Article, Cardiology

Development and validation of clinical risk score to predict the cardiac rupture in patients with STEMI

a b s t r a c t

Background: Cardiac rupture (CR) is a fatal complication of ST-elevation myocardial infarction with poor prognosis. The aim of this study was to develop and validate practical risk score to predict the CR after STEMI. Methods: A total of 11,234 STEMI patients from 7 centers in China were enrolled in our study, we firstly developed a simplified fast-track CR risk model from 7455 STEMI patients, and then prospectively validated the CR risk model using receiver-operating characteristic (ROC) curves by the other 3779 consecutive STEMI patients. This trial is registered with ClinicalTrials.gov, number NCT02484326.

Results: The incidence of CR was 2.12% (238/11,234), and the thirty-day mortality in CR patients was 86%. We de- veloped a risk model which had 7 independent baseline Clinical predictors (female sex, advanced age, anterior myocardial infarction, delayed admission, heart rate, elevated white blood cell count and anemia). The CR risk score system differentiated STEMI patients with incidence of CR ranging from 0.2% to 13%. The risk score system demonstrated good predictive value with area under the ROC of 0.78 (95% CI 0.73-0.84) in validation cohort. Pri- mary percutaneous coronary intervention decreased the incidence of CR in High risk group (3.9% vs. 6.2%, p b 0.05) and very high risk group (8.0% vs. 15.2%, p b 0.05).

Conclusions: A simple risk score system based on 7 baseline clinical variables could identify patients with high risk of CR, for whom appropriate treatment strategies can be implemented.

(C) 2016

Introduction

Cardiac rupture (CR) is an uncommon but fatal complication of ST- elevation myocardial infarction (STEMI). Along with the development of Primary percutaneous coronary intervention and medication therapy, CR still constitutes the important cause of in-hospital mortality in the acute phase of STEMI [1-3]. The risk stratification plays an impor- tant role in the prevention of CR. Independent risk factors of CR reported from literature include Female gender, advanced age, lower blood pres- sure, higher heart rate, delayed admission and thrombolysis [4-7]. How- ever, there is still lack of an effective and practical CR risk stratification model so far. This study was designed to develop and validate a risk pre- diction model to identify patients with high risk of CR.

? This research was supported by Chinese PLA General Hospital, Beijing, China (2016FC- TSYS-1001).

* Corresponding author.

E-mail addresses: [email protected], [email protected] (Y. Chen).

1 These authors contributed to the work equally and should be regarded as co-first authors.

Methods

Study population

Our research enrolled a total of 11,234 consecutive STEMI patients who were admitted from January 2012 to January 2013 from 7 centers (Chinese People’s Liberation Army General Hospital, Beijing An-Zhen Hospital, Beijing Fu-Wai Hospital, Beijing Chao-Yang Hospital, Shanghai Zhong-shan Hospital, Shanghai Hua-shan Hospital and Sichuan West China Hospital). CR occurred in 238 of these patients (133 with free wall rupture, 80 with ventricular septal rupture, and 25 with Papillary muscle rupture). We retrospectively analyzed 7455 STEMI patients to build a logistic regression risk model. In the second part of our study, we prospectively validated the Risk scoring system in the other 3779 consecutive patients admitted for STEMI during a subsequent 6- month period. Our second part of research is a prospective observation- al study to validate our prediction risk score for CR, and the principal in- clusion criterion is STEMI: Patients who presented with STEMI within 24 h were potentially eligible for the study. The principal exclusion criteria included: b 18 years old; complicated with malignant tumor; re- fused to participate in observational study. The study was approved by

http://dx.doi.org/10.1016/j.ajem.2016.12.033 0735-6757/(C) 2016

the Institutional Review Board and Ethics Committee of Chinese People’s Liberation Army General Hospital and performed in conformity with good clinical practice. Written informed consent was provided by all patients before enrolment. We followed up patients in validation co- hort for three month to observe the CR events. This trial is registered with ClinicalTrials.gov, number NCT02484326.

Definitions

Diagnosis of STEMI was based on the concurrence of symptoms (chest pain or symptoms compatible with acute heart failure or unex- plained syncope) and electrocardiogram findings (new onset left bun- dle branch block; ST-segment elevation >= 1 mm in >= 2 inferior leads or

>= 2 mm in >= 2 precordial leads). The diagnosis of free wall rupture was based on necropsy or clear clinical evidence (Pericardial tamponade or electromechanical dissociation accompanied with Massive pericardial effusion and diagnostic pericardiocentesis confirmed bloody fluid). The diagnosis of ventricular septal rupture and papillary muscle rupture were established by autopsy or the emergence of systolic murmurs ac- companied with the evidence of echocardiography. CR events were judged by the independent event committee, and 34% of the cardiac rupture patients were diagnosed by autopsy. Time-to-hospital admis- sion was defined as the time between the onset of sustained chest pain and admission to the emergency department of the medical insti- tutions. The presence and severity of heart failure at the time of initial presentation was categorized by the Killip classification. Infarct site was confirmed by the results of electrocardiogram and echocardiogra- phy. The definitions in our study were according to the European society of cardiology (ESC) guidelines for acute myocardial infarction in pa- tients presenting with ST-segment elevation [8].

Treatment and laboratory examination

STEMI patients chewed 300 mg aspirin and 600 mg clopidogrel in the emergency department, followed by oral 100 mg aspirin and 75 mg clopidogrel daily for at least 12 months. STEMI patients received Low Molecular Weight Heparin , ?-blockers, and Angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) according to the ESC STEMI guideline [8], unless there were con- traindications to these drugs. Peripheral blood samples were collected from patients within 2 h of admission for blood routines and blood bio- chemistry. White blood cell counts and level of hemoglobin were assessed with automated cell counters via standard techniques (Coulter SH-750, Coulter Electronics and Sysmex SE-9500, TOA Medical Elec- tronics, Kobe, Japan).

Compliance with ethics guidelines

All procedures followed were in accordance with the ethical stan- dards of the responsible committee on human experimentation (insti- tutional and national) and with the Helsinki Declaration of 1975, as revised in 2008. Informed consent was obtained from all enrolled pa- tients. The study was approved by the Chinese People’s Liberation Army General Hospital’s Human Ethics Committee.

Statistical analysis

Variables following a normal distribution were expressed as mean +- standard deviations (SD). Variables following a non-normal distribution were expressed as median (interquartile range). The means of normally distributed variables were compared using the

Fig. 1. Flow diagram for prospective observational study. We categorized the patients into five risk groups on the basis of the cardiac rupture risk score and followed up for 3-month period to validate the risk scoring system. A total of 3779 STEMI patients completed the observational study. STEMI: ST-elevation myocardial infarction.

Student’s t-test. For comparisons of the distributions of variables be- tween groups, Chi-square or Fisher exact tests was used. The Mann- Whitney U test was used for variables with non-normal distribution. The development risk score model was formed by identifying predictors of CR based on the clinical variables. The associations between variable and CR were evaluated using bivariate logistic regression analyses. Can- didate predictors with a value of p b 0.05 were eligible into stepwise multivariate logistic regression to build the CR risk model (stepwise re- gression hazards analysis with backward selection). Numeric clinical variables were made binary using cutoff points in order to find a simple, convenient scoring method to be derived from them. We estimated the ability of the model to discriminate between patients with and without CR using the area under the receiver-operating characteristic (ROC). All statistical analyses were performed using SPSS statistical software (ver- sion 18.0; SPSS, Inc., Chicago, Ill., USA). Statistical significance was set at p b 0.05.

Results

Incidence and prognosis of CR

In development cohort, the total of 7455 STEMI patients had a medi- an age of 62 years, with 79% male, and CR occurred in 158 patients with the incidence was 2.12% (1.18% in free wall rupture; 0.71% in ventricular septal rupture; 0.21% in papillary muscle rupture). Patients who experi- enced CR had significantly higher in-hospital mortality compared with those who did not (136/158, 86.1% vs. 374/7297, 5.1%; p b 0.001). Only 12.0% CR patients received cardiac surgery or transcatheter clo- sure, and mortality significantly declined in patients with operation (52.6% vs. 90.6%; p b 0.001). There were a total of 510 patients in devel- opment set died during the acute phase of STEMI with early mortality of 6.84%. Of all dead patients, CR constituted the second common cause of early mortality (26.7%, 136/510), while pump failure was the first cause of early mortality in patients with STEMI in our research (60.4%, 308/ 510). A total of 3779 patients in the validation cohort completed the ob- servational study and included in primary analysis (Fig. 1). Compared with the patients (n = 7455) in the development set, patients in the validation set (n = 3779) had no significant difference in the baseline characteristics. CR incidences were no significant differences between the development set and validation set (2.12% vs. 2.12%, p = 0.889), as well as the mortality for thirty-day (6.84% vs. 6.83%, p = 0.792).

Predictors of CR

Univariate analysis showed that age, gender, hypertension, current smoking, heart rate, systolic blood pressure, Killip class, anterior myo- cardial infarction, hemoglobin level, count of white blood cell, time to admission, initial random glucose, eGFR were all significantly associated with CR in the development cohort (all p b 0.01; Table 1). These vari- ables were entered into the multivariable logistic regression analysis, and multivariable regression analysis showed independent predictors of CR: advanced age (>= 65 years, OR 1.58, 95% CI 1.18-2.11; p b 0.01), fe- male gender (OR 2.10, 95% CI 1.56-2.82; p b 0.001), anterior myocardial infarction (OR 1.48, 95% CI 1.08-2.01; p b 0.05), time-to-hospital admis- sion (>= 12 h, OR 1.99, 95% CI 1.51-2.63; p b 0.001), heart rate on admis- sion (>= 80 bpm, OR 2.20, 95% CI 1.65-2.93; p b 0.001), count of white blood cell (>= 10 x 109/l, OR 2.57, 95% CI 1.95-3.40; p b 0.001) and hemo- globin on admission (<= 120 g/l, OR 2.84, 95% CI 2.08-3.89; p b 0.001)

(Table 2).

Development and validation for risk model of CR

To calculate risk score, we assigned each of the seven variables a number of points that were proportional to its regression coefficient in multivariate analysis to develop the risk score (Table 3). The total risk score for an individual patient is the sum of all points, and CR

incidence gradually increases with the increase of total CR risk score in the derivation cohort (Fig. 2). The patients were categorized into five groups based on the risk score: Very low risk group (risk score 0- 2), low risk group (risk score 3-5), moderate risk group (risk score 6- 8), high risk group (risk score 9-11) and very high risk group (risk score N 11). The incidence of CR in patients with very low risk, low risk, moderate risk, high risk and very high risk in the development set were 0.24%, 0.80%, 2.03%, 5.36% and 12.84%, respectively. In the val- idation cohort, the incidence of CR also gradually increased across five risk groups (0.47%, 0.72%, 1.64%, 5.48% and 13.48%, respectively; p for trend b 0.001), in which the rate of CR increased more than tenfold (0.47% vs. 13.48%) from the very low group to the very high risk group. Fig. 3 and Table 4 indicated good ability of risk model to predict the incidence of CR. The area under the ROC for CR risk model in the val- idation cohort was 0.78 (95% CI 0.73-0.84), and risk model was able to identify the patients with high risk of CR.

The treatment of lowering the risk of CR

In retrospective study by total of 11,234 STEMI patients according to CR risk stratification, the incidence of CR was decreased if given ?- blockers as compared with no-?-blocker medications in high risk group (4.5% vs. 7.8%, p b 0.05). The incidence of CR significantly de- creased with Primary PCI in high risk group (3.9% vs. 6.2%) and very high risk group (8.0% vs. 15.2%, both p b 0.05, Fig. 4). intra-aortic balloon pump (IABP) was also associated with the decreased occurrence of CR for patients in high risk group (3.7% vs. 6.3%, p b 0.05).

Discussion

The current incidence of CR reported in the literature is between 1% and 4% in STEMI patients, and CR is increasingly rare in the primary PCI era, but mortality of CR remains high [9-11]. It is reported that STEMIs in

Table 1

Clinical characteristics and treatments in 7455 STEMI patients with and without cardiac rupture.

Variables

CR group

Control group

p value

(n = 158)

(n = 7297)

Male (%)

90 (57.0%)

5794 (79.4%)

b0.001

Age (years)

67 +- 10

61 +- 13

b0.001

BMI (kg/m2)

25.0 +- 3.9

25.0 +- 3.6

0.994

Hypertension (%)

104 (65.8%)

3984 (54.6%)

0.006

Diabetes mellitus (%)

37 (23.4%)

1766 (24.2%)

0.851

Hypercholesterolemia (%)

35 (22.2%)

1270 (17.4%)

0.079

Current smoking (%)

58 (36.7%)

3904 (53.5%)

b0.001

Anterior myocardial infarction (%)

91 (57.6%)

3420 (46.9%)

0.007

SBP (mm Hg)

111 +- 21

123 +- 22

b0.001

DBP (mm Hg)

71 +- 14

73 +- 14

0.092

Heart rate (bpm)

91 +- 20

77 +- 16

b0.001

Killip class III or IV (%)

75 (47.5%)

1590 (21.8%)

b0.001

Initial white blood cell (109/l)

10.8 +- 4.6

9.4 +- 3.7

b0.001

Initial hemoglobin (g/l)

122 +- 20

133 +- 20

b0.001

Time from onset to admission (h)

16 +- 20

9 +- 11

b0.001

Initial random glucose (mmol/l)

9.9 +- 4.9

8.2 +- 3.7

b0.001

Initial LDL-c (mmol/l)

2.75 +- 1.12

2.67 +- 0.78

0.474

eGFR (ml/min)

64 +- 26

84 +- 27

b0.001

Left ventricular ejection fraction (%)

42 +- 11

45 +- 11

b0.001

All cause mortality for thirty-day (%)

136 (86.1%)

374 (5.1%)

b0.001

Aspirin + Thienopyridine (%)

147 (93.0%)

6830 (93.6%)

0.168

?-Blocker (%)

108 (68.4%)

5852 (80.2%)

b0.001

ACEI/ARB (%)

65 (41.1%)

3488 (47.8%)

0.009

IABP (%)

19 (12.0%)

1072 (14.7%)

0.151

Primary PCI(%)

57 (36.1%)

5086 (69.7%)

b0.001

Thrombolysis (%)

25 (15.8%)

719 (9.85%)

0.016

STEMI: ST-elevation myocardial infarction; BMI: body mass index; SBP: systolic blood pressure; DBP: diastolic blood pressure; LDL-c: low density lipoprotein cholesterol; eGFR: estimated glomerular filtration rate; ACEI/ARB: angiotensin converting enzyme in- hibitors or angiotensin receptor blockers; IABP: intra-aortic balloon pump; PCI: percutane- ous coronary intervention.

Table 2 univariate and multivariate analyses of clinical characteristics for cardiac rupture patients in derivation cohort.

Univariate analysis Multivariate analysis

p

p

Variables

OR

95% CI

value

OR

95% CI

value

Age >= 65 years

2.33

1.79-3.03

b 0.001

1.58

1.18-2.11

0.002

Female gender

2.96

2.28-3.83

b 0.001

2.10

1.56-2.82

b0.001

Heart rate >= 80 bpm

2.93

2.23-3.83

b 0.001

2.20

1.65-2.93

b0.001

Anterior myocardial

1.71

1.32-2.22

b 0.001

1.48

1.08-2.01

0.011

infarction

Hemoglobin <= 120 g/l

3.45

2.60-4.58

b 0.001

2.84

2.08-3.89

b0.001

Count of white blood cell

>= 10 x 109/l

2.26

1.74-2.93

b 0.001

2.57

1.95-3.40

b0.001

Time to admission >= 12 h

2.56

1.97-3.32

b 0.001

1.99

1.51-2.63

b0.001

China always didn’t receive reperfusion therapy because of delay admis- sion, and the proportion of patients in China who didn’t receive primary PCI did not significantly change in the last ten years in China [12], and low proportion of reperfusion therapy induced the high incidence of CR in China.

Clinical prediction models for cardiovascular disease such as GRACE and Crusade risk score have been extensively used in clinical practice to predict adverse events and identify patients who may benefit from specific interventions [13,14], however there are few studies on CR events risk stratification. It is important to develop an early, accurate and effective risk model for STEMI patients to prevent CR. In our study, we have explored some new risk factors [15,16], and given the STEMI patients overall CR risk assessment. We further emphasized both anemia and higher white blood cell count on the risk stratification for CR events. Clinical studies have found more severe inflammation in- filtration and myocardial hemorrhage in hearts of patients who devel- oped CR than non-CR patients [1,9,18,19]. More sever inflammation infiltration is associated with higher white blood cell count, while myo- cardial hemorrhage is associated with anemia. Most of the previous studies explored independent risk factors of CR by retrospective analy- sis, while the second part of our study was a prospective observational study to validate our CR risk model. The prospective observational study indicated good ability of our fast-track risk model to discriminate between patients who did and didn’t have CR.

Our study is consistent with the treatment status of STEMI in China [12], and clinical feature of CR patients in our study is similar with com- monalities among CR patients as reported [17]. CR was the important

Fig. 2. Incidence of cardiac rupture by risk score in the derivation cohort. Cardiac rupture incidence increases with the increase of cardiac rupture risk score.

cause of early death for STEMI in China, while pump failure was the first cause of early mortality in STEMIs in our research, which is similar with other research [20]. It is more important to prevent than to treat this fatal complication, and risk stratification plays an important role in the prevention of CR. Our fast-track risk model for CR is an easy- memorized checklist for junior medical staff. This scoring system could be applied to identify the high risk CR patients and make benefi- cial treatments decisions for CR prevention. We also compared our CR risk score with traditional GRACE risk score, the area under the ROC curve in our risk score was more than GRACE risk model (0.78 vs. 0.73), and therefore our CR risk score was superior to the GRACE score to predict CR. Our study has showed the patients with high risk of CR (risk score >= 9) could benefit from use of ?-blocker for CR prevention. Primary PCI was also found associated with obvious reduction in inci- dence of CR in high risk group (risk score 9-11) and very high risk group (risk score N 11), and incidence of CR in the western country de- clined progressively in parallel with progressive use of primary PCI [21]. We firstly found IABP therapy could further prevent CR event in high risk patients (risk score >= 9), but his is just a correlation in the ret- rospective analysis, and effective prevention for CR should be further established by prospective randomized controlled trial. Such knowledge

Table 3

clinical risk scores for cardiac rupture base on development cohort.

Score value

Age

>= 65 years

2

b65 years

0

Female

Yes

2

No

0

Heart rate

>= 80 bpm

2

b80 bpm

0

Anterior myocardial infarction Yes

1

No

0

Hemoglobin

<= 120 g/l

3

N 120 g/l

0

White blood cell count

>= 10 x 109/l 3

b10 x 109/l 0

Time-to-hospital admission

>= 12 h 2

b12 h 0

Fig. 3. Incidence of cardiac rupture in both validation cohort and development cohort according to the risk score. Cardiac rupture incidences are similar between development set and validation set in different risk group according to the risk model.

Table 4

Distribution by risk scores and cardiac rupture incidence in development and validation groups.

study design, data collection, analysis, interpretation. The authors de- clare that there is no any potential conflict of interest.

Development set Validation set

Risk score

Patients

CR

case

CR incidence (%)

Patients

CR

case

CR incidence (%)

0

309

1

0.32

169

1

0.59

1

326

0

0

186

0

0

2

620

2

0.32

278

2

0.72

3

831

5

0.60

408

2

0.49

4

816

6

0.74

369

3

0.81

5

970

10

1.03

479

4

0.84

6

897

14

1.56

478

4

0.84

7

779

15

1.92

368

7

1.90

8

680

20

2.94

374

9

2.41

9

401

9

2.24

236

8

3.39

10

383

27

7.05

218

14

6.42

11

186

16

8.60

75

7

9.33

12

127

11

8.66

61

5

8.20

13

95

13

13.68

51

7

13.72

14

14

2

14.28

14

2

14.28

15

21

7

33.33

15

5

33.33

CR: cardiac rupture.

will help facilitate personalized decision-making for patients who are at high risk of CR.

There are still some study limitations in this study. Although the pro- posed risk scoring system had adequate performance as assessed by comparison of actual and predicted rates of CR, the risk score was pro- spectively validated only in seven centers in China, and further external validation of this risk score is required to evaluate its predictive value in large-scale prospective studies. CR is a rare complication of STEMI, path- ological diagnosis is the golden criteria of the CR event, but in our study 34% of patients with cardiac rupture were diagnosed by autopsy, the other was recognized by clinical and echocardiography.

Conclusions

A simple risk score system based on 7 baseline clinical variables could identify patients with high risk of CR, for whom appropriate treat- ment strategies can be implemented.

Funding sources

This research was supported by Chinese PLA General Hospital, Pe- king, China. The funding source (2016FC-TSYS-1001) had no role in

Fig. 4. Association between primary PCI and cardiac rupture. The incidence of cardiac rupture is decreased if given primary PCI as compared with no primary PCI in low risk group (0.8% vs. 0.9%), moderate risk group (1.7% vs. 2.2%), high risk group (3.9% vs. 6.2%) and very high risk group (8.0% vs. 15.2%). PCI: percutaneous coronary intervention.

Acknowledgments

We wish to thank all patients who participated in the study. We sin- cerely thank MD. Changzhong Chen (Dana-Farber Cancer Institute, Bos- ton, Massachusetts, USA), Yuejin Yang (Beijing Fu-Wai Hospital, Beijing, China) and Xinchun Yang (Beijing Chao-Yang Hospital, Beijing, China) for providing valuable statistical analysis for this study.

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