Key result
IMPROVE trial evaluates endovascular-first strategy versus open repair for ruptured abdominal aortic aneurysm survival.
Why the study?
Systematic reviews suggested a survival advantage for ruptured AAA patients managed by endovascular repair, but these were based on single centre experiences of selected patients.
Does an endovascular-first strategy improve 30-day survival compared to standard open repair in patients with ruptured abdominal aortic aneurysm?
RCT (n=600)
Yes
Does an endovascular-first strategy improve 30-day survival compared to standard open repair in patients with ruptured abdominal aortic aneurysm?
The IMPROVE trial is designed to determine if an endovascular-first strategy improves 30-day survival compared to standard open repair in patients with ruptured abdominal aortic aneurysms.
Will test endovascular-first versus open repair in ruptured AAA; provides first major RCT to guide future guidelines.
BACKGROUND: Systematic reviews have suggested a survival advantage for patients with ruptured abdominal aortic aneurysm (AAA), who are managed by endovascular repair. These reviews are based on single centre experiences of selected patients. OBJECTIVE: To determine whether a policy of endovascular repair improves the survival of all patients with ruptured AAA. METHODS: A randomized controlled trial, IMPROVE (ISRCTN 48334791) will randomize patients with a clinical diagnosis of rAAA, made in hospital, either to immediate CT scan and endovascular repair whenever anatomically suitable (endovascular first), or to open repair, with CT scan being optional (normal care), The trial is set on a background of guidelines for emergency care, CT scanning and anaesthesia, which incorporate the protocol of permissive hypotension. Recruitment started in October 2009 and 600 patients are required to show a 14% survival benefit at 30 days (primary outcome) for the endovascular first policy. Recruitment will be from the UK and Europe. Secondary outcomes include 24h, in-hospital and 1 year survival, complications, major morbidities, costs and quality of life. DISCUSSION: This is a "real life" trial that will answer the fundamental relevant clinical dilemma, namely, do patients who present with ruptured AAA derive benefit from treatment in a system, which offers a preferential strategy of endovascular repair? The trial addresses whether the anticipated reduced mortality and morbidity associated with endovascular repair is offset by the relatively greater ease of access and speed to conventional surgery. This issue is pivotal to future patient care and provision of services.
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Powell et al. (2009) conducted an RCT in ruptured abdominal aortic aneurysm (rAAA) (n=600). Immediate CT scan and endovascular repair (endovascular first) vs. Open repair with optional CT scan (normal care) was evaluated on 30-day survival. The IMPROVE trial is designed to randomize 600 patients with ruptured abdominal aortic aneurysm to an endovascular-first strategy versus open repair to evaluate 30-day survival.
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