Post-licensed 1-year experience of systemic thrombolysis with tissue plasminogen activator for ischemic stroke in a Japanese neuro-unit

Yoneda, Yukihiro; Yamamoto, Shinji; Hara, Yoshie; Ohta, Kohei; Matsushita, Makoto; Yamamoto, Daisuke; Yamashita, Haruo; Hosoda, Kohkichi

doi:10.1016/j.clineuro.2007.05.002

Cited by 19 publications

(15 citation statements)

References 14 publications

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“…Utilization of MRI or vascular imaging before thrombolysis can provide a higher accuracy of stroke diagnosis [9] and may detect the contra-indicated conditions such as cerebral aneurysm or other vascular anomalies. However, these additional imaging studies may delay the delivery of tPA.…”

Section: Discussionmentioning

confidence: 99%

Unruptured Cerebral Aneurysm Detected after Intravenous Tissue Plasminogen Activator for Stroke

Yoneda¹,

Yamamoto²,

Hara

et al. 2009

Case Rep Neurol

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Therapeutic guidelines of intravenous thrombolysis with tissue plasminogen activator (tPA) for hyperacute ischemic stroke are very strict. Because of potential higher risk of bleeding complications, the presence of unruptured cerebral aneurysm is a contraindication for systemic thrombolysis with tPA. According to the standard CT criteria, a 66-year-old woman who suddenly developed aphasia and hemiparesis received intravenous tPA within 3 h after ischemic stroke. Magnetic resonance angiography during tPA infusion was performed and the presence of a small unruptured cerebral aneurysm was suspected at the anterior communicating artery. Delayed cerebral angiography confirmed an aneurysm with a size of 7 mm. The patient did not experience any adverse complications associated with the aneurysm. Clinical experiences of this kind of accidental off-label thrombolysis may contribute to modify the current rigid tPA guidelines for stroke.

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Section: Discussionmentioning

confidence: 99%

Unruptured Cerebral Aneurysm Detected after Intravenous Tissue Plasminogen Activator for Stroke

Yoneda¹,

Yamamoto²,

Hara

et al. 2009

Case Rep Neurol

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“…Patients enrolled in the low-dose rtPA study were older, had more severe stroke and more common cardioembolic stroke subtype [ Table 2]. SAMURAI registry [5] 600 0.6 199 (33.2) 43 (7.2) 8 (1.3) † J-ACT [6] 103 0.6 38 (36.9) 10 (9.7) 6 (5.8)* TTT-AIS [7] 125 vs 116 0.90 ± 0.02 vs 0.72 ± 0.07 57 (48.7) vs 60 (58.8) ‡ 16 (12.8) vs 8 (6.9) 10(8) vs 3(2.6)* Dharmasaroja et al [8] 197 0.9 93 (47.2) 23 (11.7) 9/206 (4.3)* Sharma et al [9] 82 vs 48 0.9 vs 0.67 (0.5-0.9) 48 (59) vs 17 (35) 11 (13) vs 5 (10) 1 (1.2) vs 7 (14.5)* Suwanwela et al [11] 32 vs 2 0.9 vs 0.6 NA NA 4 (11.8)* Yoneda et al [12] 20 0.6 5 (25) 3 (15) 1 (5)* J-ACT II [14] 58 0.6 27 (46.6) 1 (1.7) 0* J-MARS [15] 7492 0.6 1637/4944 (33.1) 985/7492 (13.1) 259 (3.5)* *sICH by ECASS criteria [10] = intracerebral hemorrhage associated with worsening of ≥4 points on the NIHSS score, † sICH by SITS-MOST [12] …”

Section: Resultsmentioning

confidence: 96%

“…Of these, 46 articles were excluded because they did not meet the purpose of this review--they were not performed on East Asian patients, did not use intravenous thrombolysis as a treatment, or were not original studies. Finally, there were nine studies reviewed [5][6][7][8][9][10][11][12][13][14][15] [ Table 1]. Studies that met the following criteria were included: (a) rates of symptomatic intracerebral hemorrhage, favorable outcome, and death at 3 months were reported; (b) baseline characteristics of the patients were presented; and (c) patients receiving intravenous rtPA were East Asian.…”

Section: Methodsmentioning

confidence: 99%

Low vs standard dose of recombinant tissue plasminogen activator in treating East Asian patients with acute ischemic stroke

Dharmasaroja

Pattaraarchachai

2011

Neurol India

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“…Of these, 3 reported treatment under a modified NINDS protocol and were excluded (2 used a lower IV-TPA dose, 1 sub-selected NINDS-eligible patients based on ability to pay for treatment) [17,18,19]. Thus, a total of 30 studies were included (tables 1, 2, 3).…”

Section: Resultsmentioning

confidence: 99%

Safety and Efficacy of IV-TPA for Ischaemic Stroke in Clinical Practice – A Bayesian Analysis

O’Rourke

Walsh²,

Kelly³

2009

Cerebrovasc Dis

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Background: Observational studies of new treatments in routine practice are clinically important but may be limited by bias. We used a Bayesian approach to interpret and sequentially combine phase 4 studies of IV-TPA within 3 h for acute ischaemic stroke to quantify the cumulative evidence for the efficacy and safety of this therapy in clinical practice. Methods: Prior probability distributions for favourable outcome (modified Rankin Score, mRS, 0–1), symptomatic intracerebral haemorrhage, and mortality 3 months after IV-TPA were derived from the NINDS trial. Phase 4 studies from observational case series and from regulator-mandated large registries were included. A cumulative analysis was performed to quantify the increase in the total evidence base over time, unadjusted and adjusted for potential bias. Results: The cumulative analysis indicated that IV-TPA <3 h was associated with 3-month favourable outcome in 37.1% (95% credible interval, CrI, 36.1–38.0%, n = 9,578) compared to 26% (95% confidence interval, CI, 19.6–32.9%, n = 165) in placebo-treated patients in NINDS, symptomatic intracranial haemorrhage in 6.6% (95% CrI 5.9–7.4%, n = 10, 834) compared to 6.4% (95% CI 4.0–9.4%) in the NINDS IV-TPA group, and 3-month mortality in 13.6% (95% CrI 12.6–14.8%, n = 9, 901) compared to 20.5% (95% CI 16.0–25.0%, n = 312) in the NINDS placebo group. Conclusion: A Bayesian approach provides further confirmatory evidence of the efficacy and safety of IV-TPA for treatment of acute ischaemic stroke within 3 h in diverse clinical practice settings, after adjusting for potential observational bias.

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Post-licensed 1-year experience of systemic thrombolysis with tissue plasminogen activator for ischemic stroke in a Japanese neuro-unit

Cited by 19 publications

References 14 publications

Unruptured Cerebral Aneurysm Detected after Intravenous Tissue Plasminogen Activator for Stroke

Unruptured Cerebral Aneurysm Detected after Intravenous Tissue Plasminogen Activator for Stroke

Low vs standard dose of recombinant tissue plasminogen activator in treating East Asian patients with acute ischemic stroke

Safety and Efficacy of IV-TPA for Ischaemic Stroke in Clinical Practice – A Bayesian Analysis

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