Hyperacute thrombolysis with recombinant tissue plasminogen activator of acute ischemic stroke: Feasibility and effectivity from an Indian perspective

Abstract

Given the constraints of resources, thrombolysis for acute ischemic stroke (AIS) is under evaluation in developing countries like India, especially in areas such as western Utter Pradesh, where it is overly crowded and there is poor affordability.Aim:This study was done to evaluate recombinant tissue plasminogen activator r-tpa in acute ischemic stroke in hyper acute phase, in selected patients of western Utter Pradesh, in terms of feasibility and effectivity.Design:Open, non randomized study.Materials and Methods:Thirty two patients were classified using Trial of ORG 10172 in Acute Stroke treatment (TOAST) criteria (large artery atherosclerotic = 8; cardio embolic = 6; small vessel occlusion = 14; other determined etiology = 2; undetermined etiology = 2). The mean time to reach the hospital was 2 h (1.15-3.0), the mean door to CT scan 20 min (10-40) and door to r-tpa injection was 30 min (24-68). The National Institute of Health Stroke Scale (NIHSS) scores ranged from 11-22 (mean 15.5 +2.7). The dose of r-tpa administered was 0.9 mg/kg.Results:Twenty one patients (65.6%) showed significant improvement on the NIHSS score, at 48 h (4 points). (Mean change = 10; range = 4-17). At one month, 25 (78%) recorded improvement on the Barthel index (mean change = 45%). One developed frontal lobe hemorrhage and another developed recurrent stroke; one died of aspiration; and four showed no improvement. Modified Rankin score (m RS) was administered at the end of three months to 28 patients (90%); however, the rest could not be directly observed. The average modified Rankin Score was 1.2 (0-2).Conclusions:Hyperacute thrombolysis was found feasible and effective in selected patients with AIS from western Utter Pradesh and who had poor affordability.

Early outcomes of thrombolysis for acute ischaemic stroke in a South African tertiary care centre

“…9 In 3 studies from developing countries the mortality at discharge ranged from 0 to 5.9%. 13,14,16 It is estimated that <2% of patients with ischaemic stroke in our hospital drainage area received thrombolysis, which seems comparable with data from other developing countries. 15,16 However, our reported thrombolysis rate is an overestimation for the general population, as most patients with acute stroke are managed conservatively at lower level facilities where thrombolysis is not available.…”

“…9 Pooled data from five observational studies from developing countries show a lower proportion of patients suffering SICH, 9/293 (3.1%), but the rates ranged from 0 to 5.9% between the different centres. [13][14][15][16][17] Although the number is small and does not represent a significant association, all three of our patients over the age of 75 had bleeding complications. Studies in the developed world support the safety of tPA in patients over 80 years.…”

“…6 Smaller studies from other developing countries reported similar results. [13][14][15][16][17] The European Medicines Evaluation Agency allowed registration of tPA for acute stroke in 2002, on condition that an observational safety study be performed to address concerns about the applicability of data from randomised controlled trials to individuals in daily clinical practice. At 3-month followup, 54.8% of patients in this SITS-MOST cohort were functionally independent, 7 compared with 40.5% at the time of discharge in our study.…”

“…However, there is growing evidence of of its comparable efficacy and safety when used in these settings. [13][14][15][16][17] The new South African national stroke guidelines recommend tPA as treatment for acute ischaemic stroke within 4.5 hours of symptom onset. 18 However, there are no published data on the use of thrombolysis in Africa.…”

Gaps and Hurdles Deter against Following Stroke Guidelines for Thrombolytic Therapy in Iran: Exploring the Problem

“…A recent systematic review 17 assessed the global use of rtPA for AIS among 214 countries and found that only 54 (25%) of these countries reported its administration, ranging from as low as 3% (1 of 36) of low-income, to 13% (7 of 54) of lower middle-income, to 28% (15 of 54) of upper middle-income, and to 44% (31 of 70) of highincome countries. 17 In comparison, access to rtPA in Iran is lower than in most of the developed countries [18][19][20][21][22][23][24][25] but comparable with other developing countries [26][27][28][29][30][31][32] ( Fig 2). The barriers of timely administration of rtPA in developing countries include limited resources, prehospital delay, sparse numbers of stroke units, 16,33 poor stroke awareness in the general population, 33 lack of general knowledge and professional education, 33,34 the high cost of rtPA, lack of insurance coverage, low socioeconomic status of patients, 16,33 and physician reluctance and concerns about the benefits compared with its serious side effects, especially bleeding.…”