SPACE 2 carotid study is halted

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Vascular News has learnt that the SPACE 2 (Stent-protected angioplasty in asymptomatic carotid stenosis vs. endarterectomy) study has been halted due to persistently low recruitment rates. This decision to halt SPACE 2 comes just over a year after changes were made to the study protocol in an attempt to rectify the same problem.

The aim of the SPACE 2 study was to assess if best medical therapy plus intervention (carotid endarterectomy or carotid stenting) in patients with asymptomatic carotid stenosis is superior to best medical therapy alone. The principal coordinating investigator was Werner Hacke (professor and chairman of the Department of Neurology, University of Heidelberg, Germany), with co-principal investigators Hans-Henning Eckstein (director of the Department of Vascular and Endovascular Surgery, Technical University of Munich, Germany) and Olav Jansen (director of the Department of Radiology and Neuroradiology, University of Kiel, Germany).

When the study was initiated in 2009, the recruitment target was 3,600 patients, but in 2012, with recruitment only at 400 patients, it was decided to change the SPACE 2 study protocol from a three-arm study to a two-arm study.he aim of the SPACE 2 study was to assess if best medical therapy plus intervention (carotid endarterectomy or carotid stenting) in patients with asymptomatic carotid stenosis is superior to best medical therapy alone. The principal coordinating investigator was Werner Hacke (professor and chairman of the Department of Neurology, University of Heidelberg, Germany), with co-principal investigators Hans-Henning Eckstein (director of the Department of Vascular and Endovascular Surgery, Technical University of Munich, Germany) and Olav Jansen (director of the Department of Radiology and Neuroradiology, University of Kiel, Germany).

In a previous interview with Vascular News, study investigator Gustav Fraedrich (director of the University Clinic of Vascular Surgery, University Hospital Innsbruck, Innsbruck, Austria) explained that, “Initially, SPACE 2 was a designed as a three-arm study in which patients would be randomised to receive best medical therapy alone, best medical therapy plus carotid endarterectomy, or best medical therapy plus carotid stenting.” The change in protocol meant that patients were randomised to receive best medical therapy alone or best medical therapy plus intervention (carotid endarterectomy or carotid stenting).

Now, over a year after the protocol change, recruitment is still well below what was expected and the decision has been made to halt recruitment altogether.

News has reached Vascular News however, that the steering committee has agreed to analyse the available data from the more than 500 patients enrolled, the results of which will be presented this year.

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