Comparison of Anatomical and Clinical Scores in Predicting Outcomes in Primary Percutaneous Coronary Intervention

Abstract

Background:

Different scores based on anatomical and/or clinical features have been developed for risk stratification of patients undergoing percutaneous coronary intervention (PCI). Studies comparing the ability of these different models in predicting major adverse cardiac and cerebrovascular events (MACCE) in patients submitted to primary PCI are limited.

Objectives:

The aim of this study was to compare the ability of the scores SYNTAX (SS), Clinical SYNTAX (CSS), ACEF, and modified ACEF (ACEF_Mod) to predict MACCE in patients with ST-elevation myocardial infarction (STEMI) submitted to primary PCI.

Methods:

We analyzed 311 consecutive patients with STEMI submitted to primary PCI between April/2011 and December/2015. The area under the ROC curve was calculated to evaluate the ability of these scores in predicting MACCE. P-values were considered significant at < 0.05.

Results:

Mean age of the patients was 60.2 ± 12.0 years, 35.4% were females, and 22.5% had diabetes. MACCE occurred in 23.8% of the patients. The area under the ROC curve was 0.586 (p = 0.028) for ACEF, 0.616 (p = 0.003) for SS, 0.623 (p = 0.002) for ACEF_Mod, and 0.658 (p < 0.001) for CSS. In multivariate analysis, only high SS (p = 0.011) and CSS (p = 0.002) were independent predictors of MACCE.

Conclusions:

High SS and CSS were independent predictors of MACCE. In our cohort of STEMI patients undergoing primary PCI, pure anatomical SS calculated at the baseline coronary angiography was a useful tool to predict MACCE. (Int J Cardiovasc Sci. 2017; [online].ahead print, PP.0-0)

Keywords:
Myocardial Infarction; Percutaneous Coronary Intervention; Coronary Artery Disease; Probability

Resumo

Fundamento:

Diferentes escores baseados em variáveis anatômicas e/ou clínicas têm sido desenvolvidos para estratificação de risco em pacientes submetidos à intervenção coronariana percutânea (ICP). Estudos comparando a capacidade desses modelos na predição de eventos cardíacos e cerebrovasculares adversos maiores (ECCAM) em pacientes submetidos à ICP primária são escassos.

Objetivo:

O objetivo desse estudo foi o de comparar os escores SYNTAX (SS), Clinical SYNTAX (CSS), ACEF e ACEF modificado (ACEF_Mod) na predição de ECCAM em pacientes com infarto agudo do miocárdico com supradesnivelamento do segmento ST (IAMCSST) submetidos à ICP primária.

Métodos:

Foram analisados 311 pacientes consecutivos com IAMCSST submetidos a ICP primária entre abril/2011 e dezembro/2015. As áreas sob a curva característica de operação do receptor (ROC) foram calculadas para avaliar a habilidade desses escores em predizer ECCAM. O nível de significância adotado em todos os testes foi de 5%.

Resultados:

Os pacientes apresentaram idade média de 60,2 ± 12,0 anos, 35,4% eram do sexo feminino e 22,5% eram diabéticos. A ocorrência de ECCAM foi observada em 23,8% dos participantes. A área sob a curva ROC foi 0,586 (p = 0,028) para ACEF, 0,616 (p = 0,003) para SS, 0,623 (p = 0,002) para ACEF_Mod e 0,658 (p < 0,001) para CSS. Na análise multivariada, apenas SS (p = 0,011) e CSS (p = 0,002) foram preditores independentes de ECCAM.

Conclusões:

SS e CSS elevados foram preditores independentes de ECCAM. Em nossa coorte de pacientes com IAMCSST submetidos à ICP primária, o SS calculado à cineangiocoronariografia inicial mostrou-se uma ferramenta útil para predizer ECCAM. (Int J Cardiovasc Sci. 2017; [online].ahead print, PP.0-0)

Palavras-chave:
Infarto do Miocárdio; Intervenção Coronária Percutânea; Doença da Artéria Coronariana; Probabilidade.

Introduction

Different scores based on anatomical and/or clinical features have been developed for risk stratification of patients undergoing percutaneous coronary intervention (PCI). However, studies comparing the ability of these different models to predict cardiac events in patients submitted to primary PCI are limited.

The SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) score (SS)¹ was developed as part of the SYNTAX² trial with the objective of characterizing and objectively quantifying the severity and extent of coronary artery disease.³ SS is broadly used to stratify the outcomes of elective PCI in left main and multivessel coronary intervention when compared with coronary artery bypass grafting (CABG). Recent studies have utilized this tool to stratify outcomes after primary PCI but are limited by short duration of follow-up or small numbers of patients.⁴-¹²

Age, creatinine and ejection fraction (ACEF)¹³ score appears to be equivalent to more complex scores in predicting mortality in patients undergoing elective CABG. This score has also been applied in patients submitted to PCI to stratify risk of mortality and myocardial infarction (MI).¹¹,¹⁴-¹⁶ Modified ACEF score (ACEF_Mod) considers creatinine clearance (CrCl) as a semicontinuous variable, representing a better estimate of the underlying renal function compared with serum creatinine. This modification improves the predictive accuracy of ACEF in patients undergoing PCI.¹⁷

Combining clinical and anatomical variables in the same score provides a better performance in risk stratification.³ The Clinical SYNTAX score (CSS) incorporates ACEF_Mod to SS and is able to predict major adverse cardiac and cerebrovascular events (MACCE) in patients with complex coronary artery disease.¹⁵ However, limited number of studies have evaluated the role of this score in patients undergoing PCI.¹¹,¹²,¹⁵

Risk stratification is a relevant issue in patients undergoing PCI after MI.¹⁶The aim of this study was to compare SS, CSS, ACEF, and ACEF_Mod in predicting MACCE in patients with ST-elevation MI (STEMI) undergoing primary PCI.

Methods

This cohort study included consecutive patients with STEMI undergoing primary PCI between April/2011 and December/2015 in a tertiary university hospital in southern Brazil. STEMI was defined as a typical chest pain at rest associated with ST-segment elevation of at least 1 mm in two contiguous leads in the frontal plane or 2 mm in the horizontal plane, or typical pain at rest in patients with a new, or presumably new, left bundle-branch block. Exclusion criteria were previous CABG (excluded in the SYNTAX trial²), absence of admission laboratory testing or echocardiogram, and lack of 30-day follow-up. The study was approved by the institution's Research and Ethics Committee and informed consent was obtained from all patients.

All patients were pretreated with a loading dose of acetylsalicylic acid (300 mg) and clopidogrel (600 mg). Unfractioned heparin was used during the procedure (70-100 IU/kg). Use of IIb/IIIa glycoprotein, aspirative thrombectomy, and PCI technical strategies (i.e., predilation, direct stent placement, postdilation) were performed according to the operator's choice. Coronary flow before and after the procedure was assessed and described according to the Thrombolysis in Myocardial Infarction (TIMI) criteria.¹⁸ Anticoagulants were suspended after the end of the procedure, and double antiplatelet therapy was recommended for 12 months after the event.

SS was derived from the sum of individual scores for each separate lesion (defined as > 50% stenosis in vessels > 1.5 mm). Full details on the SS calculation are reported elsewhere.¹ ACEF was computed as follows: (age/left ventricle ejection fraction) + 1 if serum creatinine value was > 2 mg/dL.¹³ In ACEF_Mod, 1 point was added for every 10 mL/min reduction in CrCl < 60 mL/min/1.73 m² (up to a maximum of 6 points).¹⁵ Therefore, a CrCl between 50 to 59 mL/min/1.73 m², 40 to 49 mL/min/1.73 m², and 30 to 39 mL/min/1.73 m² would receive 1, 2, and 3 points, respectively. CSS was calculated retrospectively for each patient using the following formula: CSS = SS x ACEF_Mod.¹⁵ We determined cutoff values for the scores above to define them as low or high risk. These cutoff values were obtained by multiplying sensitivity and specificity of each value within the receiver operator characteristic (ROC) curve of the different scores; the value with the highest product (sensitivity X specificity) was established as the cutoff point.

Blood samples were collected by venipuncture before the procedure, as part of routine patient care. CrCl was estimated according to the Modification of Diet in Renal Disease (MDRD) equation. Left ventricular ejection fraction (LVEF) was determined before patient discharge using transthoracic echocardiography and applying either Simpson (in the presence of segmental dysfunction) or Teicholz method.

Clinical follow-up was performed with either outpatient visit or telephone contact. MACCEs were defined as death from all cause, new MI, stroke, Canadian Cardiovascular Society (CCS) class III/IV angina, or rehospitalization for congestive heart failure 30 days after the primary PCI. New MI was defined as recurrent chest pain with ST-segment elevation or new Q waves and increase in serum biomarkers after their initial decrease. Stroke was defined as a new, sudden-onset focal neurological deficit of presumably cerebrovascular cause, irreversible (or resulting in death), and not caused by other readily identifiable causes.

Statistical analysis

Continuous variables are expressed as mean (± standard deviation) or median (interquartile range). Categorical variables are represented by relative and absolute frequencies. ROC curves were used to evaluate the discriminatory power of the different scores. Comparison of ROC curves was performed by DeLong test using the software R, version 3.1.2. Patients groups were compared using independent samples Student's t test (for normally distributed variable) or Mann-Whitney U test (for other variables) for continuous variables and χ² test or Fisher's exact tests for categorical variables. Multivariate analysis was performed by multiple logistic regression. P-values were considered significant at < 0.05. Data were analyzed using Statistical Package for the Social Sciences (SPSS), version 18.0.

Results

We included 311 (78.3%) of the 397 patients who underwent primary PCI for STEMI in the analyzed period. Mean age was 60.2 ± 12.0 years, 35.4% were women, and 22.5% had diabetes. LVEF was < 40% in 18.3%, and estimated CrCl was < 60 mL/min/1.73 m² in 21.9% of the patients. Complete demographic data are described in Table 1.

Table 1
Demographic data

Variable	n = 311
Age (years)	60.2 ± 12.0
Female sex	110 (35.4)
Hypertension	196 (63.0)
Diabetes	70 (22.5)
Current smoking	161 (51.8)
Previous MI	27 (8.7)
Previous stroke	20 (6.4)
Killip 3 or 4	35 (11.3)
Creatinine > 2 mg/dL	12 (3.9)
Previous ASA use	70 (22.5)
LVEF (%)	50.9 ± 13.1
SYNTAX score	15.5 (10.0-21.5)
Clinical SYNTAX score	19.0 (10.0-35.7)
ACEF score	1.19 (0.94-1.55)
Modified ACEF score	1.21 (0.95-1.88)

• Abbreviations: MI: myocardial infarction; ASA: acetylsalicylic acid; LVEF: left ventricular ejection fraction. Data are presented as number (%), mean (± standard deviation) or median (interquartile range).

Complete procedure-related data are shown in Table 2. The incidence of MACCE at 30 days was 23.8%, as detailed in Table 3.

Table 2
Procedural data

Variable	n = 311
Pain-to-door time (hours)	4 (3.00-6.75)
Door-to-balloon time(minutes)	68 (55.0-90.0)
Cardiac arrest	24 (7.7)
Total AV block	20 (6.4)
IABP	10 (3.2)
Radial access	178 (57.2)
Anterior MI	140 (45.0)
Culprit vessel
LAD artery	131 (42.1)
Right coronary artery	112 (36.0)
Circumflex artery	38 (12.2)
Other vessels	30 (9.7)
Three-vessel disease	63 (20.3)
Thrombus aspiration	115 (37.0)
DES	12 (3.9)
Postprocedural TIMI 3	277 (89.1)
Abciximab use	134 (43.1)
Contrast volume (mL)	180 (150-250)
Implanted stents	1.29 ± 0.68
Treated lesions	1.19 ± 0.52

• Abbreviations: AV: atrioventricular; IABP: intraaortic balloon pump; MI: myocardial infarction; LAD: left anterior descending; DES: drug‑eluting stent; TIMI: Thrombolysis in Myocardial Infarction. Data are presented as number (%), mean (± standard deviation) or median (interquartile range).

Table 3
In-hospital and 30-day MACCE

MACCE	n (%)
In-hospital death	31 (9.3)
In-hospital reinfarction	9 (2.7)
Stent thrombosis	6 (1.8)
In-hospital stroke	4 (1.2)
30-day death	35 (10.5)
30-day CCS 3-4 angina	17 (5.1)
30-day rehospitalization for CHF	14 (4.2)
30-day reinfarction	13 (3.9)
30-day stroke	5 (1.5)
30-day MACCE	74 (23.8)

• Abbreviations: MACCE: major adverse cardiac and cerebrovascular events; CCS: Canadian Cardiovascular Society; CHF: congestive heart failure. Data are presented as number (%).

ROC curves are presented in Figure 1. All curves were statistically significant, and the CSS curve had the largest area under the curve (AUC): CSS > ACEF_Mod > SS > ACEF. However, when the AUCs were compared two-by-two with DeLong test, there was no statistically significant differences, except in the comparison of ACEF versus CSS (p = 0.02) (Figure 2).

Figure 1
Receiver operating characteristic (ROC) curves. Abbreviations: AUC: area under the curve; CI: confidence interval.

Figure 2
P-values (DeLong test) for two-by-two comparisons of the areas under the curve (AUCs) among prediction scores.

Univariate analysis of MACCE according to high or low risk score values (cutoff point determination previously described in the Methods section) showed that high-risk CCS, SS, ACEF, and ACEF_Mod were significantly associated with higher MACCE rates (p < 0.001, p < 0.001, p < 0.002, and p < 0.040, respectively). Other clinical variables associated with MACCE in univariate analysis were age > 65 years (p = 0.007), female sex (p = 0.041), Killip 3 or 4 (p < 0.001), and postprocedural TIMI 0-2 (p = 0.006). When adjusted by these variables, only SS and CSS remained independent predictors of MACCE (Table 4).

Table 4
Multivariate analysis of the incidence of MACCE according to high or low score values

Scores	n	MACCE n (%)	p-value	Adjusted OR (95% CI)	Adjusted p-value
SYNTAX ≥ 18.25	Yes: 116	39 (33.6)	0.002	2.11 (1.19-3.74) *	0.011*
	No: 190	33 (17.4)
Clinical SYNTAX ≥ 26.0	Yes: 115	43 (37.4)	< 0.001	2.49 (1.39-4.44)†	0.002†
	No: 162	29 (15.2)
ACEF ≥ 1.235	Yes: 138	41 (29.7)	0.040	1.35 (0.77-2.37)†	0.297†
	No: 173	33 (19.1)
Modified ACEF ≥ 1.505	Yes: 107	38 (35.5)	0.001	1.35 (0.77-2.37)†	0.079†
	No: 204	36 (17.6)

• Abbreviations: OR: odds ratio; CI: confidence interval.
• ^*
  Adjusted for age > 65 years, female sex, Killip 3 or 4, and postprocedural TIMI 0-2.
• ^†
  Adjusted for female sex, Killip 3 or 4, and postprocedural TIMI 0-2.

Discussion

We assessed in the present study the ability of SS, CSS, ACEF, and ACEF_Mod in predicting MACCE in STEMI patients undergoing primary PCI. Our data showed that CSS had the largest AUC; however, when compared two-by-two, the AUC for CSS was only statistically larger than that for ACEF. When we divided the scores between low and high risk, high-risk SS and CSS emerged as independent MACCE predictors; high-risk ACEF and ACEF_Mod were predictors of MACCE in univariate analysis, but this association was lost after adjustment for clinical variables.

The prognostic value of the ACEF score in patients who underwent PCI after acute MI was assessed by Lee et al.,¹⁶ who analyzed 12,000 patients in this setting. The ACEF was significantly higher in nonsurvivors (1.95 ± 0.82 versus 1.28 ± 0.50, p < 0.001) and was an independent predictor of 1-year mortality (HR, p < 0.001). Capodanno et al.¹⁷ have demonstrated that including CrCl (calculated either by MDRD or Cockcroft-Gault) in ACEF yields superior calibration compared with the original serum creatinine-based equation, and improves the predictive accuracy of ACEF in patients undergoing PCI. In our analysis, despite having a larger area under the ROC curve compared with ACEF and SS, ACEF_Mod was not an independent predictor MACCE.

The use of SS, originally developed in patients with stable coronary disease, has also been evaluated in acute coronary syndromes for outcome prediction.⁴-¹² In a study including 807 patients with STEMI, Garg et al.⁵ identified SS as an independent predictor of mortality, MACCE, and stent thrombosis up to a 1-year follow-up. However, it is important to highlight that the study was not performed aiming to define cutoff points for the analyzed scores to predict MACCE, but only to define the relationship of SS with MACCE occurrence. The same author showed an improvement in the ability of the SS to predict MACCE and mortality in patients undergoing PCI by combining SS and ACEF_Mod, (CSS).¹⁵ This improvement was also observed in the present study.

The use of CSS in patients with STEMI was evaluated in two studies,¹¹,¹² which showed an improved outcome prediction accuracy compared with SS. Cetinkal et al.¹¹ recently evaluated 433 patients in this setting with the objective of validating CSS as a predictor of prognosis, and also evaluated SS and ACEF. The primary endpoint was a composite of all-cause mortality, MI, and cerebrovascular events, with a follow-up of 15 months. CSS > 26 was identified as an independent predictor of events. The AUC was 0.66 (p < 0.001), 0.59 (p = 0.01), and 0.64 (p < 0.001) for CSS, SS, and ACEF, respectively. However, all cases were performed by femoral access and there was an extremely low mortality in patients with low/moderate CSS (one death over 285 patients in a 15-month follow-up), which jeopardizes the external validity of the study.

Girasis et al.¹²analyzed 848 patients undergoing PCI with drug-eluting stents (only 25.3% were patients with STEMI) and demonstrated that both SS and CSS were able to stratify risk of very long-term adverse clinical outcomes. The AUC for the incidence of MACCE was 0.61 (95% CI: 0.56-0.65) and 0.62 (95% CI: 0.57-0.67), respectively. Nevertheless, it is important to highlight the small proportion of patients with STEMI and the lower anatomical complexity compared with our patients [median SS 10.0 (6-16) versus 15.5 (10.0-21.5) in the present study]. Also of note, use of drug-eluting stent in all STEMI patients is a distant reality in developing countries.

There are some limitations in our study. First, the retrospective design may have influenced the quality and consistency of the collected data. Second, the relatively small number of patients may have reduced the power of the study to detect some associations. Third, the fact that the study was conducted at a single center may also be considered a limitation.

Conclusion

SS and CSS were independent MACCE predictors in this study. In our cohort of primary PCI in patients with STEMI, pure anatomical SS calculated at baseline coronary angiography was a useful tool in predicting short-term MACCE.

• Sources of Funding
  There were no external funding sources for this study.
• Study Association
  This study is not associated with any thesis or dissertation work.
• Ethics approval and consent to participate
  This study was approved by the Ethics Committee of the do Hospital de Clínicas de Porto Alegre (HCPA) under the protocol number 15-0557. All the procedures in this study were in accordance with the 1975 Helsinki Declaration, updated in 2013. Informed consent was obtained from all participants included in the study.

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Publication Dates

• Publication in this collection
  23 Oct 2017
• Date of issue
  Jan-Feb 2018

History

• Received
  13 Apr 2016
• Reviewed
  05 June 2017
• Accepted
  07 June 2017