Effectiveness of intravenous r-tPA versus UK for acute ischaemic stroke: a nationwide prospective Chinese registry study

Xinhong Wang; Xiaoqiu Li; Yuming Xu; Runhui Li; Qingcheng Yang; Yong Zhao; Fengyun Wang; Baoying Sheng; Runqing Wang; Shaoyuan Chen; Lihua Wang; Liying Shen; Xiaowen Hou; Yu Cui; Duolao Wang; Bin Peng; Craig S. Anderson; Huisheng Chen

doi:10.1136/svn-2020-000640

Effectiveness of intravenous r-tPA versus UK for acute ischaemic stroke: a nationwide prospective Chinese registry study

Xinhong Wang
, Xiaoqiu Li
, Yuming Xu
, Runhui Li
, Qingcheng Yang
, Yong Zhao
, Fengyun Wang
, Baoying Sheng
, Runqing Wang
, Shaoyuan Chen
, Lihua Wang
, Liying Shen
, Xiaowen Hou
, Yu Cui
, Duolao Wang
, Bin Peng
, Craig S. Anderson
, Huisheng Chen

Clinical Sciences

Research output: Contribution to journal › Article › peer-review

32 Citations (Scopus)

Abstract

BACKGROUND

Intravenous recombinant tissue plasminogen activator (r-tPA) and urokinase (UK) are both recommended for the treatment of acute ischaemic stroke (AIS) in China, but with few comparative outcome data being available. We aimed to compare the outcomes of these two thrombolytic agents for the treatment of patients within 4.5 hours of onset of AIS in routine clinical practice in China.

METHODS

A pre-planned, prospective, nationwide, multicentre, real-world registry of consecutive patients with AIS (age ≥18 years) who received r-tPA or UK within 4.5 hours of symptom onset according to local decision-making and guideline recommendations during 2017-2019. The primary effectiveness outcome was the proportion of patients with an excellent functional outcome (defined by modified Rankin scale scores 0 to 1) at 90 days. The key safety endpoint was symptomatic intracranial haemorrhage according to standard definitions. Multivariable logistic regression was used for comparative analysis, with adjustment according to propensity scores to ensure balance in baseline characteristics.

RESULTS

Overall, 4130 patients with AIS were registered but 320 had incomplete or missing data, leaving 3810 with available data for analysis of whom 2666 received r-tPA (median dose 0.88 (IQR 0.78-0.90) mg/kg) and 1144 received UK (1.71 (1.43-2.00)×10 international unit per kilogram). There were several significant intergroup differences in patient characteristics: r-tPA patients were more educated, had less history of stroke, lower systolic blood pressure, greater neurological impairment and shorter treatment times from symptom onset than UK patients. However, in adjusted analysis, the frequency of excellent outcome (OR 1.18, 95% CI 1.00 to 1.40, p=0.052) and symptomatic intracranial haemorrhage (OR 0.70, 95% CI 0.33 to 1.47, p=0.344) were similar between groups.

CONCLUSIONS

UK may be as effective and carry a similar safety profile as r-tPA in treating mild to moderate AIS within guidelines in China. REGISTRATION: http://www.clinicaltrials.gov. unique identifier: NCT02854592.

Original language	English
Pages (from-to)	603-609
Number of pages	7
Journal	Stroke and Vascular Neurology
Volume	6
Issue number	4
Early online date	26 Apr 2021
DOIs	https://doi.org/10.1136/svn-2020-000640
Publication status	Published - 1 Dec 2021

Keywords

stroke
thrombolysis

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Cite this

Wang, X., Li, X., Xu, Y., Li, R., Yang, Q., Zhao, Y., Wang, F., Sheng, B., Wang, R., Chen, S., Wang, L., Shen, L., Hou, X., Cui, Y., Wang, D., Peng, B., Anderson, C. S., & Chen, H. (2021). Effectiveness of intravenous r-tPA versus UK for acute ischaemic stroke: a nationwide prospective Chinese registry study. Stroke and Vascular Neurology, 6(4), 603-609. https://doi.org/10.1136/svn-2020-000640

@article{ceecfec6157a4e449989e4c04673f549,

title = "Effectiveness of intravenous r-tPA versus UK for acute ischaemic stroke: a nationwide prospective Chinese registry study",

abstract = "BACKGROUNDIntravenous recombinant tissue plasminogen activator (r-tPA) and urokinase (UK) are both recommended for the treatment of acute ischaemic stroke (AIS) in China, but with few comparative outcome data being available. We aimed to compare the outcomes of these two thrombolytic agents for the treatment of patients within 4.5 hours of onset of AIS in routine clinical practice in China.METHODSA pre-planned, prospective, nationwide, multicentre, real-world registry of consecutive patients with AIS (age ≥18 years) who received r-tPA or UK within 4.5 hours of symptom onset according to local decision-making and guideline recommendations during 2017-2019. The primary effectiveness outcome was the proportion of patients with an excellent functional outcome (defined by modified Rankin scale scores 0 to 1) at 90 days. The key safety endpoint was symptomatic intracranial haemorrhage according to standard definitions. Multivariable logistic regression was used for comparative analysis, with adjustment according to propensity scores to ensure balance in baseline characteristics.RESULTSOverall, 4130 patients with AIS were registered but 320 had incomplete or missing data, leaving 3810 with available data for analysis of whom 2666 received r-tPA (median dose 0.88 (IQR 0.78-0.90) mg/kg) and 1144 received UK (1.71 (1.43-2.00)×10 international unit per kilogram). There were several significant intergroup differences in patient characteristics: r-tPA patients were more educated, had less history of stroke, lower systolic blood pressure, greater neurological impairment and shorter treatment times from symptom onset than UK patients. However, in adjusted analysis, the frequency of excellent outcome (OR 1.18, 95\% CI 1.00 to 1.40, p=0.052) and symptomatic intracranial haemorrhage (OR 0.70, 95\% CI 0.33 to 1.47, p=0.344) were similar between groups.CONCLUSIONSUK may be as effective and carry a similar safety profile as r-tPA in treating mild to moderate AIS within guidelines in China. REGISTRATION: http://www.clinicaltrials.gov. unique identifier: NCT02854592.",

keywords = "stroke, thrombolysis",

author = "Xinhong Wang and Xiaoqiu Li and Yuming Xu and Runhui Li and Qingcheng Yang and Yong Zhao and Fengyun Wang and Baoying Sheng and Runqing Wang and Shaoyuan Chen and Lihua Wang and Liying Shen and Xiaowen Hou and Yu Cui and Duolao Wang and Bin Peng and Anderson, \{Craig S.\} and Huisheng Chen",

year = "2021",

month = dec,

day = "1",

doi = "10.1136/svn-2020-000640",

language = "English",

volume = "6",

pages = "603--609",

journal = "Stroke and Vascular Neurology",

issn = "2059-8688",

publisher = "BMJ Publishing Group",

number = "4",

}

Wang, X, Li, X, Xu, Y, Li, R, Yang, Q, Zhao, Y, Wang, F, Sheng, B, Wang, R, Chen, S, Wang, L, Shen, L, Hou, X, Cui, Y, Wang, D, Peng, B, Anderson, CS & Chen, H 2021, 'Effectiveness of intravenous r-tPA versus UK for acute ischaemic stroke: a nationwide prospective Chinese registry study', Stroke and Vascular Neurology, vol. 6, no. 4, pp. 603-609. https://doi.org/10.1136/svn-2020-000640

TY - JOUR

T1 - Effectiveness of intravenous r-tPA versus UK for acute ischaemic stroke: a nationwide prospective Chinese registry study

AU - Wang, Xinhong

AU - Li, Xiaoqiu

AU - Xu, Yuming

AU - Li, Runhui

AU - Yang, Qingcheng

AU - Zhao, Yong

AU - Wang, Fengyun

AU - Sheng, Baoying

AU - Wang, Runqing

AU - Chen, Shaoyuan

AU - Wang, Lihua

AU - Shen, Liying

AU - Hou, Xiaowen

AU - Cui, Yu

AU - Wang, Duolao

AU - Peng, Bin

AU - Anderson, Craig S.

AU - Chen, Huisheng

PY - 2021/12/1

Y1 - 2021/12/1

N2 - BACKGROUNDIntravenous recombinant tissue plasminogen activator (r-tPA) and urokinase (UK) are both recommended for the treatment of acute ischaemic stroke (AIS) in China, but with few comparative outcome data being available. We aimed to compare the outcomes of these two thrombolytic agents for the treatment of patients within 4.5 hours of onset of AIS in routine clinical practice in China.METHODSA pre-planned, prospective, nationwide, multicentre, real-world registry of consecutive patients with AIS (age ≥18 years) who received r-tPA or UK within 4.5 hours of symptom onset according to local decision-making and guideline recommendations during 2017-2019. The primary effectiveness outcome was the proportion of patients with an excellent functional outcome (defined by modified Rankin scale scores 0 to 1) at 90 days. The key safety endpoint was symptomatic intracranial haemorrhage according to standard definitions. Multivariable logistic regression was used for comparative analysis, with adjustment according to propensity scores to ensure balance in baseline characteristics.RESULTSOverall, 4130 patients with AIS were registered but 320 had incomplete or missing data, leaving 3810 with available data for analysis of whom 2666 received r-tPA (median dose 0.88 (IQR 0.78-0.90) mg/kg) and 1144 received UK (1.71 (1.43-2.00)×10 international unit per kilogram). There were several significant intergroup differences in patient characteristics: r-tPA patients were more educated, had less history of stroke, lower systolic blood pressure, greater neurological impairment and shorter treatment times from symptom onset than UK patients. However, in adjusted analysis, the frequency of excellent outcome (OR 1.18, 95% CI 1.00 to 1.40, p=0.052) and symptomatic intracranial haemorrhage (OR 0.70, 95% CI 0.33 to 1.47, p=0.344) were similar between groups.CONCLUSIONSUK may be as effective and carry a similar safety profile as r-tPA in treating mild to moderate AIS within guidelines in China. REGISTRATION: http://www.clinicaltrials.gov. unique identifier: NCT02854592.

AB - BACKGROUNDIntravenous recombinant tissue plasminogen activator (r-tPA) and urokinase (UK) are both recommended for the treatment of acute ischaemic stroke (AIS) in China, but with few comparative outcome data being available. We aimed to compare the outcomes of these two thrombolytic agents for the treatment of patients within 4.5 hours of onset of AIS in routine clinical practice in China.METHODSA pre-planned, prospective, nationwide, multicentre, real-world registry of consecutive patients with AIS (age ≥18 years) who received r-tPA or UK within 4.5 hours of symptom onset according to local decision-making and guideline recommendations during 2017-2019. The primary effectiveness outcome was the proportion of patients with an excellent functional outcome (defined by modified Rankin scale scores 0 to 1) at 90 days. The key safety endpoint was symptomatic intracranial haemorrhage according to standard definitions. Multivariable logistic regression was used for comparative analysis, with adjustment according to propensity scores to ensure balance in baseline characteristics.RESULTSOverall, 4130 patients with AIS were registered but 320 had incomplete or missing data, leaving 3810 with available data for analysis of whom 2666 received r-tPA (median dose 0.88 (IQR 0.78-0.90) mg/kg) and 1144 received UK (1.71 (1.43-2.00)×10 international unit per kilogram). There were several significant intergroup differences in patient characteristics: r-tPA patients were more educated, had less history of stroke, lower systolic blood pressure, greater neurological impairment and shorter treatment times from symptom onset than UK patients. However, in adjusted analysis, the frequency of excellent outcome (OR 1.18, 95% CI 1.00 to 1.40, p=0.052) and symptomatic intracranial haemorrhage (OR 0.70, 95% CI 0.33 to 1.47, p=0.344) were similar between groups.CONCLUSIONSUK may be as effective and carry a similar safety profile as r-tPA in treating mild to moderate AIS within guidelines in China. REGISTRATION: http://www.clinicaltrials.gov. unique identifier: NCT02854592.

KW - stroke

KW - thrombolysis

U2 - 10.1136/svn-2020-000640

DO - 10.1136/svn-2020-000640

M3 - Article

SN - 2059-8688

VL - 6

SP - 603

EP - 609

JO - Stroke and Vascular Neurology

JF - Stroke and Vascular Neurology

IS - 4

ER -

Effectiveness of intravenous r-tPA versus UK for acute ischaemic stroke: a nationwide prospective Chinese registry study

Abstract

Keywords

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