title: Open versus endovascular stent graft repair of abdominal aortic aneurysms: do we need more randomized clinical trials?
abstract: We performed an analysis to assess the need for conducting additional randomized controlled trials (RCTs) comparing open and endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA). Trial sequential analysis (TSA) is a statistical methodology that can calculate the required information size of a meta-analysis and assess the risk of random errors similar to interim analysis in a single optimally powered trial. It helps to decide whether we have obtained sufficient evidence or whether further RCTs are required. For short-term mortality reintervention rates, TSA showed firm evidence that there would be no extra benefit in conducting more RCTs to detect the effectiveness of EVAR versus open repair. For long-term mortality, TSA revealed either inconclusive evidence to support or refute endovascular or open repair; so, further RCTs should be performed to investigate long-term, all-cause mortality after AAA repair.
authors.affiliation: Department of Internal Medicine, University of Missouri, Columbia, MO, USA Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark FirwanaB@health.missouri.edu.
authors.forename: Belal
authors.initials: B
authors.lastname: Firwana
authors.affiliation: Department of Family Medicine, King Saud Bin Abdulaziz University for Health Sciences, National and Gulf Center for Evidence-Based Health Practice, Riyadh, Saudi Arabia.
authors.forename: Mazen
authors.initials: M
authors.lastname: Ferwana
authors.affiliation: Department of Internal Medicine, University of Missouri, Columbia, MO, USA.
authors.forename: Rim
authors.initials: R
authors.lastname: Hasan
authors.affiliation: Division of Cardiology, University of Missouri, Columbia, MO, USA.
authors.forename: Martin A
authors.initials: MA
authors.lastname: Alpert
authors.affiliation: Division of Vascular Surgery, Cardiovascular Institute, Mount Sinai Medical Center, Mount Sinai School of Medicine, New York, NY, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Faries
authors.affiliation: Division of Cardiology, Cardiovascular Institute, Mount Sinai Medical Center, Mount Sinai School of Medicine, New York, NY, USA.
authors.forename: George
authors.initials: G
authors.lastname: Dangas
authors.affiliation: Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000401:mortality* / Q000628:therapy; D001019:Aortic Rupture / Q000401:mortality* / Q000628:therapy; D006801:Humans; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012306:Risk; D013223:Statistics as Topic / Q000379:methods; D015607:Stents; D016896:Treatment Outcome
keywords: abdominal aortic aneurysm; aortic aneurysm; endovascular procedure; general surgery; randomized clinical trials; trial sequential analysis; vascular disease; vascular surgical procedures