Objective Overall, percutaneous coronary intervention (PCI) can improve the symptoms and quality of life (QoL) of patients with coronary artery disease. Older patients account for an increasing number and proportion of PCIs, however they are more prone to adverse events. This study systematically reviews the QoL benefits in this sub-group.
Design and setting A systematic review was undertaken, in accordance with the Preferred Reporting Items for Systematic reviews and Meta-analysis (PRISMA) guidelines, using Medline, Embase and Science Direct databases. The search was limited to studies available in English; last run on 31 December 2012.
Patients Patients aged ≥80 years.
Main outcome measure QoL.
Results The process identified 11 articles which reported QoL outcomes in octogenarians following PCI. In total, there were 700 octogenarian patients identified within the 11 studies with a mean age of 82.9 years. Studies were heterogeneity in the populations, methodology and QoL tools utilised. Overall, the literature suggests that QoL for octogenarians improves following PCI. Older patients improve at least as much as younger patients and may gain more in the areas of physical functioning and improved angina status. The benefits are greatest in the first 6 months and may continue until at least 3 years.
Conclusions QoL following PCI in octogenarians improves at least as much as in younger patients. Given the small number of studies resulting in a total of 700 octogenarian patients, further studies would be useful in determining those octogenarian patients who are likely to derive the greatest benefit.
- CORONARY ARTERY DISEASE
- QUALITY OF CARE AND OUTCOMES
- MYOCARDIAL ISCHAEMIA AND INFARCTION (IHD)
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Reduced fertility rates and substantial rises in life expectancy at birth and at 65 years, have resulted in an increasingly older population.1 Coronary arterial disease (CAD) remains the most commonly reported limiting longstanding illness and accounts for more than a quarter of all deaths in both men and women.2 Mortality and morbidity from CAD are strongly associated with age.3 Among people aged 75 years and over, more than one-third of men and around one-quarter of women are living with CAD.4 CAD may be managed using medical therapy or with revascularisation techniques such as percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). As a result of the ageing population, older patients account for an increasing number and proportion of patients attending for management of CAD by PCI.5 Studies show that older patients undergoing PCI have a higher risk profile, in terms of co-morbid conditions, multivessel disease and arterial calcification, and suffer more adverse events than their younger counterparts.5–7
Assessments of reductions in early and long-term adverse clinical outcomes (such as myocardial infarction) are important considerations following PCI. However, as PCI is generally undertaken to relieve the signs and symptoms of myocardial ischaemia, the effects on symptom relief and quality of life are more critical considerations for patient and health service decision-making. This is particularly pertinent in the older population as ‘the longevity benefits (of PCI) are frequently limited by multiple competing risks and the goal of therapy is often to maintain independent living with reasonable comfort’.8 Health related quality of life (QoL) measures are increasing being used to assess the effectiveness of interventions in all age groups. Their use takes into consideration the impact of the intervention on the patients’ physical health, emotional and social wellbeing.9
There has been a previous systematic review which assessed clinical outcomes following PCI in octogenarians (e.g. death or major adverse cardiac events). This did not assess any impact on QoL.10 It demonstrated that PCI in octogenarians was well tolerated and associated with acceptable short-term and long-term outcomes. However, the authors described the evidence as of ‘low quality’ because of their small study sizes or observational nature—despite containing some large well conducted observational studies.
Another systematic review assessed the impact of drug-eluting coronary stents (DES) on QoL.11 This included studies which either excluded older patients altogether, or had very small numbers of those aged 80 years or older (eg, the RITA study12). Its main focus was on healthcare costs and the impact of target vessel revascularisation (TVR) on QoL (DES are associated with a reduced need for TVR). It concluded that there was ‘a lack of convergence in the literature’ on costs and QoL improvements associated with DES.
This article aims to collate the available evidence by undertaking a systematic review and critical appraisal of the relevant studies which assess QoL following PCI in octogenarians.
A systematic review was undertaken in accordance with the Preferred Reporting Items for Systematic reviews and Meta-analysis (PRISMA) guidelines (http://www.prisma-statement.org/). The aim of the search was to identify articles reporting QoL outcomes in older patients (aged 80 years or older) who underwent PCI and where possible, compare results with younger patients.
Search strategy and selection criteria
Four journal databases were used (Ovid Medline 1948 to September week 1 2011, Ovid Embase 1996 to 2011 week 36, Science Direct and the Cochrane Library of Systematic Reviews from 1995 to 2010 inclusive) with the following search terms and Boolean connectors applied: (‘coronary’ OR ‘heart’ OR ‘cardi*’ OR ‘myocardi*’) AND (‘stent’ OR ‘PCI’ OR ‘revascularisation’ OR ‘percutaneous coronary’ OR ‘percutaneous intervention’ OR ‘angio*’ OR ‘percutaneous transluminal’) AND (‘quality of life’ OR ‘psychological adaptation’ OR ‘attitude to health’ OR ‘health status’ OR ‘life change events’ OR ‘EQ5D’ OR ‘SF*36’ OR ‘SF*12’ OR ‘SF*24’ OR ‘DASI’ OR ‘HRQOL’ OR ‘Seattle Angina Questionnaire (SAQ)’ OR ‘RAND 36’) AND (‘octogen*’ OR ‘*80-year*’). The search was limited to studies conducted on humans and those which were available in English, and was last run on 31 December 2012. In cases where studies had duplicate publications, the most recent publication was used. Only studies which reported QoL and outcomes in cohorts aged 80 years and over were included. Exclusion criteria included: reviews, editorials, studies of procedures other then PCI and those which reported clinical outcomes only (eg, death or major adverse cardiac events). The reference lists of relevant articles (including reviews and editorials) were reviewed to identify additional articles that were potentially relevant.
Titles and then abstracts were reviewed to exclude articles that did not satisfy the inclusion criteria. The full texts of the remaining articles were obtained and reviewed by two of the authors (CJ and JPP) in detail to determine their eligibility for inclusion. Methodological quality scores were independently assigned and compared. The data extracted from eligible articles included the publication date, indication for PCI, study setting, study population size and characteristics, intervention details, QoL measurement, length of follow-up, results and measures of statistical significance (table 1). Corresponding authors were contacted to obtain any missing information and to request sub-group data where appropriate. Summary figures were calculated based on available data from included studies.
A total of 185 articles were identified by the electronic search, of which 36 were discarded as duplicates (figure 1). Title review resulted in the exclusion of a further 81 articles. The abstracts of the remaining 68 were screened and an additional 25 were excluded. The full manuscripts of the remaining 43 were reviewed and 11 were judged eligible for inclusion in the review. The eligible studies were published between 1993 and 2012 inclusive. They included a total of 700 older patients within the 11 studies with a mean age of 82.9 years (range 82.1–83.9 years) across the studies. The oldest patient was reported as 96 years of age. Five studies reported separate results for both older patients and their younger counterparts, with four of them making direct comparisons. Six studies provided before and after comparisons.
Six studies included patients with a mixture of stable and unstable angina; two included only elective PCIs and two had only PCIs undertaken following acute events. There was insufficient information provided by one study to determine PCI indication. The follow-up time for QoL ranged from 5 to 39.9±30.1 months post-PCI. The Short Form Health Survey with 36 items (SF-36), was the most commonly used tool and was used in four studies, followed by SAQ in three studies. The EQ5D (EuroQol 5 Domains), the RAND 36 (a 36-item health survey from RAND Health) and the WHOQOL-BREF (World Health Organisation Quality of Life shortened version) were used in only one study each. (One study assessed QoL using two different assessment tools in the same population.) Two studies did not use a validated QoL instrument but asked patients to classify their own QoL following PCI as excellent, good, fair or poor; or score it on a 0–10 scale, with no pre-intervention measurement.
Krumholz et al13 in 1993 was one of the first studies to report QoL outcomes following PCI in octogenarians. This cross-sectional study assessed QoL after PCI only; not before and after. They compared 41 patients undergoing PCI with 18 undergoing coronary arterial bypass grafting (CABG) and 34 managed medically. They used a simple self-rating system where patients graded their average QoL after discharge as: excellent, good, fair or poor. At 1 year follow-up, 86% of patients treated by PCI rated their QoL as good or excellent, compared with 89% treated by CABG and 44% of those managed conservatively. No tests of statistical significance were reported but post hoc analyses suggests that the outcome following PCI was comparable to CABG and better than medical management alone. However, five patients who underwent PCI died prior to follow-up, making generalisation of the findings problematic.
A simple self-rating scoring system was also used by Little et al14 in 1993 to compare outcomes of PCI in 118 octogenarians to that of 500 younger patients. There were significant baseline differences between the groups in: sex, left ventricular dysfunction, indication for PCI, severity of angina and complexity of PCI. QoL outcomes were measured between 6 and 48 months later in 110 of the 112 octogenarian hospital survivors, but not in the younger patients. Among long-term survivors, QoL was rated as 8.3±2.0 using a 10-point scale, with 95% stating that they felt their QoL had improved following the procedure. No baseline score were undertaken to assess improvement from baseline.
Four additional studies assessed QoL after PCI without formal baseline comparisons. Günal et al15 assessed outcomes at 1 year follow-up using the RAND-36 instrument in 68 of the 75 octogenarians recruited to the study who rated their general health as 57±19 points on a 0–100 scale. The authors stated that ‘at follow-up the general health was rated as fairly good and better than before PCI’ but provided no data to support this statement. Older patients had fewer symptoms of angina at follow-up, assessed using the Canadian Cardiovascular Society Classification. RAND-36 scores were compared with octogenarians from the Netherlands general population and no differences were demonstrated in the scores for either physical or mental well-being. In a retrospective study, Kamiya et al16 used a modified SAQ in 58 PCI patients aged ≥80 years who survived to follow up (39±20.4 months). Favourable QoL scores were obtained for the physical and mental domains. Both univariate and multivariate analyses of the predictors of unsatisfactory QoL were undertaken. This showed that left ventricular dysfunction was the only significant factor that influenced QoL. QoL scores were also found to be comparable with optimal medical therapy or coronary arterial bypass grafting.
Martin et al17 compared QoL outcomes of minimally invasive direct coronary artery bypass (MIDCAB) and PCI for left anterior descending artery (LAD) revascularisation. The SF-36 was used in 330 patients (172 MIDCAB, 158 PCI). No baseline measurements were undertaken, however follow-up was continued up to 84 months (average follow-up to 38 months). They concluded that QoL was better in patients aged <80 years who had undergone MIDCAB compared with PCI; but not in those aged ≥80 years. The number of patients aged ≥80 years is not presented. While propensity score matching was used to select the PCI patients, baseline QoL is not included.
Cassar et al18 used the WHOQOL-BREF (Maltese version) tool to assess QoL in 228 patients following PCI to examine differences between sub-groups. Patients aged ≥40 years were chosen randomly to receive the questionnaire; a response rate of 64% was achieved. Only 11 patients were aged ≥80 years and no statistically significant difference was found by age group.
A total of five studies, importantly, assessed and included baseline QoL in the analyses. Agarwal et al19 assessed QoL in 74 consecutive octogenarians undergoing PCI using both the SAQ and the SF-36. Functional status and QoL of life, at both 6 and 12 months, was found to be lower than the age-specific general population norms, but substantially improved compared with baseline measurements. The use of both SAQ and SF-36 enabled the researchers to assess both disease-specific and general health status. The consecutive nature of recruitment resulted in mainly patients with acute coronary syndrome and multivessel disease being included in the study.
Graham et al20 used the Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease (APPROACH) register to assess QoL in patients undergoing PCI compared with optical medical therapy and coronary arterial bypass grafting. Revascularisation patients reported improved QoL scores more than those treated medically over the full 3-year follow-up period. Overall response rates for patients aged ≥80 years was reported as 77.7% at 1 year. Sixty-nine per cent of those responding at 1 year also completed a SAQ questionnaire at 3 years. Non-responders were much more likely to have received medical therapy alone, suggesting possible overestimation of the QoL benefit in older patients. They were also more likely to have missing data, particularly their exertional capacity scores. No patients ≥80 years of age who were managed by optical medical therapy, subsequently underwent revascularisation.
Kaehler et al21 compared QoL, measured using the German translation of the SF-36 at 6 months following PCI (in only 34 patients aged 80 years and over) with the same number of younger patients. Immediately following PCI, physical functioning and general health were worse in those ≥80 years. However, all other SF-36 domains were better in patients aged ≥80 years at baseline. They found that the benefits of PCI were at least equal, and for some measures were even more pronounced, in the older patients.
More recent studies have also demonstrated greater improvements in QoL among octogenarians than younger patients, following PCI. In 2010, Li et al22 reported the results of a prospective study of 624 patients who underwent PCI or medical therapy for acute coronary syndrome in a single centre. Older patients reported lower QoL scores at baseline but reported greater improvements in physical health following PCI than younger patients (using the validated SF-36 Chinese version) (p<0.001). Eighty per cent of patients were followed-up to 6 months which is comparable with other PCI follow-up studies. However, this means longer-term QoL was not assessed.
An abstract presented orally at the Cardiac Society of Australia and New Zealand conference 201023 reported the results for 795 consecutive patients in Hong Kong who were managed by PCI for stable angina or acute coronary syndrome. The EQ5D was used to assess QoL at baseline and 6 months following PCI and compared with medical therapy across three age groups (<60, 60–79 and >80 years). EQ5D scores at baseline and at 6 months showed no significant differences between the age groups, with 86%, 84% and 73% (p=0.32), respectively, of patients in each age group experiencing improvements in QoL following PCI.
This systematic review identified 11 studies which have examined the impact of PCI on QoL among 700 octogenarian patients. The mean age was 82.9 years (range 82.1–83.9 years). The evidence, to date, suggests that the QoL for octogenarians does improve following PCI. The benefits are found to be greatest in the first 6 months but may continue for at least 3 years. Older patients improve at least as much as younger patients and appear to gain more in the areas of physical functioning and angina status.
To our knowledge, this is the first systematic review to assess QoL after revascularisation by PCI in octogenarians. The results are in keeping with other studies which demonstrate improved QoL in younger and older patients following PCI.24–27 The TIME study (Trial of Invasive versus Medical therapy in Older patients) demonstrated significant improvements in QoL following revascularisation compared with baseline.24 These QoL improvements in older patients (defined as ≥75 years rather than as octogenarians), as measured by the SF-36 and Duke’s Activity Status Index (DASI) appeared to be maintained at 1 year follow-up and were found to be initially superior to optimal medical therapy alone. Improvements in QoL in the optical medical therapy group were thought to be the result of a high crossover rate (46%) to revascularisation. While this small selective randomised controlled trial may not necessarily be generalisable, it did consider QoL as a primary endpoint and therefore included it in the power calculation. In addition, CABG and PCI have been reported together as ‘revascularisation’, making it difficult to assess the improvement following PCI alone.
There have been a number of other studies that have shown that PCI produces improvements in QoL measures in older patients that are equivalent to, or even better than, those observed in younger patients. Spertus et al26 assessed this and concluded that age was an independent predictor of QoL benefit in 1518 consecutive patients in the USA. Seto et al27 assessed QoL using the SF-36 and angina symptoms with the SAQ during 1-year follow-up in 295 patients aged over 70 years compared with 1150 younger patients (maximum age 89 years). At baseline, older patients reported lower scores for physical functioning but similar for mental health, when compared with younger patients. At the 6-month follow-up, both older and younger patients reported significant improvements in mental health, physical health and angina status. Similar to the findings of this study, the benefits persisted and, at 1 year follow-up, 60% of each group reported no angina. They concluded that QoL improvements after PCI were not age-dependent.
The studies included in this systematic review were heterogeneous in nature: five studies included differences between older patients and their younger counterparts; six provided before and after comparisons, and six included a mixture of stable and unstable patients; two included only elective patients and two included only PCIs undertaken following acute events. Follow-up of QoL following PCI ranged from to 5 to 39.9 (+/− 30.1) months. QoL was assessed using five different validated QoL tools or by informal self-reported QoL.
QoL tools can be generic (eg, SF-36) or disease specific (eg, SAQ). Generic instruments address multiple aspects of patients’ experience following interventions rather than focusing on specific features of a particular disease. There is much debate in the literature as to which tool is most appropriate to measure improvements following PCI28 or to assess QoL often in older people.29 Disease specific instruments (eg, SAQ) are considered more appropriate to assess QoL directly in the presence of coronary artery disease.
This systematic review concentrated on octogenarians as representative of much older patients. There are numerous studies in the literature which assess clinical outcomes in octogenarians following PCI.10 ,30 ,31 The ageing population and increased life expectancy has resulted in more octogenarians presenting for PCI, suggesting that investigating outcomes in this group is important and hence the choice of age cut-off. Authors of individual studies likely to contain participants >80 years, which were identified through the search strategy, were contacted with requests for sub-group data. Only one study was able to provide such data—the RITA study.12 This has not been included in this systematic review as it contained only one participant aged ≥80 years.
As with all systematic reviews, publication bias may be important because negative studies are less likely to be published. Publication bias is particularly important in this field, given that the number of published studies is small. The possibility of confounding and bias is a likely issue within the studies included in this review because only one study reported statistical adjustment for confounding variables such as baseline QoL and participant characteristics. This limits the conclusions which can be drawn from the existing literature. The studies also used widely different election criteria, making it difficult to generalise the results. The search strategy excluded non-English language studies, which may have excluded some studies. However, English tends to be the language used in cardiology interventional studies, therefore there is likely only to be a very small number of studies which report in another language. Heterogeneity among the populations and the QoL tools utilised plus the missing QoL scoring data from most of the studies meant that meta-analysis was inappropriate.
The benefits of this systematic review are that it used a robust search strategy which used multiple databases and followed the PRISMA guidelines—making it unlikely that relevant studies were missed. Two independent reviewers were used to assign quality scores to each of the studies.
This systematic review shows that QoL following PCI in octogenarians improves at least as much as in younger patients. Given the small number of studies with only 700 octogenarians, further studies would be useful in determining those octogenarian patients who are likely to derive the greatest benefit from the procedure and to investigate a consensus in the measurement tool utilised to measure QoL following PCI in older patients. This is particularly important as we have an ageing population, which will result in an increase in the number and proportion of octogenarians likely to undergoing PCI in the future.
Contributors CJ, KGO and JPP developed the research question. CJ and JPP systematically reviewed and critically appraised the literature used in the manuscript. DFM provided statistical support for the meta-analysis which was not successfully performed due to heterogeneity of the data and missing QoL scoring. CJ, KGO, JPP and DFM were involved in drafting and revising the manuscript. CJ and JPP are responsible for the overall content as guarantors.
Competing interests None.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Further data is available on request, for example synthesis of results table and findings of the attempted meta-analysis—unable to be successfully performed due to heterogeneity of the data.
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