p 
Eta 
Square 
Model 
39.7 
8 
4.96 
5.4 
0.0001 
0.4 
Table 16 Characteristics of model LGTnI1 = LGMPOPostOp LGMPOPreOp CPBTYPE 
LGMPOPreOp*CPBTYPE AoClamp CPBTime AoClamp*CPBTime OpTime CPBTime* OpTime 
AoClamp*OpTime 
Source 
Sum of 
Squares 
(Type III) 
df 
Mean 
Square 
F 
p 
Partial Eta 
Squared 
LGMPOPostOp 
1.3 
1 
1.3 
1.4 
0.2 
0.02 
LGMPOPreOp 
3.9 
1 
3.9 
4.2 
0.04 
0.06 
AoClamp 
0.9 
1 
0.9 
1.0 
0.3 
0.02 
CPBTime 
7.4 
1 
7.4 
8.1 
0.006 
0.1 
OpTime 
3.4 
1 
3.4 
3.7 
0.06 
0.05 
CPBTime*OpTime 
0.01 
1 
0.1 
0.1 
0.8 
0.0009 
AoClamp*CPBTime 
5.5 
1 
5.5 
5.9 
0.02 
0.08 
AoClamp*OpTime 
1.6 
1 
1.6 
1.7 
0.2 
0.026 
Summary: troponin I level 1st day after on-pump CABG affected by length of cardiopulmonary 
bypass, preoperative MPO level and interaction of duration of aortic cross clamping and length 
of cardiopulmonary bypass. 
Ischemic – reperfusion injury analysis (TnI level 1st day after off – pump CABG) 
Hypothesis: TnI level 1st day after off-pump CABG depends on length of operation, MPO level 
before procedure and after suture performing 
Method of hypothesis testing: ANCOVA 
ANCOVA model: LGTnI1= LGMPOPostOp LGMPOPreOp OpTime 
Table 17 Variables description 
Variable 
Description 
Note 
TnI1 
Troponin I level 1st day after 
procedure 
Continuous variable 
LGMPOPostOp 
Logarithm of MPO level during 
CABG (after suture performing) 
Log – transformation for normal 
distribution 
LGMPOPreOp   Logarithm of MPO level before 
CABG (after suture performing) 
Log – transformation for normal 
distribution 
OpTime 
Length of procedure, min 
Continuous variable 
Table 18 Characteristics of model 
Source 
Sum of 
Squares  
df 
Mean 
Square 
F 
p 
Eta 
Square 
Model 
43.7 
3 
14.6 
7.0 
0.0002 
0.15 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Table 19 Characteristics of model LGTnI1= LGMPOPostOp LGMPOPreOp OpTime 
Source 
Sum of 
Squares 
(Type III) 
df 
Mean 
Square 
F 
p 
Partial Eta 
Squared 
LGMPOPostOp 
0.1 
1 
0.1 
0.06 
0.8 
0.0005 
LGMPOPreOp 
4.9 
1 
4.9 
2.36 
0.1 
0.02 
OpTime 
38.5 
1 
38.5 
18.58 
0.0001 
0.1 
Summary: troponin I level 1st day after on-pump CABG affected by length of operation. 
Ischemic – reperfusion injury analysis (TnI level 1st day after pump – assisted CABG) 
Hypothesis: TnI level 1st day after pump – assisted CABG depends on length of operation, MPO 
level before procedure and after suture performing and cardiopulmonary bypass. 
Method of hypothesis testing: ANCOVA 
ANCOVA model: LGTnI1= LGMPOPostOp LGMPOPreOp OpTime CPBType 
Table 20 Variables description 
Variable 
Description 
Note 
TnI1 
Troponin I level 1st day after 
procedure 
Continuous variable 
LGMPOPostOp 
Logarithm of MPO level during 
CABG (after suture performing) 
Log – transformation for normal 
distribution 
LGMPOPreOp   Logarithm of MPO level before 
CABG (after suture performing) 
Log – transformation for normal 
distribution 
OpTime 
Length of procedure, min 
Continuous variable 
CPBType 
Group of intervention 
1 – off-pump CABG 
2 – on – pump CABG 
3 – pump-assisted CABG 
 
Table 21 Characteristics of model 
Source 
Sum of 
Squares  
df 
Mean 
Square 
F 
p 
Eta 
Square 
Model 
3.7 
4 
0.9 
0.8 
0.6 
0.45 
Summary: TnI level 1st day after pump – assisted CABG does not depend on MPO level and 
length of cardiopulmonary bypass grafting. 
Hypothesis: Myeloperoxidase can predict death after CABG. 
Missing data handling: exclude from logistic regression model. 
Hypothesis testing: logistic regression model death=MPO 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Table 22 Logistic regression variables specification 
Characteristic 
Variable 
name 
in 
database 
Description 
Type of variable 
Death after CABG 
Death30 
Response 
Binary 
MPO level after CABG 
MPOPostOp 
Predictor 
Continuous  
Table 23 Logistic regression model Death = MPO after CABG 
 
Predictor 
 
β 
 
SE β 
 
Wald’s χ2 
 
df 
 
p 
 
eβ (odds ratio) 
 
Constant 
0.0047 
0.0022 
4.4592 
1 
0.0001 
0.0078 
MPOPostOp -4.8498 
0.7172 
45.7300 
1 
0.00347 1.0047 
 
Test 
 
 
χ2 
 
df 
 
p 
 
  Overall model evaluation 
 
 
 
 
  Likelihood ratio test 
3.33 
1 
0.0679 
 
  Score test 
5.3072 
1 
0.0347 
 
  Wald test 
4.4592 
1 
0.0347 
 
Goodness-of-fit test 
 
 
 
 
  Hosmer & Lemeshow 
9.14 
8 
0.3305 
 
 
 
 
 
 
Cox and Shnell R2 = 0.052, Nagelkerke R2 (Max rescaled R2) = 0.0726. Kendall’s Tau-a = 0.011.  
Goodman – Kruskal Gamma = 0.276. Sommer’s Dxy=0.27. c-statistics = 63.6%. All statistics 
reported herein use 4 decimal places in oder to maintain statistical precision. 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Table 24 ROC-curve for model death=MPO 
 
Missing data analysis 
Table 25 Missing data analysis 
MPOPostOp 
off-pump CABG 
(N=181) 
on-pump CABG 
(N=128) 
pump-assisted CABG 
(N=27) 
                 Present 153 (84.5) 
102 (79.7) 
14 (51.9) 
                 Missing 28 (15.5) 
26 (20.3) 
13 (48.1) 
CABG – coronary artery bypass grafting. 
Reason of missingness: laboratory test shows exceeding upper scale limit. Results could be 
biased. 
Hypothesis: postoperative MPO level too high to determine with current assay. 
Hypothesis testing: new clinical trial with larger number of patients could this hypothesis tested. 
Mechanism of missingness detecting 
Hypothesis: missingness due to severity of postoperative status. 
Hypothesis testing: logistic regression model missing data (MPOPostOp)= (complications + 
group) 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Table 26 Variables specification for missing data analysis 
Characteristic 
Variable 
name 
in 
database/ SAS-code 
Description 
Type of variable 
Complications 
Complication 
Summarize 
all 
complications 
Ordinal 
Group 
CPBType 
Grouping variable 
Ordinal  
Missing data (MPO 
level after CABG) 
MISSING 
MISSING=1 
when 
data omitted 
Binary 
MPO – myeloperoxidase, CABG – coronary artery bypass grafting. 
Table 27 Logistic regression model Missing data = complications 
 
Predictor 
 
β 
 
SE β 
 
Wald’s χ2 
 
df 
 
p 
 
eβ (odds ratio) 
 
Constant 
-3.6145 
0.5957 
36.8138 
1 
0.0001 0.02693 
Complication 
0.8242 
0.2453 
11.2900 
1 
0.0008 2.2801 
CPBType 
0.8871 
0.3168 
7.8406 
1 
0.0051 2.4282 
CPBType*Complication -0.2294 
0.1238 
3.4338 
 
0.0639 0.7950 
 
Test 
 
 
χ2 
 
df 
 
p 
 
 
Overall model evaluation 
 
 
 
 
  Likelihood ratio test 
39.0463 
3 
0.0001  
  Score test 
39.5144 
3 
0.0001  
  Wald test 
32.6207 
3 
0.0001  
Goodness-of-fit test 
 
 
 
 
  Hosmer & Lemeshow 
6.7779 
6 
0.3419  
Cox and Shnell R2 = 0.1097, Nagelkerke R2 (Max rescaled R2) = 0.1736. Kendall’s Tau-a = 0.15.  
Goodman – Kruskal Gamma = 0.505. Sommer’s Dxy=0.467 c-statistics = 0.734. All statistics 
reported herein use 4 decimal places in order to maintain statistical precision. 
Table 28 ROC - curve for model Missing data = complications 
 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Summary: Missing data can be classified as ‘missing not at random (MNAR)’.  
Bias estimation: underestimating predictive value of MPO.  
Missing data handling: exclude from logistic regression model. Missing data imputation is not 
applicable due to MNAR. 
Secondary Endpoint Analysis 
Hypothesis testing: 
- 
Normality test (Kolmogorov-Smirnov test, Shapiro-Wilk test) 
Group comparing: 
 
Continuous variables 
- 
Non-normal distribution: Kruskal-Wallis test with adjustment for multiple 
comparisons 
Table 29 Postoperative characteristics 
Variables 
off-pump 
CABG 
(N=181) 
on-pump 
CABG 
(N=128) 
pump-
assisted 
CABG 
(N=27) 
P 
Valu
e 
ICU days 
 
 
 
<.00
01* 
      Mean±SD 
2.5±2.2 
3.1±3.1 
3.3±1.9 
 
      Min–Max 
1.0–20.0 
1.0–26.0 
2.0–7.0 
 
      Median (IQR) 
2.0 (1.0–
2.0) 
2.0 (2.0–
3.0) 
2.0 (2.0–
5.0) 
 
Days in hospital after CABG 
 
 
 
0.00
66* 
      Mean±SD 
12.6±6.1 
13.6±5.5 
12.9±4.1 
 
      Min–Max 
0.0–50.0 
0.0–33.0 
3.0–25.0 
 
      Median (IQR) 
12.0 
(10.0–
13.0) 
13.0 (11.0–
15.0) 
13.0 (10.0–
15.0) 
 
Vasopressor and inotrope demand 
 
 
 
0.02
04* 
      Mean±SD 
0.1±0.5 
0.2±0.9 
0.2±0.5 
 
      Min–Max 
0.0–4.2 
0.0–8.4 
0.0–2.1 
 
      Median (IQR) 
0.0 (0.0–
0.1) 
0.0 (0.0–
0.1) 
0.0 (0.0–
0.1) 
 
Levosimendan demand 
 
 
 
0.02
20* 
      Mean±SD 
0.0±0.1 
0.2±1.8 
0.7±3.8 
 
      Min–Max 
0.0–0.8 
0.0–20.0 
0.0–20.0 
 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Variables 
off-pump 
CABG 
(N=181) 
on-pump 
CABG 
(N=128) 
pump-
assisted 
CABG 
(N=27) 
P 
Valu
e 
      Median (IQR) 
0.0 (0.0–
0.0) 
0.0 (0.0–
0.0) 
0.0 (0.0–
0.0) 
 
Lenght of pulmonary ventilation 
 
 
 
0.01
81* 
      Mean±SD 
1.2±1.2 
1.5±1.6 
1.4±0.7 
 
      Min–Max 
0.0–14.0 
0.0–13.0 
1.0–3.0 
 
      Median (IQR) 
1.0 (1.0–
1.0) 
1.0 (1.0–
1.0) 
1.0 (1.0–
2.0) 
 
ESV after CABG 
 
 
 
0.12
83* 
      Nmiss (%) 
22 (12.2) 
22 (17.2) 
3 (11.1) 
 
      Mean±SD 
42.7±23.5 
45.2±21.0 
50.9±32.2 
 
      Min–Max 
10.0–
149.0 
19.0–155.0 19.0–170.0 
 
      Median (IQR) 
37.0 
(27.0–
50.0) 
40.5 (31.0–
52.0) 
40.5 (34.0–
52.5) 
 
EDV after CABG 
 
 
 
0.05
08* 
      Nmiss (%) 
22 (12.2) 
22 (17.2) 
3 (11.1) 
 
      Mean±SD 
103.7±37.
7 
107.2±32.6 122.3±40.4 
 
      Min–Max 
41.0–
243.0 
44.0–212.0 73.0–222.0 
 
      Median (IQR) 
97.0 
(79.0–
122.0) 
106.0 
(81.0–
131.0) 
109.5 
(96.0–
136.5) 
 
EF after CABG 
 
 
 
0.98
20* 
      Nmiss (%) 
22 (12.2) 
21 (16.4) 
4 (14.8) 
 
      Mean±SD 
59.6±10.3 
59.8±7.7 
60.5±12.3 
 
      Min–Max 
29.0–86.0 
28.0–73.0 
23.0–88.0 
 
Median (IQR) 
61.0 (54.0–66.0) 61.0 (58.0–65.0) 
60.0 (55.0–67.0) 
 
End Systolic Volume 
 
 
 
0.41
78* 
      Nmiss (%) 
5 (2.8) 
5 (3.9) 
 
 
      Mean±SD 
48.0±28.0 
46.8±23.0 
50.5±20.7 
 
      Min–Max 
11.0–
178.0 
12.0–138.0 23.0–107.0 
 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Variables 
off-pump 
CABG 
(N=181) 
on-pump 
CABG 
(N=128) 
pump-
assisted 
CABG 
(N=27) 
P 
Valu
e 
      Median (IQR) 
40.5 
(31.0–
55.0) 
43.0 (32.0–
54.0) 
44.0 (38.0–
55.0) 
 
Low Cardiac Output Syndrome 
 
 
 
0.39
45* 
                 No 
166 (91.7) 113 (88.3) 
26 (96.3) 
 
                 Yes 
15 (8.3) 
15 (11.7) 
1 (3.7) 
 
Reoperation Cardio 
 
 
 
0.83
61** 
                 No 
176 (97.2) 126 (98.4) 
27 (100) 
 
                 Yes 
5 (2.8) 
2 (1.6) 
 
 
Reoperation non cardio 
 
 
 
0.07
40** 
                 No 
177 (97.8) 119 (93.0) 
27 (100) 
 
                 Yes 
4 (2.2) 
9 (7.0) 
 
 
Kidney Damage 
 
 
 
<.00
01** 
  Cr< URL 
130 (71.8) 
52 (40.6) 
17 (63.0) 
 
  Cr> 25% URL 
49 (27.1) 
70 (54.7) 
7 (25.9) 
 
Hemodialisys 
2 (1.1) 
6 (4.7) 
3 (11.1) 
 
Atrial fibrillation 
 
 
 
0.07
84** 
                 No 
155 (85.6) 101 (78.9) 
19 (70.4) 
 
                 Yes 
26 (14.4) 
27 (21.1) 
8 (29.6) 
 
Multiorgan dysfunction after CABG 
 
 
 
0.00
17** 
                 No 
179 (98.9) 116 (90.6) 
25 (92.6) 
 
                 Yes 
2 (1.1) 
12 (9.4) 
2 (7.4) 
 
Infection or leukocytosis or febril >7 days 
 
 
 
0.86
34** 
                 No 
166 (91.7) 117 (91.4) 
26 (96.3) 
 
                 Yes 
15 (8.3) 
11 (8.6) 
1 (3.7) 
 
Bleeding after CABG 
 
 
 
0.00
14** 
                 No 
178 (98.3) 114 (89.1) 
26 (96.3) 
 
                 Yes 
3 (1.7) 
14 (10.9) 
1 (3.7) 
 
Graft thrombosis within 30d after CABG 
 
 
 
0.82
95** 
                 No 
175 (96.7) 122 (95.3) 
26 (96.3) 
 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Variables 
off-pump 
CABG 
(N=181) 
on-pump 
CABG 
(N=128) 
pump-
assisted 
CABG 
(N=27) 
P 
Valu
e 
                 Yes 
6 (3.3) 
6 (4.7) 
1 (3.7) 
 
Pulmonary dysfunction after CABG 
 
 
 
0.04
92** 
                 No 
171 (94.5) 117 (91.4) 
21 (80.8) 
 
                 Yes 
10 (5.5) 
11 (8.6) 
5 (19.2) 
 
Neurological complications within 30d after 
CABG 
 
 
 
0.03
22** 
                 No 
175 (96.7) 124 (96.9) 
23 (85.2) 
 
                 Yes 
6 (3.3) 
3 (2.3) 
3 (11.1) 
 
Death within 30d after CABG 
 
 
 
0.25
45** 
                 No 
177 (97.8) 121 (94.5) 
27 (100) 
 
                 Yes 
4 (2.2) 
7 (5.5) 
 
 
Intestinal complications within 30d after CABG 
 
 
 
0.27
73** 
                 No 
180 (99.4) 127 (99.2) 
26 (96.3) 
 
                 Yes 
1 (0.6) 
1 (0.8) 
1 (3.7) 
 
* Kruskal-Wallis test, ** exact Fisher’s test. Nmiss – number of missing values, SD – standard 
deviation, IQR – interquartile range, CABG – coronary artery bypass grafting 
Table 30 Troponin I level after CABG 
Variables 
off-pump 
CABG 
(N=181) 
on-pump CABG 
(N=128) 
pump-assisted 
CABG 
(N=27) 
P 
Value 
TnI before CABG 
 
 
 
0.0938 
      Nmiss (%) 
145 (80.1) 
99 (77.3) 
19 (70.4) 
 
      Mean±SD 
0.0±0.1 
0.0±0.1 
0.0±0.0 
 
      Min–Max 
0.0–0.5 
0.0–0.2 
0.0–0.1 
 
      Median (IQR) 
0.0 (0.0–0.0) 
0.0 (0.0–0.0) 
0.0 (0.0–0.1) 
 
TnI 1st day 
 
 
 
<.0001 
      Nmiss (%) 
17 (9.4) 
10 (7.8) 
1 (3.7) 
 
      Mean±SD 
2.5±8.9 
6.0±10.3 
4.7±7.3 
 
      Min–Max 
0.0–98.0 
0.0–93.0 
0.3–31.1 
 
      Median (IQR) 
0.4 (0.2–1.0) 
3.1 (1.8–6.3) 
1.4 (0.7–6.8) 
 
TnI 2st day 
 
 
 
<.0001 
      Nmiss (%) 
104 (57.5) 
39 (30.5) 
9 (33.3) 
 
      Mean±SD 
3.5±8.2 
3.9±7.9 
4.5±5.9 
 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Variables 
off-pump 
CABG 
(N=181) 
on-pump CABG 
(N=128) 
pump-assisted 
CABG 
(N=27) 
P 
Value 
      Min–Max 
0.0–50.0 
0.0–50.0 
0.2–18.8 
 
      Median (IQR) 
0.4 (0.2–2.1) 
1.5 (0.7–3.4) 
0.9 (0.4–6.1) 
 
TnI 3st day 
 
 
 
0.1936 
      Nmiss (%) 
149 (82.3) 
90 (70.3) 
21 (77.8) 
 
      Mean±SD 
3.4±7.4 
2.5±2.8 
4.8±4.5 
 
      Min–Max 
0.1–40.7 
0.1–14.6 
0.5–10.9 
 
      Median (IQR) 
1.1 (0.2–3.5) 1.4 (0.6–3.5) 
2.6 (1.9–
10.0) 
 
TnI 4st day 
 
 
 
0.3843 
      Nmiss (%) 
168 (92.8) 
108 (84.4) 
22 (81.5) 
 
      Mean±SD 
5.4±7.5 
2.3±3.0 
2.7±3.2 
 
      Min–Max 
0.0–27.9 
0.1–10.7 
0.2–8.3 
 
      Median (IQR) 
3.2 (1.3–7.5) 0.9 (0.4–2.6) 1.5 (1.4–2.0) 
 
TnI 5st day 
 
 
 
0.2222 
      Nmiss (%) 
158 (87.3) 
106 (82.8) 
23 (85.2) 
 
      Mean±SD 
1.5±2.1 
0.9±1.4 
2.4±1.9 
 
      Min–Max 
0.0–6.6 
0.0–5.9 
0.5–4.9 
 
      Median (IQR) 
0.3 (0.0–2.5) 0.4 (0.1–0.8) 2.2 (1.2–3.7) 
 
 
Table 30 Troponin I level after CABG in patients without low cardiac output syndrome after CABG 
 
 
Variables 
off-pump CABG 
(N=166) 
on-pump CABG 
(N=113) 
pump-assisted 
CABG 
(N=26) 
P Value 
MPO before operation 
 
 
 
0.3871 
      Nmiss (%) 
27 (16.3) 
18 (15.9) 
9 (34.6) 
 
      Mean±SD 
36.0±32.6 
38.8±29.5 
29.0±15.3 
 
      Min–Max 
2.8–237.8 
4.1–168.9 
5.6–65.4 
 
      Median (IQR) 
28.1 (16.4–40.6) 30.8 (19.3–47.7) 
28.7 (18.7–34.0) 
 
MPO after operation 
 
 
 
0.3871 
      Nmiss (%) 
27 (16.3) 
18 (15.9) 
9 (34.6) 
 
      Mean±SD 
36.0±32.6 
38.8±29.5 
29.0±15.3 
 
      Min–Max 
2.8–237.8 
4.1–168.9 
5.6–65.4 
 
      Median (IQR) 
28.1 (16.4–40.6) 30.8 (19.3–47.7) 
28.7 (18.7–34.0) 
 
TnI before CABG 
 
 
 
0.0403 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Variables 
off-pump 
CABG 
(N=181) 
on-pump CABG 
(N=128) 
pump-assisted 
CABG 
(N=27) 
P 
Value 
      Nmiss (%) 
134 (80.7) 
89 (78.8) 
18 (69.2) 
 
      Mean±SD 
0.0±0.1 
0.0±0.1 
0.0±0.0 
 
      Min–Max 
0.0–0.5 
0.0–0.2 
0.0–0.1 
 
      Median (IQR) 
0.0 (0.0–0.0) 
0.0 (0.0–0.0) 
0.0 (0.0–0.1) 
 
TnI 1st day 
 
 
 
<.0001 
      Nmiss (%) 
14 (8.4) 
8 (7.1) 
1 (3.8) 
 
      Mean±SD 
1.1±2.6 
4.1±4.0 
4.1±7.0 
 
      Min–Max 
0.0–18.5 
0.0–18.7 
0.3–31.1 
 
      Median (IQR) 
0.4 (0.2–0.7) 
2.5 (1.7–5.0) 
1.4 (0.7–2.7) 
 
TnI 2st day 
 
 
 
<.0001 
      Nmiss (%) 
100 (60.2) 
37 (32.7) 
9 (34.6) 
 
      Mean±SD 
1.9±4.7 
2.3±3.0 
3.9±5.5 
 
      Min–Max 
0.0–29.8 
0.0–15.0 
0.2–18.8 
 
      Median (IQR) 
0.3 (0.1–1.0) 
1.2 (0.6–2.5) 
0.9 (0.4–5.9) 
 
TnI 3st day 
 
 
 
0.0828 
      Nmiss (%) 
140 (84.3) 
84 (74.3) 
21 (80.8) 
 
      Mean±SD 
1.4±2.0 
1.8±1.8 
3.5±3.7 
 
      Min–Max 
0.1–9.2 
0.1–6.5 
0.5–10.0 
 
      Median (IQR) 
0.6 (0.2–2.1) 
1.1 (0.5–2.9) 
2.3 (1.9–3.0) 
 
TnI 4st day 
 
 
 
0.6389 
      Nmiss (%) 
158 (95.2) 
99 (87.6) 
21 (80.8) 
 
      Mean±SD 
2.6±3.1 
2.0±2.7 
2.7±3.2 
 
      Min–Max 
0.0–9.1 
0.1–8.3 
0.2–8.3 
 
      Median (IQR) 
1.6 (0.3–4.1) 
0.8 (0.4–2.6) 
1.5 (1.4–2.0) 
 
TnI 5st day 
 
 
 
0.0541 
      Nmiss (%) 
149 (89.8) 
96 (85.0) 
22 (84.6) 
 
      Mean±SD 
0.8±1.6 
0.7±1.0 
2.4±1.9 
 
      Min–Max 
0.0–5.8 
0.0–3.8 
0.5–4.9 
 
      Median (IQR) 
0.1 (0.0–0.9) 
0.3 (0.1–0.8) 
2.2 (1.2–3.7) 
 
 
Table 31: Troponin I level in patients with low cardiac output syndrome after CABG 
 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
Variables 
off-pump CABG 
(N=15) 
on-pump 
CABG 
(N=15) 
pump-assisted 
CABG 
(N=1) 
P Value 
MPO before 
operation 
 
 
 
0.7362 
      Nmiss (%) 
7 (46.7) 
3 (20.0) 
 
 
      Mean±SD 
32.8±22.1 
48.8±38.3 
32.7± 
 
      Min–Max 
8.2–76.7 
4.0–115.2 
32.7–32.7 
 
      Median (IQR) 
25.8 (17.5–45.3) 
37.4 (16.3–
76.8) 
32.7 (32.7–32.7) 
 
MPO after 
operation 
 
 
 
0.7362 
      Nmiss (%) 
7 (46.7) 
3 (20.0) 
 
 
      Mean±SD 
32.8±22.1 
48.8±38.3 
32.7± 
 
      Min–Max 
8.2–76.7 
4.0–115.2 
32.7–32.7 
 
      Median (IQR) 
25.8 (17.5–45.3) 
37.4 (16.3–
76.8) 
32.7 (32.7–32.7) 
 
TnI before CABG 
 
 
 
0.8065 
      Nmiss (%) 
11 (73.3) 
10 (66.7) 
1 (100) 
 
      Mean±SD 
0.0±0.0 
0.0±0.0 
± 
 
      Min–Max 
0.0–0.1 
0.0–0.0 
– 
 
      Median (IQR) 
0.0 (0.0–0.0) 0.0 (0.0–0.0) 
(–) 
 
TnI 1st day 
 
 
 
0.8742 
      Nmiss (%) 
3 (20.0) 
2 (13.3) 
 
 
      Mean±SD 
20.0±27.0 
21.0±24.8 
17.6± 
 
      Min–Max 
0.2–98.0 
2.6–93.0 
17.6–17.6 
 
      Median (IQR) 
13.0 (4.8–20.6) 
13.8 (9.7–
18.0) 
17.6 (17.6–17.6) 
 
TnI 2st day 
 
 
 
0.6954 
      Nmiss (%) 
4 (26.7) 
2 (13.3) 
 
 
      Mean±SD 
13.1±15.9 
13.4±16.9 
14.7± 
 
      Min–Max 
0.0–50.0 
1.2–50.0 
14.7–14.7 
 
      Median (IQR) 
8.0 (2.6–15.2) 
5.1 (4.0–
14.1) 
14.7 (14.7–14.7) 
 
TnI 3st day 
 
 
 
0.2275 
      Nmiss (%) 
9 (60.0) 
6 (40.0) 
 
 
      Mean±SD 
11.7±14.6 
4.7±4.2 
10.9± 
 
      Min–Max 
2.1–40.7 
0.6–14.6 
10.9–10.9 
 
      Median (IQR) 
5.4 (4.0–
12.3) 
3.8 (2.0–5.1) 
10.9 (10.9–10.9) 
 
TnI 4st day 
 
 
 
0.1441 

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG 
(ClinicalTrials.gov Identifier: NCT03050489). Corresponding author: Bunenkov Nikolay 
bunenkov2006@gmail.com +7-950-028-17-40 
Date of the document 06 December 2016 
 
      Nmiss (%) 
10 (66.7) 
9 (60.0) 
1 (100) 
 
      Mean±SD 
9.9±10.5 
3.2±3.8 
± 
 
      Min–Max 
1.3–27.9 
0.4–10.7 
– 
 
      Median (IQR) 
7.5 (4.3–8.4) 
2.4 (0.7–2.6) 
(–) 
 
TnI 5st day 
 
 
 
0.0679 
      Nmiss (%) 
9 (60.0) 
10 (66.7) 
1 (100) 
 
      Mean±SD 
3.5±2.3 
1.7±2.4 
± 
 
      Min–Max 
0.8–6.6 
0.0–5.9 
– 
 
      Median (IQR) 
2.9 (2.0–6.2) 
0.6 (0.4–1.7) 
(–) 
 
 
References 
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