|Year : 2022 | Volume
| Issue : 1 | Page : 93-96
Intravenous thrombolysis in acute ischemic stroke: A prospective cross-sectional observational study in Kashmir
Javed Khan1, Irfan Yousuf Wani2, Showkat Mufti1, Ravouf Asimi3
1 Department of Emergency Medicine, SKIMS, Srinagar, Jammu and Kashmir, India
2 Department of Medicine, GMC, Srinagar, Jammu and Kashmir, India
3 Department of Neurology, SKIMS, Srinagar, Jammu and Kashmir, India
|Date of Submission||05-Jul-2020|
|Date of Decision||01-Dec-2020|
|Date of Acceptance||05-Jul-2021|
|Date of Web Publication||18-Oct-2022|
Irfan Yousuf Wani
Department of Medicine, GMC, Srinagar, Jammu and Kashmir
Source of Support: None, Conflict of Interest: None
Background: Till date, no data has been published about the use of intravenous (IV) thrombolysis in acute ischemic stroke (AIS) from Kashmir valley. Objective: The objective of the study is to assess and determine the pattern of use of IV thrombolysis for AIS in Kashmir, including its efficacy and the difficulties faced in providing this modality of treatment. Materials and Methods: This was a prospective cross-sectional observational study conducted from July 2016 to July 2018. All those patients who were admitted with a diagnosis of stroke and gave informed consent were included in this study. Results: A total of 2023 patients of stroke presented to our emergency department during the study period. Out of them, 1085 (53.6%) cases were found to have hemorrhagic stroke and 938 (46.3%) patients were having ischemic stroke. 9.2% patients of ischemic stroke presented within the window period of thrombolysis, but only 34 (3.6%) patients received IV alteplase. The mean onset to door time in those who received thrombolysis was 103.5 ± 51.17 min. Door-to-needle time (DNT) of ≤60 min was achieved in only 14 (41.2%) cases, whereas mean DNT was 82.7 ± 49.17. There was a statistically significant improvement in the National Institutes of Health Stroke Scale in those who received thrombolysis as compared to those who did not receive it. Conclusion: Hemorrhagic stroke occurs in majority of stroke patients (53.6%) in our community. 3.6% of ischemic stroke patients were thrombolyzed. Thrombolytic therapy presented positive outcomes in comparison to nonthrombolyzed patients which, however, was not statistically significant.
Keywords: Alteplase, stroke, thrombolysis
|How to cite this article:|
Khan J, Wani IY, Mufti S, Asimi R. Intravenous thrombolysis in acute ischemic stroke: A prospective cross-sectional observational study in Kashmir. CHRISMED J Health Res 2022;9:93-6
|How to cite this URL:|
Khan J, Wani IY, Mufti S, Asimi R. Intravenous thrombolysis in acute ischemic stroke: A prospective cross-sectional observational study in Kashmir. CHRISMED J Health Res [serial online] 2022 [cited 2022 Dec 8];9:93-6. Available from: https://www.cjhr.org/text.asp?2022/9/1/93/358824
| Introduction|| |
Stroke is reported to be among the first three causes of disability worldwide leaving behind 15%–30% of survivors with a permanent disability and around 20% dependent on rehabilitative care even after 3 months of surviving a stroke. As reported that one stroke occurs every forty seconds, the impact it has on health and economy is huge. In a survey of preferences among individuals with higher risk of stroke, more than 45% believed that suffering stroke would be worse than death, indirectly meaning that they would prefer death rather than live with disability and being dependent on others. The economic impact of stroke is staggering and unbelievable which can be judged from the fact that the total projected cost between 2005 and 2050 is estimated to be $1.52 trillion, $379 billion, and $313 billion for Whites, Blacks, and Hispanics, respectively. $73.7 billion was the amount utilized in 2010 worldwide, for providing care to stroke patients which included direct as well as indirect costs. In India, stroke is the 4th leading killer while in the USA, it is on 5th rank, causing death of around 129,000 people a year.
Usually, ischemic stroke is more prevalent than hemorrhagic stroke. However, a clinicoradiological profile study in Kashmir valley has found intracerebral hemorrhage (ICH) more common than ischemic stroke.
The use of intravenous (IV) recombinant tissue plasminogen activator (tPA) has revolutionized the treatment of acute ischemic stroke (AIS). Nowadays, the treatment has seen a lot of improvement because of mechanical thrombectomy in eligible stroke patients. However, resource-poor regions such treatment options are not being utilized or are not available at all. The present scenario in our region, i.e., Kashmir valley, is no different. We conducted this study at Sher-i-Kashmir Institute of Medical Sciences (SKIMS), a tertiary care hospital to see the pattern of IV thrombolysis with recombinant tissue plasminogen activator (rtPA) received by eligible ischemic stroke patients.
| Materials and Methods|| |
This prospective cross-sectional observational study was conducted in the Department of Emergency Medicine in collaboration with Neurology Department of SKIMS. Ethical clearance was taken from the Institutional Ethical Committee. All the consecutive patients above 18 years of age who presented with AIS, within window period to the emergency department (ED) of SKIMS, between July 2016 and July 2018 and gave an informed consent were included in this study. After initial assessment in emergency room (ER) by Physician, a Neurologist evaluated the patients. Radiological diagnosis was made by noncontrast brain computed tomography (CT). All the patients were evaluated by a neurologist, and all images were evaluated by a radiologist and data collected for type of stroke. The guideline of the American Heart Association was taken into consideration for determining the patients in whom thrombolytic therapy was indicated.
The following parameters were taken into consideration for patients of ischemic stroke admitted within window period:
- Demography of patient
- Risk factor profile
- Stroke severity (National Institutes of Health Stroke Scale [NIHSS] Score) on admission and after 24 h
- Blood pressure
- Noncontrast CT (NCCT) finding on admission and after 24h
- Laboratory parameters (random blood sugar, coagulation profile, lipid profile, electrolyte)
o Onset of symptoms to ER time
o Door to imaging time
o Door to needle time (DNT).
- Contraindication for thrombolysis
- Complication due to thrombolysis
- Complication during hospital stay
- Condition on discharge (modified Rankin score [mRS])
- Follow-up of patient at 3 months (mRS).
Demographic and other background data were summarized with basic descriptive statistics in all the patients. The recorded data were compiled and entered in a Spreadsheet (Microsoft Excel), and then, analysis was done by using SPSS version 20.0 (SPSS Inc., Chicago, IL, USA). Continuous variables were summarized in the form of means and standard deviations, and categorical variables were summarized as frequencies and percentages. Categorical variables were compared and analyzed by using Chi-square test or Fisher's exact test as appropriate. A P value was considered statistically significant only if <0.05. Data obtained from cases was compared with controls.
| Results|| |
A total of 2023 patients of stroke presented to our ED in the study period. Out of these, 1085 (53.6%) cases were found to be of hemorrhagic stroke which included 973 (89.6%) cases of ICH and 112 (10.3%) cases of subarachnoid hemorrhage. Nine hundred and thirty-eight (46.3%) patients were admitted with ischemic stroke, and out of them, 27% patients had lacunar stroke. A total of 61% of the ischemic stroke patients had middle cerebral artery territory involvement followed by 9.6% of posterior cerebral artery territory involvement, and anterior cerebral artery territory was involved in 2.4% of patients. Eighty-seven (9.2%) patients of ischemic stroke presented within the window period for thrombolysis but only 34 (3.6%) patients received IV alteplase. These 34 patients were grouped as rtPA group. Eighteen patients were excluded as they had contraindication to thrombolysis. Thirty-five patients who did not receive IV alteplase though eligible for it were grouped as non-rtPA group.
The mean age of the patients in our study was 62.4 ± 13.62 in rtPA group and 60.8 ± 17.04 in non-rtPA group. The maximum number of patients was in the age group of 60–69 years. In both groups, there was a predominance of males, 24 (70.6%) in rtPA group and 20 (57.1%) in non-rtPA group. Most of the patients in rtPA group belonged to urban area (88.2%) in comparison to non-rtPA group (51.4%). This difference was statistically significant. In our study, the major risk factor for stroke was hypertension (75.3%) followed by smoking (47.8%) and atrial fibrillation (20.2%).
The mean onset to door time (OTD) for all enrolled patients was 141.9 ± 60.89 min. In rtPA group, the mean OTD was 103.5 ± 51.17 min and only 8 (23.5%) patients reached within 60 min of onset of symptoms. In non-rtPA group, the mean OTD was 179.1 ± 44.48 min and no patient reached within 60 min, i.e., a statistically significant difference between the two groups as shown in [Table 1].
Ideal time for door to CT (DTC) initiation is ≤25 min. In our study, this was achieved in only 10 (29.4%) cases in rtPA group and 2 (3.2%) in non-rtPA group. Mean DTC in all cases was 42.2 ± 24.60 min. Overall, only 12 (17.4%) patients underwent CT scanning in recommended time of ≤25 min as shown in [Table 2].
|Table 2: Door to needle time of patients in recombinant tissue plasminogen activator group|
Click here to view
DNT of ≤60 min was achieved in only 14 (41.2%) cases. Whereas, mean DNT was 82.7 ± 49.17 (minimum: 15–maximum: 190) as shown in [Table 3].
|Table 3: Significant improvement on the basis of the National Institutes of Health Stroke Scale at 24 h in alteplase and control group|
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NIHSS score on admission in rtPA group was 13.4 ± 5.53 and in non-rtPA group was 11.2 ± 4.66 (P = 0.069). At 24 h, the mean NIHSS improved more in rtPA group than non-rtPA group (P = 0.428). Significant improvement in NIHSS defined as an improvement of 8 or more points on NIHSS score was better in rtPA group (23.5%) as compared to non-rtPA group (5.7%) (P = 0.039) as shown in [Table 4].
Hemorrhagic transformation was present on repeat NCCT head after 24–36 h postthrombolysis in 6 (17.6%) patients in rtPA group and 3 (8.6%) in non-rtPA group (P = 0.446). However, s-ICH was seen in only 1 (2.9%) patient in the rt-PA group. None of the patients in non-rt-PA group developed s-ICH.
mRS at the time of discharge with favorable outcome (mRS: 0–1) was seen in 7 (20.6%) patients in rtPA group and 4 (11.4%) patients in non-rtPA group. mRS on 90-day follow-up with favorable outcome (mRS: 0–1) was seen in 17 (50.0%) patients in rtPA group and 13 (37.1%) patients in non-rtPA group (P = 0.068).
| Discussion|| |
Ischemic stroke management has shown a lot of changes and improvement over the last decade. Endovascular treatment has revolutionized the treatment, especially in large vessel strokes where IV thrombolysis has been found to have a limited role. However, these treatment options are still limited to major cities in India. In our region, no such facility is available at present. Even IV thrombolysis is being done only at few places and that too in the capital city of Srinagar only. Hence, only those patients who reach these hospitals in the window period have a chance of receiving thrombolysis if indicated. In our study, we found that hemorrhagic stroke is much more frequent than ischemic stroke as was reported in the previous study from the same region. However, the incidence of hemorrhagic stroke in our study was little less as compared to previous study. The reason for this decrease in incidence could be that more ischemic stroke patients are being referred to our hospital due to the availability of thrombolysis. Similar findings of higher incidence of hemorrhagic strokes have been reported in some other studies.,,,,
9.2% (87) patients of ischemic stroke presented within the window period of thrombolysis in our study. Eighteen patients were excluded from the study as they had contraindication to thrombolysis. Thirty-four (3.6%) patients received IV thrombolysis (alteplase). Similar thrombolysis rate has been reported by other studies from India.,, In our study, majority of patients who were thrombolyzed belonged to urban areas especially areas near to our tertiary care hospital. This provides a hope that more eligible stroke patients will get thrombolysis when such facility is made available at District Hospital level. The major reasons for not receiving thrombolysis despite being eligible for it, has been reported by many studies. In our study, we found that the biggest hurdle was the nonacceptance of the risk of hemorrhagic transformation by the attendants. Other than that, the high cost of treatment is the main constraint as majority of patients, especially those living in rural areas, did not have an insurance policy.
In our study, the mean DTC in all cases was 42.2 min. Overall, only 12 patients underwent CT scanning in recommended time of ≤25 min. Mean DNT was 82.7 (minimum: 15–maximum: 190) whereas DNT of ≤60 min was achieved in only 14 cases. Both DTC and DNT in our study were comparable to one study but much longer than other studies done in India.,,, Improvements can be made in these parameters by having a proper stroke protocol, sensitization of residents working in ER, and easy availability of thrombolytic agent in ER.
Symptomatic ICH was seen in 1 patient only. mRS on 90-day follow-up with favorable outcome (mRS: 0–1) was seen in 17 (50.0%) patients among those who received thrombolysis and 13 (37.1%) patients among those who were not thrombolyzed. The outcome though better in the group who received thrombolysis was, however, statistically not significant. There was no statistically significant difference in the mortality rate between those who received thrombolysis and those who did not. Hence, our study should encourage residents and medical officers working in different hospitals of our region to be more enthusiastic in offering IV thrombolysis in eligible stroke patients and allaying the fears of attendants regarding the safety of this treatment.
| Conclusion|| |
The burden of hemorrhagic stroke is more than ischemic stroke in our region. Thrombolysis rate in our study is comparable to other studies from India, but the mean DTC and DNT are still longer. A positive approach is needed to increase the thrombolysis rate and improve the DTC/DNT time which includes the availability of such treatment at district hospitals. Tertiary care hospitals should work toward providing endovascular treatment to improve stroke services.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]