Objective: elderly stroke patients were excluded or underrepresented in the randomised controlled trials of intravenous thrombolysis with recombinant tissue plasminogen activator (rtPA) applied within 3 h. Cohort studies comparing intravenous rtPA in stroke patients of >/=80 versus <80 years of age were limited by small sample sizes and yielded conflicting results. Thus, we performed a systematic review across all such studies.
Methods: a systematic literature search (PubMed; Science Citation Index) was performed to retrieve all eligible studies. Two reviewers independently extracted data on 'death', 'favourable 3-month outcome (modified Rankin Scale </=1)' and 'symptomatic intracranial haemorrhage (sICH)'. Across studies, weighted odds ratios (ORs) with 95% confidence intervals (95% CI) were calculated.
Results: six studies were included [n = 2,244 patients; 477 (21%) aged >/=80 years]. Significant differences in baseline characteristics to the disadvantage of older patients were present in all studies. Compared with younger patients, older patients had a 3.09-time (95% CI = 2.37-4.03; P < 0.001) higher 3-month mortality and were less likely to regain a 'favourable outcome' (OR = 0.53; 95% CI = 0.42-0.66; P<0.001). The likelihood for 'sICH' (OR = 1.22; 95% CI = 0.77-1.94; P = 0.34) was similar in both age groups.
Conclusion: intravenous rtPA-treated stroke patients of >/=80 years of age have a less favourable outcome than younger ones. Imbalances in predictive baseline variables to the disadvantage of the older patients may contribute to this finding. Compared with the younger cohort, rtPA-treated stroke patients aged >/=80 years do not seem exceedingly prone to sICH. Thus, there is scope for benefit from thrombolysis for the older age group. Hence, to obtain reliable evidence on the balance of risk and benefit of intravenous rtPA for stroke patients aged >/=80 years, it is safe and reasonable to include such patients in randomised placebo-controlled trials.