OBJECTIVE: Randomized comparison of endovascular repair (EVAR) with open repair (OR) in patients with a ruptured abdominal aortic aneurysm (RAAA). BACKGROUND: Despite advances in operative technique and perioperative management RAAA remains fraught with a high rate of death and complications. Outcome may improve with a minimally invasive surgical technique: EVAR. METHODS:All patients with a RAAA in the larger Amsterdam area were identified. Logistics for RAAA patients was changed with centralization of care in 3 trial centers. Patients both fit for EVAR and for OR were randomized to either of the treatments. Nonrandomized patients were followed in a prospective cohort. Primary endpoint of the study was the composite of death and severe complications at 30 days. RESULTS:Between April 2004 and February 2011, we identified 520 patients with a RAAA of which 116 could be randomized. The primary endpoint rate for EVAR was 42% and for OR was 47% [absolute risk reduction (ARR) = 5.4%; 95% confidence interval (CI): -13% to +23%]. The 30-day mortality was 21% in patients assigned to EVAR compared with 25% for OR (ARR = 4.4% 95% CI: -11% to +20%). The mortality of all surgically treated patients in the nonrandomized cohort was 30% (95% CI: 26%-35%) and 26% (95% CI: 20% to 32%) in patients with unfavorable anatomy for EVAR, treated by OR at trial centers. CONCLUSIONS: This trial did not show a significant difference in combined death and severe complications between EVAR and OR. Mortality for OR both in randomized patients and in cohort patients was lower than anticipated, which may be explained by optimization of logistics, preoperative CT imaging, and centralization of care in centers of expertise.
RCT Entities:
OBJECTIVE: Randomized comparison of endovascular repair (EVAR) with open repair (OR) in patients with a ruptured abdominal aortic aneurysm (RAAA). BACKGROUND: Despite advances in operative technique and perioperative management RAAA remains fraught with a high rate of death and complications. Outcome may improve with a minimally invasive surgical technique: EVAR. METHODS: All patients with a RAAA in the larger Amsterdam area were identified. Logistics for RAAA patients was changed with centralization of care in 3 trial centers. Patients both fit for EVAR and for OR were randomized to either of the treatments. Nonrandomized patients were followed in a prospective cohort. Primary endpoint of the study was the composite of death and severe complications at 30 days. RESULTS: Between April 2004 and February 2011, we identified 520 patients with a RAAA of which 116 could be randomized. The primary endpoint rate for EVAR was 42% and for OR was 47% [absolute risk reduction (ARR) = 5.4%; 95% confidence interval (CI): -13% to +23%]. The 30-day mortality was 21% in patients assigned to EVAR compared with 25% for OR (ARR = 4.4% 95% CI: -11% to +20%). The mortality of all surgically treated patients in the nonrandomized cohort was 30% (95% CI: 26%-35%) and 26% (95% CI: 20% to 32%) in patients with unfavorable anatomy for EVAR, treated by OR at trial centers. CONCLUSIONS: This trial did not show a significant difference in combined death and severe complications between EVAR and OR. Mortality for OR both in randomized patients and in cohort patients was lower than anticipated, which may be explained by optimization of logistics, preoperative CT imaging, and centralization of care in centers of expertise.
Authors: Andreas S Peters; Maani Hakimi; Philipp Erhart; Michael Keese; Thomas Schmitz-Rixen; Markus Wortmann; Moritz S Bischoff; Dittmar Böckler Journal: Langenbecks Arch Surg Date: 2016-04-07 Impact factor: 3.445
Authors: Klaas H J Ultee; Sara L Zettervall; Peter A Soden; Jeremy Darling; Daniel J Bertges; Hence J M Verhagen; Marc L Schermerhorn Journal: J Vasc Surg Date: 2016-07-27 Impact factor: 4.268
Authors: Gino Gialdini; Neal S Parikh; Abhinaba Chatterjee; Michael P Lerario; Hooman Kamel; Darren B Schneider; Babak B Navi; Santosh B Murthy; Costantino Iadecola; Alexander E Merkler Journal: Stroke Date: 2017-06-27 Impact factor: 7.914