Intravenous Thrombolysis with rt-PA in Acute Ischemic Stroke Patients Aged Older than 80 Years in Italy

Abstract

Background: Intravenous (i.v.) thrombolysis with rt-PA within 3 h from symptom onset is the only approved treatment of pharmacological revascularization in acute ischemic stroke. However, little information exists on its use in elderly patients, in particular those aged >80 years, who at present are excluded from treatment. Methods: In a multicenter Italian study on i.v. thrombolysis, patients aged >80 years (n = 41) were compared with those aged ≤80 years (n = 207) regarding the percentage of symptomatic (nonfatal and fatal) intracerebral hemorrhage (SICH), favorable 3-month functional outcome (modified Rankin Scale score 0–2) and poor outcome (death or dependence, i.e. modified Rankin Scale score 3–5). Results: The percentage of SICH (nonfatal and fatal) was comparable between older (2.4%, 2.4%) and younger (2.4%, 2.4%) patient groups (p = 1.0). At 3 months, favorable outcome occurred in 44% and dependence in 22% of the older, and respectively in 58.5 and in 30.9% of the younger patients (p = 0.897). Patients aged >80 years had a higher mortality (34.1%) as compared to those aged ≤80 years (10.6%) (p < 0.001). Baseline National Institute of Health Stroke Scale score was the only statistically significant predictor of both mortality (OR = 1.26; 95% CI = 1.07–1.50) and poor outcome (OR = 1.39; 95% CI = 1.14–1.68) in the >80-year-old group. Conclusions: Acute ischemic stroke patients aged >80 years treated with i.v. rt-PA have a higher mortality than younger patients, but there are no differences for SICH nor for favorable outcome. Our data suggest that thrombolytic therapy should not be a priori denied for appropriately selected >80-year-old patients but randomized controlled clinical trials are necessary before definite recommendations can be given.

Off-Label Thrombolysis Is Not Associated With Poor Outcome in Patients With Stroke

“…The American license does not include an upper age limit. Previous observational studies 16 have reported 3-month mortality between 20% and 40% and sICH rates between 3% and 13% in this patient group, which are comparable to our results (27% and 11% accordingly). Selection of patients Ͼ80 years with MRI instead of CT has been associated with less intracranial hemorrhage but no difference in clinical outcome.…”

Thrombolysis in Patients Aged over 80 Years Is Equally Effective and Safe

“…Many other studies had previously reported similar rates of symptomatic and asymptomatic intracranial hemorrhages between younger and older patients. 7,9,11,[14][15][16]19,20,23,24 In contrast to our study, most previous studies revealed an increased 30-day mortality. 7,[9][10][11][13][14][15][16]24 So, according to our results, older patients seem to also be likely to benefit in the short and long term from IVrtPA and do not seem to be in increased risk of mortality or hemorrhagic transformation.…”

“…Most studies seem to show worse outcome and increased mortality in patients aged over 80 years old with acute ischemic stroke treated with IV-rtPA when compared with younger counterparts. [7][8][9][10][11][12][13][14][15][16][17] Nevertheless, patients from this age group still seem to benefit from this treatment and do not seem to have an increased risk of symptomatic intracranial hemorrhage after IV-rtPA, as demonstrated in several observational studies [7][8][9][11][12][13][14]16,[18][19][20][21][22][23][24][25] and also in a randomized controlled trial. 26 Thus, there is increasing evidence supporting the finding that old age, by itself, should not be a reason to exclude patients from treatment with IV-rtPA.…”

Effectiveness and Safety of Thrombolysis in Ischemic Stroke Patients Aged 80 Years or Older

“…[4][5][6][7][8][9] Observational studies comparing patients aged with respect to the effect of intravenous (IV) or intra-arterial (IA) thrombolysis. [10][11][12][13][14][15] Most of studies showed that the elderly treated with thrombolysis have higher mortality than the younger, and they tend to have worse outcome. The risk of symptomatic hemorrhagic transformation (sHT) is not different between the elderly and younger patients, although there are persistent concerns that advanced age increases the risk of sHT related to thrombolysis, 11,12,16,17 By including only the patients received thrombolysis, most of previous studies made a comparison between the old, thrombolysis-treated patients and the young, also thrombolysis-treated ones.…”