The PIVOTAL study: A randomized comparison of endovascular repair versus surveillance in patients with smaller abdominal aortic aneurysms

Abstract

The diameter of an abdominal aortic aneurysm (AAA) is the single most important factor in deciding whether to repair an aneurysm or to monitor it conservatively. Open surgical repair does not appear to be beneficial until the diameter of the aneurysm is >5.5 cm. Prospective clinical trials, however, confirmed a lower risk of operative mortality after endovascular aneurysm repair (EVAR) than after open surgical repair. Further, retrospective analyses of EVAR databases suggested that EVAR outcome is directly related to aneurysm size and is better for smaller aneurysms than for larger aneurysms. Noting similar results with open surgical management vs surveillance in patients with smaller AAA, lower morbidity rates with EVAR vs open repair, and the favorable results with EVAR in smaller aneurysms, a clinical trial testing the hypothesis that EVAR is beneficial in patients with small AAA appeared warranted. To answer this question, the 70-site Positive Impact of endoVascular Options for Treating Aneurysm earLy (PIVOTAL) was begun. PIVOTAL has an enrollment goal of up to 1025 patients with a 4- to 5-cm AAA, randomly assigning patients to EVAR or surveillance. The primary end points of PIVOTAL are aneurysm rupture and AAA-related death at up to 36 months after randomization. When complete, the results of PIVOTAL should provide objective evidence to guide the use of EVAR for small AAAs.

Significant sac retraction after endovascular aneurysm repair is a robust indicator of durable treatment success

“…25 As a consequence, current studies are investigating the benefice of an early EVAR for AAA smaller than 55 mm. 26 Other factors favoring aneurysm shrinkage are also present in the literature, but were not found to be significant in our series. Bertges et al 27 found that shrinkage was correlated with the type and the manufacturer of the stent graft implanted.…”

Grey Relational Analysis of Benefit of Surgical Management for Abdominal Aortic Aneurysm

“…[1][2][3][4][5][6][7] The results of the present study are in agreement with those of meta-analyses 2,7 comparing outcomes of patients undergoing EVAR and open repair for AAA. These data have not demonstrated the longterm survival benefit of EVAR over open repair for AAA.…”

“…Our grey The short-term mortality had varied definitions among studies. [1][2][3][4][5][6][7]12,13 Dangas et al 12 reported 30-day mortality data and did not include in-hospital mortality, whereas two large scale studies of RCT, DREAM and OVER 12,13 , used a combination of 30-day and in-hospital mortality. Contrary to previous study results, our present study showed similar short-term mortality between EVAR and open repair; the disparity from DREAM trial 6,12 could be due to the limited number of patients we studied.…”

Efficacy of endovascular management approach of ruptured abdominal aortic aneurysm

“…However, if there was any procedure with morbidity and survival uniforms, all aneurysms would be treated, regardless of their size. 23 Open surgical repair of ruptured AAA is similar to elective AAA repair with technical modifications that reflect the urgency of the patient's clinical presentation and pathophysiology of break. 24 The incision open surgical correction of the AAA can be performed through the midline abdominal or retroperitoneal left by.…”