This article is more than 5 years old. Information may no longer be current.
EVAR yields early survival benefit, inferior late survival vs. open aneurysm repair in patients with intact AAA
Click Here to Manage Email Alerts
Compared with open surgical repair of intact abdominal aortic aneurysms, endovascular aneurysm repair confers an early survival benefit but inferior late survival outcomes, warranting lifelong monitoring of EVAR and reintervention if needed, according to recent findings.
In the randomized controlled trial, researchers evaluated 711 participants (mean age, 80 years) who were under extended follow-up in the EVAR 1 trial as of Sept. 1, 2009. The EVAR 1 trial enrolled 1,252 patients aged 60 years or older from 37 hospitals in the United Kingdom from September 1999 to August 2004. Eligible participants had an aortic aneurysm of at least 5.5 cm in diameter with aortic morphology suitable to endograft placement within the manufacturers’ indications for use, and were considered viable candidates for open repair with acceptable postoperative mortality risk for both procedures.
The 711 surviving patients in the extended follow-up consisted of 357 patients in the EVAR group and 354 in the open-repair group.
The primary outcomes were aneurysm-related mortality and total mortality. The researchers defined aneurysm-related mortality as all mortality from aneurysm rupture before repair, within 30 days of primary repair, within 30 days of any intervention related to the aneurysm, from other aneurysm-associated causes, or from secondary aneurysm rupture after repair. The secondary outcome was reintervention, defined as time to first reintervention, first reintervention for a life-threatening problem, and first serious reintervention. Follow-up occurred until June 30, 2015, (mean, 12.7 years); mean person-years of observation until either death or study conclusion was 8 years. After follow-up, four patients were lost due to death, and 25 were lost due to reinterventions (five in the EVAR group vs. 20 in the open-repair group).
Deaths documented
During 9,968 person-years of follow-up, there were 910 deaths, 101 (11%) of which were aneurysm-related. In terms of total mortality, the researchers documented 9.3 deaths per 100 person-years in the EVAR group and 8.9 deaths per 100 person-years in the open-repair group (adjusted HR = 1.11; 95% CI, 0.97-1.27).
Aneurysm-related mortality was 1.1 deaths per 100 person-years in the EVAR group vs. 0.9 deaths per 100 person-years in the open-repair group (adjusted HR = 1.31; 95% CI, 0.86-1.99).
Although patients who underwent EVAR had lower rates of mortality vs. patients who underwent open repair at 0 to 6 months (total mortality, adjusted HR = 0.61; 95% CI, 0.37-1.02; aneurysm-related mortality, adjusted HR = 0.47; 95% CI, 0.23-0.93), patients who underwent open repair had significantly lower mortality beyond 8 years of follow-up (total mortality, adjusted HR = 1.25; 95% CI, 1-1.56; aneurysm-related mortality, adjusted HR = 5.82; 95% CI, 1.64-20.65).
According to the researchers, increased aneurysm-related deaths in the EVAR group after the first 6 months were largely due to secondary sac rupture, as were increased aneurysm-related deaths in the EVAR group after 8 years (13 deaths [7%] in the EVAR group vs. two [1%] in the open-repair group). The EVAR group also demonstrated increased cancer mortality.
Lifelong surveillance
During the entire follow-up interval, two aneurysm-related deaths followed reintervention, but the deaths from secondary sac rupture were partly attributable to a failure to correct underlying causes of sac expansion, the researchers wrote. The rate of reintervention was higher at all follow-up time points.
“The loss of early EVAR survival benefit, followed by inferior late survival benefit and durability compared with open repair, needs to be addressed by lifelong surveillance of EVAR and prompt reintervention if necessary,” the researchers wrote. “There is no time when it is safe to discontinue surveillance in patients who have had EVAR. Sac expansion needs to be tracked for all time periods, and the underlying cause corrected.” – by Jennifer Byrne
Disclosure: One researcher reports serving as a salaried director of BIBA Medical and having an equity interest in the company, and also serving as an expert witness on behalf of patients with vascular disease.
Click Here to Manage Email Alerts