Argatroban with antiplatelets did not improve stroke recovery overall

Design

Systematic review and meta-analysis of randomised and observational studies

Population

17 studies, about 70,000 patients with acute ischaemic stroke

Primary outcome

Modified Rankin score 0-2 and composite haemorrhage

Effect

mRS 0-2 RR 1.03 (95% CI 0.97-1.10); early deterioration RR 0.48 (0.30-0.75)

A meta-analysis in the European Journal of Clinical Pharmacology pooled 17 studies, randomised and observational, comparing argatroban plus antiplatelet therapy with antiplatelets alone in acute ischaemic stroke.

The chance of a modified Rankin score of 0 to 2 at follow-up did not differ (RR 1.03, 95% CI 0.97 to 1.10), nor did composite bleeding overall. Argatroban was associated with less early neurological deterioration (RR 0.48) and slightly more patients reaching a Rankin score of 0 to 1. Restricted to randomised trials, though, argatroban increased both composite and intracranial haemorrhage.

Argatroban is used in some Asian centres, including in India, for progressing stroke. This analysis gives little support for routine use: the main functional outcome did not move, and the more rigorous trials show a bleeding cost.

Certainty ranged from very low to high, and mixing observational data with trials weakens the overall estimate.

• Do not add argatroban routinely to antiplatelet therapy in acute ischaemic stroke
• If argatroban is considered for progressing stroke, weigh the bleeding seen in randomised trials
• Keep standard antiplatelet regimens, including short-course dual therapy where indicated
• Monitor neurological status closely in the first 72 hours whatever the regimen

Why it matters

It questions a practice used for deteriorating stroke in parts of Asia.

Don't overread it

The reduction in early deterioration came largely from mixed study designs and is a secondary outcome.

The statistics, in plain English

The main outcome's confidence interval (0.97 to 1.10) includes no effect. The bleeding signal appeared only in the randomised-trial subgroup, which is the more reliable evidence even though subgroup results are usually treated with caution.

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