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Recombinant tissue plasminogen activator for acute ischaemic stroke: an updated systematic review and meta-analysis
The Lancet, 07/11/2012
Evidence Based Medicine
Clinical Article
Wardlaw JM et al. – The evidence indicates that intravenous rt–PA increased the proportion of patients who were alive with favourable outcome and alive and independent at final follow–up. The data strengthen previous evidence to treat patients as early as possible after acute ischaemic stroke, although some patients might benefit up to 6 h after stroke.
Methods- The authors searched for randomised trials of intravenous rt–PA versus control given within 6 h of onset of acute ischaemic stroke up to March 30, 2012.
- The authors estimated summary odds ratios (ORs) and 95% CI in the primary analysis for prespecified outcomes within 7 days and at the final follow–up of all patients treated up to 6 h after stroke.
- In up to 12 trials (7012 patients), rt–PA given within 6 h of stroke significantly increased the odds of being alive and independent (modified Rankin Scale, mRS 0—2) at final follow–up (1611/3483 [46.3%] vs 1434/3404 [42.1%], OR 1.17, 95% CI 1.06—1.29; p=0.001), absolute increase of 42 (19—66) per 1000 people treated, and favourable outcome (mRS 0—1) absolute increase of 55 (95% CI 33—77) per 1000.
- The benefit of rt–PA was greatest in patients treated within 3 h (mRS 0—2, 365/896 [40.7%] vs 280/883 [31.7%], 1.53, 1.26—1.86, p<0.0001), absolute benefit of 90 (46—135) per 1000 people treated, and mRS 0—1 (283/896 [31.6%] vs 202/883 [22.9%], 1.61, 1.30—1.90; p<0.0001), absolute benefit 87 (46—128) per 1000 treated.
- Numbers of deaths within 7 days were increased (250/2807 [8.9%] vs 174/2728 [6.4%], 1.44, 1.18—1.76; p=0.0003), but by final follow–up the excess was no longer significant (679/3548 [19.1%] vs 640/3464 [18.5%], 1.06, 0.94—1.20; p=0.33).
- Symptomatic intracranial haemorrhage (272/3548 [7.7%] vs 63/3463 [1.8%], 3.72, 2.98—4.64; p<0.0001) accounted for most of the early excess deaths.
- Patients older than 80 years achieved similar benefit to those aged 80 years or younger, particularly when treated early.