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A Randomized Controlled Trial of Endovascular Aneurysm Repair Versus Open Surgery for Abdominal Aortic Aneurysms in Low- to Moderate-Risk Patients
Study Questions:
Does endovascular abdominal aneurysm repair (EVAR) confer a survival advantage over open surgical repair (OSR) when applied to low/moderate-risk patients?
Methods:
Between 2003 and 2008 at 25 French centers, 316 patients anatomically suitable for EVAR and considered low/moderate risk for surgery were randomized to EVAR or OSR. All aneurysms were >5 cm in diameter. Of the 299 patients that were suitable for analysis, 149 were randomized to OSR and 150 to EVAR. There were 21 crossovers (17 from OSR to EVAR, and 4 from EVAR to OSR) due to patient preference, but analysis was by intention to treat. Patient follow-up was 5 years. Primary endpoints were death and any major adverse event (myocardial infarction, stroke, permanent hemodialysis, major amputation, paraplegia, or bowel infarction). Secondary endpoints included vascular re-interventions, sexual impairment, buttock claudication, and incisional complications.
Results:
Median study follow-up was 3 years (range, 0-4.8). No difference in cumulative survival or major adverse events was noted between OSR and EVAR at 1 and 3 years (95.9 ± 1.6% vs. 93.2 ± 2.1% and 85.1 ± 4.5% vs. 82.4 ± 3.7%). In-hospital mortality was 0.6% for OSR and 1.3% for EVAR (p = 1). EVAR was associated with higher re-intervention rates (2.4% vs. 16%, p < 0.001) and a trend toward higher aneurysm-related mortality (0.7% vs. 4%, p = 0.12). Postoperative length of stay was significantly less in the EVAR group. There was no difference in minor complication rates, although the OSR group had more minor cardiac and incision complications. Buttock claudication was more common in the EVAR group.
Conclusions:
The authors concluded that OSR is as safe as EVAR in patients with low/moderate risk factors for surgery. OSR remains a more durable repair option than EVAR.
Perspective:
EVAR is increasing becoming the first-line treatment for all-comers with abdominal aortic aneurysm (AAA). OSR was previously considered first-line treatment in patients ages ≤65 years old, but these patients are now being offered EVAR preferentially. I have personally explanted a few endografts in low-risk AAA patients in their 50s for complications of EVAR. The argument for the use of EVAR in younger, lower-risk patients has been the reputed lower 30-day (and possibly 1-year) mortality rates compared to OSR. This study, although flawed by being somewhat underpowered, suggests that low/moderate-risk patients may benefit most from OSR with its freedom from endoleaks and re-intervention (not to mention yearly exposure to radiation and contrast), and comes at a time when many surgeons are concerned that OSR of AAAs is rapidly becoming a lost art.
Keywords: Myocardial Infarction, Infarction, Follow-Up Studies, Risk Factors, Paraplegia, Aortic Aneurysm, Abdominal
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