Tirofiban added to aspirin did not reduce deterioration in branch atheromatous stroke

Design

Multicentre, double-blind, randomised, placebo-controlled trial (STRATEGY), 90-day follow-up

Population

970 adults with MRI-confirmed branch atheromatous disease stroke within 48 hours, 38 hospitals in China

Primary outcome

Early neurological deterioration within 7 days or new stroke within 90 days

Effect

17.1% tirofiban vs 19.6% placebo; HR 0.88 (95% CI 0.65 to 1.19), P = 0.39

STRATEGY randomised 970 patients with acute ischaemic stroke from branch atheromatous disease, confirmed on MRI within 48 hours of onset, at 38 Chinese hospitals. All received aspirin (300 mg loading, then 100 mg daily to day 90) and were assigned to intravenous tirofiban for 24 hours or placebo. The design was double-blind and placebo-controlled.

The primary endpoint, early neurological deterioration within 7 days or new stroke within 90 days, occurred in 17.1% on tirofiban and 19.6% on placebo (hazard ratio 0.88, 95% CI 0.65 to 1.19, P = 0.39). Moderate or severe bleeding was reported in 1 of 486 on tirofiban and none on placebo.

The trial shows no significant benefit from adding tirofiban to aspirin in this population, with a confidence interval that still allows a modest effect in either direction. It does not address other antiplatelet combinations or patients treated in the first hours after onset.

• Do not add intravenous tirofiban to aspirin routinely in branch atheromatous stroke on this evidence
• Monitor closely for early neurological deterioration in the first week regardless of treatment
• Bleeding events were rare in the trial, but the study was not designed to prove safety
• Established antiplatelet options and guidelines for acute stroke have not changed

Why it matters

Branch atheromatous disease is a recognised cause of early worsening, and intensifying antiplatelet therapy was a plausible fix that this trial did not support.

Don't overread it

A negative result for one regimen does not rule out benefit from other combinations or different timing.

The statistics, in plain English

A hazard ratio of 0.88 with an interval from 0.65 to 1.19 means the result is compatible with anything from a 35% reduction to a 19% increase in events, so the trial could not show benefit. A non-significant result in a trial of this size excludes a large benefit but not a small one.

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