|Year : 2020 | Volume
| Issue : 2 | Page : 153-161
Primary percutaneous coronary intervention in elderly (age ≥75 years) Indian population – Immediate- and short-term results
Ankur Gautam, Jamal Yusuf, Vimal Mehta, Saibal Mukhopadhyay
Department of Cardiology, Govind Ballabh Pant Institute of Postgraduate Medical Education and Research (GIPMER), New Delhi, India
|Date of Submission||07-May-2020|
|Date of Decision||11-Jun-2020|
|Date of Acceptance||01-Jul-2020|
|Date of Web Publication||27-Aug-2020|
Dr. Jamal Yusuf
Department of Cardiology, First Floor, Academic Block, Govind Ballabh Pant Institute of Postgraduate Medical Education and Research (GIPMER), New Delhi
Source of Support: None, Conflict of Interest: None
Background: Primary percutaneous coronary intervention (PCI) is the best reperfusion strategy for patients presenting with ST-segment elevation myocardial infarction (STEMI). Limited data exist on outcomes of primary PCI in elderly patients due to frequent exclusions of this cohort from the trials. The aim of the present study was to evaluate the acute and short-term outcomes of primary PCI in STEMI patients aged ≥75 years. Material and Methods: A total of 50 elderly patients undergoing primary PCI were prospectively enrolled between December 2017 and May 2019. Inhospital and 6-month outcomes of patients were recorded and analyzed. Results: The mean age of the patients was 78.32 ± 3.1 years (range = 75–90 years), and 38.0% were women. Almost half of the patients had triple-vessel disease, and the most common infarct-related artery was left anterior descending artery. Angiographic success was achieved in 78% of the patients, and inhospital mortality rate was 8%. Complete heart block at presentation, Killip Class III, delayed presentation (>6 h), moderate-to-severe left ventricular systolic dysfunction, slow-flow or no-reflow phenomenon, diabetes, and nonresolution of ST segment were major predictors of inhospital mortality. Conclusion: We demonstrate the favorable immediate- and short-term outcomes of primary PCI in elderly patients aged ≥75 years presenting with STEMI and conclude that it can be safely and successfully performed in this population with acceptable rate of complications.
Keywords: Angiographic success, elderly, inhospital mortality, primary percutaneous coronary intervention, ST-segment elevation myocardial infarction
|How to cite this article:|
Gautam A, Yusuf J, Mehta V, Mukhopadhyay S. Primary percutaneous coronary intervention in elderly (age ≥75 years) Indian population – Immediate- and short-term results. J Pract Cardiovasc Sci 2020;6:153-61
|How to cite this URL:|
Gautam A, Yusuf J, Mehta V, Mukhopadhyay S. Primary percutaneous coronary intervention in elderly (age ≥75 years) Indian population – Immediate- and short-term results. J Pract Cardiovasc Sci [serial online] 2020 [cited 2021 Aug 1];6:153-61. Available from: https://www.j-pcs.org/text.asp?2020/6/2/153/293588
| Introduction|| |
Age is a major cardiovascular risk factor, and coronary artery disease (CAD) is the most common cause of death in the elderly. CAD and its associated acute events such as ST-segment elevation myocardial infarction (STEMI) are very frequent in the aged population and cause significant morbidity and mortality., Worse outcome is influenced not only by more complex comorbidities but also by the extensive CAD, advanced coronary lesions, significant coronary calcification, tortuous vascular anatomy, and suboptimal angiographic results. In addition, elderly patients are more likely to suffer from complications following revascularization procedures. Moreover, their presentations are frequently atypical, leading to incomplete diagnosis and delayed presentation. Even though elderly patients constitute a major high-risk population of patients with STEMI who might benefit from more invasive therapies, they are frequently excluded from clinical trials owing to higher morbidity and mortality associated with the primary percutaneous coronary intervention (PCI).
Primary PCI is currently the treatment of choice and the best reperfusion strategy for patients presenting with STEMI., Although the effectiveness and safety of primary PCI among patients (<75 years old) has been proven through randomized trials, current guidelines showed no specific recommendations for older STEMI patients (≥75 years) with regard to the reperfusion strategy because of the lack of evidence. Given the limited data on outcomes of primary PCI in elderly patients, we planned to evaluate the inhospital acute and short-term outcomes of primary PCI in patients aged ≥75 years.
| Materials and Methods|| |
Our study is an observational prospective study, carried out over a period of 18 months from December 2017 to May 2019. The study protocol was approved by the local ethics committee (ID NO. 17/IEC/2017/216), and each participant provided written informed consent. A total of 50 patients with STEMI aged ≥75 years were prospectively enrolled. STEMI was defined as patients presenting with symptoms of myocardial ischemia accompanied by a persistent elevation of the ST segment at J point of ≥2 mm (0.2 millivolts [mV]) in men or ≥1.5 mm (0.15 mV) in women in leads V2–V3 or ≥1 mm (0.1 mV) in two other contiguous chest leads or limb leads or new left bundle branch block on presenting electrocardiogram (ECG).,
Patients with chest pain accompanied by ST-segment elevation presenting within the first 12 h after the symptom onset with age ≥75 years were included.
Patients with killip class- IV, cardiogenic shock, left main coronary artery involvement, mechanical complications of myocardial infarction (MI) requiring surgical intervention, history of coronary artery bypass grafting, rheumatic heart disease, any malignancy, life expectancy < 1 year and inability to receive dual antiplatelet therapy were excluded from the study.
Aims and objectives
The aim of the study was to evaluate the inhospital acute and short-term outcomes of primary PCI in STEMI patients aged ≥75 years. The objectives of the study were the clinical outcomes in terms of the composite of death from any cause, MI, target vessel revascularization (TVR), and stroke at the time of index hospitalization as well as at 6-month follow-up and correlate it with various demographic, clinical, and angiographic variables of the participants.
All patients had undergone detailed history and clinical examination. Details of the history, examination, investigations, demographic characteristics, Killip class, and time from symptom onset to PCI were recorded on a predesigned pro forma after due consent. Baseline routine blood investigations – complete blood count, kidney function test, random blood sugar, and viral markers – were done (2 ml of blood). Loading dose of 325 mg of aspirin and 600 mg of clopidogrel was given in the emergency room. A 12-lead ECG (25 mm/s paper speed) was recorded at admission and immediately after primary PCI of each patient. ST-segment resolution was measured manually in infarct-related leads. ST-segment resolution was defined as resolution of the initial sum of ST-segment elevation ≥70%.
Angiographic characteristics and procedural information were recorded. The procedure was done by either radial or femoral approach (at operator's discretion) immediately without delay. Unfractionated heparin bolus (60–70 U/kg) was given during the procedure. The target level of activated clotting time after 10 min was maintained at 250–350 s. Details of number of diseased vessels, infarct-related artery (IRA), and postprocedure thrombolysis in myocardial infarction (TIMI) grade flow were recorded. Angiographic or anatomical success was defined as the attainment of a residual diameter stenosis <20% and normal epicardial flow based on TIMI-flow grade.
Echo was performed during hospitalization and at 6-month clinical follow-up. All echocardiographic examinations were performed using Philips echo machine (model number UTAP20W) with 2.5–3.5 MHz transducers. The left ventricular ejection fraction (LVEF) was calculated according to modified Simpson's method. The 17-segment model was used for scoring the severity of segmental wall motion abnormalities by wall motion score index according to the American Society of Echocardiography.
Statistical analysis was done using SPSS (Statistical Package for the Social Science) version 17.0 (SPSS Inc., Chicago, IL, USA). Continuous variables were expressed as mean ± standard deviation and categorical variables as percentages. Continuous variables were assessed by Student's t-test. Correlation analysis was done by Spearman's correlation analysis. The association of mortality and anatomical success with plausible risk factors was performed using Chi-square/Fisher's exact test. The odds ratio and 95% confidence interval of variables with angiographic success were also calculated. The odds ratio of outcomes were not determined due to small or empty cell. The Chi-square test was used to compare the numerical variables. Six-month cumulative survival rates were assessed with the Kaplan–Meier curve. P < 0.05 was considered statistically significant.
| Results|| |
A total of 50 patients with STEMI aged ≥75 years who fulfilled the eligibility criteria were included in the study [Figure 1].
The age of the patients ranged from 75 to 90 years. The mean age of the study population was 78.32 ± 3.182. Thirty-one patients (62%) were male, and 19 patients (38%) were female. Hypertension and smoking were the most common risk factors in our study, each seen in 19 patients (38%). The baseline demographic characteristics, comorbidities, and risk factors of the study participants are summarized in [Table 1].
The most common presentation was anterior wall myocardial infarction (AWMI) in 52% of the patients. Most of the patients who presented with AWMI had moderate-to-severe left ventricular systolic dysfunction (LVSD) and higher Killip class compared to inferior wall myocardial infarction (IWMI). Six patients (12%) had complete heart block (CHB) at the time of presentation. It was seen more commonly with IWMI. Most of the patients (72%) presented in Killip Class I. Cardiogenic shock was one of the exclusion criteria, and none of the patients with Killip Class IV were included in our study. Four patients (8%) presented in Killip class III; out of these four patients, three patients expired within 48 h of hospitalization. Delayed presentation (>6 h of chest pain) was seen in twenty patients (40%). Almost half of the patients (46%) presented in the emergency department with moderate-to-severe LVSD. The mean LVEF% at presentation was 39.48 ± 5.97, and it was 44.62 ± 5.56 at 6 months. Improvement in LVEF was statistically significant (P < 0.001). Patients who presented with AWMI had more improvement in LVEF compared to patients with IWMI. The baseline clinical characteristics of the study participants are shown in [Table 2].
Almost half of the patients (48%) had triple-vessel disease (TVD). The most common IRA was left anterior descending artery (LAD) in 26 patients (52%). Plain balloon angioplasty (POBA) was done in five patients (10%) who had complex lesion morphology and severe calcified vessels. Out of these five patients who underwent POBA, three patients had involvement of the right coronary artery (RCA) and two patients had involvement of LAD as IRA. The average number of stents used in PCI was 1.26 per procedure. Angiographic success (TIMI-3 flow) was achieved in 39 patients (78%). The slow-flow phenomenon (TIMI-2) was seen in six patients (12%), and the no-reflow phenomenon (TIMI-0 and TIMI-1) was seen in five patients (10%). The angiographic characteristics of the patients are summarized in [Table 3].
We analyzed the clinical outcomes in terms of the composite of death from any cause, MI, TVR, and stroke at the time of index hospitalization as well as at 6-month follow-up. The inhospital and 6-month adverse events are shown in [Table 4] and [Figure 2]. In this study, inhospital mortality rate was 8%, and during the follow-up period, it was 2%. The survival rate at 6 months was 90% in this study. The Kaplan–Meier estimate of cumulative inhospital and 6-month survival rate is shown in [Figure 3].
|Figure 3: Kaplan–Meier estimate of cumulative inhospital and 6-month survival rate.|
Click here to view
Predictors of angiographic success and inhospital mortality
In this study, diabetes and delayed presentation were associated with slow-flow and no-reflow phenomenon. We found that predictors of inhospital mortality were CHB at presentation, Killip class III, delayed presentation (>6 h), moderate-to-severe LVSD, postprocedure TIMI flow <3, history of diabetes, and nonresolution of ST segment (P < 0.05). Inhospital mortality was not significantly associated with patients' age, number of diseased vessels, and IRA (P > 0.05). The predictors of angiographic success and inhospital mortality are summarized in [Table 5] and [Table 6].
| Discussion|| |
Elderly patients are less likely to receive coronary revascularization when compared to their younger counterparts. An elderly population presents numerous challenges to the interventional cardiologist in the form of advanced complex coronary disease and multiple comorbidities. In addition, data are lacking on the periprocedural and long-term outcomes., Elderly patients were frequently excluded or underrepresented in randomized trials that resulted in a lack of evidence regarding the best treatment for this specific population. In this study, we discussed immediate- and short-term outcomes of primary PCI in elderly patients aged ≥75 years and correlated with their various clinical and angiographic characteristics.
Regarding procedural aspects, the femoral approach was used in most of the patients (88%), whereas radial approach was used in six patients (12%). The radial access is superior to the femoral access, but this approach can be more difficult in elderly patients in primary PCI setting and is associated with higher failure rates and access site crossover. However, elderly patients also have a higher risk of bleeding with femoral access. In our study, the femoral access was associated with lower rate of local site complications. Only two patients (4%) had vascular access groin hematoma, which was managed conservatively without any surgical intervention.
All the patients were anticoagulated with unfractionated heparin. In seven patients (14%), we used glycoprotein IIb/IIIa receptor inhibitor, and they had high thrombus burden. None of the patients were anticoagulated with bivalirudin. However, its use would be more attractive in elderly population due to their higher bleeding risk. The use of low-molecular-weight heparin was avoided in elderly patients because of their low creatinine clearance. Prasugrel was not administered in any of the patients due to advanced age. We used clopidogrel in all patients along with aspirin. However, ticagrelor appears as an interesting alternative to clopidogrel.,
In our study, four patients (8%) expired within 48 h of procedure. Out of these, one patient had hemorrhagic stroke (major bleeding) and other three patients had no reflow with persistent severe LVSD. Later on, they developed refractory cardiogenic shock, leading to inhospital mortality. Out of 46 survived cases, one patient (2%) developed stent thrombosis in the left circumflex artery during hospitalization. He was immediately taken up for revascularization by thrombosuction without any additional stent implantation. He was discharged successfully later on. Two patients (4%) had TIMI minor bleeding in the form of vascular access groin hematoma. Both the patients were managed medically without any need of blood transfusion.
During the follow-up period, one patient (2%) expired after 3 months, probably because of persisting severe LVSD. His LVEF was 30% at the time of the procedure and remained the same at 2-month follow-up. Another patient (2%) had stent thrombosis at the end of 2 months. He presented with chest pain in the emergency and was taken up for immediate revascularization of LAD with thrombosuction without implantation of any additional stent, successfully discharged later. None of the patients had stroke or major bleeding during follow-up period. Minor bleeding was seen in two patients (4%): one patient had hematuria and the other patient had epistaxis which subsided on its own.
In our study, inhospital mortality rate was 8%, and during the follow-up period, it was 2%. Since we had excluded the patients who were in cardiogenic shock at the time of presentation, hence the mortality rate was lower compared to other studies.,
Noohi et al. in their retrospective study included 100 primary PCI patients aged ≥75 years. They had shown that inhospital mortality was 2.4% in patients without cardiogenic shock and 83% in those with cardiogenic shock. They also found that the mortality rate during 6-month follow-up period was 2%.
Valente et al. in their prospective study assessed short- and long-term outcomes of 88 elderly patients aged ≥85 years in Italy, who underwent primary PCI, and they found that inhospital mortality was 17%. They found that the mortality rate was significantly higher in patients with cardiogenic shock, poor postprocedure TIMI flow, Killip Class ≥III on admission, and chronic renal failure. Major bleeding occurred in 11 patients (12%), mostly vascular access groin hematoma. Compared to their study, we found low inhospital mortality rate (8%), because we had excluded the patients with cardiogenic shock.
In our study, we found that predictors of inhospital mortality were CHB at presentation, Killip Class III, delayed presentation (>6 h), moderate-to-severe LVSD, postprocedure TIMI flow <3, history of diabetes, and nonresolution of ST segment.
Six patients (12%) presented with CHB. It was seen more commonly with IWMI. Out of these six patients, four patients had IWMI and two patients had AWMI. Both the patients of CHB with AWMI expired during index hospitalization. They had severe ostial LAD stenosis and persistent severe LVSD. One patient of CHB with IWMI expired. He had super-dominant RCA and did not achieve TIMI-3 flow after the procedure. The rest three patients of CHB with IWMI normalized to sinus rhythm after the procedure, and they were discharged successfully. CHB at presentation was one of the predictors of inhospital mortality in our study. Tok et al. determined clinical outcome of patients older than 75 years who were treated with primary PCI in their retrospective study. They found that atrioventricular block was one of the independent predictors of mortality.
In our study, the maximum number of patients (60%, n = 30) presented within 6 h of chest pain. Delayed presentation (> 6 h of chest pain) was significantly associated with inhospital mortality. Most of the patients who had delayed presentation had a higher killlip class. Delay from symptoms to primary PCI was a result of multiple factors including difficulties in diagnosis, atypical presentations, nondiagnostic ECG changes, and sometimes refusal from other health-care providers to perform interventional procedures in elderly patients. Hernández et al. also found that delayed presentation (>6 h) was an independent predictor of inhospital mortality in their retrospective study.
Cardiogenic shock was one of the exclusion criteria in our study and none of the patients with Killip Class IV were included. Patients who presented with AWMI had higher Killip class compared to IWMI. Killip Class III is one of the major predictors of short-term mortality in our study. The mortality rate was 2.7%, 0%, and 75% in Killip Class I, Killip Class II, and in Killip Class III, respectively, in our study. Noohi et al. found that 18% of the elderly primary PCI patients presented with cardiogenic shock in their retrospective study, and they found that it was an independent predictor of inhospital mortality. None of the patients had systolic blood pressure <90 mmHg during the procedure in our study, so neither continuous inotropic support nor intra-aortic balloon pump support was required during the procedure.
Angiographic success was achieved in 39 patients (78%). All the four patients who expired during index hospitalization had not achieved TIMI-3 flow. Noohi et al. had shown that postprocedure TIMI-3 flow was achieved in 73% of the patients, and Claessen et al. found postprocedural TIMI-3 flow in 78% of the elderly patients who underwent primary PCI. Diabetes and delayed presentation were associated with slow-flow or no-reflow phenomenon in our study. Noohi et al. also found that anatomical success is significantly associated with procedural success in their retrospective analysis. Moonen et al. had also shown that postprocedure TIMI flow was significantly associated with mortality.
Moderate-to-severe LVSD at presentation was significantly associated with inhospital mortality. Bromage et al. also found that poor left ventricular function was an independent predictor of mortality in octogenarian patients with STEMI treated with primary PCI in their retrospective study.
The elderly patients are at increased risk of contrast-induced nephropathy. Iodinated contrast agents increase the risk of contrast-induced acute renal failure (ARF), and it is aggravated by the frequent Killip III/IV presentation with associated organ hypoperfusion. In our study, we selectively used isosmotic nonionic contrast agent (iodixanol [Visipaque]) in every patient. However, even though ARF had developed in five patients (10%) during the hospital stay, this was transient and it recovered on its own. It is important to note that no death resulted from renal failure and none of the patients required hemodialysis.
In our study, half of the patients had TVD and more advanced complex coronary lesions with arterial calcification. We did angioplasty of culprit lesions only in primary PCI setting. None of the patients had undergone nonculprit PCI lesion in the same setting or during index hospitalization. We have addressed nonculprit lesion PCI in patients who had angina or had evidence of significant ischemic burden on investigations during follow-up period. The most common nonculprit vessel was RCA. Ten patients (20%) had undergone staged PCI of nonculprit lesions. We used only drug-eluting stents in our study. We avoided high-pressure dilatation following stenting to decrease the incidence of slow-flow or no-reflow phenomenon. Patients' age, site of MI, number of diseased vessels, and IRA were not associated with major adverse cardiac events.
We conclude favorable immediate- and short-term outcomes of primary PCI among elderly populations who presented with STEMI. This study suggests that primary PCI can be safely and successfully performed in elderly patients presenting with STEMI in Indian population. To the best of our knowledge, this is the first prospective study on outcomes of primary PCI in elderly patients aged ≥75 years from India.
Small sample size and exclusion of the patients with cardiogenic shock at the time of presentation are the major limitations of our study.
| Conclusions|| |
PCI is a more challenging procedure in the elderly population because of complex coronary lesions, comorbidities, and frailty. There is frequent delay in presentation of these patients to hospital after onset of symptoms and efforts should be undertaken to shorten this period. The transradial approach may be routinely chosen to reduce puncture site-related bleeding complications. Primary PCI can be safely and successfully performed in this population with acceptable rate of complications. Further prospective studies involving larger number of elderly patients and newer antithrombotic approaches may help to better define the risk and benefit ratio of primary PCI in elderly patients with acute STEMI.
We are thankful to Dr Rajeev Kumar Malhotra, Scientist (statistician), Delhi cancer registry, Dr B.R.A. IRCH, AIIMS, Delhi for statistical analysis.
The institutional ethical committee has approved the study protocol.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]