SWIFT-DIRECT

SWIFT-DIRECT is a multicenter, randomized controlled clinical trial to assess whether thrombectomy alone is non-inferior to intravenous alteplase plus thrombectomy for treating acute stroke patients with large vessel occlusions.

SWIFT-DIRECT was conducted in 42 centers in Europe and Canada and included adult patients with severe acute ischemic strokes who could be randomized within 4 hours and 15 minutes after stroke onset. The primary outcome was functional independence at 90 days, further outcomes included degree of disability, mortality, reperfusion rate, quality of life and safety. The primary outcome was assessed for non-inferiority as omitting intravenous alteplase would be advantageous regarding the risk of intracerebral hemorrhages and systemic bleeding.

Non-inferiority could not be demonstrated and successful reperfusion was less common in patients assigned to thrombectomy alone. The authors conclude that the trial does not support omitting intravenous alteplase before thrombectomy in the eligible patient population.

The results were published in the Lancet.

Main publication & registry entry

Services

Methodology

CTU Bern was involved in the planning phase of the trial and contributed to the trial design and protocol.

Data Management

CTU Bern was responsible for setting up the study database.

Monitoring

Monitoring was performed by a CTU Monitor visiting participating sites.

Central Data Monitoring

CTU Bern monitored database entries during the course of the study and ensured data quality.

Statistics

All main analyses were done at CTU Bern.