Alteplase demonstrated as safe, effective stroke treatment


Alteplase demonstrated to be safe and effacious for use in treatment of stroke within 3 hours of onset, according to a large multicenter, observational study.

Key Points

The purpose of the SITS-MOST study was to assess the safety profile of alteplase in routine clinical practice when used within 3 hours of the onset of stroke symptoms. The study consisted of a cohort of patients from the SITS-International Stroke Thrombolysis Register (SITS-ISTR). The register serves to continuously monitor the use of thrombolytic therapy for treating ischemic stroke and includes information from European Union states, Norway, and Iceland. Inclusion requirements for centers involved in SITS-ISTR were: national recognition as a stroke unit, routine monitoring of patients during and after thrombolytic therapy, and the employment of practitioners experienced in the treatment of stroke patients.

A total of 6,483 adult patients presenting within 3 hours of stroke onset were enrolled in SITS-MOST from December 25, 2005, to April 30, 2006. Patients with contraindications to thrombolytic therapy, those presenting >3 hours after stroke onset, and patients with a severe stroke as evidenced by either baseline CT imaging or by a baseline National Institutes of Health stroke scale (NIHSS) score of ≥25 were excluded. This study compared the incidence of symptomatic intra-cerebral hemorrhage (SICH) and death within 3 months to a pooled historical treatment group from prior randomized and controlled trials (NINDS, ECASS I-II, and ATLANTIS).

The authors stated that: "When used in routine practice, [alteplase] has a safety profile at least as good as that seen in randomized controlled trials and is an effective treatment when used within 3 hours of stroke onset." Even stroke centers with little previous experience of thrombolytic therapy for acute stroke showed beneficial outcomes, they stated.

In an accompanying editorial, Gregory Albers, MD, et al, stated that: "The laudable results in this mammoth study confirm the safety of intravenous alteplase," even though the inclusion criteria for SITS-MOST were restrictive (excluding patients aged >80 years and those with higher NIHSS scores). "Appropriate selection of patients is essential, not only to avert adverse outcomes but also to avoid depriving eligible patients from thrombolytic therapy," they stated.

It is estimated that >700,000 strokes occur annually in the United States, resulting in >160,000 deaths. Early recognition of stroke symptoms and early thrombolysis are paramount in preventing death and functional impairment. Lifestyle modification, including smoking cessation; control of hypertension, diabetes, dyslipidemia and atrial fibrillation; and utilizing appropriate pharmacologic agents, can significantly help prevent incident and recurrent stroke.


Wahlgren N, Dávalos, Ford GA, Grond M, et al; for the SITS-MOST Investigators. Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): An observational study. Lancet. 2007;369:275–282.

Albers GW, Olivot J-M. Intravenous alteplase for ischaemic stroke [editorial]. Lancet. 2007;369:249–250.

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