European Heart Journal Advance Access originally published online on December 11, 2006
European Heart Journal 2007 28(3):370-375; doi:10.1093/eurheartj/ehl421
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Carotid artery stenting in octogenarians: results from the ALKK Carotid Artery Stent (CAS) Registry
1 Städtisches Klinikum, Med. Klinik 8, Kardiologie/Angiologie/Internistische Intensivmedizin, Klinikum Nürnberg, Süd Breslauer Straße 201, 90471 Nürnberg, Germany
2 Städtisches Klinikum, Kardiologie, München-Bogenhausen, Germany
3 Herzzentrum, Kardiologie, Ludwigshafen, Germany
4 Stadtkrankenhaus, Kardiologie, Worms, Germany
5 Marienhospital, Kardiologie, Osnabrück, Germany
6 Krankenhaus der Barmherzigen Brüder, Kardiologie, Trier, Germany
7 Klinikum Schweinfurt, Kardiologie, Schweinfurt, Germany
8 Herzzentrum, Kardiologie, Duisburg, Germany
9 Herz Jesu Krankenhaus, Kardiologie, Dernbach, Germany
10 Städtisches Klinikum, München-Neu-Perlach, Germany
Received 5 October 2006; revised 26 October 2006; accepted 10 November 2006; online publish-ahead-of-print 11 December 2006.
* Corresponding author. Tel: +49 911 398 2989; fax: +49 911 398 2988. E-mail address: erzahn{at}aol.com
See page 276 for the editorial comment on this article (doi:10.1093/eurheartj/ehl498)
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Abstract |
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Aims We tried to determine the influence of age on complication rates of carotid artery stenting (CAS).
Methods and results Two thousand seven hundred eighty CAS procedures were included in the registry. Median age of the patients was 70.8 years, with a proportion of octogenarians of 11.2% and a significant increase between 1996 (5.9%) and 2005 (13.7%; P for trend = 0.002). In octogenarians, a symptomatic stenosis was a more frequent indication for CAS (60.7% vs. 48%, P < 0.001), the CAS procedure was aborted more frequently (6.9% vs. 2.2%; P < 0.001) and the duration of intervention was longer (Median 45 vs. 40 min; P = 0.008). Increasing age was associated with a significant increase in the in-hospital death or stroke rate (P for trend: 0.001). In-hospital death or stroke rate was also higher in octogenarians compared with younger patients (5.5 vs. 3.2%; P = 0.032, OR = 1.79; 95%CI: 1.04–3.06). Logistic regression analysis showed that age analysed as a continuous variable was a strong predictor of in-hospital death or stroke (P < 0.001), whereas octogenarians had only a trend towards a higher event rate (P = 0.062).
Conclusion CAS in octogenarians is performed in an increasing proportion of patients. In-hospital stroke or death rates increase significantly with older age; however, there was no excess complication rate in octogenarians.
Key Words: Carotid artery stenosis • Carotid artery stenting • Angioplasty • Age • Octogenarian
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Introduction |
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Carotid artery stenting (CAS) has been introduced as an alternative to carotid endarterectomy (CEA) for the treatment of carotid stenoses.1–3 With growing experience1 and the development of new techniques, such as embolic protection devices (EPDs), CAS has become safer as shown by data from registries.4–6 Therefore, CAS is currently judged to be an alternative to CEA.7
Both CEA as well as CAS carry the burden of a small but clinically important rate of periprocedural complications, mainly cerebral ischaemic events.
Advanced age has shown to be an independent predictor of complications in many medical interventions. Data from CEA registries showed a small increase of complication rates in older patients.8–10 Furthermore, data from randomized controlled clinical trials comparing CEA with medical therapy only11 also identified increasing age to be a predictor of ischaemic complications, questioning the value of CEA when compared with medical treatment only in older, especially in older asymptomatic patients.12,13
The most important predictors of periprocedural ischaemic events during CAS seem to be the presence of a symptomatic stenosis, not to use an EPD and may be older age.1,6 Some recent studies raised the question whether CAS performed in older patients, especially in octogenarians, may be associated with an excess complication rate, thus making CAS probably an inappropriate therapeutic option for such patients.14–16
However, another CAS registry did not find such an excess in the complication rate during CAS in older patients.17
To determine the use and effectiveness of CAS in octogenarians, we analysed the data of the prospective Carotid Artery Stent (CAS) Registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK) in Germany.
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Methods |
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The CAS Registry of the ALKK is an ongoing registry, which was initiated 1996 and has been described in detail previously.6
In brief, all interventions were prospectively enrolled in the registry. All complications occurring in the catheterization laboratory and during the in-hospital phase were documented. All data from the initiation of the registry in 1996 until end of December 2005 were analysed for this report.
Patient selection
All patients undergoing CAS for a carotid stenosis at the participating hospitals were considered for this analysis. Patients with symptomatic carotid stenoses had a history of an ipsilateral stroke, at least one transient ischaemic attack (TIA) or an episode of amaurosis fugax. In these patients, an angiographically documented stenosis 
70% according to the diagnostic criteria of the North American Symptomatic Carotid Endarterectomy Trial (NASCET)18 was suggested to be an indication for an intervention. In the case of asymptomatic patients, a stenosis 80% was suggested as an indication for an intervention. The decision to treat a given patient was left to the treating physician. The patients were enrolled on an intention-to-treat basis: Patients in whom the CAS procedure was prematurely stopped were included in the final data set.
Definitions
Amaurosis fugax was defined as a retinal ischaemia with transient monocular blindness and a TIA as a focal neurological deficit that resolved spontaneously within 24 h. Stroke was defined as a loss of neurological function caused by an ischaemic or haemorrhagic event with residual symptoms at least 24 h after onset; a minor stroke was diagnosed if symptoms disappeared within 1 week after onset and a major stroke if symptoms persisted for at least more than 1 week after onset.
No differentiation between ischaemic, haemorrhagic, and strokes with unknown aetiology and no quantification of the severity of stroke (such as the National Institute of Health stroke scale),19 besides its reversibility, was made.
Endpoints were evaluated by a neurologist either immediately at the occurrence of symptoms or at the end of the hospital stay. We did not separately evaluate 30-day follow-up endpoints. The combined clinical endpoint of all death and all strokes was prospectively defined as the primary endpoint.
CAS procedure
The CAS procedure was performed according to the standard protocol of each participating centre.
Data collection: Every participating centre was committed by written consent to include each patient during the study period. The patients gave informed consent for the processing of their anonymous data. Data analysis: The patient population is described by absolute numbers and percentages. Medians and quartiles are given for continuous variables. Dichotomous values were compared by chi-square test and crude OR with 95%CI were computed. Continuous variables were compared by Mann–Whitney U test. The Cochran-Armitage trend test was used to analyse changes in the use of CAS for octogenarians over time as well as the association of increasing age and cerebral ischaemic complications or death. Logistic regression analysis was used to adjust for factors influencing the combined clinical endpoint of all death and all strokes. In addition to age (dichotomized to age 80 and < 80 years) and gender, the established risk factors with showed a difference between age classes in univariate analysis were included in the model (reference): symptomatic stenosis, use of an EPD, right carotid artery treated, diabetes, coronary heart disease, atrial fibrillation (AF), hyperlipidaemia, smoking, visible thrombus, and ulcer. A forward-selection was made including the variables available for the whole sample. Then variables available only for a subset of patients were entered one at a time to assess if they had additional significance. A further regression analysis was performed with age as continuous variable. We used the C-statistic to assess the association of predicted probabilities and observed response of the logistic regression model. P-values < 0.05 were considered significant. All P-values are results of two-tailed tests. The calculations were performed using SAS©, version 9.1 (Cary, NC, USA).
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Results |
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From July 1996 to December 2005 2878, CAS procedures from 31 hospitals were included in the prospective ALKK CAS Registry. The median hospital stay was 3 days (quartiles: 2–6 days). Median age of the patients was 70.8 years (quartiles: 64.7–73.3). The distribution of the different age groups is shown in Figure 1. The proportion of octogenarians was 11.2%, with a significant increase in the proportion of patients
80 years between 1996 and 2005 (1996: 5.9% to 2005: 13.7%; P for trend = 0.002) (Figure 2).
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Patient characteristics
Median age in octogenarians was 82.5 years when compared with 69.4 years in patients < 80 years (P < 0.001). Therefore, octogenarians were less frequently male [64.8% (208/321) vs. 73.5% (1879/2557), P = 0.001]. They were treated significantly more often for a symptomatic stenosis [60.7% (184/303) vs. 48% (1191/2483), P < 0.001], with only minor differences in the kind of symptoms in these symptomatic patients. They had less often diabetes mellitus [26.9% (61/227) vs. 33.2% (522/1570), P = 0.055], hyperlipidaemia [78.5% (179/228) vs. 86.2% (1363/1581); P = 0.002] and were less often smoker [9.8% (22/225) vs. 33.2% (520/1566); P < 0.001], whereas AF was more often prevalent [16.4% (37/226) vs. 7.9% (125/1574); P < 0.001] (Table 1).
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Lesion and interventional characteristics
In octogenarians treatment of the right carotid artery was less frequent [43.1% (128/297) vs. 50% (1243/2486); P = 0.025] and residual stenosis after CAS was higher than in younger patients (10 vs. 5%; P = 0.006). The CAS procedure was aborted more frequently in octogenarians [6.9% (22/321) vs. 2.2% (57/2557); P < 0.001] and the duration of the intervention was longer (Median 45 vs. 40 min; P = 0.008). No differences were seen in the use of EPD (P = 0.32) and the rate of stent implantation (P = 0.80) (Table 2).
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Medication of the patients during hospital stay
Octogenarians were less likely to be treated with aspirin [91% (283/311) vs. 94.9% (2384/25511), P = 0.004], statins [70.7% (152/215) vs. 83.5% (1276/1528); P < 0.001], and ß-blockers [47.4% (101/213) vs. 64% (977/1526); P < 0.001], with no differences in the use of ticlopidine or clopidogrel, phenprocoumon, and angiotensin-converting enzyme inhibitors (Table 3).
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Clinical events and age
Complications at the access site occurred in 2.5% (8/321) in octogenarians when compared with 1.3% (34/2557) in younger patients (P = 0.13). The in-hospital death or stroke rate was higher in octogenarians when compared with younger patients [5.5% (17/309) vs. 3.2% (80/2533); P = 0.032, OR = 1.79; 95%CI: 1.04–3.06], which was mainly due to an increase in the occurrence of ipsilateral major strokes [2.6% (8/309) vs. 1.4% (36/2533); P = 0.13]. Ipsilateral TIAs also occurred more frequently in octogenarians (4.9% (15/309) vs. 2.5% (63/2533); P = 0.016), whereas contralateral ischaemic events were not different between the two groups [1.6% (5/309) vs. 1.4% (35/2533), P = 0.80] (Table 3).
As shown in Table 4, older age was associated with an increase in the stroke rate during CAS (P for trend: 0.004) as well as a tendency towards a higher death rate in older patients (p for trend: 0.09), resulting in a significant increase of the in-hospital death or stroke rate in older patients (P for trend: 0.001). In-hospital death or stroke rate was 7.1% (13/184) in symptomatic octogenarians when compared with 3.4% (4/119) in asymptomatic octogenarians. The corresponding in-hospital death or stroke rate for symptomatic patients < 80 years was 3.9% (47/1191) and 2.6% (33/1292) in asymptomatic patients.
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In addition to age, the use of EPD (OR = 0.41; 95%CI: 0.27–0.62, P < 0.001) and symptomatic stenosis (OR = 1.60; 95%CI: 1.03–2.48, P = 0.036) were shown by multiple logistic regression analysis to be independently associated with the in-hospital death or stroke rate, as well as right carotid artery treated (OR = 0.56; 95%CI: 0.36–0.87, P = 0.009) (Table 5). The effect of age
80 years stayed nearly unaffected by adjustment for the other factors and remained borderline significant in the final model (OR–1.71; 95%CI: 0.97–3.01, P = 0.062). The C-value for this model was 0.68. If age was included in the model as a continuous variable, it turned out to be a much stronger predictor (P < 0.001). This model reached a C-value of 0.71.
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Discussion |
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Growing age of the population in the western industrial nations will be accompanied by an increase in interventional procedures in an increasingly older population.
Mean age in the CAS registry in 2878 patients from 31 hospitals was already 70.0 ± 8.6 years, with a proportion of patients 80 years of 11.2% and six patients 90 years. This is very close to the average of 70 years and a proportion of 9.9% of patients > 80 years reported by the Pro-CAS registry20 and the 69 ± 10 years reported by Roubin et al.1 We observed a significant increase in the proportion of patients 80 years between 1996 and 2005 (1996: 5.9% to 2005: 13.7%; P for trend = 0.002), which may be the result of the growing burden of older patients as well as the growing acceptance of interventionalists to treat such patients with CAS.
Differences between octogenarians and younger patients
With the exception of arterial hypertension, other conventional risk factors of atherosclerosis were significantly less often prevalent in octogenarians: diabetes mellitus (P = 0.055), hyperlipidaemia (P = 0.002), and smoking (P < 0.001). One reason might be that only healthier patients with less risk factors may reach the eighties or that the healthier people get their carotid stenosis some years later.
We observed that CAS performed in octogenarians was more likely to be done for symptomatic stenoses when compared with younger patients (60.7% vs. 48%, P < 0.001), with only minor differences in the kind of symptoms in the symptomatic patients. The results of the Asymptomatic Carotid Surgery Trial (ACST)13 showed that CEA was superior to medical treatment only in patients with high-grade but asymptomatic carotid stenoses. However, in patients older than 74 years, there was no advantage of CEA, mainly due to a high mortality rate in the following years in both groups. Thus, the selection of more symptomatic patients in our registry may already reflect the restriction of the treating physicians to high-risk candidates of stroke in the very old.
There were some interventional differences in octogenarians: residual stenosis after CAS was higher than in younger patients (10 vs. 5%; P = 0.006), the CAS procedure was aborted three times more frequently (6.9 vs. 2.2%; P < 0.001) and the duration of the intervention took 5 min longer (Median 45 vs. 40 min; P = 0.008). The higher rate of interruption of the procedure may be due to a more difficult vascular access in the elderly, which may also be the reason for the longer duration of intervention. The higher residual stenosis in octogenarians is more difficult to explain. It might be due to a less aggressive approach in the very old or due to more calcified lesions, which are harder to dilate appropriately.
Age and outcome of CAS
Some recent studies raised the question whether CAS performed in older patients, especially in octogenarians, may be associated with excess complication rates.14–16
Chastain et al.16 reported the complication rates in 182 patients with CAS. The overall per patient rate of death or major stroke was 1.6%. However, neurological complications were clearly related to increased age with rates of 25.0% in octogenarians vs. 8.6% in patients 
75 years (P = 0.042). Kastrup et al.15 reported data of 110 patients of 75 years treated with either CAS or CEA between 1997 and 2001. In neither group, there was any fatal stroke or myocardial infarction. The 30-day stroke rate was significantly higher in the CAS group (four minor and two major strokes; 11.3%) than in the CEA group (no minor and two major strokes; 1.8%; P < 0.05). While the 30-day major stroke rate between CAS and CEA groups was comparable (3.8 vs. 1.8%; ns), this effect was mainly attributable to a significantly higher rate of minor stroke in the CAS group (7.5 vs. 0%; P < 0.05). Hobson et al.14 for the Multicenter Carotid Revascularization Endarterectomy vs. Stent Trial (CREST) investigators reported from the CREST lead-in phase. In 749 patients in the lead-in phase, an increasing proportion of patients suffered stroke and death with increasing age (P = 0.0006): 2 (1.7%) of 120 patients under age 60, 3 (1.3%) of 229 aged 60–69, 16 (5.3%) of 301 aged 70–79, and 12 (12.1%) of 99 patients aged 80 years and older. These increasingly high complicated rates with older age were not mediated by adjustment for confounding factors. As a consequence of these findings, they stopped the inclusion of octogenarians in the lead-in phase of CREST. One reason for this high complication rate might be that it occurred in the lead-in phase of CREST, and therefore might reflect the learning curve of some investigators.
Increasing age was associated with an increase in the stroke rate during CAS in our registry (P for trend: 0.004) as well as a tendency towards a higher death rate in older patients (P for trend: 0.09), resulting in a significant increase of the in-hospital death or stroke rate in older patients (P for trend: 0.001). This was confirmed by logistic regression analysis after adjusting for confounders if age was included in the model as a continuous variable (P < 0.001). In-hospital death or stroke rate was also higher in octogenarians (321 patients) when compared with younger patients (5.5 vs. 3.2%; P = 0.032, OR = 1.79; 95%CI: 1.04–3.06), which was mainly due to an increase in the occurrence of ipsilateral major strokes (2.6 vs. 1.4%). However, logistic regression analysis showed only a strong trend but no significant association of age 80 years with in-hospital death or stroke when compared with younger patients (OR = 1.71; 95%CI: 0.97–3.01, P = 0.062). This lack of significance could perhaps be due to insufficient power (type II error) to detect such a small difference. Nevertheless, our report is based on the by far largest data set of octogenarians undergoing CAS. Our data as well as the data from other CAS registries1 clearly show increasing age to be an independent predictor of in-hospital death or stroke rates. However, although octogenarians have the highest complication rates, we did not observe an excess complication rate, which is confirmed by other registry data.17
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Conclusions |
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The current study from a large number of patients treated with CAS, shows the increasing proportion (13.7% in 2005) of patients being 80 years or older. Octogenarians show a lot of significant clinical differences when compared with younger patients; especially the indication for CAS is more often a symptomatic rather than an asymptomatic stenosis. In-hospital stroke or death rates were significantly rising with increasing age; however, there was no excess complication rate in octogenarians. Data from randomized controlled clinical trails comparing CAS with CEA will help more definitely assess the impact of increasing patient age on early results of either method.
Limitations of the study
We obtained only data until hospital discharge. Therefore, it may be difficult to compare our data to 30 days outcome data of other studies. However, clinical events are extremely low after the first days of stent implantation.21,22
Conflict of interest: none declared.
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Appendix |
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Institutions and people who participated in the ALKK CAS Registry are listed elsewhere.6
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Footnotes |
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Deceased. 
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References |
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