medwireNews: THRACE study findings confirm the benefits of rapid mechanical thrombectomy after intravenous alteplase in a broad range of patients with acute ischaemic stroke.
The trial (THrombectomie des Artères CErebrales) conducted in 26 centres in France showed that patients receiving the combined treatment were a significant 55% more likely to be functionally independent at 3 months, with no increased risk of death, than those treated with alteplase alone.
These findings confirm those of previous studies, but with two key differences, the researchers led by Serge Bracard (University Hospital of Nancy, France) explain.
For THRACE, patient selection was wider with no imaging-based criteria used beyond computed tomography or magnetic resonance angiography to confirm arterial occlusion and exclude haemorrhage.
“Thus, results of the THRACE trial showed a benefit in functional outcome for the combined approach in a broad population of patients similar to that encountered in routine clinical practice”, says the team.
Also, randomisation was rapid, occurring within 20 minutes of intravenous thrombolysis initiation, so fast responders to intravenous alteplase were not excluded.
As a consequence of this, around a third of patients assigned to the thrombectomy group did not undergo the procedure because they already showed clinical improvement or partial or complete recanalisation.
Commentators Olvert Berkhemer and Diederik Dippel, both from Erasmus University Medical Center in Rotterdam, the Netherlands, say that these design differences mean the “results could provide crucial information for clinical practice.”
In all, 404 patients aged 18–80 years with moderate-to-severe stroke (US National Institutes of Health Stroke Scale [NIHSS] 10–25) caused by occlusion of a proximal cerebral artery who could be treated within 4 hours of symptom onset participated in the trial.
Of these, 106 (53%) of 202 patients receiving intravenous thrombolysis (alteplase 0.9 mg/kg over 60 minutes) plus thrombectomy within 4 and 5 hours of symptom onset, respectively, achieved functional independence at 3 months. This compared with 85 (42%) of 202 patients receiving thrombolysis alone.
As reported in The Lancet Neurology, mechanical thrombectomy did not increase the risk of mortality or symptomatic intracranial haemorrhage. Rates of the former were similar at 13% with alteplase and 12% with intravenous thrombolysis plus thrombectomy, while symptomatic intracranial haemorrhage occurred in 2% of patients in each group.
Common adverse events associated with thrombectomy were vasospasm and embolisation in a new territory, but overall event rates did not differ significantly between the two treatment groups.
Subanalyses also confirmed no significant thrombectomy effect modification with age, gender, NIHSS score, occlusion location, diabetes, hypertension or hypercholesterolaemia, leading the team to conclude that the procedure “should be considered for a wide range of patients with large-vessel occlusions of the anterior circulation”.
Indeed, this was echoed by Berkhemer and Dippel, who believe: “Now is the time to implement this treatment to save lives and prevent disability caused by ischaemic stroke.”
By Lucy Piper
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