Dataset Information

Thrombolysis for acute ischemic stroke: results of the Canadian Alteplase for Stroke Effectiveness Study.

ABSTRACT:

Background

Thrombolysis for acute ischemic stroke has remained controversial. The Canadian Alteplase for Stroke Effectiveness Study, a national prospective cohort study, was conducted to assess the effectiveness of alteplase therapy for ischemic stroke in actual practice.

Methods

The study was mandated by the federal government as a condition of licensure of alteplase for the treatment of stroke in Canada. A registry was established to collect data over 2.5 years for stroke patients receiving such treatment from Feb. 17, 1999, through June 30, 2001. All centres capable of administering thrombolysis therapy according to Canadian guidelines were eligible to submit patient data to the registry. Data collection was prospective, and follow-up was completed at 90 days after stroke. Copies of head CT scans obtained at baseline and at 24-48 hours after the start of treatment were submitted to a central panel for review.

Results

A total of 1135 patients were enrolled at 60 centres in all major hospitals across Canada. The registry collected data for an estimated 84% of all treated ischemic stroke patients in the country. An excellent clinical outcome was observed in 37% of the patients. Symptomatic intracranial hemorrhage occurred in only 4.6% of the patients (95% confidence interval [CI] 3.4%-6.0%); however, 75% of these patients died in hospital. An additional 1.3% (95% CI 0.7%-2.2%) of patients had hemiorolingual angioedema.

Conclusions

The outcomes of stroke patients undergoing thrombolysis in Canada are commensurate with the results of clinical trials. The rate of symptomatic intracranial hemorrhage was low. Stroke thrombolysis is a safe and effective therapy in actual practice.

SUBMITTER: Hill MD

PROVIDER: S-EPMC557101 | biostudies-literature | 2005 May

REPOSITORIES: biostudies-literature

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Publications

Thrombolysis for acute ischemic stroke: results of the Canadian Alteplase for Stroke Effectiveness Study.

Hill Michael D MD Buchan Alastair M AM

CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne 20050501 10

<h4>Background</h4>Thrombolysis for acute ischemic stroke has remained controversial. The Canadian Alteplase for Stroke Effectiveness Study, a national prospective cohort study, was conducted to assess the effectiveness of alteplase therapy for ischemic stroke in actual practice.<h4>Methods</h4>The study was mandated by the federal government as a condition of licensure of alteplase for the treatment of stroke in Canada. A registry was established to collect data over 2.5 years for stroke patien ...[more]

PMID: 15883405

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Project description:Tenecteplase is a fibrinolytic drug with higher fibrin specificity and longer half-life than the standard stroke thrombolytic, alteplase, permitting the convenience of single bolus administration. Tenecteplase, at 0.5 mg/kg, has regulatory approval to treat ST-segment-elevation myocardial infarction, for which it has equivalent 30-day mortality and fewer systemic hemorrhages. Investigated as a thrombolytic for ischemic stroke over the past 15 years, tenecteplase is currently being studied in several phase 3 trials. Based on a systematic literature search, we provide a qualitative synthesis of published stroke clinical trials of tenecteplase that (1) performed randomized comparisons with alteplase, (2) compared different doses of tenecteplase, or (3) provided unique quantitative meta-analyses. Four phase 2 and one phase 3 study performed randomized comparisons with alteplase. These and other phase 2 studies compared different tenecteplase doses and effects on early outcomes of recanalization, reperfusion, and substantial neurological improvement, as well as symptomatic intracranial hemorrhage and 3-month disability on the modified Rankin Scale. Although no single trial prospectively demonstrated superiority or noninferiority of tenecteplase on clinical outcome, meta-analyses of these trials (1585 patients randomized) point to tenecteplase superiority in recanalization of large vessel occlusions and noninferiority in disability-free 3-month outcome, without increases in symptomatic intracranial hemorrhage or mortality. Doses of 0.25 and 0.4 mg/kg have been tested, but no advantage of the higher dose has been suggested by the results. Current clinical practice guidelines for stroke include intravenous tenecteplase at either dose as a second-tier option, with the 0.25 mg/kg dose recommended for large vessel occlusions, based on a phase 2 trial that demonstrated superior recanalization and improved 3-month outcome relative to alteplase. Ongoing randomized phase 3 trials may better define the comparative risks and benefits of tenecteplase and alteplase for stroke thrombolysis and answer questions of tenecteplase efficacy in the >4.5-hour time window, in wake-up stroke, and in combination with endovascular thrombectomy.

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Dataset Information

Thrombolysis for acute ischemic stroke: results of the Canadian Alteplase for Stroke Effectiveness Study.

Background

Methods

Results

Conclusions

Publications

Thrombolysis for acute ischemic stroke: results of the Canadian Alteplase for Stroke Effectiveness Study.

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