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The association between subjective health status and 14-year mortality in post-PCI patients
IJCA-24080; No of Pages 5 International Journal of Cardiology xxx (2016) xxx–xxx
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
The association between subjective health status and 14-year mortality in post-PCI patients☆ Tom A.J. de Jager a, Karolijn Dulfer b, Kimberley Pieters a, Elisabeth M.W.J. Utens b, Joost Daemen a, Mattie J. Lenzen a, Ron T. van Domburg a,⁎ a b
Department of Cardiology, Thoraxcenter Erasmus Medical Centre, Rotterdam, The Netherlands Department of Child and Adolescent Psychiatry/Psychology, Erasmus Medical Centre-Sophia Children's Hospital, Rotterdam, The Netherlands
a r t i c l e
i n f o
Article history: Received 6 September 2016 Accepted 7 November 2016 Available online xxxx Keywords: Percutaneous coronary intervention Subjective health status Mortality
a b s t r a c t Background: Poor subjective health status significantly predicted short-term mortality in patients with coronary artery disease (CAD). However, the relation between subjective health status and long-term mortality remains limited in patients treated with PCI. The aim of this study is to investigate the association between subjective health status and 14-year mortality in patients treated with percutaneous coronary intervention (PCI). Methods: A consecutive cohort with 1111 patients treated for CAD who completed the SF-36 questionnaire was included between 2001 and 2002 as part of the RESEARCH registry. Results: After adjustment, physical functioning (HR: 1.96; 95% CI: 1.59–2.43), social functioning (HR: 1.53; 95% CI: 1.24–1.88), role limitations due to physical functioning (HR: 1.75; 95% CI: 1.41–2.16), role limitations due to emotional functioning (HR: 1.34; 95%CI: 1.08–1.67), mental health (HR: 1.52; 95% CI: 1.24–1.88), vitality (HR: 1.66; 95% CI: 1.35–2.03), bodily pain (HR: 1.63; 95% CI: 1.32–2.02) and general health (HR: 1.82; 95% CI: 1.49–2.23) were all associated with an increased risk of 14-year mortality. Conclusion: Physical and mental subjective health status as measured with the SF-36 appeared to be a strong predictor for 14-year mortality in post-PCI patients. © 2016 Elsevier Ireland Ltd. All rights reserved.
1. Introduction Coronary artery disease (CAD) is the world's most common cause of death and heart failure [1]. However, mortality in patients with CAD has decreased in the last decade because of the improved treatment. Therefore, subjective health status becomes increasingly important to identify the impact of morbidity after percutaneous coronary intervention (PCI) in these patients [2]. Subjective health status is the self-reported impact of disease on a patient's functioning which proved to add important patient-centered information in addition to the parameters collected in a standard clinical patient record [3]. While subjective self-reported health status and physician's assessed health status are often discordant, it is remarkable that subjective health status questionnaires are rarely used in clinical practice [3,4]. Information on subjective health status may help identify patients at risk for poor prognosis and guide the clinical management of these patients [5].
Cardiac risk factors, including lifestyle and dietary factors, have often been investigated over the past years to identify patients who might benefit from secondary prevention to improve their long-term outcome. Many of these risk factors were associated with an increased risk of cardiovascular morbidity and mortality [2,6]. Several studies investigated the association between subjective health status and mortality in patients with CAD [6–8]. An increased mortality risk for patients with poor subjective health status after PCI has been described, up to 6 years of follow-up [9,10]. However, the relation between subjective health status and long-term mortality remains limited in patients treated with PCI. Considering the previous indications that subjective health status is a risk factor for short-term mortality, this prospective study aims to further investigate the predictive value of subjective health status as measured with the Short-Form Health Survey (SF-36) on long-term mortality, i.e. 14 years after percutaneous coronary intervention. 2. Methods
☆ All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation ⁎ Corresponding author at: Erasmus MC Rotterdam, The Netherlands. E-mail address: [email protected] (R.T. van Domburg).
2.1. Study population Between 2 September 2001 and 31 October 2002, a cohort of 1675 consecutive patients treated with PCI with either sirolimus-eluting stenting (SES) or bare metal stenting
http://dx.doi.org/10.1016/j.ijcard.2016.11.218 0167-5273/© 2016 Elsevier Ireland Ltd. All rights reserved.
Please cite this article as: T.A.J. de Jager, et al., The association between subjective health status and 14-year mortality in post-PCI patients, Int J Cardiol (2016), http://dx.doi.org/10.1016/j.ijcard.2016.11.218
2
T.A.J. de Jager et al. / International Journal of Cardiology xxx (2016) xxx–xxx
(BMS) were included as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. These patients were treated for myocardial infarction (MI) or angina (unstable or stable) in the Erasmus Medical Center Rotterdam, The Netherlands. The design of the RESEARCH registry has been published elsewhere [11,12]. In brief, the RESEARCH registry was designed to evaluate the efficacy and safety of SES implantation in the “real world” of interventional cardiology. Therefore, no exclusion criteria were applied for patients entering the registry [11]. At 6 months post-PCI (baseline), all surviving patients were contacted by mail and asked to fill in a self-report questionnaire. Assessment at 6 months was chosen due to logistic reasons and to represent patients in stable condition, as the risk for restenosis is increased in the 0–6 months period post-PCI [13,14]. This study was not subjected to the Dutch Medical Research Involving Human Subjects Act. Approval from the local research ethics committee to conduct this prospective follow-up study was not required at the time of enrolment. Moreover, the study was conducted according to the Helsinki Declaration [15]. All patients consented to participation in this study. 2.2. Variables 2.2.1. Baseline data The following variables were collected: socio-demographic characteristics included gender and age, clinical characteristics included renal impairment (creatinine clearance b60 mL/min), cardiac risk factors (hypertension, hypercholesterolemia, diabetes mellitus, family history of CAD, smoking), cardiac history (previous MI, coronary artery bypass grafting (CABG), PCI, multi-vessel disease, recent event), left ventricular ejection fraction (LVEF) and indication for intervention. Hypercholesterolemia was defined as total cholesterol levels ≥240 mg/dL or on lipid-lowering medication. Hypertension was defined as blood pressure N 140/90 mm Hg or being treated for hypertension. Diabetes mellitus was defined as being treated for diabetes. All data on baseline and the medical history of patients were collected from medical charts. 2.2.2. Subjective health status (Short Form-36) Subjective health status was measured with the SF-36. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes 36 items that can be divided in eight sub-scales: 1. Limitations in physical activities because of health problems; 2. Limitations in social activities because of physical or emotional problems; 3. Limitations in usual role activities because of physical health problems; 4. Bodily pain; 5. General mental health; 6. Limitations in usual role activities because of emotional problems; 7. Vitality; 8. General health perceptions [16]. The summed scale scores of each subdomain are computed into scaled scores ranging from 0 to 100. A higher score represents a better functioning. The SF-36 has adequate reliability, with a median Cronbach's α of 0.85 [17]. 2.3. Outcome The endpoint was defined as all-cause mortality at 14 years. Deaths (n = 54) occurring between 0 and 6 months were excluded as an endpoint for analyses. Post-discharge survival status was collected from the Municipal Civil Registries. Survival status at follow-up (June 2016) was known for 98.0% of the patients. 2.4. Statistical analysis Continuous variables are reported as mean or median scores with their corresponding standard deviation (SD). Dichotomous variables will be presented as numbers and percentages. Discrete variables are compared with X2 tests and continuous variables with Student t-tests. Univariable and multivariable Cox proportional hazard regression analyses will be used to examine the impact of subjective health status on 14-year mortality. To enhance the clinical interpretability the SF-36 domains were dichotomized with the lowest tertile indicating poor health status and the other 2 highest tertiles indicating good health status. In multivariable analysis, all specific SF-36 subdomains were adjusted for the following baseline characteristics: gender, age, dyslipidemia, hypertension, family history of CAD, current smoking, former smoking, diabetes mellitus, multi vessel disease, recent event, renal impairment, indication PCI, LVEF, previous myocardial infarction, previous CABG, previous PCI. Kaplan-Meier curves were constructed for patients with poor versus good subjective health status. The log-rank test was used to ascertain whether differences between groups were statistically significant. A probability value of b0.05 was considered statistically significant. For Cox proportional hazard regression analyses, hazard ratios (HRs) and their corresponding 95% confidence intervals (95% CIs) are reported. All analyses were performed using SPSS version 21 for Windows (SPSS Inc., Chicago, IL).
3. Results 3.1. Baseline characteristics During the study period 1675 patients were eligible for inclusion, 54 patients died within 6 months. The remaining 1621 patients were asked by mail to fill in the SF-36 questionnaire, of which 415 did not return the questionnaire (74.4% response rate). The remaining 1206 patients returned the SF-36 questionnaire, of which 95 had N 50% missing data
Fig. 1. Patient flowchart.
on at least one sub-domain of the SF-36 and therefore excluded for analysis. Ultimately, 1111 patients were included in the analysis (Fig. 1). Mean age in the population was 62.1 years and 73.3% were men (Table 1). During the 14-year follow up period 417 patients died. The median follow-up period for all-cause mortality was 13.9 ± 3.7 years (range [0.7–14.8]). There were no significant differences between responders and non-responders with the exception of a higher rate of previous PCI (32% vs 23%, P = 0.03) in the non-responders.
3.2. Association between subjective health status and 14-year mortality Patients with a good subjective health status at baseline had a better 14-year survival post-PCI. Survival curves of the physical domains continue to diverge 14 years after PCI (Fig. 2). Cumulative survival curves of the mental domains remain running parallel at follow-up (Fig. 3). In univariable analyses, poor self-reported health status on the SF-36 was associated with an increased risk of 14-year mortality, with HRs ranging from 1.24 to 2.64. In multivariable Cox proportional hazard regression analyses, physical functioning (HR: 1.96; 95% CI: 1.59–2.43), social functioning (HR: 1.53; 95% CI: 1.24–1.88), role limitations due to physical functioning (HR: 1.75; 95% CI: 1.41–2.16), role limitations due to emotional functioning (HR: 1.34; 95%CI: 1.08–1.67), mental health (HR: 1.52; 95% CI: 1.24–1.88), vitality (HR: 1.66; 95% CI: 1.35–2.03), bodily pain (HR: 1.63; 95% CI: 1.32–2.02) and general health (HR: 1.82; 95% CI: 1.49–2.23) remained all associated with an increased risk for 14-year mortality (Table 2).
Please cite this article as: T.A.J. de Jager, et al., The association between subjective health status and 14-year mortality in post-PCI patients, Int J Cardiol (2016), http://dx.doi.org/10.1016/j.ijcard.2016.11.218
T.A.J. de Jager et al. / International Journal of Cardiology xxx (2016) xxx–xxx
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4. Discussion
Table 1 Patients characteristics. Total sample (N = 1111) Socio-demographic characteristics Male sex, N (%) Mean age, years (SD)
814 (73.3) 62.1 (11.0)
Indication (%) Stable angina Unstable angina Acute myocardial infarction
560 (50.4) 396 (35.6) 155 (14.0)
Cardiac history (%) Prior myocardial infarction Prior percutaneous coronary intervention Prior coronary artery bypass grafting Recent event Multi vessel disease
438 (39.4) 312 (28.1) 139 (12.5) 116 (10.4) 584 (52.6)
Risk factors Current smoker Former smoker Family history Hypertension Hyperlipidaemia Diabetes mellitus Renal impairment
451 (40.6) 165 (14.9) 330 (29.7) 341 (30.7) 677 (60.9) 158 (14.2) 28 (2.5)
Left ventricular ejection fraction (LVEF) Good Impaired Missing
623 (56.1) 132 (11.9) 356 (32.0)
Recent event = MI, CABG, or PCI between 0 and 6 months post-PCI.
In a consecutive cohort of patients treated for ischemic heart disease with PCI, subjective health status at 6 months post-PCI appeared to be a strong predictor for mortality at 14 years, with the adjusted HRs ranging from 1.34 to 1.96. In particular, the physical domains of the SF-36 were highly associated with all-cause mortality. Several studies have reported the association between subjective health status and short-term follow-up, which showed a 2–3-fold increased risk of 1-year mortality [9,18]. The most powerful predictors of death at 1 year were subjective health status, age and presence of congestive heart failure [7]. Iestra et al. found that physical activity resulted in a 25% risk reduction of short-term mortality [6]. While an earlier study from our research group found that all SF-36 subdomains except role emotional functioning were associated with 6-year mortality [10], our study shows that the association between subjective health status and mortality is not only visible in the early years post-PCI, it is a trend that continues to diverge even after six and ten years post-PCI (Fig. 2). Long-term outcome studies are rare. A single Scandinavian study, in which three types of index events (AMI,CABG and PCI) were used to investigate whether subjective health status predicted 10 year mortality [19]. While the authors concluded that the patients' own experience of his or her quality of life has a prognostic importance for long-term mortality, the 413 patients were included in the late eighties and are probably no longer representative of a contemporary PCI population. To the best of our knowledge our study is the first study to examine whether poor subjective health status is associated with 14-year mortality post-PCI.
Fig. 2. Kaplan-Meier curves for the physical health domains.
Please cite this article as: T.A.J. de Jager, et al., The association between subjective health status and 14-year mortality in post-PCI patients, Int J Cardiol (2016), http://dx.doi.org/10.1016/j.ijcard.2016.11.218
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Fig. 3. Kaplan-Meier curves for the mental health domains.
The results of our study may have important implications for clinical practice. Patients with poor subjective health status might not be identified in clinical practice based on the clinician's judgement alone, in particular since physicians seem to underestimate the disability of patients [3]. Therefore it is important that physicians are aware of the association between subjective health status and long-term mortality. It is recommended to assess subjective health status post-PCI, in order to identify patients at risk for a poor prognosis. Our study has some limitations. First, non-responders had to be excluded from analysis. However a comparison between non-responders
Table 2 The association between poor self-reported health status and 14 year mortality. SF-36 domains
Multivariatea
Univariate HR
95% CI
HR
95% CI
Physical health domains Physical functioning Role physical functioning Bodily pain General health
2.64 1.95 1.63 1.82
2.18–3.20 1.60–2.37 1.33–1.99 1.50–2.21
1.96 1.75 1.63 1.82
1.59–2.43 1.41–2.16 1.32–2.02 1.49–2.23
Mental health domains Social functioning Role emotional functioning Mental health Vitality
1.48 1.24 1.37 1.61
1.22–1.79 1.01–1.53 1.13–1.67 1.32–1.95
1.53 1.34 1.52 1.66
1.24–1.88 1.08–1.67 1.24–1.88 1.35–2.03
a
and responders did not show major differences in baseline risk profile. Non-responders only had more previous PCI, for which we adjusted in multivariable analyses. Second, it is possible that other baseline variables also had an influence on the association between subjective health status and mortality. However, we adjusted for several risk factors after which an impaired health status remained significantly associated with 14-year mortality. The strengths of our study were the prospective study design, large study population, median follow-up of 13.9 years and the generalizability to daily clinical practice. In conclusion, the risk of 14-year mortality was increased almost twofold in patients treated with PCI with a poor self-reported physical and general health at 6 months post-PCI. Mental sub-domains of the SF-36 were less powerful but still significant predictors for 14 years mortality.
Adjusted for the following baseline characteristics: gender, age, dyslipidemia, diabetes mellitus, hypertension, family history of CAD, current smoking, former smoking, renal impairment, indication intervention, previous MI, previous PCI, previous CABG, recent event, multivessel disease, LVEF.
Conflict of interest None. Acknowledgments None. References [1] Organization WH, The 10 Leading Causes of Death in the World, 2000 and 2012, 2016. WHO, 2016 ([updated May 2014. Available from: http://www.who.int/ mediacentre/factsheets/fs310/en/). [2] S.T. Nauta, J.W. Deckers, M. Akkerhuis, M. Lenzen, M.L. Simoons, R.T. van Domburg, Changes in clinical profile, treatment, and mortality in patients hospitalised for
Please cite this article as: T.A.J. de Jager, et al., The association between subjective health status and 14-year mortality in post-PCI patients, Int J Cardiol (2016), http://dx.doi.org/10.1016/j.ijcard.2016.11.218
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Please cite this article as: T.A.J. de Jager, et al., The association between subjective health status and 14-year mortality in post-PCI patients, Int J Cardiol (2016), http://dx.doi.org/10.1016/j.ijcard.2016.11.218
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
The association between subjective health status and 14-year mortality in post-PCI patients☆ Tom A.J. de Jager a, Karolijn Dulfer b, Kimberley Pieters a, Elisabeth M.W.J. Utens b, Joost Daemen a, Mattie J. Lenzen a, Ron T. van Domburg a,⁎ a b
Department of Cardiology, Thoraxcenter Erasmus Medical Centre, Rotterdam, The Netherlands Department of Child and Adolescent Psychiatry/Psychology, Erasmus Medical Centre-Sophia Children's Hospital, Rotterdam, The Netherlands
a r t i c l e
i n f o
Article history: Received 6 September 2016 Accepted 7 November 2016 Available online xxxx Keywords: Percutaneous coronary intervention Subjective health status Mortality
a b s t r a c t Background: Poor subjective health status significantly predicted short-term mortality in patients with coronary artery disease (CAD). However, the relation between subjective health status and long-term mortality remains limited in patients treated with PCI. The aim of this study is to investigate the association between subjective health status and 14-year mortality in patients treated with percutaneous coronary intervention (PCI). Methods: A consecutive cohort with 1111 patients treated for CAD who completed the SF-36 questionnaire was included between 2001 and 2002 as part of the RESEARCH registry. Results: After adjustment, physical functioning (HR: 1.96; 95% CI: 1.59–2.43), social functioning (HR: 1.53; 95% CI: 1.24–1.88), role limitations due to physical functioning (HR: 1.75; 95% CI: 1.41–2.16), role limitations due to emotional functioning (HR: 1.34; 95%CI: 1.08–1.67), mental health (HR: 1.52; 95% CI: 1.24–1.88), vitality (HR: 1.66; 95% CI: 1.35–2.03), bodily pain (HR: 1.63; 95% CI: 1.32–2.02) and general health (HR: 1.82; 95% CI: 1.49–2.23) were all associated with an increased risk of 14-year mortality. Conclusion: Physical and mental subjective health status as measured with the SF-36 appeared to be a strong predictor for 14-year mortality in post-PCI patients. © 2016 Elsevier Ireland Ltd. All rights reserved.
1. Introduction Coronary artery disease (CAD) is the world's most common cause of death and heart failure [1]. However, mortality in patients with CAD has decreased in the last decade because of the improved treatment. Therefore, subjective health status becomes increasingly important to identify the impact of morbidity after percutaneous coronary intervention (PCI) in these patients [2]. Subjective health status is the self-reported impact of disease on a patient's functioning which proved to add important patient-centered information in addition to the parameters collected in a standard clinical patient record [3]. While subjective self-reported health status and physician's assessed health status are often discordant, it is remarkable that subjective health status questionnaires are rarely used in clinical practice [3,4]. Information on subjective health status may help identify patients at risk for poor prognosis and guide the clinical management of these patients [5].
Cardiac risk factors, including lifestyle and dietary factors, have often been investigated over the past years to identify patients who might benefit from secondary prevention to improve their long-term outcome. Many of these risk factors were associated with an increased risk of cardiovascular morbidity and mortality [2,6]. Several studies investigated the association between subjective health status and mortality in patients with CAD [6–8]. An increased mortality risk for patients with poor subjective health status after PCI has been described, up to 6 years of follow-up [9,10]. However, the relation between subjective health status and long-term mortality remains limited in patients treated with PCI. Considering the previous indications that subjective health status is a risk factor for short-term mortality, this prospective study aims to further investigate the predictive value of subjective health status as measured with the Short-Form Health Survey (SF-36) on long-term mortality, i.e. 14 years after percutaneous coronary intervention. 2. Methods
☆ All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation ⁎ Corresponding author at: Erasmus MC Rotterdam, The Netherlands. E-mail address: [email protected] (R.T. van Domburg).
2.1. Study population Between 2 September 2001 and 31 October 2002, a cohort of 1675 consecutive patients treated with PCI with either sirolimus-eluting stenting (SES) or bare metal stenting
http://dx.doi.org/10.1016/j.ijcard.2016.11.218 0167-5273/© 2016 Elsevier Ireland Ltd. All rights reserved.
Please cite this article as: T.A.J. de Jager, et al., The association between subjective health status and 14-year mortality in post-PCI patients, Int J Cardiol (2016), http://dx.doi.org/10.1016/j.ijcard.2016.11.218
2
T.A.J. de Jager et al. / International Journal of Cardiology xxx (2016) xxx–xxx
(BMS) were included as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. These patients were treated for myocardial infarction (MI) or angina (unstable or stable) in the Erasmus Medical Center Rotterdam, The Netherlands. The design of the RESEARCH registry has been published elsewhere [11,12]. In brief, the RESEARCH registry was designed to evaluate the efficacy and safety of SES implantation in the “real world” of interventional cardiology. Therefore, no exclusion criteria were applied for patients entering the registry [11]. At 6 months post-PCI (baseline), all surviving patients were contacted by mail and asked to fill in a self-report questionnaire. Assessment at 6 months was chosen due to logistic reasons and to represent patients in stable condition, as the risk for restenosis is increased in the 0–6 months period post-PCI [13,14]. This study was not subjected to the Dutch Medical Research Involving Human Subjects Act. Approval from the local research ethics committee to conduct this prospective follow-up study was not required at the time of enrolment. Moreover, the study was conducted according to the Helsinki Declaration [15]. All patients consented to participation in this study. 2.2. Variables 2.2.1. Baseline data The following variables were collected: socio-demographic characteristics included gender and age, clinical characteristics included renal impairment (creatinine clearance b60 mL/min), cardiac risk factors (hypertension, hypercholesterolemia, diabetes mellitus, family history of CAD, smoking), cardiac history (previous MI, coronary artery bypass grafting (CABG), PCI, multi-vessel disease, recent event), left ventricular ejection fraction (LVEF) and indication for intervention. Hypercholesterolemia was defined as total cholesterol levels ≥240 mg/dL or on lipid-lowering medication. Hypertension was defined as blood pressure N 140/90 mm Hg or being treated for hypertension. Diabetes mellitus was defined as being treated for diabetes. All data on baseline and the medical history of patients were collected from medical charts. 2.2.2. Subjective health status (Short Form-36) Subjective health status was measured with the SF-36. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes 36 items that can be divided in eight sub-scales: 1. Limitations in physical activities because of health problems; 2. Limitations in social activities because of physical or emotional problems; 3. Limitations in usual role activities because of physical health problems; 4. Bodily pain; 5. General mental health; 6. Limitations in usual role activities because of emotional problems; 7. Vitality; 8. General health perceptions [16]. The summed scale scores of each subdomain are computed into scaled scores ranging from 0 to 100. A higher score represents a better functioning. The SF-36 has adequate reliability, with a median Cronbach's α of 0.85 [17]. 2.3. Outcome The endpoint was defined as all-cause mortality at 14 years. Deaths (n = 54) occurring between 0 and 6 months were excluded as an endpoint for analyses. Post-discharge survival status was collected from the Municipal Civil Registries. Survival status at follow-up (June 2016) was known for 98.0% of the patients. 2.4. Statistical analysis Continuous variables are reported as mean or median scores with their corresponding standard deviation (SD). Dichotomous variables will be presented as numbers and percentages. Discrete variables are compared with X2 tests and continuous variables with Student t-tests. Univariable and multivariable Cox proportional hazard regression analyses will be used to examine the impact of subjective health status on 14-year mortality. To enhance the clinical interpretability the SF-36 domains were dichotomized with the lowest tertile indicating poor health status and the other 2 highest tertiles indicating good health status. In multivariable analysis, all specific SF-36 subdomains were adjusted for the following baseline characteristics: gender, age, dyslipidemia, hypertension, family history of CAD, current smoking, former smoking, diabetes mellitus, multi vessel disease, recent event, renal impairment, indication PCI, LVEF, previous myocardial infarction, previous CABG, previous PCI. Kaplan-Meier curves were constructed for patients with poor versus good subjective health status. The log-rank test was used to ascertain whether differences between groups were statistically significant. A probability value of b0.05 was considered statistically significant. For Cox proportional hazard regression analyses, hazard ratios (HRs) and their corresponding 95% confidence intervals (95% CIs) are reported. All analyses were performed using SPSS version 21 for Windows (SPSS Inc., Chicago, IL).
3. Results 3.1. Baseline characteristics During the study period 1675 patients were eligible for inclusion, 54 patients died within 6 months. The remaining 1621 patients were asked by mail to fill in the SF-36 questionnaire, of which 415 did not return the questionnaire (74.4% response rate). The remaining 1206 patients returned the SF-36 questionnaire, of which 95 had N 50% missing data
Fig. 1. Patient flowchart.
on at least one sub-domain of the SF-36 and therefore excluded for analysis. Ultimately, 1111 patients were included in the analysis (Fig. 1). Mean age in the population was 62.1 years and 73.3% were men (Table 1). During the 14-year follow up period 417 patients died. The median follow-up period for all-cause mortality was 13.9 ± 3.7 years (range [0.7–14.8]). There were no significant differences between responders and non-responders with the exception of a higher rate of previous PCI (32% vs 23%, P = 0.03) in the non-responders.
3.2. Association between subjective health status and 14-year mortality Patients with a good subjective health status at baseline had a better 14-year survival post-PCI. Survival curves of the physical domains continue to diverge 14 years after PCI (Fig. 2). Cumulative survival curves of the mental domains remain running parallel at follow-up (Fig. 3). In univariable analyses, poor self-reported health status on the SF-36 was associated with an increased risk of 14-year mortality, with HRs ranging from 1.24 to 2.64. In multivariable Cox proportional hazard regression analyses, physical functioning (HR: 1.96; 95% CI: 1.59–2.43), social functioning (HR: 1.53; 95% CI: 1.24–1.88), role limitations due to physical functioning (HR: 1.75; 95% CI: 1.41–2.16), role limitations due to emotional functioning (HR: 1.34; 95%CI: 1.08–1.67), mental health (HR: 1.52; 95% CI: 1.24–1.88), vitality (HR: 1.66; 95% CI: 1.35–2.03), bodily pain (HR: 1.63; 95% CI: 1.32–2.02) and general health (HR: 1.82; 95% CI: 1.49–2.23) remained all associated with an increased risk for 14-year mortality (Table 2).
Please cite this article as: T.A.J. de Jager, et al., The association between subjective health status and 14-year mortality in post-PCI patients, Int J Cardiol (2016), http://dx.doi.org/10.1016/j.ijcard.2016.11.218
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4. Discussion
Table 1 Patients characteristics. Total sample (N = 1111) Socio-demographic characteristics Male sex, N (%) Mean age, years (SD)
814 (73.3) 62.1 (11.0)
Indication (%) Stable angina Unstable angina Acute myocardial infarction
560 (50.4) 396 (35.6) 155 (14.0)
Cardiac history (%) Prior myocardial infarction Prior percutaneous coronary intervention Prior coronary artery bypass grafting Recent event Multi vessel disease
438 (39.4) 312 (28.1) 139 (12.5) 116 (10.4) 584 (52.6)
Risk factors Current smoker Former smoker Family history Hypertension Hyperlipidaemia Diabetes mellitus Renal impairment
451 (40.6) 165 (14.9) 330 (29.7) 341 (30.7) 677 (60.9) 158 (14.2) 28 (2.5)
Left ventricular ejection fraction (LVEF) Good Impaired Missing
623 (56.1) 132 (11.9) 356 (32.0)
Recent event = MI, CABG, or PCI between 0 and 6 months post-PCI.
In a consecutive cohort of patients treated for ischemic heart disease with PCI, subjective health status at 6 months post-PCI appeared to be a strong predictor for mortality at 14 years, with the adjusted HRs ranging from 1.34 to 1.96. In particular, the physical domains of the SF-36 were highly associated with all-cause mortality. Several studies have reported the association between subjective health status and short-term follow-up, which showed a 2–3-fold increased risk of 1-year mortality [9,18]. The most powerful predictors of death at 1 year were subjective health status, age and presence of congestive heart failure [7]. Iestra et al. found that physical activity resulted in a 25% risk reduction of short-term mortality [6]. While an earlier study from our research group found that all SF-36 subdomains except role emotional functioning were associated with 6-year mortality [10], our study shows that the association between subjective health status and mortality is not only visible in the early years post-PCI, it is a trend that continues to diverge even after six and ten years post-PCI (Fig. 2). Long-term outcome studies are rare. A single Scandinavian study, in which three types of index events (AMI,CABG and PCI) were used to investigate whether subjective health status predicted 10 year mortality [19]. While the authors concluded that the patients' own experience of his or her quality of life has a prognostic importance for long-term mortality, the 413 patients were included in the late eighties and are probably no longer representative of a contemporary PCI population. To the best of our knowledge our study is the first study to examine whether poor subjective health status is associated with 14-year mortality post-PCI.
Fig. 2. Kaplan-Meier curves for the physical health domains.
Please cite this article as: T.A.J. de Jager, et al., The association between subjective health status and 14-year mortality in post-PCI patients, Int J Cardiol (2016), http://dx.doi.org/10.1016/j.ijcard.2016.11.218
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T.A.J. de Jager et al. / International Journal of Cardiology xxx (2016) xxx–xxx
Fig. 3. Kaplan-Meier curves for the mental health domains.
The results of our study may have important implications for clinical practice. Patients with poor subjective health status might not be identified in clinical practice based on the clinician's judgement alone, in particular since physicians seem to underestimate the disability of patients [3]. Therefore it is important that physicians are aware of the association between subjective health status and long-term mortality. It is recommended to assess subjective health status post-PCI, in order to identify patients at risk for a poor prognosis. Our study has some limitations. First, non-responders had to be excluded from analysis. However a comparison between non-responders
Table 2 The association between poor self-reported health status and 14 year mortality. SF-36 domains
Multivariatea
Univariate HR
95% CI
HR
95% CI
Physical health domains Physical functioning Role physical functioning Bodily pain General health
2.64 1.95 1.63 1.82
2.18–3.20 1.60–2.37 1.33–1.99 1.50–2.21
1.96 1.75 1.63 1.82
1.59–2.43 1.41–2.16 1.32–2.02 1.49–2.23
Mental health domains Social functioning Role emotional functioning Mental health Vitality
1.48 1.24 1.37 1.61
1.22–1.79 1.01–1.53 1.13–1.67 1.32–1.95
1.53 1.34 1.52 1.66
1.24–1.88 1.08–1.67 1.24–1.88 1.35–2.03
a
and responders did not show major differences in baseline risk profile. Non-responders only had more previous PCI, for which we adjusted in multivariable analyses. Second, it is possible that other baseline variables also had an influence on the association between subjective health status and mortality. However, we adjusted for several risk factors after which an impaired health status remained significantly associated with 14-year mortality. The strengths of our study were the prospective study design, large study population, median follow-up of 13.9 years and the generalizability to daily clinical practice. In conclusion, the risk of 14-year mortality was increased almost twofold in patients treated with PCI with a poor self-reported physical and general health at 6 months post-PCI. Mental sub-domains of the SF-36 were less powerful but still significant predictors for 14 years mortality.
Adjusted for the following baseline characteristics: gender, age, dyslipidemia, diabetes mellitus, hypertension, family history of CAD, current smoking, former smoking, renal impairment, indication intervention, previous MI, previous PCI, previous CABG, recent event, multivessel disease, LVEF.
Conflict of interest None. Acknowledgments None. References [1] Organization WH, The 10 Leading Causes of Death in the World, 2000 and 2012, 2016. WHO, 2016 ([updated May 2014. Available from: http://www.who.int/ mediacentre/factsheets/fs310/en/). [2] S.T. Nauta, J.W. Deckers, M. Akkerhuis, M. Lenzen, M.L. Simoons, R.T. van Domburg, Changes in clinical profile, treatment, and mortality in patients hospitalised for
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