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Neurology. 2005 Dec 13;65(11):1690-1
Editorials
Stroke thrombolysis in the elderly
Risk or benefit?
J. Claude Hemphill, III, MD and Patrick Lyden, MD
From the Department of Neurology (Dr. Hemphill), University of California, San Francisco; and Department of Neurosciences (Dr. Lyden), University of California, San Diego.
As the population ages the proportion of patients with stroke who are elderly is increasing. With the rise of stroke centers, stroke units, and public education regarding acute stroke intervention, we should expect that many of the patients who present for ultra-early treatment of acute ischemic stroke will be elderly. Therefore, it becomes important to know whether advanced age, in and of itself, should influence how a patient is treated and, specifically, whether recombinant tissue plasminogen activator (t-PA) should be administered. While some might wonder whether age influences t-PA efficacy, the central issue is one of safety.
Age is an independent predictor of outcome after ischemic stroke. Older patients, especially those over 80 years old, are more likely to die in the hospital after stroke and less likely to make a favorable long-term recovery.1 The fact that elderly patients are at high risk for stroke-related death and disability makes them an important target group for acute treatment. However, the elderly may also be at increased risk for hemorrhagic complications from t-PA. Older patients have a higher risk of intracranial hemorrhage after thrombolysis for myocardial infarction2 and patients over the ages of 80 or 85 were excluded from many clinical trials of thrombolysis for acute ischemic stroke (although not the National Institute of Neurologic Disorders and Stroke t-PA study).3 Perhaps because of this concern and relative lack of information, the European Medicines Evaluation Agency provisional license for alteplase (recombinant t-PA) indicates that it is not recommended for treatment of acute ischemic stroke in patients over the age of 80.4 Information about t-PA in the elderly patient with stroke is sorely needed.
In this issue of Neurology, Engelter et al. report findings from a nine-center Swiss stroke thrombolysis registry regarding the impact of advanced age (80 years) on outcome after t-PA treatment for ischemic stroke.5 Elderly patients constituted 12% (n = 38) of their t-PA treated patients and were more likely to be women and to have atrial fibrillation and cardioembolic stroke etiology. Older patients were much more likely to die in hospital (32% vs 12%). However, among patients surviving for 3 months, those over age 80 had essentially the same likelihood of a favorable outcome as younger patients (42% vs 43%). While not significantly different, the rate of symptomatic intracranial hemorrhage was higher in the patients 80 years old (13% vs 8%). Of note, in their cohort, age (either dichotomous as age 80 or as a continuous variable) did not independently predict outcome. As this was not a randomized trial, there was no untreated comparison group; treatment bias could not be assessed.
The findings of this study are similar but not identical to those from other studies of stroke thrombolysis in the very old. A US study that included 30 patients age 80 or older found comparable outcomes and no increase in hemorrhage risk vs patients below age 80.6 In a Canadian cohort of 62 patients age 80 or older who received t-PA for ischemic stroke, 9.7% of patients had a symptomatic intracranial hemorrhage with half being fatal.7 In a German study of 1,658 t-PA patients, those over the age of 75 (n = 396) were more than twice as likely to have an intracranial hemorrhage as those younger than 55 years of age (10.3% vs 4.9%); age and disturbed consciousness were independent predictors of in-hospital death.8 Interestingly, in the National Institute of Neurologic Disorders and Stroke t-PA trial (which included 42 patients over the age of 80), outcome was related to an age-by-neurologic deficit interaction which did not effect the likelihood of favorable response to t-PA and age did not independently influence risk of intracranial hemorrhage.9,10 Of the 49 patients in the National Institute of Neurologic Disorders and Stroke trial older than 75 years and who also had an NIH Stroke Scale score of >20, none improved to an NIH Stroke Score of 0 or 1 in either the placebo or t-PA groups; however, the t-PA group had overall lower NIH Stroke Scale scores at 3 months and better scores on the Barthel Index.9
So what are we to do? The results of these studies could be used both by those who support the use of t-PA in elderly stroke patients (on the grounds of similar efficacy) and those who reject it (on the basis of possible increased risk of hemorrhage). While some may call for a randomized trial in elderly patients, the existing regulatory approval and current use of t-PA probably make this unlikely to happen. Elderly patients present a clinical conundrum: those most likely to do poorly as a result of stroke itself are also at highest risk for stroke treatment complications. Current evidence does not indicate that the risk of t-PA outweighs (or even equals) the benefit in elderly patients. In these recent reports, the lack of an untreated comparison group makes the determination of risk/benefit ratio impossible. Case-control studies and systematic reviews or meta-analyses involving elderly patients (and adjusting for other characteristics such as stroke severity and CT findings) could provide more clarity. In the meantime, physicians and patients face a central question in elderly ischemic patients with stroke who meet all other t-PA eligibility criteria: withhold treatment in those least likely to survive and recover or treat knowing that there may be an increased risk of hemorrhagic complications? We usually choose treatment but hope that future randomized trials will include adequate numbers of elderly patients to answer the question.