Research Article
Clinical Medicine
Cardiology
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Introduction: The existing data reveals percutaneous intervention (PCI) in the elderly are associated with increased risk of complications compared to younger patients. So we planned the study to assess the outcome of coronary angioplasty in elderly.
Methods: This prospective observational study included patients of age ≥65 years undergoing PCI. Parameters were assessed at baseline, pre-discharge, 30-days and 6-months follow-up for procedure related parameters. MACE (cardiac death, non-fatal MI, cerebrovascular accident, stent thrombosis and TVR) was taken as primary composite end point.
Results: Patients (n = 240) were divided into 2 groups: Group I (65–69 years, n = 178, 74.2%) and Group II (≥70 years, n = 62, 25.8%). At baseline, prior H/O angina and ACS, smoking, dyslipidemia, heart failure and cardiogenic shock were significantly more in Gp II. Angiographic [overall (90.8%), Gp I (97.8%), Gp II (70.9%), (p <0.001)], procedural [overall (85%), Gp I (97.2%), Gp II (50.0%), (p <0.001)] and clinical success [overall (85%), Gp I (97.2%), Gp II (50.0%), (p <0.001)] were significantly decreased in Gp II. Bleeding complications and coronary complications were significantly increased in Gp II. MACE inhospital were significantly increased in Group II (p <0.001).
Conclusion: PCI and stenting can be done in elderly patients (>65 years) with reasonably high success and acceptable complication rates. Within the group, the more elderly (>70 years) have higher risk profile, lesser success and higher complications and MACE.
Keywords percutaneous intervention, coronary angioplasty, elderly, outcome, complications.
Author info
1) Department of Cardiology, VMMC & Safdarjang Hospital, New Delhi, India
2) All India Institute of Medical Sciences, New Delhi, India
RecievedMar 1 2014 AcceptedApr 25 2014 PublishedMay 14 2014
CitationGupta P, Bansal S, Isser HS, Chakraborty P, Garg R (2014) To study the outcome of coronary angioplasty in elderly population in India. Science Postprint 1(1): e00019. doi: 10.14340/spp.2014.05A0001
Copyright©2014 The Authors. Science Postprint is published by General Healthcare Inc. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs 2.1 Japan (CC BY-NC-ND 2.1 JP) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
FundingNone
Competing interestNone
Ethics statementEthical approval was taken from Institute as this was superspeciality research project of an DNB candidate. Though this was an observational study, but all patients were informed about data collection and written consent was taken from all patients.
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Corresponding authorPreeti Gupta
AddressDepartment of Cardiology, VMMC & Safdarjang Hospital
58-E, Kavita Colony, Nangloi, Delhi - 110041, India.
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According to World Health Organization (WHO) (2002), Cardiovascular disease (CVD) will be the largest cause of death and disability by 2020 in India. In 2020, 2.6 million Indians are predicted to die due to coronary artery disease (CAD) which constitutes 54.1% of all cardiovascular deaths 1, 2 The elderly constitute a rapidly expanding segment of our population and CVD becomes more prevalent with increasing age. Sixty percent of the patients with ST-elevation myocardial infarction (STEMI) are older than 65 years 3, 4. Data show that nearly 83% of all CVD deaths are experienced by persons aged ≥65 years 5.
Existing data have shown that percutaneous coronary interventions (PCI) in the elderly are associated with an increased risk of in-hospital complications compared to younger patients. Registry data suggest in-hospital mortality risk of <1% in patients <60 years of age that increases to about 4% in patients >75 years of age and is >80 years of age 6-8. The total complication rate for elderly patients is 9%, compared to 6% for that of younger patients. Elderly have more CAD and lesions that are more calcific. Coronary arteries are rigid and tortuous in elderly 9-11. These morphological and angiographic characteristics make coronary angioplasty technically more difficult to perform and may lead to less satisfactory results. Post procedural renal failure and bleeding are more common in elderly patients undergoing PCI than in younger patients 12, 13. Because Coronary Artery Bypass Grafting (CABG) results in a significantly higher morbidity and prolonged hospitalization in the older patient group, PCI is an attractive alternative for providing myocardial revascularization in group of older patients with appropriate lesions for dilatation. A recent systematic review and meta-analysis to evaluate the clinical outcome of patients aged ≥80 years undergoing coronary revascularization indicated clinical outcomes were similar for patients undergoing PCI and CABG despite higher pre-procedural risk among patients undergoing PCI 14. So we planned to study the impact of angioplasty in elderly patients in Indian scenario.
After institutional research board, ethical committee approval and written informed consent, patients over age 65 years undergoing PCI were taken up for the study from 1st June 2009 to 31st November 2010. All patients enrolled were followed for at least 6 months. Those patients of ≥65 years, coronary artery disease—a) Chronic stable angina, b) Acute coronary syndrome destined for PCI with stenting—bare metal stent (BMS) or drug eluting stent (DES) on denovo, native lesions were included in the study. The patients having history of PCI/CABG in in-segment disease were excluded from the study.
Patient demographics including risk factors like diabetes mellitus (DM), hypertension, smoking, dyslipidemia, renal dysfunction, history of prior PCI or CABG, ischemic heart disease, prior left ventricular dysfunction and calculated risk scores were studied. Risk stratification was done using Thrombolysis In Myocardial Infarction (TIMI) risk score 15. Renal function (glomerular filtration rate, GFR) was calculated by the Cockroft-Gault formula 16.
PCI was performed using standard technique and a steerable catheter system on major coronary arteries which had ≥70% narrowing diameter.
Data was recorded as in-hospital, early outcome defined as 30-day and late outcome defined as 6 month primary composite end point taken as major adverse cardiac events (MACE) which includes cardiac death, non-fatal MI, cerebrovascular accident, stent thrombosis and restenosis, and target vessel revascularization (TVR) respectively. Follow-up was performed up to six months and data was collected during hospital stay post procedure, 30 days and six month intervals.
Data was recorded on a predesigned proforma and was managed on an excel spread sheet. STATA 12 statistical software has been used for statistical analysis. All entries were checked for any possible keyboard error. Qualitative variables were summarized as frequency and fischer exact test is used to compare the difference in proportion in the two groups. The quantitative variables (after conforming for approximate normality) were summarized by mean ± SD and student t test was used to compare the two groups. Within group change in continuous parameters was seen by repeated measure ANOVA (2 Way ANOVA). Between the group change was analyzed by t-test/Wilcoxon rank-sum as appropriate. In case of categorical variables, between the groups comparison was done by chi-square/Fischer exact test. Correlation at each time point was seen by Carl Pearson correlation. p value <0.05 is taken as statistically significant.
In our study, 240 patients of age ≥65 years were enrolled and followed up of 6 months. Ten patients were lost to follow up. The demographic profile of the study population is summarized in Table 1. Baseline parameters and investigative findings are presented in Table 1.
Data represented as percentage (number of patients) or as specified
Angiographic and procedural characteristics including indication of angioplasty, type of CAD, American College of Cardiology (ACC) and the American Heart Association (AHA) classification of lesions, presence of calcification, percent diameter stenosis, final stent luminal diameter on quantitative coronary angiography (QCA), mean lesion length, presence of thrombus, chronic total occlusion (CTO), Number of vessels treated, mean stent length, type of stent used, GpIIb/IIIa inhibitor therapy, Adenosine diphosphate (ADP) antagonist therapy, angiographic success and complications are mentioned in Table 2 a, b, Table 3 and 4.
a)
b)
Data represented as percentage (number of patients) or as specified
Data represented as percentage (number of patients)
Data represented as percentage (number of patients)
The risk factors which increased the bleeding complications in our study population included age, female sex, renal failure, hypertension and anemia. We studied the correlation of above risk factors with the bleeding complications which included drop in hemoglobin post-procedure, groin hematoma, need for blood transfusion and retroperitoneal/intraperitoneal hemorrhage (Table 5 a, b). Renal failure and anemia were the significant factors producing more bleeding complications in our study.
a)
b)
The outcomes of the patients recruited in hospital, at 30 day and at 6 month are summarized in Figure 1.The risk factors for bleeding were analyzed from the study and are summarized in Figure 2.
Our study shows that PCI can be performed with a high primary success rate and an acceptable rate of complications in elderly patients (≥65 years). These success rates are comparable to those of younger population in earlier studies.
Angiographic success was achieved in 90.8% patients, decreasing with advanced age and was statistically significant (p <0.001). Procedural success achieved in 85% patients, decreasing with advanced age (p <0.001). Clinical success also achieved in 80.8% patients, statistically significant on correlating with age (p <0.001). Previous studies reports variable success rates 17–24. In a study performed in elderly >70 years by Jaegere et al., angiographic success rate was 85% and clinical success was 86% 17. In ≥70 years, they were reported by Dorros et al., Holt et al., Simpfendorfer et al. to be (89%, 83%), (--, 80%), (--, 90%) and (--, 93%) respectively 18-20. In ≥80 years they were reported by Kern et al. and Rich et al. to be (78%, 67%) and (89 %, --) respectively 21, 22. As compared to these studies in 80s, our study reports better success rates with advancement of equipment and technology.
TIMI 3 flow was achieved in 75% patients. No reflow was seen in 8.3% patients with higher number in Gp II as compared to Gp I (p <0.001). TIMI 3 flow reported in elderly >75 years in a study was 84.8% post-procedure, although lesser than younger population (94.7%, p <0.002) 24. TIMI 3 flow was achieved after the procedure in 82.4% of the patients who underwent primary PCI in TRIANA study 24. Side branch occlusion (SBO) was found in 2.5% being higher in Gp II (p = 0.001). Residual coronary dissection was present in 3.8% of patients, more prevalent in higher age groups (p <0.001). Coronary perforation was seen in only one patient in Gp II (p = 0.09), revealing complications are more in very elderly age group. Bleeding complications was higher in Gp II (p <0.001). Need for blood transfusion was present in 0.8% [Gp I (0%), Gp II (3.2%), (p = 0.02)]. Most of bleeding complications were seen in very elderly age group. Bleeding complications in-hospital in PCI group in ≥65 years were 1.6% 25. Women experience more bleeding than men whether or not they are treated with GpIIb/IIIa inhibitors, however, because of frequent excessive dosing in women, up to one fourth of this sex-related risk difference in bleeding is avoidable 26.
Contrast induced nephropathy was found in 12.9% patients, significantly increased in higher age groups (p <0.001). The presence of CKD, DM, and other risk factors including hemodynamic instability, use of intra-aortic balloon counterpulsation, heart failure, older age (age >75 years), hyperglycemia, and anemia in the same patient can produce a predicted probability of CI-AKI more than 50% 27. Acute renal failure needing dialysis was present in 4.2% overall being higher in Gp II (p <0.001). Pericardial tamponade occurred significantly increasing with age (p = 0.005). Complete heart block (CHB) occurred in 1.2% of patients during or after procedure, higher in higher age groups (p = 0.003).
Non-compliance for dual antiplatelet therapy (DAPT) was found on follow-up in 5.4% overall and comparable in two groups (p = 0.28). Non-compliance for multiple drug therapy including beta-blockers, ACE inhibitors, statins, etc. was higher, 40% patients, almost thoroughly present in advanced age groups (p <0.001).
Although the complications post-procedure increased with advancing age, they were comparable to younger age groups studied in other studies as discussed later on. There had been controversial aspects regarding higher number of target vessel revascularization reported in some studies following PCI in elderly as compared to CABG. SoS trial reported that one-year procedural outcomes were similar between treatment groups regardless of age, with the exception of more repeat revascularizations after PCI (age ≤65, 16.1% vs. 4.8%; 19.5% vs. 3.4%; both p <0.001). Although PCI and CABG result in similar rates in clinical outcomes irrespective of age, younger patients reported more health status benefits from CABG as compared with PCI, whereas in older patients the two approaches resulted in similar 1-year health status benefits 25.
Non-fatal MI was more in higher age group at eaach interval [in-hospital (p <0.001); at 30 days (p = 0.001); at 6 months (p = 0.001)]. Non-fatal MI rate was found to be higher in elderly >75 years (7.6% vs. 2.6%, p <0.05) in Zheng et al. which was also observed until 6 months follow-up (6.1% vs. 0, p <0.05) 23. Jaegere et al. reported non-fatal MI in-hospital in 3% which rose to 5% on 3 months follow-up in >70 years old 17, comparable to our study. In-hospital MI in SoS trial in ≥65 years was 2.6%.
Rate of angina recurrence was also higher in elderly age group ie GpII [in-hospital (p <0.001)], at 30 days (p <0.001)]; at 6 months (p <0.001)]. Angina recurred in 27% in elderly >70 years on follow-up in Jaegere et al 17. In a study of 102 STEMI patients aged >75years, 50 patients underwent primary PCI (pPCI) and the remaining 52 patients received conservative treatment. Patients, in whom pPCI was performed, had recurrent ischemia in the course of hospitalization significantly less frequently than patients treated conservatively 28.
Stent thrombosis was detected in-hospital in 1.2% patients and comparable in two groups (p = 0.1). However it was significantly higher with increasing duration in elderly age group. Subacute stent thrombosis during in-hospital period was reported by Zheng et al. in >75 years old to be 4.5% which was not significantly higher than younger population (2.2%, p = 0.469) 23. With the routine use of high-pressure stent postdilation and dual antiplatelet therapy after stent implantation, the rate of stent thrombosis has declined to approximately 1% within the five years after stenting. Lesion-specific factors that increase the likelihood of stent thrombosis include a residual dissection at the margin of the stent, small stent diameters (<3 mm), long stent lengths, and treatment of an AMI, among other factors. Noncompliance of the patient with dual antiplatelet therapy, resistance to antiplatelet effects of aspirin and clopidogrel, and hypercoagulability may also play important roles in the development of stent thrombosis.
Restenosis rate was also higher in Gp II at all time intervals. Clinical restenosis after stent implantation is less common (10-20%) as compared to balloon angioplasty (20–30%) and is attributed to intimal hyperplasia within the stent. Clinical recurrence caused by restenosis is least common (3–5%) after DES placement because of focal tissue growth within the stent or at its margins. Clinical restenosis resulting from lumen narrowing at the site of PCI generally develops within the first 6 to 9 months after PCI. The need for recurrent target lesion revascularization (TLR) increased with increasing ISR class, from 19% to 35%, 50% and 83% in classes I through IV, respectively (p <0.001) 29. Restenosis after DES implantation is generally focal than after BMS placement 28, 29.
Deterioration in ejection fraction (EF) was noted in – hospital in 3.8% patients [Gp I (1.1%), Gp II (11.3%), significantly increasing with age (p <0.001)]. EF deterioration at 30 days was present in 5.8% patients [Gp I (1.7%), Gp II (17.7%), significant (p <0.001)]. EF deterioration at 6 months was seen in 11.2% patients [Gp I (1.7%), Gp II (38.7%), significant (p<0.001)]. In a retrospective analysis performed on octogenarians, they were less likely to have a normal left ventricular function as compared to younger ages during follow-up (48.3% vs. 66.7%) 30.
Cerebrovascular accidents (CVA) including transient ischemic attack (TIA) in-hospital occurred in 0.4% [Gp I (0%), Gp II (1.6%), close to significance (p = 0.09)]. CVA at 30 days amounted to 0.8% patients [Gp I (0%), Gp II (3.2%), significantly increasing with age (p = 0.01)]. CVA at 6 months was present in 1.2% [Gp I (0%), Gp II (4.8%), significant (p = 0.003)]. No irreversible CVA was reported in patients >75 years in study by Jaegere et al. 17. CVA in-hospital reported after PCI in ≥65 years was 0.5%, comparable to our study 25. Multiple clinical trials and observational studies indicate improved survival and low risk of stroke with primary PCI compared with thrombolysis in elderly patients with STEMI 31-33. The risk of intracranial hemorrhage was found to be 2.5% in patients over 75 years of age in the NRMI-2 study 32. Combination therapies aiming at increasing the effectiveness of fibrinolytic therapy in ASSENT-3 and GUSTO-V studies did not increase the general .effectiveness but increased the risk of hemorrhage in patients over 75 years of age 32, 33.
MACE included death due to cardiac causes including arrhythmias, non-fatal MI, CVA including TIA, stent thrombosis and restenosis. MACE in-hospital amounted to 9.4% [Gp I (1.2%), Gp II (32.2%), significantly increasing with age (p <0.001)]. MACE at 30 days occurred in 16.2% patients [Gp I (3.9%), Gp II (84.6%), significant with age (p <0.001)]. MACE at 6 months was seen in 32.1% [Gp I (11.2%), Gp II (91.9%), significantly increasing with age (p <0.001)]. MACE in-hospital reported to be 25.4% in study by Zheng et al. in >75 years old which was significantly higher than younger population (15.1%, p <0.03) 23. In-hospital, 30 days and one year MACE rates in elderly ≥80 years reported by Chen are 5%, 5% and 10.7% respectively 23, comparable to our study.
Cardiac mortality occurred in 3.8% patients in-hospital [Gp I (1.1%), Gp II (1.6%), significantly increasing with age (p <0.001)]. Cardiac mortality at 30 days occurred in 6.2% [Gp I (2.2%), Gp II (17.7%), significantly increasing with age (p<0.001)]. Cardiac mortality at 6 months was found in 11.7% [Gp I (2.2%), Gp II (38.7%), significantly occurring at higher age groups (p <0.001)]. Death due to cardiac causes in-hospital was reported to be 16.7%, 6-month death in 9.1% vs. 0, p <0.001 in elderly >75 years by Zheng et al. 23. In the Primary Angioplasty in Myocardial Infarction study, 38% of patients enrolled were ≥65 years of age 34. This investigation showed a trend towards fewer deaths (5.7% vs. 15.0%; p = 0.066), lower rate of recurrent ischemia (8.6% vs. 20%; p = 0.048), and a lower composite rate of recurrent MI and death (8.6% vs. 27.5%; p = 0.0003) in elderly patients who underwent angioplasty than in those who received thrombolytic therapy.
The largest randomized trial, the Global Use of Strategies To Open occluded coronary arteries in acute coronary syndromes-IIb (GUSTO-IIb), also showed a trend towards lower 30-days mortality with primary PCI than with thrombolytic therapy among patients ≥70 years of age 34. The Primary Coronary Angioplasty Trialists investigators studied 2,635 patients enrolled in 10 randomized trials of primary angioplasty versus thrombolysis 35. They found that, as compared with thrombolysis, primary angioplasty was most effective in reducing mortality at 30 days among patients ≥70 years of age than in those <70 years 36.
A recently published very small trial randomly assigned patients aged >75 years with STEMI to receive either primary PCI (n = 47) or intravenous streptokinase (n = 41) and suggested a lower composite of death, reinfarction, or stroke at one year with primary PCI (13% vs. 44%; RR 0.19; 95% CI 0.06 to 0.59). The 30-days (7% vs. 22%; RR 0.25; 95% CI 0.04 to 1.11) and 1-year mortality rates (11% vs. 29%; RR 0.29; 95% CI 0.07 to 1.00) were also lower in the primary PCI group 37.
Overall mortality due to all causes shows significantly increasing incidence with age (p <0.001)]. In-hospital mortality in elderly >75 years was reported to be higher than younger population (p <0.05) which also persisted in 6 month follow-up (9.1% vs. 0), 6-month overall death in 25.8% vs. 1.5% in younger subset, p <0.001 in Zheng et al. 28. In-hospital mortality in >70 years old in Jaegere et al. was 2%, which rose to 10% on 9-months follow-up 17. In-hospital mortality reported by SoS trial in ≥65 years was 0 25. In a study by Nicolau et al comparing invasive strategy with conservative therapy in elderly >70 years, it was found that in the adjusted models, invasive therapy correlated significantly and inversely with long term mortality in the elderly group (hazard ratio = 0.64, p = 0.001), but the hazard ratio obtained for the younger group did not reach statistical significance (hazard ratio = 0.74, p = 0.073). Invasive therapy in the in-hospital phase was at least as effective in elderly patients as in younger patients 38.
In a retrospective analysis performed on octogenarians, short-term mortality was higher among the elderly patients as compared to younger age group; 30 days mortality 26.3% vs. 9.6%. Age adjusted mortality between 30 days and one year was comparable in the two groups and similar to natural survival in Netherlands 39.
In studies comparing fibrinolytic therapy with primary PCI (pPCI) in elderly, Polewczyk et al. compared elderly over 65 years in which reperfusion therapy was used in 52.2% (15.1% fibrinolysis, 37.1% primary angioplasty) 40. The in-hospital and 6 month mortality tended to be lower in the PCI group vs. thrombolysis, (9% vs. 21.5%, p <0.001) and (12.9% vs. 22.5%, p <0.001) respectively. In patients undergoing primary PCI, in-hospital mortality was the lowest in patients undergoing invasive treatment which was associated with a 62% decrease in 6-month mortality as compared with those receiving conservative treatment (p <0.001). Invasive treatment significantly improves in-hospital and long-term survival in older patients with STEMI.
A large ACS Registry of over 8000 STEMI patients aged >75 years hospitalized in the years 2000-2002 showed that 51% received conservative treatment, 19% received fibrinolysis and 30% underwent pPCI. In-hospital mortality rates were 23.4%, 25.4% and 10.2%, respectively. Total mortality rates at one year were 52.4%, 41.3% and 19.3%, respectively 41. Similar conclusions concerning the benefit of interventional treatment in elderly patients can be drawn from a 1-year observation of 127 STEMI patients aged >75 years 42. TRIANA study compared the effectiveness and safety of pPCI in the very elderly. Patients from the oldest age group i.e. aged >75 years, admitted with STEMI or new left bundle branch block up to 6 hours from symptom onset, were randomized to PCI or fibrinolysis (tenecteplase and unfractionated heparin). PCI treated patients derived benefit, as the composite endpoint including death, MI or stroke at 30 days was lower in this subset (25.4 vs. 18.9%, OR 1.46, 95% CI 0.81–2.61). In the subgroup receiving fibrinolysis, the risks of death (OR 1.31, 95% CI 0.67–2.56, p = 0.43), re-infarction (OR 1.60, 95% CI 0.60–4.25, p = 0.35), and stroke resulting in disability (OR 4.03, 95% CI 0.44–36.5, p = 0.18) were higher. At 12-months, the benefits of PCI seemed to continue (death/re-infarction/ disabling stroke: 32.1 vs. 27.3%, OR 1.26, 95% CI 0.74–2.14). The authors conclude that PCI should be the preferred method of STEMI treatment in elderly patients 43.
As per literature reviewed, apart from age, other risk factors which increased the bleeding complications in our study population included female sex, renal failure, hypertension and anemia. Bleeding complications in our study were higher than overall patients (22.7% vs. 17.9%), although not statistically significant in our study as females constituted only 18.3% of study population. From the results of CRUSADE, women had higher rates of major bleeding than men among those treated with GP IIb/IIIa inhibitors (15.7% versus 7.3%, p <0.0001) and among those not treated (8.5% versus 5.4%, p <0.0001).
Our study identified renal failure as an independent factor for bleeding complication peri- and post-procedure. Bleeding with GpIIb/IIIa inhibitors is more common among patients with diminished renal function 44. The strong relationship between serum levels of GpIIb/IIIa inhibitors and platelet inhibition establishes the link between drug clearance and pharmacodynamic effects 45, 46.
Our results are consistent with other studies performed on elderly undergoing PCI like results from Thai National PCI Registry (TPCIR) which highlights the safety and effectiveness of PCI in elderly patients since advanced age is not a predictor of in-hospital mortality 47. NHLBI PCI Registry revealed that PCI can be performed with acceptably low mortality and morbidity. Jaegere et al reported that coronary angioplasty can be performed with a high initial success rate and an acceptable incidence rate of complications in patients over 70 years 48. Therefore, PCI may offer an alternative to CABG in the highly selected symptomatic older patient.
Age has been shown to be an independent predictor of early and late mortality with either PCI or CABG 49. Over the last decade, the use of coronary revascularization in elderly patients has increased and has been associated with improved outcomes 50. The APPROACH registry has also shown the elderly patients with ischemic heart disease undergoing revascularization procedures (PCI or CABG) had better outcomes than those treated with medications only 51. Thus benefits of revascularization should not be withheld from elderly population on context of advanced age or comorbidities.
In our study, PCI whether primary, pharmaco-invasive or elective performed in STEMI patients aged ≥75 years achieved a satisfactory angiographic result in most cases. These findings are consistent with data from previous studies 52–56. Previous studies have suggested that primary PCI appeared to be the most optimal reperfusion therapy compared to thrombolysis and conservative therapy for the elderly people with AMI. 2004 ACC/AHA guidelines for STEMI do not make direct reference to age as either a relative or absolute contraindication for primary PCI. In another word, the primary PCI is recommended by guidelines in the elderly as the reperfusion strategy of choice, unless there are contraindications 57, 58. Despite increased morbidity and mortality for older patients with CAD and ACS compared with younger patients, risk-adjusted AMI mortality in the United States has decreased from 1995-2006 in the Medicare population 59. In analyses of community practice outcomes of five recommended therapies (early use of aspirin, beta blockers, heparin, GP IIb/IIIa inhibitors, and cardiac catheterization), in-hospital mortality declined as a function of the number of guideline-recommended therapies given in patients aged ≥75 years, with greater benefit with use of guideline-recommended therapies in older than in younger patients. With special attention to alter dosing for and sensitivity of older patients and close observation for adverse effects of intensive medical and interventional management in elderly subgroups with ACS, short-term morbidity can potentially be further reduced. In contrast to current trends for increased rates of cardiac catheterization and revascularization in lower risk MI patients, use of early invasive strategies should be redirected to high-risk patients, who may have greater benefit.
Although direct comparison with younger population was not possible due to large sample size and longer follow-up period needed, comparison with literature available of general or younger population reveals that although the early morbidity and mortality is more in elderly population, PCI is a cost-effective and beneficial procedure in elderly in comparison to fibrinolytic therapy or CABG. Keeley and Grines performed a meta-analysis of 23 randomized trials incorporating 7739 patients comparing primary PCI with fibrinolytic therapy for STEMI 59. Primary PCI was superior to fibrinolytic therapy with results for PCI. A pooled analysis of the short term results from 17 randomized trials comparing facilitated PCI with primary PCI without antecedent pharmacologic therapy in 4504 patients revealed results for PCI as follows: (mortality, 3.4%); (nonfatal reinfarction, 1.8% ); (urgent TVR, 1.2%); (major bleed, 4.8%); (intracranial bleed, 0.09%); (total stroke, 0.3%) 60. In our study on elderly patients, short term results assessed in-hospital to 30 days were as follows: (emergency/elective CABG, 0.4–1.2%); (repeat PCI, 3.3–4.6%); (non-fatal MI, 2.5–2.9%) ; (angina recurrence rate, 6.2–8.8%) ; (stent thrombosis, 1.2–1.7%) ; (deterioration in EF, 3.8–5.8%) ; (CVA, 0.4–0.8%), (cardiac mortality, 3.8–6.2%), (MACE, 9.4–16.2%) and (all-cause mortality, 5.0–13.3%). Although the TVR, non-fatal MI, MACE and all-cause mortality were higher than general population (17.9%, 4.2%, 32.1%, and 27.1% respectively), but significant contributions of multiple comorbidities and non-compliance for dual-antiplatelet therapy were noted on long-term follow-up. Thus, elderly should not be deprived of beneficial effects of primary PCI in comparison to fibrinolytic therapy, conservative management or CABG as demonstrated by an acceptable short-term morbidity and mortality not significantly higher than the general population.
Our data showed that PCI and stent can be done with high clinical success in elderly patients. Furthermore, in patients with multivessel disease, complete revascularization is still very high. The most common reasons for incomplete revascularization were long-term total occlusions and diffuse disease. In accordance with the literature, for patients at high risk in the presence of multivessel disease and low LVEF, clinical success varies from 57–93 %, and the in-hospital mortality rate varies from 0.9–19 %. Follow-up results were encouraging. For 80.8% of patients in our study who had clinical success after PCI, the long-term results continued to be beneficial. Studies show that invasive strategy still improves in-hospital and 1-year survival 60. Jeroudi et al. showed that survival at one year was 81% and at three years, 80% 61. We identified low LV function, heart failure and impaired renal function as independent predictors of unfavorable outcome at long-term follow-up. Bell et al. reported that survival of patients with multivessel disease is influenced by the baseline clinical variables but not the degree of revascularization 62. The CASS study showed that survival of elderly patients was influenced by both the LVEF and also the associated medical disease 63.
Age alone should not be only criterion in considering revascularization procedures. Treatment decisions in elderly patients are often automatically considered to be difficult, which may result in under-treatment or no treatment at all. This has been referred to as discrimination towards the elderly. Primary angioplasty should not be withheld on the basis of age alone.There is a clear role for individualized risk assessment and respect for the patient’s preference in the decision–making process. Short- and long- term benefit should be considered in the context of anticipated life-span and quality of life of the patient.
It is well known that advanced age and worse clinical characteristics can cause hesitation when aggressive treatment methods are considered. In the current ACS registries, the issue of patient selection for interventional treatment is increasingly recognized It is believed that reliable risk and benefit assessment should be carried out concerning particular age subsets (65–74, 75–84 and >85). This in turn would lead to better global outcome of the elderly patients.
With special attention to altered dosing for and sensitivity of older patients and close observation for adverse effects of intensive medical and interventional management in elderly subgroups with ACS, short term, morbidity can potentially be further reduced.
CABG in geriatric patients is associated with increased morbidity and mortality 64. The utilization of urgent CABG surgery in patients with STEMI is limited due to the 3-fold higher mortality rate for urgent surgery than for elective surgery, and due to fact that as the time between the onset of STEMI and CABG surgery shortens the mortality risk increases. Coronary angioplasty is a less invasive procedure and may be an attractive non-surgical alternative. In the United States one third of the cardiac catheterizations and one third of the CABG operations are performed on elderly patients 60–64. It is widely acknowledged that the optimal management of elderly patients with ACS must take into account the risk/ benefit ratio, and current guidelines recognize elderly patients as a ‘special population’, justifying tailored treatments 64.
We conclude from our study that PCI is an acceptable intervention in elderly population as well. Although short-term complications especially bleeding complications increased in elderly, there is an acceptable rate of morbidity and mortality rates in elderly undergoing PCI.
Angiographic success rate, procedural success rate, and clinical success rate was significantly less in Gp II compared to Gp I. Coronary complications including no reflow, residual coronary dissection, side branch occlusion were significantly more in Gp II compared to Gp I, while coronary perforation was comparable in both groups. Bleeding complications including drop in hemoglobin, need for blood transfusion, groin hematoma and intraperitoneal or retroperitoneal hemorrhage were significantly more in Gp II compared to Gp I. Contrast induced nephropathy, dialysis needing acute renal failure, pericardial tamponade, and complete heart block were significantly more in Gp II compared to Gp No significant difference in rates of emergency or elective CABG on in-hospital, 30-day and 6-month follow up in both groups. Target vessel revascularization by repeat PCI was significantly more in Gp II compared to Gp I on in-hospital, 30-day and 6-month follow up. Non-fatal MI, angina recurrence, deterioration in ejection fraction and restenosis rate was significantly more in Gp II compared to Gp I on in-hospital, 30-day and 6-month follow up. Stent thrombosis rate was significantly more in Gp II compared to Gp I on 30-day and 6-month follow up, although no significant difference was noted on in-hospital follow-up. Cerebrovascular accident including transient ischemic attack was significantly more in Gp II compared to Gp I on 30-day and 6-month follow up, although no significant difference was noted on in-hospital follow-up. Cardiac mortality was significantly more in Gp II compared to Gp I on in-hospital, 30-day and 6-month follow up. MACE and all-cause mortality was significantly more in Gp II on in-hospital, 30-day and 6-month follow up. Renal failure and anemia were found to be significant predictors of bleeding complications in elderly.
Preeti Gupta: Involved in designing study, collected data, Analysed data, Discussion and writing the final manuscript.
Sandeep Bansal: Involved in designing study, Discussion and writing the final manuscript.
HS Isser: Involved in designing study, Discussion and writing the final manuscript.
P Chakraborty: Writing the final manuscript.
Rakesh Garg: Analysis, Discussion and writing the final manuscript.
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