EVAR for ruptured AAAs -- Do we need randomized controlled trials?
Endovascular abdominal aortic aneurysm (EVAR) repair has an established role in elective management of abdominal aortic aneurysms (AAA). The application of EVAR to ruptured AAAs (rAAA) is evolving and developing a strong evidence base in selected patients. Although EVAR has been utilized to manage rAAA for greater than ten years, to-date no randomized study has been completed to confirm superiority over traditional open surgical repair. Randomized controlled trials (RCTs) allow unbiased objective comparison of two techniques and are the most powerful scientific instrument available for clinical assessment; they form the corner-stone of surgical evidence-based practice. In light of current understanding, the role of a RCT to compare emergency EVAR (eEVAR) with open surgery has been challenged. Whether an RCT is necessary, is ethical or can mimic routine clinical practice are questions open to debate. This review presents the current best evidence for eEVAR, the arguments for and against an RCT, and details current and prospective clinical trials designed to identify the optimal management of rAAA.
NORDON
I M
IM
St George's Vascular Institute, St James' Wing, St George's Hospital, London, UK. inordon@sgul.ac.uk
HINCHLIFFE
R J D
RJ
HOLT
P J
PJ
MORGAN
R
R
LOFTUS
I M
IM
THOMPSON
M M
MM
D017544:Aortic Aneurysm, Abdominal / Q000401:mortality / Q000601:surgery*; D001019:Aortic Rupture / Q000401:mortality / Q000601:surgery*; D019985:Benchmarking; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000401:mortality; D019317:Evidence-Based Medicine; D006801:Humans; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D016896:Treatment Outcome