Article

Endovascular repair compared with surveillance for patients with small abdominal aortic aneurysms

Division of Vascular Surgery, Columbia University and NewYork-Presbyterian Hospital, New York, NY, USA.
Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter (Impact Factor: 3.02). 03/2010; 51(5):1081-7. DOI: 10.1016/j.jvs.2009.10.113
Source: PubMed
ABSTRACT
Although repair of large abdominal aortic aneurysms (AAAs) is well accepted, randomized clinical trials have failed to demonstrate benefit for early surgical repair of small aneurysms compared with surveillance. Endovascular repair has been shown to be safer than open surgical repair in patients with large aneurysms, prompting a randomized trial of early endovascular repair vs surveillance in patients with small aneurysms.
We randomly assigned 728 patients (13.3% women; mean age, 71 +/- 8 years) with 4 to 5 cm AAAs to early endovascular repair (366 patients) or ultrasound surveillance (362 patients). Rupture or aneurysm-related death and overall mortality in the two groups were compared during a mean follow-up of 20 +/- 12 months.
Among patients randomized to treatment, 89% underwent aneurysm repair. Among patients randomized to surveillance, 31% underwent aneurysm repair during the course of the study. After a mean follow-up of 20 +/- 12 months (range, 0-41 months), 15 deaths had occurred in each group (4.1%). The unadjusted hazard ratio (95% confidence interval) for mortality after early endovascular repair was 1.01 (0.49-2.07, P = .98). Aneurysm rupture or aneurysm-related death occurred in two patients in each group (0.6%). The unadjusted hazard ratio was 0.99 (0.14-7.06, P = .99) for early endovascular repair.
Early treatment with endovascular repair and rigorous surveillance with selective aneurysm treatment as indicated both appear to be safe alternatives for patients with small AAAs, protecting the patient from rupture or aneurysm-related death for at least 3 years.

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CLINICAL RESEARCH STUDIES
From the Society for Vascular Surgery
Endovascular repair compared with surveillance
for patients with small abdominal aortic aneurysms
Kenneth Ouriel, MD,
a
Daniel G. Clair, MD,
b
K. Craig Kent, MD,
c
and Christopher K. Zarins, MD,
d
for
the Positive Impact of Endovascular Options for treating Aneurysms Early (PIVOTAL) Investigators,
New York, NY; Cleveland, Ohio; Madison, Wisc; and Palo Alto, Calif
Background: Although repair of large abdominal aortic aneurysms (AAAs) is well accepted, randomized clinical trials have
failed to demonstrate benefit for early surgical repair of small aneurysms compared with surveillance. Endovascular repair
has been shown to be safer than open surgical repair in patients with large aneurysms, prompting a randomized trial of
early endovascular repair vs surveillance in patients with small aneurysms.
Methods: We randomly assigned 728 patients (13.3% women; mean age, 71 8 years) with 4 to 5 cm AAAs to early
endovascular repair (366 patients) or ultrasound surveillance (362 patients). Rupture or aneurysm-related death and
overall mortality in the two groups were compared during a mean follow-up of 20 12 months.
Results: Among patients randomized to treatment, 89% underwent aneurysm repair. Among patients randomized to
surveillance, 31% underwent aneurysm repair during the course of the study. After a mean follow-up of 20 12 months
(range, 0-41 months), 15 deaths had occurred in each group (4.1%). The unadjusted hazard ratio (95% confidence
interval) for mortality after early endovascular repair was 1.01 (0.49-2.07, P .98). Aneurysm rupture or aneurysm-
related death occurred in two patients in each group (0.6%). The unadjusted hazard ratio was 0.99 (0.14-7.06, P .99)
for early endovascular repair.
Conclusions: Early treatment with endovascular repair and rigorous surveillance with selective aneurysm treatment as
indicated both appear to be safe alternatives for patients with small AAAs, protecting the patient from rupture or
aneurysm-related death for at least 3 years. ( J Vasc Surg 2010;51:1081-7.)
Aortic aneurysm repair is performed to prevent rupture,
an event strongly correlated with the diameter of the aneu-
rysm.
1
The mortality from aneurysm repair itself, however,
can be significant.
2
Operative risk must be balanced against
the risk of rupture when deciding between repair and
observation. Repair is indicated in most patients with larger
aneurysms, but two prospective randomized clinical trials
failed to detect benefits of early open surgical repair com-
pared with surveillance in patients with small aneurysms
of 5.5 cm in diameter.
3,4
Operative mortality rates of 2.7% and 5.8% in these two
trials raised the question of whether a procedure with lower
operative mortality might provide benefit compared with ob-
servation in patients with smaller aneurysms, and endovascular
aneurysm repair (EVAR) has been shown to have a lower
perioperative mortality rate than open surgical repair.
5-7
The
Positive Impact of Endovascular Options for Treating Aneu-
rysms Early (PIVOTAL) trial was organized to determine
whether early EVAR reduced the risk of rupture or aneurysm-
related death compared with surveillance in patients with
small (4- to 5-cm) abdominal aortic aneurysms (AAAs). Here
we report the early results of this first randomized clinical trial
comparing the two modalities.
METHODS
Study design. The trial was approved by the human
subject research committees of each participating center. The
trial management was coordinated centrally by a steering
committee, and the safety of the study was monitored by an
independent patient safety committee that met biannually.
Eligible patients were aged between 40 and 90 years,
with infrarenal AAAs between 4.0 and 5.0 cm in diameter
by computed tomography (CT) performed 3 months of
screening. Patients were excluded from the study if they
From the Division of Vascular Surgery, Columbia University and NewYork-
Presbyterian Hospital;
a
Heart and Vascular Institute, Cleveland Clinic;
b
Department of Surgery, University of Wisconsin, Madison;
c
and Division
of Vascular Surgery, Stanford University.
d
Competition of interest: Christopher Zairns and Daniel Clair receive re-
search funding from Medtronic and are consultants for the company.
Reprint requests: Kenneth Ouriel, MD, NewYork-Presbyterian Hospital, 14
E 60th St, No. 1201, New York, NY 10022 (e-mail: ourielk@nyp.org).
The editors and reviewers of this article have no relevant financial relationships
to disclose per the JVS policy that requires reviewers to decline review of any
manuscript for which they may have a competition of interest.
0741-5214/$36.00
Copyright © 2010 by the Society for Vascular Surgery.
doi:10.1016/j.jvs.2009.10.113
1081
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