Journal of Cardiovascular Nursing
Vol. 30, No. 4, pp 351Y359 x Copyright B 2015 Wolters Kluwer Health, Inc. All rights reserved.
Depression and Anxiety as Predictors of Recurrent Cardiac Events 12 Months After Percutaneous Coronary Interventions Jin-Hee Park, PhD, RN; Seung-Jea Tahk, PhD, MD; Sun Hyoung Bae, PhD, RN Background: Anxiety and depression are associated with recurrent cardiac events after percutaneous coronary interventions (PCIs). However, few investigators have evaluated the impact of depression and anxiety on recurrent cardiac events in Korea. Objective: The aim of this study was to examine the relationship among depression, anxiety, and recurrent cardiac events in Korean patients with coronary artery disease (CAD) after PCI. Methods: A prospective longitudinal study was undertaken with a sample of 133 CAD patients with PCI. Data were collected between August 2009 and September 2010, and patients were followed after discharge through 2011 with self-report questionnaires on anxiety and depression using the Hospital Anxiety and Depression Scale and with patient medical records on sociodemographic and clinical characteristics. Recurrent cardiac events were collected for 12 months after discharge and were assessed by patient interviews and medical records. Results: There were 18 recurrent cardiac events (13.5%) among the 133 participants. After adjustment for sociodemographic and clinical characteristics, a hierarchical Cox proportional hazards regression model found that a moderate or severe level of anxiety (hazard ratio, 6.21; 95% confidence interval, 1.64Y23.54) and a moderate or severe level of depression (hazard ratio, 4.32; 95% confidence interval, 1.35Y13.88) were independent predictors of recurrent cardiac events. Conclusions: Patients with CAD who have a high level of anxiety and depression are at increased risk for recurrent cardiac events after PCI. Screening should be focused on patients who experience anxious and depressive feelings in addition to traditional risk factors. Furthermore, psychoeducational support interventions to reduce anxiety and depression after PCI may improve health outcomes. KEY WORDS:
anxiety, coronary artery disease, depression, percutaneous coronary intervention, recurrence
C
oronary artery disease (CAD) is 1 of the leading causes of morbidity and mortality worldwide.1 Coronary artery disease is 1 of the leading causes of death in Korea, and its incidence has increased from 35.3 in 100 000 individuals in 2003 to 45 in 100 000 individuals in 2009.2 Percutaneous coronary intervention (PCI) has become a more frequently used treatment Jin-Hee Park, PhD, RN Associate Professor, College of Nursing, Ajou University, Suwon, Gyeonggi-Do, Republic of Korea.
Seung-Jea Tahk, PhD, MD Professor, School of Medicine, Department of Cardiology, Ajou University, Suwon, Gyeonggi-Do, Republic of Korea.
Sun Hyoung Bae, PhD, RN Assistant Professor, College of Medicine, Department of Nursing, Dong-A University, Busan, Republic of Korea. This work was supported by Basic Science Research Program through the National Research Foundation of Korea funded by the Ministry of Education, Science and Technology (2009-0065948). The authors have no conflicts of interest to disclose.
Correspondence Sun Hyoung Bae, PhD, RN, College of Medicine, Department of Nursing, Dong-A University, Gudeok Campus, Dongdaesin-dong 3(sam)-ga, Seo-gu, Busan, Republic of Korea ([email protected]). DOI: 10.1097/JCN.0000000000000143
than coronary artery bypass graft (CABG) for CAD3 because PCI is safe and effective and is a less expensive revascularization procedure.4 The Korean Registry of Myocardial Infarction data showed that primary PCI was performed in 91.6% of ST elevation myocardial infarction (STEMI) patients, and early revascularization was performed in 63.3% of non-STEMI patients.3 The use of drug-eluting stents (DESs), in which medications such as sirolimus or paclitaxel are applied to bare-metal stents (BMSs), has been reported to reduce rates of restenosis or stent thrombosis compared with BMS.4 Restenosis rates were reduced from 30%Y40%4 to 5%Y10% at 6 months and to 15% or less within 12 months in patients who underwent PCI with DES.4Y8 However, restenosis and stent thrombosis still pose clinical problems.9 Moreover, recurrence of cardiac events has been associated with increased cardiac mortality.9 Therefore, most PCI patients should receive appropriate pharmacological therapy and an effort should be made to control the risk factors of CAD to prevent recurrent cardiac events.9,10 The growing body of evidence confirms that in patients with CAD, comprehensive risk factor management reduces risk as assessed by a variety 351
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352 Journal of Cardiovascular Nursing x July/August 2015 of outcomes, including improved survival, reduced recurrent events, decreased need for revascularization procedures, and improved quality of life.10,11 Numerous studies have identified the risk factors for CAD and recurrent cardiac events. Age, gender, hypertension (HTN), dyslipidemia, diabetes mellitus (DM), obesity, smoking, family history (FHx), and stress have been universally accepted as the traditional risk factors for CAD.10,11 In addition, nontraditional risk factors, such as the serum level of high-sensitivity C-reactive protein (hsCRP)12,13 and angiographic severity,13,14 have been considered predictors of adverse cardiovascular outcomes among patients with CAD after PCI. Highsensitivity C-reactive protein is an acute-phase reactant and a nonspecific marker for inflammation. Highsensitivity C-reactive protein may affect immunity and lead to plaque deposition, which raises the risk of restenosis after coronary stenting.12,13 Angiographic severity of CAD, such as diameter and lesion length, has also been considered a risk factor of recurrent cardiac events. It is known that longer lesions and smaller vessels correlate with higher restenosis and major adverse cardiac event rates in PCI patients.13,14 However, these risk factors do not fully explain the development and progression of CAD.15 Although the importance of psychosocial factors in the development and expression of CAD has been debated, extensive recent literature over the past decades16Y28 has shown that psychosocial factors are related to cardiac morbidity and mortality. Depression and anxiety, in particular, are significantly associated with negative cardiac outcomes in CAD.29Y31 Depression is a common problem in patients after acute cardiac events.15,29,31 Research has demonstrated that patients who are depressed in the weeks after an acute coronary syndrome or during hospitalization after PCI have a poor cardiac outcome.16,19,23,24,26,28,29 Several studies have demonstrated that depression is associated with a 2- to 4-fold increase in risk of adverse health outcomes in patients undergoing coronary revascularization,17,24,28 independently of traditional risk factors, although counterexamples exist.20,21 This link between depression and cardiac morbidity most likely involves both physiologic and behavioral effects of depression. Depression has been linked to dysregulation of serotonergic pathways, platelet abnormalities, inflammation, autonomic nervous system dysfunction, vascular changes, and nutritional deficiencies.29,31 Furthermore, depressed patients are less likely to practice health-related behaviors, such as smoking cessation, exercise, physical activity, healthy diet, and adherence to medication.16,31 Anxiety is also considered a risk factor in cardiac patients. Anxiety is potentially related to several pathophysiological processes in patients with CAD, including arrhythmic mechanisms and dysfunction of the autonomic nervous system, such as reduced baroreflex
cardiac control and reduced heart rate variability.30 In addition, patients with anxiety disorders are prone to unhealthy lifestyle behaviors such as smoking, drinking, and poor patient compliance.16,32 All of the above possibilities might contribute to the increased risk of recurrent cardiac events in anxious patients with CAD. Previous studies have shown that anxiety can adversely influence outcomes in CAD patients,21,22,26Y28,30 although the investigation for anxiety disorders is not performed frequently.16,22 However, the study of anxiety in this context has produced even more inconsistent results.16,17,19,20 Because of this discrepancy, more prospective research is needed to investigate the impact of depression and anxiety on recurrent cardiac events in CAD patients. Although depression and anxiety are the risk factors for recurrent cardiac events and are also common in patients with CAD,16,22,23,27,29Y31 only a few studies have evaluated the impact of depression and anxiety on recurrent cardiac events in Korean patients.7,8 Therefore, this prospective study was conducted to further examine the effect of baseline depression and anxiety measured during hospitalization after PCI with DES on recurrent cardiac events in Korean patients with CAD during the subsequent 12 months.
Methods Design and Sample A prospective longitudinal study was used. Patients who met the established criteria were recruited from a cardiology unit at a tertiary medical center in Korea between August 2009 and September 2010, and they were followed-up after discharge through 2011. After patients were admitted to the cardiology unit, patient eligibility was confirmed by reviewing their medical records with respect to the inclusion and/or exclusion criteria. Patients were included if they were (1) 18 to 70 years old; (2) diagnosed with either angina pectoris or myocardial infarction (MI) for the first time by a cardiologist; (3) scheduled to undergo PCI with DES during hospitalization; (4) willing to participate in this study; and (5) able to speak, read, and write Korean. Patients were excluded if they (1) were scheduled for surgical treatment; (2) had previous coronary revascularization; (3) were diagnosed with depression and/or anxiety disorder or other psychiatric diseases or were currently taking antidepressants, antianxiety medications, or other psychotic treatment; or (4) had a terminal illness. To calculate the sample size for the Cox proportional hazards regression model, we used the statistical software package Power Analysis and Sample Size System,33 which provides power and sample size calculations for Cox proportional hazards regression. The sample size was calculated for a 2-tailed test, to achieve
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Recurrent Cardiac Events After PCI 353
a power of .80, an ! level of .05, and hazard ratios (HRs) of 1.50. Assuming an overall rate of recurrent cardiac events of 15% within 12 months after PCI, on the basis of on previous studies,5Y8 we needed a minimum sample size of 103. A total of 149 eligible patients were contacted, of whom 135 (90.6%) signed the informed consent. Among these 135 patients, 2 patients were lost to follow-up; thus, 133 patients were included in the final analysis. Instruments and Measurements Anxiety and Depression The Hospital Anxiety and Depression Scale (HADS), a self-rated screening tool for anxiety and depression, was used.34 The HADS has been widely used as an anxiety and depression screening measure in hospital settings and has previously been used in cardiac research as it is considered to assess depressive symptoms without being confounded by somatic symptoms.21,28,35,36 The HADS is a 14-item instrument that consists of 2 subscales: a 7-item depression subscale (HADS-D) and a 7-item anxiety subscale (HADS-A).34 In this study, anxiety and depression were measured using the Korean version of the HADS.37 Each item is rated on a 4-point scale from 0 to 3 (0 = not at all; 1 = some; 2 = much; 3 = very often), giving maximum scores of 21 for anxiety and depression. Higher scores indicate more severe depression or anxiety. For descriptive purposes, we used a subscale score above 8 to indicate the presence of at least mild depression and anxiety symptoms.34 Previous studies on depression and anxiety after PCI or AMI have classified patients with a HADS score of 8 or higher as having at least mild to moderate depression and anxiety.17,35 High reliability was demonstrated in previous studies (Cronbach’s ! for HADS-A varied from .68 to .93 and for HADS-D from .67 to .90).35,37 In the current study, the Cronbach’s ! for HADS-D was .78, and the Cronbach’s ! for HADS-A was .75. Other Risk Factors Data regarding baseline demographic variables and traditional cardiovascular risk factors, that is, age, gender, current smoking status, body mass index (BMI), history of HTN, DM, or dyslipidemia, and FHx of early cardiovascular disease, were extracted from medical records at the time of screening. The diagnosis of HTN was made based on the diagnostic medical code in the patient’s medical records and current use of antihypertensive medication. The diagnosis of DM was based on a medical history of DM treated with or without drug therapies, and DM was identified by the diagnostic medical code in the patient’s medical records. The diagnosis of dyslipidemia was made based on the diagnostic medical code in the patient’s medical records and current use of a lipid-lowering medication. Current smoking status was defined as smoking on a regular basis or
smoking cessation less than 3 months before hospital admission. A positive FHx of early CVD was defined as documented evidence of premature CVD in a close relative (men G55 and women G65 years of age).38 Body mass index was calculated as weight (in kilograms from the last available value in hospitalization) divided by height (in meters, as the first available value) squared. The Framingham Recurrent Risk Model (Framingham risk score model) was used to determine recurrent coronary heart disease risk for 2 years.39 Clinical characteristics included the diagnosis, laboratory data, and angiographic findings, which were collected from the patients’ medical records. Left ventricular ejection fraction was assessed by echocardiography. Blood sample was obtained from fasting patients within 24 hours before the PCI to measure the hsCRP level. The plasma hsCRP concentration was measured by using the CRPLatex (II) immunoturbidimetric assay (Denka Seiken, Tokyo, Japan) on a TBA 200FR (Toshiba Inc, Tokyo, Japan). The lower limit of detection of this method was 0.175 mg/L, and the intra-assay coefficient of variation was less than 5%. Recurrent Cardiac Events Recurrent cardiac events occurring after the interview were included as endpoints and were assessed by patient interviews and medical records. The outcome variable for this study was the combined endpoint of recurrent cardiac events. Recurrent cardiac events included emergency department visits or rehospitalization as a result of acute cardiac problems, recurrent MI diagnosed by physicians, in-stent restenosis on follow-up angiography, and repeat revascularization procedures (PCI or CABG). The follow-up period started on the date of the PCI and lasted up to 12 months. Presentations to the hospital with chest pain that was not confirmed to be of cardiac origin after investigation were not classified as recurrent cardiac events. Ethical Considerations Before data collection, approval of the institutional review board of the hospital from which the subjects were recruited was obtained. A participant information sheet was provided to patients that explained the details of the study, and the voluntary nature of participation was also emphasized. Written informed consent was obtained before data collection. Each participant was assigned a code that was known only to the researcher to preserve confidentiality. Procedure After obtaining approval from the institutional review board of the hospital, a trained research assistant reviewed medical records to identify potentially eligible patients who were admitted to the cardiology unit for
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354 Journal of Cardiovascular Nursing x July/August 2015 primary PCI. All of the patients had undergone placement of DES. A trained research assistant contacted eligible patients and obtained their written informed consent. Participants were interviewed as soon as they were medically stable, on an average of 1.7 days after the PCI (SD, 0.97 days; range, 1Y4 days). Clinical characteristics were collected by reviewing the patients’ medical records. The trained research assistant followed up all of the patients by reviewing their medical records, outpatient contact, or monthly telephone contact for 12 months after discharge. Participants were asked whether they had experienced recurrent cardiac events, and if so, they were asked to make a list of recurrent cardiac events. A medical record review was performed for any of the patients who reported an emergency department visit, who were readmitted to the hospital, or in whom a cardiac procedure was performed to confirm the presence of a recurrent cardiac event, and they were asked to verify the date of the recurrent cardiac event. Data Analysis Descriptive analyses were performed for all of the variables. Survival analyses included Kaplan-Meier survival curves and a hierarchical Cox proportional hazards regression model. Kaplan-Meier survival curves were calculated to estimate the cumulative risk of recurrent cardiac events, and the difference in recurrent cardiac events between patients with and without depression or anxiety was tested by the Breslow estimation method. The Breslow test assesses the equality of survival functions by weighting all time points by the number of cases at risk at each time point. A hierarchical Cox proportional hazards regression model was used to adjust for potential confounders and to evaluate the influence of anxiety and depression on time to recurrence. Cox proportional hazards regression analysis was used to observe the relationship between anxiety and depression and 12-month recurrent cardiac events after adjustment for sociodemographics and clinical characteristics (ie, gender, age, history of HTN, DM, dyslipidemia, FHx of early CVD, current smoking status, BMI, hsCRP, number of diseased vessels, and percentage diameter stenosis). Anxiety scores were dichotomized using scores lower than 8 and 8 or higher, and depression scores were dichotomized using scores lower than 8 and 8 or higher to test whether the risk of recurrent cardiac events would be associated with mild to moderate anxiety or depression. Age, blood parameters, and angiographic characteristics were treated as continuous variables, whereas gender, history of HTN, DM, dyslipidemia, FHx of early CVD, current smoking status, and BMI were included as categorical variables. An HR for recurrent cardiac events was obtained for all independent variables along with 95% confidence intervals (CIs). Statistical analyses were performed by
using IBM SPSS Statistics for Windows, Version 20.0 (IBM Corp, Armonk, New York).
Results Patient Characteristics Patient age ranged from 30 to 74 years, and the mean (SD) patient age was 57.32 (9.60) years. Of the 133 patients, 78.2% were men and 21.8% were women. In this study, half of the patients (53.4%) had HTN, about one-third (30.1%) had DM, and 35.3% had dyslipidemia. About 70% of patients had an FHx of early-onset cardiovascular disease and 45.9% of patients were current smokers. The average 2-year probability of recurrent CHD was 7.76 T 3.08. Seventy-four patients were diagnosed with non-STEMI before PCI. Almost 60% of patients had normal weight. The average hsCRP level was 0.52 T 1.47 mg/dL, and the average left ventricular ejection fraction was 62.10% T 9.75%. Regarding the angiographic severity of CAD, 54.1% of patients had 1-vessel coronary disease and the average percentage diameter stenosis as assessed by quantitative coronary angiography was 85.40 T 9.49. The average anxiety score was 7.24 T 4.52, and 60.2% of the patients had a normal level of anxiety, whereas 39.8% of the patients had a moderate or severe level of anxiety. The average depression score was 6.85 T 3.41, and 66.9% of the patients had a normal level of depression, whereas 33.1% had a moderate or severe level of depression. Table 1 depicts the differences in recurrence according to patients’ characteristics. There were no statistically significant associations between recurrence and sociodemographics or clinical characteristics. The anxiety and depression scores were higher in patients with recurrent cardiac events than in patients without recurrent cardiac events (2 2 = 14.39, P G .001; 2 2 = 6.00, P = .013, respectively). Recurrent Cardiac Events During the 12-month follow-up period, 18 patients (13.5%) were hospitalized or visited the emergency department for acute cardiac problems. Of these 18 patients, 5 were treated with repeated stent insertion into a coronary artery because of restenosis in the same lesions or stenosis in new lesions. Five patients were diagnosed with in-stent restenosis on follow-up angiography and received medical treatment. Seven patients received anticoagulants and vasodilators for reperfusion when they visited the emergency department, and 1 patient underwent CABG surgery. Independent Predictors of Recurrent Cardiac Events Table 2 shows the results of a hierarchical Cox proportional hazards regression analysis for anxiety and
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Recurrent Cardiac Events After PCI 355 TABLE 1
Sociodemographic and Clinical Characteristics of 133 Patients
Characteristic
Total (n = 133)
Age, y Gender Men Women Hypertension Yes No Diabetes Yes No Dyslipidemia Yes No FHx of early CVD Yes No Current smoking status Yes No 2-y probabilities of recurring CHD Diagnosis STEMI Non-STEMI Unstable angina BMI, kg/m2 G25 (normal) Q25 (overweight or obese) hsCRP, mg/dL LVEF, % Number of diseased vessels Percentage diameter stenosis Anxiety (range, 0Y20) Normal Moderate or severe Depression (range, 0Y17) Normal Moderate or severe
Recurrence (n = 18)
Non-recurrence (n = 115)
j1.70 (.092)
57.32 T 9.60
53.78 T 8.18
104 (78.2) 29 (21.8)
17 (94.4) 1 ( 5.6)
87 (75.7) 28 (24.3)
2.22 (.137)
71 (53.4) 62 (46.6)
12 (66.7) 6 (33.3)
59 (51.3) 56 (48.7)
0.92 (.311)a
40 (30.1) 93 (69.9)
4 (22.2) 14 (77.8)
36 (31.3) 79 (68.7)
0.26 (.584)a
47 (35.3) 86 (64.7)
5 (27.8) 13 (72.2)
42 (36.5) 73 (63.5)
0.21 (.600)a
91 (68.4) 42 (31.6)
12 (66.7) 6 (33.3)
79 (68.7) 36 (31.3)
0.00 (1.000)a
61 (45.9) 72 (54.1) 7.76 T 3.08
9 (50.0) 9 (50.0) 7.83 T 2.96
52 (45.2) 63 (54.8) 7.75 T 3.11
0.02 (.801)a
28 (21.1) 74 (55.6) 31 (23.3)
5 (27.8) 9 (50.0) 4 (22.2)
78 55 0.52 62.10 1.68 85.40
(58.6) (41.4) T 1.47 T 9.75 T 0.81 T 9.49
13 (72.2) 5 (27.8) 1.33 T 2.74 59.72 T 12.43 1.56 T 0.78 87.72 T 10.01
57.88 T 9.71
t or # 2 (P)
23 (20.0) 65 (56.5) 27 (23.5) 65 (56.5) 50 (43.5) 0.40 T 1.12 62.47 T 9.27 1.70 T 0.82 85.03 T 9.40
0.11 (.913) 0.58 (.749)
1.00 (.304)a 1.43 j1.11 j0.68 1.12
(.171) (.268) (.498) (.265)
80 (60.2) 53 (39.8)
3 (16.7) 15 (83.3)
77 (67.0) 38 (33.0)
14.39 (G.001)a
89 (66.9) 44 (33.1)
7 (38.9) 11 (61.1)
82 (71.3) 33 (28.7)
6.00 (.013)a
Data are presented as n (%) or mean T SD. Abbreviations: BMI, body mass index; CHD, coronary heart disease; CVD, cardiovascular disease; FHx, family history; hsCRP, high-sensitivity C-reactive protein; LVEF, left ventricular ejection fraction; STEMI, ST-elevation myocardial infarction. a Fisher exact test.
depression and covariates as predictors of risk for 12-month recurrent cardiac events. The overall model, after entering all of the independent variables, was significant (2 2 = 34.21, df = 13, P = .001). In the unadjusted analysis, there was a significant relationship between anxiety and depression and risk of recurrent cardiac events. Patients who had a moderate or severe level of anxiety were 7.44 times (95% CI, 2.13Y25.94; P = .002) more likely to have recurrent cardiac events than were those who had a normal level of anxiety. Patients who had a moderate or severe level of depression were 2.68 times (95% CI, 1.03Y6.98; P = .043) more likely to have recurrent cardiac events than were those who had a normal level of depression. In the adjusted analysis, there was a significant association between anxiety and depression and risk of recurrent cardiac events when sociodemographics and clinical
characteristics were included as covariates. Patients who had a moderate or severe level of anxiety were 6.21 times (95% CI, 1.64Y23.54; P = .007) more likely to have recurrent cardiac events than were those who had a normal level of anxiety. Patients who had a moderate or severe level of depression were 4.32 times (95% CI, 1.35Y13.88; P = .014) more likely to have recurrent cardiac events than were those who had a normal level of depression. The Kaplan-Meier survival curve analysis showed a dose-response pattern for anxiety and depression with respect to time to recurrent cardiac events (Figures 1 and 2, respectively). The Breslow test showed that moderate or severe anxiety was associated with a higher rate of recurrent cardiac events and shorter time to recurrent cardiac events (Breslow test 2 2 = 17.05, P G .001). A statistically significant difference in time to recurrent cardiac events was observed between
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356 Journal of Cardiovascular Nursing x July/August 2015 TABLE 2
Independent Predictors of Recurrent Cardiac Events Among 133 Patients After Percutaneous Coronary Interventions Unadjusted Model Characteristic Anxiety (reference = normal) Moderate or severe Depression (reference = normal) Moderate or severe Age Gender (reference = women) Hypertension (reference = no) Diabetes (reference = no) Dyslipidemia (reference = no) Current smoking status (reference = no) FHx of early CVD (reference = no) BMI, kg/m2 (reference = normal) hsCRP, mg/dL Number of diseased vessels Percentage diameter stenosis
Adjusted Model
HR
95% CI
P
HR
95% CI
P
7.44
2.13Y25.94
.002
6.21
1.64Y23.54
.007
2.68
1.03Y6.98
.043
4.32 0.95 4.92 2.44 0.42 1.11 0.44 0.39 0.31 1.15 1.22 1.04
1.35Y13.88 0.89Y1.02 0.56Y43.59 0.81Y7.33 0.10Y1.85 0.34Y3.58 0.13Y1.50 0.12Y1.32 0.09Y1.16 0.95Y1.40 0.56Y2.66 0.98Y1.10
.014 .135 .152 .112 .252 .863 .188 .132 .082 .148 .608 .233
Overall unadjusted model: j2LL = 152.64, 2 2 = 21.83, df = 2, P G .001. Overall adjusted model: j2LL = 137.94, 2 2 = 34.21, df = 13, P = .001. Abbreviations: BMI, body mass index; CI, confidence interval; CVD, cardiovascular disease; FHx, family history; HR, hazard ratio; hsCRP, high-sensitivity C-reactive protein.
To the best of our knowledge, this is the first prospective observational study to evaluate the impact of anxiety and depression on recurrent cardiac events in Korean patients with CAD who underwent primary PCI with DES. In this study, baseline depression and anxiety measured during hospitalization after PCI were independently and significantly associated with recurrent cardiac events at the 1-year follow-up point after
adjustment for traditional risk factors and medical factors. The 12-month rate of recurrent cardiac events in this study was 13.5%. This result was similar to that reported previously in the literature among patients of other ethnic populations.5,6 Furthermore, this result was similar to that in previous studies7,8 of Korean patients who underwent PCI. These results suggested that although the use of DES greatly reduced the problem of restenosis compared with that after the use of BMS, a number of problems, such as restenosis, thrombosis, and reinfarction, still persisted.9 Hence, after PCI, nurse-led or nursecoordinated secondary prevention programs might be a way to decrease the risk of recurrent events.
FIGURE 1. Differences in time between anxiety level and recurrent cardiac events.
FIGURE 2. Differences in time between depression level and recurrent cardiac events.
patients with moderate or severe level of depression and patients with normal level of depression (Breslow test 2 2 = 8.07, P = .004).
Discussion
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Recurrent Cardiac Events After PCI 357
This study demonstrated that patients who have baseline depressive symptoms during hospitalization after PCI were approximately 4 times more likely to experience recurrent cardiac events even after controlling for other risk factors. The significant association of depression with recurrent cardiac events in our study is in agreement with that in previous studies.17,19,24 These previous studies, however, measured depression at about 1 to 6 months after the PCI.17,19,24 Therefore, our study extended these findings by demonstrating that depression measured during hospitalization after PCI remains an independent predictor of recurrent cardiac events in patients with CAD who have undergone PCI. Depression has been considered a risk factor for recurrent cardiac events, which has an adverse influence on the prognosis of patients with CAD. Although it is uncertain whether treating depression directly reduces mortality and morbidity rates, patients whose depressive symptoms do not improve may have an increased risk of recurrent cardiac events.16,40 Moreover, considering that the prevalence of depression after PCI is as high as approximately 20% to 30%,4,16,17,19,23,36 early intervention, including assessment of depression level and detection of potential depressive patients, should be performed during hospitalization. Nurses should also implement psychoeducational interventions to reduce psychological symptoms, such as depression, and manage cardiovascular risk factors by increasing patients’ involvement of positive behavioral change. Anxiety was also an independent predictor of recurrent cardiac events after adjusting for other risk factors. A statistically significant relationship between anxiety and recurrent cardiac events has been reported.21,22,26Y28 Consistent with the findings of previous studies, our data suggest that anxiety plays an independent role in increasing the risk for recurrent cardiac events in patients with CAD who have undergone PCI. Interestingly, the magnitude of anxiety was higher than the magnitude of depression in our study. This finding may be explained by the time point of assessment for anxiety. We measured anxiety and depression during hospitalization after PCI. Anxiety is 1 of the earliest and most intense psychological responses to CAD.22 During this time, patients may experience a higher level of anxiety because of the circumstances preceding PCI and uncertainty related to the outcome.22 However, considering the high level of risk estimation, symptoms of anxiety need to be considered in the risk stratification and treatment of post-MI patients. Current guidelines suggest screening cardiac patients for depression because its presence signals a poorer cardiovascular prognosis.31 However, much less attention has been focused on anxiety.16 Our findings suggest that symptoms of anxiety should be monitored in these patients. The timely identification of anxiety symptoms could lead to the ini-
tiation of appropriate interventions that will mitigate the risk of adverse cardiovascular outcomes. In this study, most of CAD patients were men (78.2%). This finding is similar to that in the Korean Registry of Myocardial Infarction.3 However, women seem to be at a greater risk of anxiety and depression than men are after a coronary event22 and report a poorer quality of life in the areas of perceived general health and psychological well-being as compared with men.41 A future study is needed to examine the sex differences among Korean patients with recurrent cardiac events. Forty-four patients (33.1%) scored 8 or higher on the depression subscale and 53 (39.8%) scored 8 or higher on the anxiety subscale recommended for identifying clinically significant anxiety and depression in this study. Our data also suggest that Korean patients with CAD express high levels of depression and anxiety. The mean scores for anxiety and depression were 7.24 and 6.85, respectively, in this study, whereas the mean scores for anxiety and depression were 4.87 and 5.05 in healthy Korean people,37 5.30 and 4.40 in Dutch residents who have undergone PCI,36 and 5.44 and 4.02 in Canadian residents with CAD, respectively.21 This result indicates that Korean patients with CAD experienced more intense anxiety and depression than did healthy Koreans without CAD and Dutch and Canadian residents with CAD. However, only a few studies have evaluated psychological factors and recurrent cardiac events in Korean patients.25,42,43 These previous studies focused on the impact of anger, but not of depression and anxiety, on recurrent cardiac events,25 and they assessed clinical outcomes (ie, coronary endothelial dysfunction), but not recurrent cardiac events,42 or examined the cross-sectional relationship between psychological factors and cardiovascular risk factors.43 Therefore, further studies are needed to evaluate the impact of depression and anxiety on recurrent cardiac events in Korean patients. Limitations This might be the first study to assess the relationship between depression and anxiety and recurrent cardiac events in Korean patients who were followed up for up to 12 months. However, the findings should be interpreted with caution. First, the study population included patients who were admitted to a single university hospital in Korea and the study had a small proportion of women. Consequently, we may not be able to generalize these findings to all Korean patients who have undergone PCI. Second, this study relied upon the HADS as a measure of depression and anxiety. Structured clinical interviews would have been more useful to confirm the diagnosis of depression and anxiety than the HADS. However, previous studies have demonstrated that the HADS has a high sensitivity and specificity for CAD patients.21,35
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358 Journal of Cardiovascular Nursing x July/August 2015
What’s New and Important h Patients with CAD who have a high level of anxiety and depression are at increased risk for recurrent cardiac events after adjustment of traditional risk factors and medical factors after PCI. h Especially anxiety has higher magnitude than depression in our study. Therefore, symptoms of anxiety need to be considered in the risk stratification and treatment of post-MI patients.
Third, we measured only baseline depression and anxiety during hospitalization. We did not observe the effect of persistent depression and/or anxiety on recurrent cardiac events 1 year later. Hence, future research should examine psychosocial variables including anxiety and depression over time as predictors of recurrent cardiac events. Finally, only 12-month short-term outcomes were examined. A long-term follow-up for major cardiovascular events associated with depressive and anxious symptoms is also necessary.
egy that encourages the practice of healthy behaviors in these patients and their enrollment in secondary prevention programs should be devised.
Conclusion The overall results of this study suggest that depression and anxiety are associated with a 4- to 6-fold increase in the risk of recurrent cardiac events after PCI with DES. Anxiety and depression may be important psychological risk factors that need to be considered when assessing the prognosis of CAD patients. Hence, identification of depressive and anxiety symptoms after PCI is a major concern for nurses. Future replication is needed using a sophisticated statistical approach to test these multiple psychosocial constructs using different measurement tools in relation to hard cardiac endpoints before we can draw definitive conclusions about the role of psychosocial factors in cardiac prognosis.
REFERENCES
Implications Despite these limitations, the results of this study have clinical implications. The findings of the present study clearly indicate the vital role of depression and anxiety in recurrent cardiac events among CAD patients with PCI. Therefore, it is important to screen for depression or anxiety after PCI, which would enable nurses to provide patients with optimal care at the proper time. In addition, it is necessary to examine psychosocial variables, including depression and anxiety, over time as predictors of poor outcomes, which would allow detection of the factors that alleviate or aggravate these symptoms. There are several valid and reliable screening tools that healthcare providers, such as nurses, could easily use to identify patients who are at a greater risk of depression or anxiety. Management of these patients may include nurse-led secondary prevention programs with more emotional and psychological support from early post-PCI, which would subsequently decrease the risk of recurrent cardiac events. In addition, nurses should closely monitor at-risk patients, and when needed, they should offer additional clinical care, such as counseling and psychological services during hospitalization or in an outpatient setting. Most of the programs that prevent recurrent cardiac events in Korean patients are focused on physical aspects, including exercise, diet, smoking cessation, and medication. According to our results, comprehensive secondary prevention programs that alleviate depression and anxiety should be implemented in a clinical setting in Korea. Moreover, depressed and anxious patients are less likely to perform health-related behaviors and participate in secondary prevention programs.32,40 Therefore, a strat-
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Vol. 30, No. 4, pp 351Y359 x Copyright B 2015 Wolters Kluwer Health, Inc. All rights reserved.
Depression and Anxiety as Predictors of Recurrent Cardiac Events 12 Months After Percutaneous Coronary Interventions Jin-Hee Park, PhD, RN; Seung-Jea Tahk, PhD, MD; Sun Hyoung Bae, PhD, RN Background: Anxiety and depression are associated with recurrent cardiac events after percutaneous coronary interventions (PCIs). However, few investigators have evaluated the impact of depression and anxiety on recurrent cardiac events in Korea. Objective: The aim of this study was to examine the relationship among depression, anxiety, and recurrent cardiac events in Korean patients with coronary artery disease (CAD) after PCI. Methods: A prospective longitudinal study was undertaken with a sample of 133 CAD patients with PCI. Data were collected between August 2009 and September 2010, and patients were followed after discharge through 2011 with self-report questionnaires on anxiety and depression using the Hospital Anxiety and Depression Scale and with patient medical records on sociodemographic and clinical characteristics. Recurrent cardiac events were collected for 12 months after discharge and were assessed by patient interviews and medical records. Results: There were 18 recurrent cardiac events (13.5%) among the 133 participants. After adjustment for sociodemographic and clinical characteristics, a hierarchical Cox proportional hazards regression model found that a moderate or severe level of anxiety (hazard ratio, 6.21; 95% confidence interval, 1.64Y23.54) and a moderate or severe level of depression (hazard ratio, 4.32; 95% confidence interval, 1.35Y13.88) were independent predictors of recurrent cardiac events. Conclusions: Patients with CAD who have a high level of anxiety and depression are at increased risk for recurrent cardiac events after PCI. Screening should be focused on patients who experience anxious and depressive feelings in addition to traditional risk factors. Furthermore, psychoeducational support interventions to reduce anxiety and depression after PCI may improve health outcomes. KEY WORDS:
anxiety, coronary artery disease, depression, percutaneous coronary intervention, recurrence
C
oronary artery disease (CAD) is 1 of the leading causes of morbidity and mortality worldwide.1 Coronary artery disease is 1 of the leading causes of death in Korea, and its incidence has increased from 35.3 in 100 000 individuals in 2003 to 45 in 100 000 individuals in 2009.2 Percutaneous coronary intervention (PCI) has become a more frequently used treatment Jin-Hee Park, PhD, RN Associate Professor, College of Nursing, Ajou University, Suwon, Gyeonggi-Do, Republic of Korea.
Seung-Jea Tahk, PhD, MD Professor, School of Medicine, Department of Cardiology, Ajou University, Suwon, Gyeonggi-Do, Republic of Korea.
Sun Hyoung Bae, PhD, RN Assistant Professor, College of Medicine, Department of Nursing, Dong-A University, Busan, Republic of Korea. This work was supported by Basic Science Research Program through the National Research Foundation of Korea funded by the Ministry of Education, Science and Technology (2009-0065948). The authors have no conflicts of interest to disclose.
Correspondence Sun Hyoung Bae, PhD, RN, College of Medicine, Department of Nursing, Dong-A University, Gudeok Campus, Dongdaesin-dong 3(sam)-ga, Seo-gu, Busan, Republic of Korea ([email protected]). DOI: 10.1097/JCN.0000000000000143
than coronary artery bypass graft (CABG) for CAD3 because PCI is safe and effective and is a less expensive revascularization procedure.4 The Korean Registry of Myocardial Infarction data showed that primary PCI was performed in 91.6% of ST elevation myocardial infarction (STEMI) patients, and early revascularization was performed in 63.3% of non-STEMI patients.3 The use of drug-eluting stents (DESs), in which medications such as sirolimus or paclitaxel are applied to bare-metal stents (BMSs), has been reported to reduce rates of restenosis or stent thrombosis compared with BMS.4 Restenosis rates were reduced from 30%Y40%4 to 5%Y10% at 6 months and to 15% or less within 12 months in patients who underwent PCI with DES.4Y8 However, restenosis and stent thrombosis still pose clinical problems.9 Moreover, recurrence of cardiac events has been associated with increased cardiac mortality.9 Therefore, most PCI patients should receive appropriate pharmacological therapy and an effort should be made to control the risk factors of CAD to prevent recurrent cardiac events.9,10 The growing body of evidence confirms that in patients with CAD, comprehensive risk factor management reduces risk as assessed by a variety 351
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352 Journal of Cardiovascular Nursing x July/August 2015 of outcomes, including improved survival, reduced recurrent events, decreased need for revascularization procedures, and improved quality of life.10,11 Numerous studies have identified the risk factors for CAD and recurrent cardiac events. Age, gender, hypertension (HTN), dyslipidemia, diabetes mellitus (DM), obesity, smoking, family history (FHx), and stress have been universally accepted as the traditional risk factors for CAD.10,11 In addition, nontraditional risk factors, such as the serum level of high-sensitivity C-reactive protein (hsCRP)12,13 and angiographic severity,13,14 have been considered predictors of adverse cardiovascular outcomes among patients with CAD after PCI. Highsensitivity C-reactive protein is an acute-phase reactant and a nonspecific marker for inflammation. Highsensitivity C-reactive protein may affect immunity and lead to plaque deposition, which raises the risk of restenosis after coronary stenting.12,13 Angiographic severity of CAD, such as diameter and lesion length, has also been considered a risk factor of recurrent cardiac events. It is known that longer lesions and smaller vessels correlate with higher restenosis and major adverse cardiac event rates in PCI patients.13,14 However, these risk factors do not fully explain the development and progression of CAD.15 Although the importance of psychosocial factors in the development and expression of CAD has been debated, extensive recent literature over the past decades16Y28 has shown that psychosocial factors are related to cardiac morbidity and mortality. Depression and anxiety, in particular, are significantly associated with negative cardiac outcomes in CAD.29Y31 Depression is a common problem in patients after acute cardiac events.15,29,31 Research has demonstrated that patients who are depressed in the weeks after an acute coronary syndrome or during hospitalization after PCI have a poor cardiac outcome.16,19,23,24,26,28,29 Several studies have demonstrated that depression is associated with a 2- to 4-fold increase in risk of adverse health outcomes in patients undergoing coronary revascularization,17,24,28 independently of traditional risk factors, although counterexamples exist.20,21 This link between depression and cardiac morbidity most likely involves both physiologic and behavioral effects of depression. Depression has been linked to dysregulation of serotonergic pathways, platelet abnormalities, inflammation, autonomic nervous system dysfunction, vascular changes, and nutritional deficiencies.29,31 Furthermore, depressed patients are less likely to practice health-related behaviors, such as smoking cessation, exercise, physical activity, healthy diet, and adherence to medication.16,31 Anxiety is also considered a risk factor in cardiac patients. Anxiety is potentially related to several pathophysiological processes in patients with CAD, including arrhythmic mechanisms and dysfunction of the autonomic nervous system, such as reduced baroreflex
cardiac control and reduced heart rate variability.30 In addition, patients with anxiety disorders are prone to unhealthy lifestyle behaviors such as smoking, drinking, and poor patient compliance.16,32 All of the above possibilities might contribute to the increased risk of recurrent cardiac events in anxious patients with CAD. Previous studies have shown that anxiety can adversely influence outcomes in CAD patients,21,22,26Y28,30 although the investigation for anxiety disorders is not performed frequently.16,22 However, the study of anxiety in this context has produced even more inconsistent results.16,17,19,20 Because of this discrepancy, more prospective research is needed to investigate the impact of depression and anxiety on recurrent cardiac events in CAD patients. Although depression and anxiety are the risk factors for recurrent cardiac events and are also common in patients with CAD,16,22,23,27,29Y31 only a few studies have evaluated the impact of depression and anxiety on recurrent cardiac events in Korean patients.7,8 Therefore, this prospective study was conducted to further examine the effect of baseline depression and anxiety measured during hospitalization after PCI with DES on recurrent cardiac events in Korean patients with CAD during the subsequent 12 months.
Methods Design and Sample A prospective longitudinal study was used. Patients who met the established criteria were recruited from a cardiology unit at a tertiary medical center in Korea between August 2009 and September 2010, and they were followed-up after discharge through 2011. After patients were admitted to the cardiology unit, patient eligibility was confirmed by reviewing their medical records with respect to the inclusion and/or exclusion criteria. Patients were included if they were (1) 18 to 70 years old; (2) diagnosed with either angina pectoris or myocardial infarction (MI) for the first time by a cardiologist; (3) scheduled to undergo PCI with DES during hospitalization; (4) willing to participate in this study; and (5) able to speak, read, and write Korean. Patients were excluded if they (1) were scheduled for surgical treatment; (2) had previous coronary revascularization; (3) were diagnosed with depression and/or anxiety disorder or other psychiatric diseases or were currently taking antidepressants, antianxiety medications, or other psychotic treatment; or (4) had a terminal illness. To calculate the sample size for the Cox proportional hazards regression model, we used the statistical software package Power Analysis and Sample Size System,33 which provides power and sample size calculations for Cox proportional hazards regression. The sample size was calculated for a 2-tailed test, to achieve
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Recurrent Cardiac Events After PCI 353
a power of .80, an ! level of .05, and hazard ratios (HRs) of 1.50. Assuming an overall rate of recurrent cardiac events of 15% within 12 months after PCI, on the basis of on previous studies,5Y8 we needed a minimum sample size of 103. A total of 149 eligible patients were contacted, of whom 135 (90.6%) signed the informed consent. Among these 135 patients, 2 patients were lost to follow-up; thus, 133 patients were included in the final analysis. Instruments and Measurements Anxiety and Depression The Hospital Anxiety and Depression Scale (HADS), a self-rated screening tool for anxiety and depression, was used.34 The HADS has been widely used as an anxiety and depression screening measure in hospital settings and has previously been used in cardiac research as it is considered to assess depressive symptoms without being confounded by somatic symptoms.21,28,35,36 The HADS is a 14-item instrument that consists of 2 subscales: a 7-item depression subscale (HADS-D) and a 7-item anxiety subscale (HADS-A).34 In this study, anxiety and depression were measured using the Korean version of the HADS.37 Each item is rated on a 4-point scale from 0 to 3 (0 = not at all; 1 = some; 2 = much; 3 = very often), giving maximum scores of 21 for anxiety and depression. Higher scores indicate more severe depression or anxiety. For descriptive purposes, we used a subscale score above 8 to indicate the presence of at least mild depression and anxiety symptoms.34 Previous studies on depression and anxiety after PCI or AMI have classified patients with a HADS score of 8 or higher as having at least mild to moderate depression and anxiety.17,35 High reliability was demonstrated in previous studies (Cronbach’s ! for HADS-A varied from .68 to .93 and for HADS-D from .67 to .90).35,37 In the current study, the Cronbach’s ! for HADS-D was .78, and the Cronbach’s ! for HADS-A was .75. Other Risk Factors Data regarding baseline demographic variables and traditional cardiovascular risk factors, that is, age, gender, current smoking status, body mass index (BMI), history of HTN, DM, or dyslipidemia, and FHx of early cardiovascular disease, were extracted from medical records at the time of screening. The diagnosis of HTN was made based on the diagnostic medical code in the patient’s medical records and current use of antihypertensive medication. The diagnosis of DM was based on a medical history of DM treated with or without drug therapies, and DM was identified by the diagnostic medical code in the patient’s medical records. The diagnosis of dyslipidemia was made based on the diagnostic medical code in the patient’s medical records and current use of a lipid-lowering medication. Current smoking status was defined as smoking on a regular basis or
smoking cessation less than 3 months before hospital admission. A positive FHx of early CVD was defined as documented evidence of premature CVD in a close relative (men G55 and women G65 years of age).38 Body mass index was calculated as weight (in kilograms from the last available value in hospitalization) divided by height (in meters, as the first available value) squared. The Framingham Recurrent Risk Model (Framingham risk score model) was used to determine recurrent coronary heart disease risk for 2 years.39 Clinical characteristics included the diagnosis, laboratory data, and angiographic findings, which were collected from the patients’ medical records. Left ventricular ejection fraction was assessed by echocardiography. Blood sample was obtained from fasting patients within 24 hours before the PCI to measure the hsCRP level. The plasma hsCRP concentration was measured by using the CRPLatex (II) immunoturbidimetric assay (Denka Seiken, Tokyo, Japan) on a TBA 200FR (Toshiba Inc, Tokyo, Japan). The lower limit of detection of this method was 0.175 mg/L, and the intra-assay coefficient of variation was less than 5%. Recurrent Cardiac Events Recurrent cardiac events occurring after the interview were included as endpoints and were assessed by patient interviews and medical records. The outcome variable for this study was the combined endpoint of recurrent cardiac events. Recurrent cardiac events included emergency department visits or rehospitalization as a result of acute cardiac problems, recurrent MI diagnosed by physicians, in-stent restenosis on follow-up angiography, and repeat revascularization procedures (PCI or CABG). The follow-up period started on the date of the PCI and lasted up to 12 months. Presentations to the hospital with chest pain that was not confirmed to be of cardiac origin after investigation were not classified as recurrent cardiac events. Ethical Considerations Before data collection, approval of the institutional review board of the hospital from which the subjects were recruited was obtained. A participant information sheet was provided to patients that explained the details of the study, and the voluntary nature of participation was also emphasized. Written informed consent was obtained before data collection. Each participant was assigned a code that was known only to the researcher to preserve confidentiality. Procedure After obtaining approval from the institutional review board of the hospital, a trained research assistant reviewed medical records to identify potentially eligible patients who were admitted to the cardiology unit for
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354 Journal of Cardiovascular Nursing x July/August 2015 primary PCI. All of the patients had undergone placement of DES. A trained research assistant contacted eligible patients and obtained their written informed consent. Participants were interviewed as soon as they were medically stable, on an average of 1.7 days after the PCI (SD, 0.97 days; range, 1Y4 days). Clinical characteristics were collected by reviewing the patients’ medical records. The trained research assistant followed up all of the patients by reviewing their medical records, outpatient contact, or monthly telephone contact for 12 months after discharge. Participants were asked whether they had experienced recurrent cardiac events, and if so, they were asked to make a list of recurrent cardiac events. A medical record review was performed for any of the patients who reported an emergency department visit, who were readmitted to the hospital, or in whom a cardiac procedure was performed to confirm the presence of a recurrent cardiac event, and they were asked to verify the date of the recurrent cardiac event. Data Analysis Descriptive analyses were performed for all of the variables. Survival analyses included Kaplan-Meier survival curves and a hierarchical Cox proportional hazards regression model. Kaplan-Meier survival curves were calculated to estimate the cumulative risk of recurrent cardiac events, and the difference in recurrent cardiac events between patients with and without depression or anxiety was tested by the Breslow estimation method. The Breslow test assesses the equality of survival functions by weighting all time points by the number of cases at risk at each time point. A hierarchical Cox proportional hazards regression model was used to adjust for potential confounders and to evaluate the influence of anxiety and depression on time to recurrence. Cox proportional hazards regression analysis was used to observe the relationship between anxiety and depression and 12-month recurrent cardiac events after adjustment for sociodemographics and clinical characteristics (ie, gender, age, history of HTN, DM, dyslipidemia, FHx of early CVD, current smoking status, BMI, hsCRP, number of diseased vessels, and percentage diameter stenosis). Anxiety scores were dichotomized using scores lower than 8 and 8 or higher, and depression scores were dichotomized using scores lower than 8 and 8 or higher to test whether the risk of recurrent cardiac events would be associated with mild to moderate anxiety or depression. Age, blood parameters, and angiographic characteristics were treated as continuous variables, whereas gender, history of HTN, DM, dyslipidemia, FHx of early CVD, current smoking status, and BMI were included as categorical variables. An HR for recurrent cardiac events was obtained for all independent variables along with 95% confidence intervals (CIs). Statistical analyses were performed by
using IBM SPSS Statistics for Windows, Version 20.0 (IBM Corp, Armonk, New York).
Results Patient Characteristics Patient age ranged from 30 to 74 years, and the mean (SD) patient age was 57.32 (9.60) years. Of the 133 patients, 78.2% were men and 21.8% were women. In this study, half of the patients (53.4%) had HTN, about one-third (30.1%) had DM, and 35.3% had dyslipidemia. About 70% of patients had an FHx of early-onset cardiovascular disease and 45.9% of patients were current smokers. The average 2-year probability of recurrent CHD was 7.76 T 3.08. Seventy-four patients were diagnosed with non-STEMI before PCI. Almost 60% of patients had normal weight. The average hsCRP level was 0.52 T 1.47 mg/dL, and the average left ventricular ejection fraction was 62.10% T 9.75%. Regarding the angiographic severity of CAD, 54.1% of patients had 1-vessel coronary disease and the average percentage diameter stenosis as assessed by quantitative coronary angiography was 85.40 T 9.49. The average anxiety score was 7.24 T 4.52, and 60.2% of the patients had a normal level of anxiety, whereas 39.8% of the patients had a moderate or severe level of anxiety. The average depression score was 6.85 T 3.41, and 66.9% of the patients had a normal level of depression, whereas 33.1% had a moderate or severe level of depression. Table 1 depicts the differences in recurrence according to patients’ characteristics. There were no statistically significant associations between recurrence and sociodemographics or clinical characteristics. The anxiety and depression scores were higher in patients with recurrent cardiac events than in patients without recurrent cardiac events (2 2 = 14.39, P G .001; 2 2 = 6.00, P = .013, respectively). Recurrent Cardiac Events During the 12-month follow-up period, 18 patients (13.5%) were hospitalized or visited the emergency department for acute cardiac problems. Of these 18 patients, 5 were treated with repeated stent insertion into a coronary artery because of restenosis in the same lesions or stenosis in new lesions. Five patients were diagnosed with in-stent restenosis on follow-up angiography and received medical treatment. Seven patients received anticoagulants and vasodilators for reperfusion when they visited the emergency department, and 1 patient underwent CABG surgery. Independent Predictors of Recurrent Cardiac Events Table 2 shows the results of a hierarchical Cox proportional hazards regression analysis for anxiety and
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Recurrent Cardiac Events After PCI 355 TABLE 1
Sociodemographic and Clinical Characteristics of 133 Patients
Characteristic
Total (n = 133)
Age, y Gender Men Women Hypertension Yes No Diabetes Yes No Dyslipidemia Yes No FHx of early CVD Yes No Current smoking status Yes No 2-y probabilities of recurring CHD Diagnosis STEMI Non-STEMI Unstable angina BMI, kg/m2 G25 (normal) Q25 (overweight or obese) hsCRP, mg/dL LVEF, % Number of diseased vessels Percentage diameter stenosis Anxiety (range, 0Y20) Normal Moderate or severe Depression (range, 0Y17) Normal Moderate or severe
Recurrence (n = 18)
Non-recurrence (n = 115)
j1.70 (.092)
57.32 T 9.60
53.78 T 8.18
104 (78.2) 29 (21.8)
17 (94.4) 1 ( 5.6)
87 (75.7) 28 (24.3)
2.22 (.137)
71 (53.4) 62 (46.6)
12 (66.7) 6 (33.3)
59 (51.3) 56 (48.7)
0.92 (.311)a
40 (30.1) 93 (69.9)
4 (22.2) 14 (77.8)
36 (31.3) 79 (68.7)
0.26 (.584)a
47 (35.3) 86 (64.7)
5 (27.8) 13 (72.2)
42 (36.5) 73 (63.5)
0.21 (.600)a
91 (68.4) 42 (31.6)
12 (66.7) 6 (33.3)
79 (68.7) 36 (31.3)
0.00 (1.000)a
61 (45.9) 72 (54.1) 7.76 T 3.08
9 (50.0) 9 (50.0) 7.83 T 2.96
52 (45.2) 63 (54.8) 7.75 T 3.11
0.02 (.801)a
28 (21.1) 74 (55.6) 31 (23.3)
5 (27.8) 9 (50.0) 4 (22.2)
78 55 0.52 62.10 1.68 85.40
(58.6) (41.4) T 1.47 T 9.75 T 0.81 T 9.49
13 (72.2) 5 (27.8) 1.33 T 2.74 59.72 T 12.43 1.56 T 0.78 87.72 T 10.01
57.88 T 9.71
t or # 2 (P)
23 (20.0) 65 (56.5) 27 (23.5) 65 (56.5) 50 (43.5) 0.40 T 1.12 62.47 T 9.27 1.70 T 0.82 85.03 T 9.40
0.11 (.913) 0.58 (.749)
1.00 (.304)a 1.43 j1.11 j0.68 1.12
(.171) (.268) (.498) (.265)
80 (60.2) 53 (39.8)
3 (16.7) 15 (83.3)
77 (67.0) 38 (33.0)
14.39 (G.001)a
89 (66.9) 44 (33.1)
7 (38.9) 11 (61.1)
82 (71.3) 33 (28.7)
6.00 (.013)a
Data are presented as n (%) or mean T SD. Abbreviations: BMI, body mass index; CHD, coronary heart disease; CVD, cardiovascular disease; FHx, family history; hsCRP, high-sensitivity C-reactive protein; LVEF, left ventricular ejection fraction; STEMI, ST-elevation myocardial infarction. a Fisher exact test.
depression and covariates as predictors of risk for 12-month recurrent cardiac events. The overall model, after entering all of the independent variables, was significant (2 2 = 34.21, df = 13, P = .001). In the unadjusted analysis, there was a significant relationship between anxiety and depression and risk of recurrent cardiac events. Patients who had a moderate or severe level of anxiety were 7.44 times (95% CI, 2.13Y25.94; P = .002) more likely to have recurrent cardiac events than were those who had a normal level of anxiety. Patients who had a moderate or severe level of depression were 2.68 times (95% CI, 1.03Y6.98; P = .043) more likely to have recurrent cardiac events than were those who had a normal level of depression. In the adjusted analysis, there was a significant association between anxiety and depression and risk of recurrent cardiac events when sociodemographics and clinical
characteristics were included as covariates. Patients who had a moderate or severe level of anxiety were 6.21 times (95% CI, 1.64Y23.54; P = .007) more likely to have recurrent cardiac events than were those who had a normal level of anxiety. Patients who had a moderate or severe level of depression were 4.32 times (95% CI, 1.35Y13.88; P = .014) more likely to have recurrent cardiac events than were those who had a normal level of depression. The Kaplan-Meier survival curve analysis showed a dose-response pattern for anxiety and depression with respect to time to recurrent cardiac events (Figures 1 and 2, respectively). The Breslow test showed that moderate or severe anxiety was associated with a higher rate of recurrent cardiac events and shorter time to recurrent cardiac events (Breslow test 2 2 = 17.05, P G .001). A statistically significant difference in time to recurrent cardiac events was observed between
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356 Journal of Cardiovascular Nursing x July/August 2015 TABLE 2
Independent Predictors of Recurrent Cardiac Events Among 133 Patients After Percutaneous Coronary Interventions Unadjusted Model Characteristic Anxiety (reference = normal) Moderate or severe Depression (reference = normal) Moderate or severe Age Gender (reference = women) Hypertension (reference = no) Diabetes (reference = no) Dyslipidemia (reference = no) Current smoking status (reference = no) FHx of early CVD (reference = no) BMI, kg/m2 (reference = normal) hsCRP, mg/dL Number of diseased vessels Percentage diameter stenosis
Adjusted Model
HR
95% CI
P
HR
95% CI
P
7.44
2.13Y25.94
.002
6.21
1.64Y23.54
.007
2.68
1.03Y6.98
.043
4.32 0.95 4.92 2.44 0.42 1.11 0.44 0.39 0.31 1.15 1.22 1.04
1.35Y13.88 0.89Y1.02 0.56Y43.59 0.81Y7.33 0.10Y1.85 0.34Y3.58 0.13Y1.50 0.12Y1.32 0.09Y1.16 0.95Y1.40 0.56Y2.66 0.98Y1.10
.014 .135 .152 .112 .252 .863 .188 .132 .082 .148 .608 .233
Overall unadjusted model: j2LL = 152.64, 2 2 = 21.83, df = 2, P G .001. Overall adjusted model: j2LL = 137.94, 2 2 = 34.21, df = 13, P = .001. Abbreviations: BMI, body mass index; CI, confidence interval; CVD, cardiovascular disease; FHx, family history; HR, hazard ratio; hsCRP, high-sensitivity C-reactive protein.
To the best of our knowledge, this is the first prospective observational study to evaluate the impact of anxiety and depression on recurrent cardiac events in Korean patients with CAD who underwent primary PCI with DES. In this study, baseline depression and anxiety measured during hospitalization after PCI were independently and significantly associated with recurrent cardiac events at the 1-year follow-up point after
adjustment for traditional risk factors and medical factors. The 12-month rate of recurrent cardiac events in this study was 13.5%. This result was similar to that reported previously in the literature among patients of other ethnic populations.5,6 Furthermore, this result was similar to that in previous studies7,8 of Korean patients who underwent PCI. These results suggested that although the use of DES greatly reduced the problem of restenosis compared with that after the use of BMS, a number of problems, such as restenosis, thrombosis, and reinfarction, still persisted.9 Hence, after PCI, nurse-led or nursecoordinated secondary prevention programs might be a way to decrease the risk of recurrent events.
FIGURE 1. Differences in time between anxiety level and recurrent cardiac events.
FIGURE 2. Differences in time between depression level and recurrent cardiac events.
patients with moderate or severe level of depression and patients with normal level of depression (Breslow test 2 2 = 8.07, P = .004).
Discussion
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Recurrent Cardiac Events After PCI 357
This study demonstrated that patients who have baseline depressive symptoms during hospitalization after PCI were approximately 4 times more likely to experience recurrent cardiac events even after controlling for other risk factors. The significant association of depression with recurrent cardiac events in our study is in agreement with that in previous studies.17,19,24 These previous studies, however, measured depression at about 1 to 6 months after the PCI.17,19,24 Therefore, our study extended these findings by demonstrating that depression measured during hospitalization after PCI remains an independent predictor of recurrent cardiac events in patients with CAD who have undergone PCI. Depression has been considered a risk factor for recurrent cardiac events, which has an adverse influence on the prognosis of patients with CAD. Although it is uncertain whether treating depression directly reduces mortality and morbidity rates, patients whose depressive symptoms do not improve may have an increased risk of recurrent cardiac events.16,40 Moreover, considering that the prevalence of depression after PCI is as high as approximately 20% to 30%,4,16,17,19,23,36 early intervention, including assessment of depression level and detection of potential depressive patients, should be performed during hospitalization. Nurses should also implement psychoeducational interventions to reduce psychological symptoms, such as depression, and manage cardiovascular risk factors by increasing patients’ involvement of positive behavioral change. Anxiety was also an independent predictor of recurrent cardiac events after adjusting for other risk factors. A statistically significant relationship between anxiety and recurrent cardiac events has been reported.21,22,26Y28 Consistent with the findings of previous studies, our data suggest that anxiety plays an independent role in increasing the risk for recurrent cardiac events in patients with CAD who have undergone PCI. Interestingly, the magnitude of anxiety was higher than the magnitude of depression in our study. This finding may be explained by the time point of assessment for anxiety. We measured anxiety and depression during hospitalization after PCI. Anxiety is 1 of the earliest and most intense psychological responses to CAD.22 During this time, patients may experience a higher level of anxiety because of the circumstances preceding PCI and uncertainty related to the outcome.22 However, considering the high level of risk estimation, symptoms of anxiety need to be considered in the risk stratification and treatment of post-MI patients. Current guidelines suggest screening cardiac patients for depression because its presence signals a poorer cardiovascular prognosis.31 However, much less attention has been focused on anxiety.16 Our findings suggest that symptoms of anxiety should be monitored in these patients. The timely identification of anxiety symptoms could lead to the ini-
tiation of appropriate interventions that will mitigate the risk of adverse cardiovascular outcomes. In this study, most of CAD patients were men (78.2%). This finding is similar to that in the Korean Registry of Myocardial Infarction.3 However, women seem to be at a greater risk of anxiety and depression than men are after a coronary event22 and report a poorer quality of life in the areas of perceived general health and psychological well-being as compared with men.41 A future study is needed to examine the sex differences among Korean patients with recurrent cardiac events. Forty-four patients (33.1%) scored 8 or higher on the depression subscale and 53 (39.8%) scored 8 or higher on the anxiety subscale recommended for identifying clinically significant anxiety and depression in this study. Our data also suggest that Korean patients with CAD express high levels of depression and anxiety. The mean scores for anxiety and depression were 7.24 and 6.85, respectively, in this study, whereas the mean scores for anxiety and depression were 4.87 and 5.05 in healthy Korean people,37 5.30 and 4.40 in Dutch residents who have undergone PCI,36 and 5.44 and 4.02 in Canadian residents with CAD, respectively.21 This result indicates that Korean patients with CAD experienced more intense anxiety and depression than did healthy Koreans without CAD and Dutch and Canadian residents with CAD. However, only a few studies have evaluated psychological factors and recurrent cardiac events in Korean patients.25,42,43 These previous studies focused on the impact of anger, but not of depression and anxiety, on recurrent cardiac events,25 and they assessed clinical outcomes (ie, coronary endothelial dysfunction), but not recurrent cardiac events,42 or examined the cross-sectional relationship between psychological factors and cardiovascular risk factors.43 Therefore, further studies are needed to evaluate the impact of depression and anxiety on recurrent cardiac events in Korean patients. Limitations This might be the first study to assess the relationship between depression and anxiety and recurrent cardiac events in Korean patients who were followed up for up to 12 months. However, the findings should be interpreted with caution. First, the study population included patients who were admitted to a single university hospital in Korea and the study had a small proportion of women. Consequently, we may not be able to generalize these findings to all Korean patients who have undergone PCI. Second, this study relied upon the HADS as a measure of depression and anxiety. Structured clinical interviews would have been more useful to confirm the diagnosis of depression and anxiety than the HADS. However, previous studies have demonstrated that the HADS has a high sensitivity and specificity for CAD patients.21,35
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358 Journal of Cardiovascular Nursing x July/August 2015
What’s New and Important h Patients with CAD who have a high level of anxiety and depression are at increased risk for recurrent cardiac events after adjustment of traditional risk factors and medical factors after PCI. h Especially anxiety has higher magnitude than depression in our study. Therefore, symptoms of anxiety need to be considered in the risk stratification and treatment of post-MI patients.
Third, we measured only baseline depression and anxiety during hospitalization. We did not observe the effect of persistent depression and/or anxiety on recurrent cardiac events 1 year later. Hence, future research should examine psychosocial variables including anxiety and depression over time as predictors of recurrent cardiac events. Finally, only 12-month short-term outcomes were examined. A long-term follow-up for major cardiovascular events associated with depressive and anxious symptoms is also necessary.
egy that encourages the practice of healthy behaviors in these patients and their enrollment in secondary prevention programs should be devised.
Conclusion The overall results of this study suggest that depression and anxiety are associated with a 4- to 6-fold increase in the risk of recurrent cardiac events after PCI with DES. Anxiety and depression may be important psychological risk factors that need to be considered when assessing the prognosis of CAD patients. Hence, identification of depressive and anxiety symptoms after PCI is a major concern for nurses. Future replication is needed using a sophisticated statistical approach to test these multiple psychosocial constructs using different measurement tools in relation to hard cardiac endpoints before we can draw definitive conclusions about the role of psychosocial factors in cardiac prognosis.
REFERENCES
Implications Despite these limitations, the results of this study have clinical implications. The findings of the present study clearly indicate the vital role of depression and anxiety in recurrent cardiac events among CAD patients with PCI. Therefore, it is important to screen for depression or anxiety after PCI, which would enable nurses to provide patients with optimal care at the proper time. In addition, it is necessary to examine psychosocial variables, including depression and anxiety, over time as predictors of poor outcomes, which would allow detection of the factors that alleviate or aggravate these symptoms. There are several valid and reliable screening tools that healthcare providers, such as nurses, could easily use to identify patients who are at a greater risk of depression or anxiety. Management of these patients may include nurse-led secondary prevention programs with more emotional and psychological support from early post-PCI, which would subsequently decrease the risk of recurrent cardiac events. In addition, nurses should closely monitor at-risk patients, and when needed, they should offer additional clinical care, such as counseling and psychological services during hospitalization or in an outpatient setting. Most of the programs that prevent recurrent cardiac events in Korean patients are focused on physical aspects, including exercise, diet, smoking cessation, and medication. According to our results, comprehensive secondary prevention programs that alleviate depression and anxiety should be implemented in a clinical setting in Korea. Moreover, depressed and anxious patients are less likely to perform health-related behaviors and participate in secondary prevention programs.32,40 Therefore, a strat-
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