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ORIGINAL ARTICLE
Year : 2012  |  Volume : 60  |  Issue : 4  |  Page : 373-378

Efficacy and safety of thrombolysis in patients aged 80 years or above with major acute ischemic stroke


1 Department of Neurology, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, South Korea
2 Departments of Neurology; Stroke Centre, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, South Korea

Date of Submission09-Jul-2012
Date of Decision17-Jul-2012
Date of Acceptance29-Jul-2012
Date of Web Publication6-Sep-2012

Correspondence Address:
Keun-Sik Hong
Departments of Neurology and Clinical Research Centre, Ilsan Paik Hospital, Inje University College of Medicine, 2240 Daehwa-dong, Ilsanseo-gu, Goyang
South Korea
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0028-3886.100719

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 » Abstract 

Background: Elderly patients with major ischemic strokes may remain severely disabled or dead. However, efficacy and safety of thrombolysis in this have not been fully explored. Materials and Methods: Data from the case records of patients aged >80 years with acute ischemic stroke with admission National Institute of Health Stroke Scale (NIHSS) score ≥10 admitted between April 2009 and May 2011 were retrieved. Outcomes in patients treated with thrombolysis and control subjects were compared. Primary outcome was 3-month modified Rankin Scale (mRS) score 0-2. Secondary outcomes were 3-month mRS score 0-3, mRS score 5-6, mortality, and improvement NIHHS score at discharge. Safety outcome was hemorrhagic transformation. Results: Study subjects included 22 patients treated with thrombolysis and 23 controls not treated with thrombolysis. Age, stroke severity, and proportion of identified major vessel occlusions were the variables for comparison between the two groups. More patients in the thrombolyzed group had mRS 0-2 outcome than in non-thrombolyzed group (18.2% vs. 0%; P = 0.049). Proportion of patients with mRS 0-3 outcome was also higher in thrombolyzed group than in non-thrombolyzed group (22.7% vs. 0%; P = 0.022). Patients in the thrombolyzed group had higher mortality, non-significant when compared to patients in the non-thrombolyzed group (18.2% vs. 8.7%; P = 0.414). However, lesser number of patients in the thrombolyzed group had mRS 5-6 outcome (35% vs. 65%; P = 0.075). Median improvement in NIHSS score at discharge also showed a more favorable trend in thrombolyzed group (10 vs. 2; P = 0.082). Rates of symptomatic and asymptomatic hemorrhagic transformations in thrombolyzed group were 4.5% and 27.3% respectively. Conclusion: For elderly patients with major ischemic strokes, thrombolysis offers a greater chance of functional independence.


Keywords: 80 years, elderly, major ischemic stroke, thrombolysis


How to cite this article:
Kim SC, Hong KS, Cho YJ, Cho JY, Park HK, Song P. Efficacy and safety of thrombolysis in patients aged 80 years or above with major acute ischemic stroke. Neurol India 2012;60:373-8

How to cite this URL:
Kim SC, Hong KS, Cho YJ, Cho JY, Park HK, Song P. Efficacy and safety of thrombolysis in patients aged 80 years or above with major acute ischemic stroke. Neurol India [serial online] 2012 [cited 2019 Oct 18];60:373-8. Available from: http://www.neurologyindia.com/text.asp?2012/60/4/373/100719



 » Introduction Top


Despite the proven efficacy of intravenous thrombolysis within a 4.5-hour window [1],[2],[3] randomized controlled trial data in patients aged ≥80 years are limited. Only the National Institute of Neurological Disorders and Stroke Tissue Plasminogen Activator (NINDS-TPA) trials enrolled patients aged >80 years, [1] European Cooperative Acute Stroke Study (ECASS) I, II, III and Alteplase Thrombolysis for Acute Non-interventional Therapy in Ischemic Stroke (ATLANTIS) trials excluded patients in this age group. [3],[4],[5],[6] As the data regarding safety and efficacy of intravenous tPA in this age group has been limited, intravenous tPA has not been formally approved in this age group in some countries including Korea. Data in regard to intra-arterial (IA) reperfusion therapy are far more limited since trials exclusively enrolled patients under 75 or 85 years. [7],[8] Most studies comparing the outcomes of intravenous thrombolysis in patients aged ≥80 and <80 years have reported that elderly patients had a less favorable outcome than younger patients. [9],[10],[11],[12],[13] However, these studies did not compare with placebo and the findings could not refute the benefit of thrombolysis in the elderly. A study analyzing a large number of patient data pooled in a database of 21 acute stroke trials demonstrated that the benefit of thrombolysis was maintained in the very elderly despite their expected poorer outcomes than younger patients. [14] Major stroke in the elderly carries a substantial hemorrhagic risk with thrombolysis. [1],[2],[15],[16] The efficacy and safety of reperfusion therapy in the elderly have not been systematically explored. This study was to assess the efficacy and safety of thrombolysis in patients aged 80 or above with major ischemic strokes.


 » Materials and Methods Top


From a prospectively captured institute stroke registry, we extracted data of patients aged ≥80 years with admission NIHSS ≥10, admitted within 7 days from stroke onset between April 2009 and May 2011. Patients with a pre-stroke modified Rankin Scale (mRS) ≥4 were excluded. Patients were categorized into thrombolyzed group (intravenous tPA alone, intra-arterial reperfusion therapy alone or combined intravenous and intra-arterial therapy) and non-thrombolyzed group (control). Treating physicians decided the modality of reperfusion therapy based on the clinical and imaging findings. For each patient demographic data, co-morbid conditions, pre-stroke mRS, onset-to-admission, onset-to-treatment for thrombolysis, initial NIHSS score, stroke subtype, NIHSS score at discharge, and 3-month mRS were prospectively captured using a structured protocol. Trained physicians or research nurses assessed mRS outcomes at 3-month from a direct or telephone interview. For patients treated with thrombolysis, recanalization was defined as having Thrombolysis In Cerebral Infarction (TICI) grade 2b or 3. [17] Symptomatic hemorrhagic transformation was determined according to the ECASS III criteria. [3] For quality monitoring and improvement of stroke care, data collection of all stroke patients was approved by the Ethics Committee of our institution. Primary outcome was mRS 0-2 at 3 months. Secondary outcomes were mRS 0-3, and mRS 5-6 at 3 months and NIHSS score improvement at discharge. Safety outcomes were symptomatic and asymptomatic hemorrhagic transformations and 3-month mortality.

Statistical analysis

Categorical variables were compared with χ2 test, and continuous variables with Mann-Whitney U test. Univariate analyses were performed to compare the outcomes between the two groups. To avoid a model over fitting for this small sample and outcome numbers, multivariable analyses were not considered unless there was a significant imbalance in well-recognized prognostic variables of age and initial NIHSS score between the two groups. From the NINDS-TPA trials database, outcomes of patients aged ≥80 years with a baseline NIHSS ≥10 were extracted and numerically compared with the outcomes of our patients.


 » Results Top


Forty-five patients were included in the current study: 22 patients in the thrombolyzed group (14 intravenous tPA alone, 4 intra-arterial reperfusion therapy alone, and 4 combined intravenous and intra-arterial therapy) and 23 in non-thrombolyzed control group. Between the treatment and control groups age (85.2 ± 5.2 vs. 85.7 ± 4.1, P = 0.735) and initial NIHSS score (median [interquartile range], 21 [16-23] vs. 20 [17-23], P = 0.707) were well-balanced. Proportion of major vessel occlusions identified on computed tomography (CT), magnetic resonance (MR), or conventional angiography was also comparable (72.2% in treatment vs. 65.2% in control, P = 0.586). For patients treated with thrombolysis, there were 7 internal carotid artery (ICA), 7 M1 portion of middle cerebral artery (MCA), 1 basilar artery (BA), and 1 P1 portion of posterior cerebral artery (PCA) occlusions; whereas, for control subjects there were 10 ICA, 4 M1 portion of MCA and 1 BA occlusions. Other baseline characteristics except for onset-to-admission were comparable between the two groups [Table 1]. In patients treated by thrombolysis, the average intervals for onset-to-treatment and door-to-treatment were 146.2 ± 73.3 and 61.6 ± 43.1 minutes.
Table 1: Baseline characteristics of patients

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Outcomes

Pimary outcome

Of the 22 patients in the thrombolyzed group, 4 (18.2%) patients had mRS 0-2 at 3 months as compared to none (0%) in the control group, (P = 0.049) [Table 2]. Secondary outcome: Proportion of patients with mRS 0-3 at 3 months was also significantly higher in patients in thrombolyzed group than in patients in the control group (22.7% vs. 0%, P = 0.022). Of the 14 patients treated with intravenous tPA alone, 2 (14.3%) patients had mRS 0-2, and 3 (21.4%) had mRS 0-3 at 3 months. Of the 8 patients treated with intra-arterial alone or combined therapy, 2 (25%) patients had mRS 0-2 (same for mRS 0-3) at 3 months. The proportion of patients with worst outcome, mRS 5-6, was substantially lower in the thrombolyzed group than the in the control group. However, this difference had not reached statistical significance (35.0% vs. 65.0%, P = 0.075). Functional outcomes in the control group were mRS of 4-6, and 61% remained in an extreme disability of mRS 5 [Figure 1]. NIHSS improvement at discharge (median, [interquartile range]) was greater in thrombolyzed group than in control group, but the difference was not statistically significant (10 [-1, 14] vs. 2 [-2, 8], P = 0.082).
Table 2: Primary and secondary outcomes

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Figure 1: 3-month mRS distribution

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Recanalization

After excluding 3 patients in the thrombolyzed group who had no major vessel occlusions on pretreatment CT angiography, recanalization status was assessed in the remaining 19 patients using CT or MR angiography within 24 hours after treatment or immediate post intra-arterial conventional angiography. Nine (47.4%) patients achieved recanalization, and 6 (31.6%) had persistent occlusions. In 4 (21.1%) patients recanalization could not be evaluated because of serious neurological conditions or refusal of surrogates. Of the 11 patients who received intravenous tPA alone, recanalization was observed in 3 (27.3%) patients within 24 hours and of the 8 patients treated with intra-arterial reperfusion therapy alone or combined therapy, 6 (75%) patients achieved recanalization on immediate post-treatment conventional angiography.

Mortality and hemorrhagic transformation

Mortality at 3-months was higher in the thrombolyzed group than in control group, but the difference did not reach a statistical significance (18.2% vs. 8.7%, P = 0.414) [Table 2]. Of the 4 patients who died after thrombolysis, 2 had recanalization and the other 2 did not. Brief case summaries of 4 these patients: (1) A patient with ICA T-occlusion and admission NIHSS score of 19 had TICI IIb recanalization with intra-arterial therapy, but subsequently developed symptomatic hemorrhagic transformation; (2) A patient with ICA T-occlusion and admission NIHSS score of 25 received intravenous tPA alone and follow-up MRI showed recanalization, but he subsequently developed malignant MCA infarction; (3) A patient with ICA T-occlusion and admission NIHSS score of 23 failed to achieve recanalization with combined therapy and subsequently developed malignant MCA infarction; and (4) A patient with basilar artery occlusion and NIHSS score of 40 was treated with intravenous tPA alone, and follow-up MRA showed persistent occlusion and infarctions in brainstem, bilateral cerebellum and bilateral PCA territory. The cause of death in these 4 patients were symptomatic hemorrhagic transformation in 1 and severe stroke in 3 patients. There were two deaths in the control group, one patient had a basilar artery occlusion with NIHSS score of 33, and the other patient had proximal ICA occlusion with NIHSS score of 26.

Symptomatic hemorrhagic transformation of parenchymal hematoma type 2 developed in one patient treated with intra-arterial therapy, who died. Asymptomatic hemorrhagic transformation was observed in 5 (27.3%) patients: 3 hemorrhagic infarction type 1 and 2 hemorrhagic infarction type 2.


 » Discussion Top


In this study, none of the elderly patients in the non-thrombolyzed group functional independence. In contrast, with thrombolytic therapy, 18% of patients could achieve good functional independence and look after their activities of daily living and 22% of patients were able to walk unassisted. In addition to improvement in global functional outcome, neurological improvement at discharge showed a favorable trend with thrombolysis. With regard to safety, the rates of fatal and asymptomatic hemorrhagic transformation of less than 5% and 22% are highly acceptable given that patients were very elderly and had severe strokes. With thrombolysis therapy, the mortality rate showed an absolute increase of 10%, but absolute decrease in extreme disability of mRS 5 by 40%. As a result, the thrombolysis therapy had an absolute 30% risk reduction for extreme disability or death. Increase in the mortality rates and decrease in the extreme disability rates in the elderly with thrombolysis is a debatable aspect from ethical point of view. In this situation, generally acceptable comparative values for death and extreme disability would help to guide a treatment decision. Most-widely employed methods of weighting diverse health conditions are quality weight and disability weight. Quality weight is derived from patients or healthy individuals, and disability weight is derived from experienced health professionals. In a quality weight study asking persons with a high risk for stroke, 45% of respondents considered major stroke to be a worse outcome than death. [18] In a disability weight study convening multinational stroke experts with diverse cultural backgrounds, the generated disability weight with achieving substantial consensus for mRS 5 was 0.944, which is almost identical to the disability weight of 1.0 for death. [19] In addition, another study surveying stroke experts' attitude also demonstrated that more than 80% of experts considered a transition from death to mRS 5 clinically not meaningful, [20] and therefore, recent major acute stroke trials considered mRS 5 and mRS 6 into a single worst-outcome category. [21],[22] Considering the greater chances of gaining functional independence and independent gait and reducing extreme disability or death, thrombolysis therapy should be strongly considered for and provided to patients aged ≥80 years with major ischemic strokes. Our findings are similar to the findings in a prior study that demonstrated a benefit of intravenous tPA in elderly patients. [14] Our results are in contrast to two earlier studies that failed to show a benefit of intravenous tPA when compared to placebo or no treatment in elderly patients. [23],[24] However, those studies included mild to moderate strokes as well as severe stroke, and were not sufficiently powered to detect the treatment effect. Despite a small sample size, exclusively enrolling severe strokes where treatment effect could be more magnified than in mild to moderate stroke might attribute to our positive results.

It would be instructive to compare the recanalization rates in the current and earlier studies. In a systematic review, recanalization rates within 24 hours were 24.1% without thrombolysis, 46.2% with intravenous fibrinolytic, 63.2% with intra-arterial fibrinolytic, and 67.5% with combined intravenous and intra-arterial therapies. [25] In the current analysis excluding patients who showed no major vessel occlusion on pre-treatment CTA, the recanalization rate of 75.0% with intra-arterial therapy alone or combined therapy was generally comparable to, but 27.3% with intravenous tPA alone was less than those estimated in the systematic review. However, since at least more than 70% of patients had major vessel occlusions, the current recanalization rate with intravenous tPA is likely to be concordant with earlier studies which demonstrated recanalization rates with intravenous tPA of 10% in ICA occlusions and less than 30% in proximal MCA occlusions. [26],[27] Accordingly, thrombolysis therapy even in elderly patients could achieve a comparable recanalization rate as in general ischemic stroke patients.

Since the current study differs with the NINDS-TPA trials in proportion of major vessel occlusions, interval of onset-to-treatment, and treatment modality, outcome comparison of two studies should be cautious, but would be informative [Figure 1]. In the NINDS-TPA trials, patients aged ≥80 years and baseline NIHSS ≥10 were 31 in tPA group and 23 in placebo group. On pretreatment CT, hyper dense MCA sign strongly suggesting a major vessel occlusion was observed in 25.8% in patients treated with tPA and 13.0% in the placebo group. As shown in [Figure 1], as compared to tPA-treated patients in NINDS-TPA trials, the current thrombolyzed patients had comparable proportions of mRS 0-2 and mRS 0-3, but were less extremely disabled or dead. In contrast, our control subjects were more severely disabled than placebo-treated patients in NINDS-TPA trials.

This study has several limitations. This is not a randomized study, and thus unable to remove selection bias in treatment allocation. Since outcome assessors were not blinded to treatment, outcome assessment could be potentially biased. However, all the patients in the control group had outcomes of mRS 4-, for which outcomes assessment are highly consistent, [28] and therefore unblended outcome assessment was less likely to alter the current results. This study was performed in acentre well-experienced with reperfusion therapies and the reperfusion therapy was not unified. Thus, our findings have a limitation for generalizability.

In conclusion, if not thrombolyzed, patients aged ≥80 years with major ischemic stroke may remain in an extreme disability or may die. Thrombolysis therapy can offer a greater chance of gaining functional independence or independent gait and reduce extreme disability or death at a price of more mortality, so it should be strongly considered for and provided to these patients.


 » Acknowledgments Top


This work was supported by a grant of Inje University in 2010 (K.-S.H.).

 
 » References Top

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