Article Text
Abstract
Objective Due to the growing ageing population worldwide, more percutaneous coronary interventions (PCI) are being performed on elderly patients; however, current national data in Southeast Asian developing countries regarding patient characteristics, procedural details and PCI outcomes in elderly patients are insufficient.
Design Observational study.
Setting Nationwide registry from 39 primary PCI facilities across Thailand.
Participants Between May 2018 and August 2019, the Thai PCI registry enrolled a total of 22 741 patients who underwent PCI. We examined patient characteristics, PCI technique and in-hospital outcomes in octogenarians (≥80 years) and non-octogenarians (18–79 years).
Results There were 2099 patients (9.2%) over the age of 80. Octogenarians were at greater risk for atherosclerosis and calcified coronary lesions that required plaque modification and a higher risk of cardiogenic shock during presentation than non-octogenarians. The success rate of PCI in octogenarians was high (95.5%) and comparable to non-octogenarians (96%). The respective PCI failure rate in non-octogenarians and octogenarians was 4% and 4.5% (p=0.251). Octogenarians had a substantially greater incidence of periprocedural problems (5.6% vs 4.5%, p=0.011). PCI was linked with more than threefold increase in in-hospital mortality in octogenarians compared with non-octogenarians (7.67% vs 2.3%, p 0.001). Nonetheless, revascularisation with PCI in octogenarians increased the EQ-5D (European Quality of Life 5 Dimensions) score by 15.7 after PCI and before hospital discharge.
Conclusions According to the Thai PCI registry, octogenarians had more complicated coronary anatomy, as well as higher procedural complications and mortality than non-octogenarians. Nonetheless, PCI in the octogenarian had a high success rate and potentially improved the patient’s quality of life.
- Aged, 80 and over
- Coronary intervention
- Cardiovascular Disease
Data availability statement
Data are available upon reasonable request.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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STRENGTHS AND LIMITATIONS OF THIS STUDY
The Thai percutaneous coronary intervention (PCI) registry is one of Southeast Asia’s largest nationwide PCI registries.
Real-world data reflected the contemporary PCI practices in the octogenarian population of developing countries
Given the nature of the registry, the study focused on the patients who only underwent PCI and excluded those who underwent coronary arterial bypass grafting or conservative medical therapy.
The rate of the radial approach was lower than the current trend of contemporary PCI compared with developed countries, which might affect the mortality and complication risk of PCI, such as bleeding risk.
The Thai PCI registry lacks patient frailty data, which might substantially influence patient outcomes.
Background
One of the most significant healthcare changes worldwide is population ageing. Improving primary care has resulted in a 4.4-year increase in life expectancy by 2040.1 Over the next three decades, developing Southeast Asian countries, including Thailand, are expected to see a 264.1% rise in the population aged 80 and older.2 According to the most recent figures, the average life expectancy in Thailand is 75 years for males and 79 years for women.3 4
Coronary artery disease (CAD) is one of the primary causes of morbidity and death in the aged population, with the majority of cases presenting with acute coronary syndrome.5 6 According to the National Health and Nutrition Examination Survey,7 the prevalence of symptomatic CAD increases with age, reaching 30.6% in men and 21.7% in women over 80. However, medical research has typically excluded this particular group,8 primarily those over 80 and older, described as ‘octogenarians’ or ‘extremely elderly’. There is disagreement on the optimum therapy management, standards and best practices for octogenarians.9 Percutaneous coronary intervention (PCI) becomes difficult for this demographic group as well. Both mortality and morbidity are much more significant in octogenarians than in non-octogenarian groups10 or even in individuals aged 75–80.11 12 In patients aged 80–84 years, the 30-day death rate rises to 31.2%.13 Ageing is thus associated with a more significant number of medical comorbidities and more complex CAD, such as left main CAD, multivessel CAD and left ventricular systolic dysfunction,14–16 leading to more complicated and high-risk PCIs.7 17–19 These comorbidities also obscure the diagnosis of acute myocardial infarction (MI) in 20% of people over the age of 85, which can delay treatment and worsen the outcomes following MI.20
The Thai National Registry of Percutaneous Coronary Interventions (TPCIR) obtained Thailand’s previous national PCI data on senior people in 2006–2007.21 22 According to that study, the death rate within 24 hours of admission was 5.3% among patients 75 years old. However, with the revolution in interventional cardiology practice and the fast expansion of PCI-capable institutions in Thailand, along with the expansion of the Thai national universal health coverage programme, a greater number of octogenarians have received PCI in the nation since then. Using data from the existing Thai PCI registry,23 the current study aims to examine the features, kinds of PCI procedures, and PCI results in the octogenarian group. Our findings would give current data on the standard of care, PCI practice and results leading to enhanced PCI quality in the senior population.
Methods
Study design
This was a descriptive comparative analysis of the Thai PCI registry database, which included 22 741 patients aged 18 and above who had PCI from May 2018 to August 2019. The Thai PCI registry is a multicentre prospective research launched by the Cardiac Intervention Association of Thailand, recruiting 39 institutions around Thailand.24 As necessary, the study was authorised by Thailand’s Central Research Ethics Committee (CREC) by the Foundation for Human Research Promotion in Thailand (COA-CREC 006/2018) (https://www.crecthailand.org), as well as the local Ethics Committee (EC) in some institutes if required for approval (online supplemental file).
Supplemental material
After the written or verbal informed consent, all consecutive adult patients aged 18 years or older who got PCI at these participating facilities were recruited. Data on patient characteristics, procedure details, equipment, medication usage, complications and in-hospital outcomes were gathered; see the Thai PCI registry research design for additional information.24
Our research factor of interest was octogenarian versus non-octogenarian, defined as age 80 versus 18–79 years. The outcomes of interest were procedure failure, complications, quality of life improvement and in-hospital death. More than 50% residual stenosis following balloon angioplasty or more than 20% after stent implantation was considered procedure failure. Procedural complication was defined as any of the following: cardiogenic shock, heart failure, cerebrovascular accident, cardiac tamponade, acute kidney injury requiring haemodialysis, infection at the access site, anaemia requiring blood transfusion, clinically significant arrhythmia and respiratory failure requiring endotracheal intubation.
Statistical analysis
Patient characteristics (categorical and continuous) were summarised using frequencies and means (with SD). Univariate analyses comparing octogenarians and non-octogenarians used χ2 tests for categorical variables (age, sex, healthcare coverage, comorbidities) and t-tests for continuous variables. Similar analyses were used to compare the CAD presentation, PCI urgency, coronary lesion characteristics, PCI access site, use of intravascular imaging, use of physiological guidance, PCI treatment modalities, plaque modification and type of antiplatelet therapy. Univariate analysis also examined the association of octogenarian status and each covariate with outcomes (death, PCI complications, PCI success). Covariates with p<0.10 in univariate analysis were entered into a multivariate logistic regression model; backward stepwise selection using likelihood ratio tests retained only variables with p<0.05. All analyses were performed using STATA V.17.0, with p<0.05 indicating statistical significance.
Patient and public involvement
None
Results
Patient population
Octogenarians made up a total of 2099 (or 9.2%) of the 22 741 patients. Among the octogenarians, 1948 (92.8%) were aged 80–89, 151 (7.2%) were aged 90 or more (nonagenarians) and 11 were aged 100 or greater (centenarians). Univariate analyses showed that males outnumbered females in all age groups, but the proportion of females increased after menopause, from 7.1% in pre-menopause to 62.9% in post-menopause (age 50 years). Overall, the proportion of females in the octogenarian group outnumbered males by a wide margin (13.7% vs 7.2%) (figure 1).
Patients in the Thai PCI registry were categorised by sex and 10-year age intervals from 18 years to ≥90 years in the last patient group. The octogenarians (≥ 80 years) comprised 2099 (9.2%) of the 22 741 patients. Among the octogenarians, 1948 (92.8%) were aged 80–89, and 151 (7.2%) were aged ≥90 (nonagenarians). Males outnumbered females in all age groups, but the proportion of females significantly increased after menopause, from 7.1% in the pre-menopause to 62.9% in the post-menopause (≥50 years). The proportion of females in the octogenarian group was greater than males (13.7% vs 7.2%).
As expected, octogenarians had a higher prevalence of comorbidities and risk factors for atherosclerotic cardiovascular disease (ASCVD) (table 1). Octogenarians had a higher percentage of patients with prior surgical revascularisation (2.4% vs 1.6%, p=0.003), history of heart failure (21.1% vs 13%, p 0.001), hypertension (77.2% vs 66.4%, p 0.001) and history of cerebrovascular disease (8.6% vs 5.4%, p 0.001). Certain ASCVD risks were also approximately twofold higher in octogenarians than in non-octogenarians, such as a history of peripheral arterial disease (3.3% vs 1.5%, p 0.001), chronic lung disease (6.3% vs 3.0%, p 0.001) and chronic kidney disease with creatinine level more than 1.5 mg/dL or estimated GFR 60 mL/min/m2 (63.6% vs 29.4%, p<0.001).
Baseline demographics of octogenarians compared with non-octogenarians in the Thai PCI registry (n=22 741)
However, several risk factors for ASCVD were less in octogenarians, such as morbid obesity (18.8% vs 40.5%, p<0.001), diabetes mellitus (39.4% vs 44.7%, p<0.001), and history of smoking (39.3% vs 56.7%, p<0.001) in octogenarians and non-octogenarians, respectively.
Thailand’s universal health coverage scheme covered the majority of patients in both age groups. Octogenarians had more patients who used the government or state enterprise officer scheme for reimbursement (40.4% vs 25.7%) than non-octogenarians. Conversely, non-octogenarians used more social security schemes than octogenarians (7.5% vs 0.5%).
CAD presentation and lesion characteristics
Although univariate analysis showed that chronic coronary syndrome (CCS) was the most common indication for PCI in both age groups, 36.9% in octogenarians and 42.6% in non-octogenarians, older patients had a significantly higher rate of non-ST elevation acute coronary syndrome (NSTE-ACS) than the younger patients (36.1% vs 29.3%). Meanwhile, ST elevation myocardial infarction (STEMI) was 27% in octogenarians compared with 28.1% in non-octogenarians.
Notably, the Thai PCI registry found no significant variations in lesion type complexity between octogenarians and non-octogenarians based on the updated American College of Cardiology (ACC)/American Heart Association (AHA) categorisation of coronary lesions.25 In both age groups, more than 80% of the patients in this registry had complicated coronary lesions (types C and B2). The type C coronary lesion was the most prevalent lesion that underwent PCI, accounting for more than 60% of the patients in both groups, followed by type B2, type B1 and type A lesions with the prevalence of 18%, 15% and 4%, respectively (table 2).
Lesion characteristics and procedural details of octogenarians compared with non-octogenarians in the Thai PCI registry (n=22 741)
PCI procedure characteristic
Univariate analysis showed that the femoral approach remained the primary arterial access route in both age groups, particularly in the octogenarian group, where it was nearly twice as common as radial access (64.1% vs 34%) (table 2). The radial approach was adopted substantially more frequently in non-octogenarians than octogenarians (45.3% vs 34%, respectively).
Even though the recommendations encourage imaging and physiological guidance for PCI operations, actual practice in Thailand revealed that it was not widespread among patients in both categories (table 2). Only 13.3% and 15% of PCI patients in octogenarians and non-octogenarians employed at least one imaging-guided PCI modality, and fewer than 2% of both groups used physiological-guided PCI, whereas the decision for angioplasty was the same. A drug-eluting stent (DES) was used in about 90% of all PCIs. Only 8–9% of total PCI procedures employed balloon angioplasty alone, and bare-metal stent (BMS) was seldom used in the present registry.
There were nearly twice as many plaque modifications in octogenarians as in non-octogenarians (7.1% vs 4.5%, p<0.001), with rotational atherectomy being the most common tool for severely calcified lesions (3.7% vs 1.8%, p<0.001) (table 2).
Clopidogrel, the most often used antiplatelet therapy during PCI, remains the most commonly used P2Y12 inhibitor, accounting for more than 90% of patients in both age groups (table 2). Patients in both groups comparably received ticagrelor (7.8% vs 9%, p=0.081), while prasugrel usage was considerably lower in octogenarians than in non-octogenarians (0.4% vs 1.9%, p<0.001). GP IIb/IIIa inhibitors and adjunctive antiplatelet therapy were used in less than 7% of participants in the registry.
PCI outcomes and complications
Given the high success rate of up to 95.5% in octogenarians, the two groups had no significant differences in procedural failure (4.5% vs 4.0%, p=0.251) as per a univariate analysis. However, the elderly had a greater rate of morbidity and death following PCI operations. PCI complications were more common in octogenarians than in non-octogenarians (5.6% vs 4.6%, p=0.011). Regarding the death rate, octogenarians outnumbered non-octogenarians (7.67% vs 2.3%, p 0.001). Cardiogenic shock, heart failure, cerebrovascular accident, cardiac tamponade, acute kidney injury requiring haemodialysis, infection at the access site, anaemia requiring blood transfusion, clinically significant arrhythmia and respiratory failure requiring endotracheal intubation were significantly more common in octogenarians than in non-octogenarians (table 3).
PCI outcomes in octogenarians compared with non-octogenarians in the Thai PCI registry (n=22 741)
After a multivariable logistic regression adjustment, octogenarians showed non-significant increases in procedural complication risk compared with the 60–79 and 45–59 years age groups (OR 1.1, 95% CI 0.9 to 1.4 and 1.2, 95% CI 0.9 to 1.5, respectively) (table 4). However, octogenarians had a significantly higher risk of death compared with patients aged <45 years (OR 7.3, 95% CI 3.4 to 15.6) and those aged 60–79 years (OR 2.1, 95% CI 1.6 to 2.7) (table 5).
Factors associated with PCI procedural complications: a multivariate analysis from the Thai PCI registry
Factors associated with death: a multivariate analysis from the Thai PCI registry
Pre-discharge management
The majority of patients in the registry were sent home on dual antiplatelet treatments, such as aspirin and clopidogrel (table 6). Aspirin was taken less frequently for octogenarians than non-octogenarians (94.1% vs 97.8%, p 0.001). Potent P2Y12 inhibitors such as ticagrelor and prasugrel were used more regularly in non-octogenarians, although in a smaller proportion, less than 10%. Warfarin was used more than novel oral anticoagulants in octogenarians who needed anticoagulants. Non-octogenarians were more likely to be prescribed statins, beta-blockers and angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers as adjuvant pharmacological treatments for cardiovascular disorders.
Post PCI care and patient quality of life of octogenarians compared with non-octogenarians in the Thai PCI registry (n=22 741)
After being discharged, less than 40% of PCI patients were referred for cardiac rehabilitation, and the elderly were less likely to be recommended for this treatment. However, patient quality of life, as measured by the mean EQ-5D (European Quality of Life 5 Dimensions) score,26 improved comparably in octogenarians and non-octogenarians following PCI (15.7 and 15.6, respectively) (table 6).
Discussion
The Thai PCI registry is one of Thailand’s largest statewide current PCI datasets, with 2099 patients aged 80 years, or 9.2% of the total 22 741 PCI patients, or as high as 18.7% for patients 75 or older. This result is greater than the Malaysian NCVD-PCI registry, which reported that around 1% of the 24 469 PCI patients were octogenarians.27 This database was more extensive than the previous research based on Thai National Percutaneous Coronary Intervention Registry (TPCIR) data between 2006 and 2007, with 639 patients, or 15.7% of the total 4156 patients, designated as old by age 75 years. This group’s mean age was 79 years, compared with 80.8 years in our present study.21 The more significant percentage of older patients reflected improved access to basic healthcare, increased PCI-capable facilities and Thailand’s expanding elderly population over the last decades. Thailand’s current health policies on the Universal Coverage Scheme and Universal Coverage for Emergency Patients programme allow all Thai elderly patients free access to coronary intervention in elective and emergency PCIs if they do not have any other healthcare coverage. However, people who use the national universal healthcare programme have fewer treatment options or access to particular medications, such as newer P2Y12 inhibitors or anticoagulants.
According to our registry, sex influences the incidence of CAD in different age groups. Although the majority of the patients enrolled in the research were men, the percentage of PCI in women rose significantly after menopause, with over half of the cases occurring in octogenarians. The sex-specific risk factors for CAD at genetic and epigenetic levels28 29 may have less influence on the elderly population.
According to our data, most octogenarians underwent PCI due to ACS rather than CCS. While NSTE-ACS was significantly more common than STEMI, STEMI remained prevalent among octogenarians, leading to a higher incidence of cardiogenic shock requiring MCS, arrhythmogenic complications, mechanical myocardial infarction sequelae and ultimately an increased risk of death. Nevertheless, the majority of studies and meta-analyses supported primary PCI for this elderly patient population.30 ,31 ,32 The results also confirmed the feasibility and mortality benefit of PCI in senior subpopulations with NSTE-ACS.33 ,34 ,35 Surprisingly, CCS-indicated PCI accounted as much as 36.9% of octogenarians despite a history of poor outcomes. Unsurprisingly, the elderly had a higher incidence of multivessel coronary artery disease, ostial lesions and calcified lesions, necessitating more complex PCIs and coronary atherectomy. However, the lesion complexity in this PCI registration based on the ACC/AHA categorisation did not reflect actual practice. Due to the nature of the PCI registry, many complex coronary patients were not included in the research, as they were instead referred for coronary bypass revascularisation or managed medically. Advances in the contemporary PCI methods and experience with senior populations have improved safety and outcomes for CCS-indicated PCI. In elective PCI cases such as CCS, the risks and benefits should be thoroughly discussed with patients. PCI should only be performed when there is favourable supporting evidence for patients.
Despite the 2020 Thai Acute Coronary Syndromes guideline recommendation that novel P2Y12 inhibitors be the first-line P2Y12 inhibitor unless there is a higher risk of bleeding,36 dual antiplatelet therapy with aspirin and clopidogrel remained the treatment of choice in octogenarians and non-octogenarians. The treatment choice might be related to the universal coverage policy, payment issues and the availability of innovative P2Y12 inhibitors outside of major metropolitan institutions. Patients with Thai national universal coverage were prohibited from taking prasugrel during data collection.
Given the baseline characteristic, the intricacy of the lesion, the degree of lesion calcification and the patients’ ageing variables, death and PCI complications were greater in octogenarians. PCI in the elderly presents a higher risk of intervention and complications. These findings contradict the prior TPCIR data,21 which found no age effect on in-hospital mortality following PCI. When compared with non-octogenarians, octogenarians had higher periprocedural complications and worse short-term outcomes after myocardial infarction.
With the current PCI techniques and instruments available in most PCI facilities in Thailand, PCI for octogenarians may have a high success rate of up to 95.5%. Our study found that PCI enhanced the quality of life for both octogenarians and non-octogenarians, even in the short period of time before hospital discharge. However, the success rate remained lower than the data from the J-PCI (Japanese Percutaneous Coronary Intervention) registry,37 ,38 which reported a PCI success rate of over 98% among patients over 80. Nevertheless, ageing did increase the risk of PCI mortality, cardiogenic shock and bleeding complications and is associated with more complex and calcified lesions, as indicated in the Thai PCI registry. The rate of radial approach in the J-PCI registry was over 66%, almost twice the 34% reported in the Thai PCI registry, and was linked to lower hospital mortality and reduced bleeding complications in these groups of patients. This highlights one solution for improving PCI quality in developing countries by increasing the adoption of the transradial approach among octogenarian patients, despite some concerns regarding the tortuosity of the subclavian artery and difficulty in obtaining radial access in the elderly population.
Limitations
Our research has a few limitations. This registry includes individuals who had PCI in 39 cardiac catheterisation facilities. As a result, there is a selection bias that may not represent the entire population of octogenarians with cardiovascular disease. Some individuals may have undergone CABG or medical treatment and were not included in the registry. There may be unmeasured confounders that influence clinical outcomes. Another significant limitation of the Thai PCI registry is no data on frailty, which is important for patient evaluation in the elderly group and might substantially influence patient outcomes.
Conclusions
The Thai PCI registry focuses on real-world practice data on persons over the age of 80 in Thailand. When compared with non-octogenarians, octogenarians experienced more difficult PCI, a greater risk of PCI complications and unfavourable in-hospital mortality. Nonetheless, PCI in the octogenarians had a high success rate and potentially improved the patient’s quality of life. Given the increasingly ageing population, further research into octogenarians will be essential to determine the optimal approach for revascularisation and treatment in this patient group.
Data availability statement
Data are available upon reasonable request.
Ethics statements
Patient consent for publication
Ethics approval
This study involves human participants and ethics approval was obtained from CREC (COA-CREC 006/2018) by the Central Research Ethical Committee of the Foundation for Human Research Promotion in Thailand (HRPT) (https://www.crecthailand.org). Local ethics approval was also obtained at each registry site according to their specific requirements. Details on ethics approval are also mentioned in the Thai PCI study design (Sansanayudh et al. J Med Assoc Thai 2021). Participants gave informed consent to participate in the study before taking part.
Acknowledgments
We would like to thank Mr. Bryan Roderick Hamman for assistance with the English-language presentation of the manuscript.
References
Footnotes
X @Kamonrat23
Contributors SR: conceptualised the study design, conducted data collection, drafted the majority of the manuscript and provided critical revisions to the manuscript. AS: developed the research methodology, assisted with data interpretation and provided significant input on the manuscript’s clarity and structure. PP: conducted data collection and assisted with data interpretation. KT: conducted data collection and assisted with data interpretation. AT: developed the research methodology, contributed to statistical analysis, contributed to data analysis, assisted with data interpretation and provided significant input on the manuscript’s clarity and structure. NS serves as the guarantor of this work and the corresponding author. NS conceptualised the study design, developed the research methodology, contributed to data analysis, contributed to statistical analysis, provided significant input on the manuscript’s clarity and structure, provided critical revisions to the manuscript and had access to the data.
Funding The Thai PCI registry was supported by funding from The Health Systems Research Institute, Thailand.
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Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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