Randomized controlled trials have shown no significant difference in survival between immediate open repair and surveillance with selective repair for asymptomatic abdominal aortic aneurysms of 4.0 to 5.5 cm in diameter. This lack of difference has been shown to hold true for all diameters in this range, in men and women, but the question of whether patients of different ages might obtain different benefits has remained unanswered. Using the pooled patient-level data for the 2,226 patients randomized to immediate open repair or surveillance in the United Kingdom Small Aneurysm Trial (UKSAT; September 1, 1991, to July 31, 1998; follow-up 2.6 to 6.9 years) or the Aneurysm Detection and Management (ADAM) trial (August 1, 1992, to July 31, 2000; follow-up 3.5 to 8.0 years), the adjusted effect of age on survival in the 2 treatment groups was estimated using a generalized propensity approach, accounting for a comprehensive array of clinical and nonclinical risk factors. No significant difference in survival between immediate open repair and surveillance was observed for patients of any age, overall (p = 0.606) or in men (p = 0.371) or women separately (p = 0.167). In conclusion, survival did not differ significantly between immediate open repair and surveillance for patients of any age, overall or in men or women. Combined with the previous evidence regarding diameter, and the lack of benefit of immediate endovascular in trials comparing it with surveillance repair for small abdominal aortic aneurysms, these results suggest that surveillance should be the first-line management strategy of choice for asymptomatic abdominal aortic aneurysms of 4.0 to 5.5 cm.
Highlights
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Immediate open repair offers no greater survival benefit compared with surveillance for patients with asymptomatic small (4.0 to 5.5 cm) AAAs.
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There is no difference in survival between immediate open repair and surveillance for any AAA diameter within the range of 4.0 to 5.5 cm, overall or in men or women.
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There is no difference in survival between immediate open repair and surveillance for patients with small AAAs of any age, overall or in men or women.
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Surveillance, as the least invasive option, should be the first-line management strategy of choice for asymptomatic AAAs of 4.0 to 5.5 cm.
Four randomized controlled trials have compared immediate repair (either open or endovascular) with surveillance and selective repair for patients with asymptomatic abdominal aortic aneurysms (AAAs) with diameters of 4.0 to 5.5 cm. None found any significant survival benefit with either management strategy; however, the question of whether this holds true for patients of all ages has remained open, particularly in the context of long-term survival.
Methods
We investigated whether survival differences existed between immediate open repair and surveillance depending on age in patients with small AAAs, overall and then by gender, using the original patient data from the United Kingdom Small Aneurysm Trial (UKSAT) and the Aneurysm Detection and Management (ADAM) trial.
UKSAT and ADAM assigned patients to the immediate open repair and surveillance arms in a 1:1 ratio, stratified by medical center. Patients randomly assigned to the immediate open repair group in either trial received standard open repair no later than 6 weeks after randomization. Likewise, patients assigned to surveillance were followed at similar intervals (at minimum, once every 6 months), and the same criteria for selective repair were applied—(1) the aneurysm reached 5.5 cm, (2) the aneurysm enlarged by a minimum of 0.7 cm in 6 months or 1.0 cm in 1 year, or (3) the aneurysm became symptomatic—and those selective repairs were performed <6 weeks after any of those criteria were met.
All men and women enrolled and randomized to either immediate open surgery or ultrasound surveillance and selective surgery in either ADAM (August 1, 1992, to July 31, 2000) or UKSAT (September 1, 1991, to July 31, 1998) were included in this study, for a combined study cohort of 2,226 ( Table 1 ). We excluded 88 patients from the adjusted analysis because data on ≥1 of the covariates listed below (and in Table 1 ) were missing. The final study cohort, therefore, included 2,138 patients. ADAM and UKSAT applied comparable inclusion and exclusion criteria. The 2 trials enrolled patients with small (4.0 to 5.4 cm), nontender asymptomatic AAAs distal to the renal arteries considered fit for immediate open repair, and excluded patients who were considered unfit for immediate open repair, had symptoms associated with the aneurysms, were unable to attend the follow-up visit, or were unable to give informed consent. The ADAM trial also excluded patients who had undergone major surgical procedures or angioplasty ≤3 months before enrollment, had myocardial infarctions ≤6 months before enrollment, or were expected to survive <5 years because of invasive cancer or other life-threatening disease. Age inclusion criteria differed between the trials (50 to 79 years for ADAM, 60 to 76 years for UKSAT) ; however, most ADAM participants (88%) fell within the same age range as those of UKSAT. More than 92% of the combined study cohort were 60 to 76 years of age.
Variable | Surveillance n = 1094 | Open Repair n = 1132 | ||||||||||
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ADAM (n = 567) | UKSAT (n = 527) | ADAM (n = 569) | UKSAT (n = 563) | |||||||||
Median | IQR | % | Median | IQR | % | Median | IQR | % | Median | IQR | % | |
Characteristic | ||||||||||||
White | — | — | 93.5% | — | — | NR | — | — | 94.5% | — | — | NR |
Black | — | — | 4.4% | — | — | NR | — | — | 2.3% | — | — | NR |
Other/Unknown | — | — | 2.1% | — | — | NR | — | — | 3.2% | — | — | NR |
Male | — | — | 99.6% | — | — | 82.3% | — | — | 98.8% | — | — | 83.1% |
Female | — | — | 0.4% | — | — | 17.7% | — | — | 1.2% | — | — | 16.9% |
Age (years) | 68.0 | 63, 72 | — | 69.4 | 66, 73 | — | 69.0 | 64, 73 | — | 69.7 | 66, 73 | — |
Height (cm) | 177.8 | 173, 183 | — | 172.0 | 165, 177 | — | 177.8 | 170, 182 | — | 172.0 | 167, 177 | — |
Weight (kg) | 86.2 | 76, 96 | — | 73.0 | 65, 82 | — | 85.7 | 77, 96 | — | 73.9 | 65, 80 | — |
BSA (Dubois Method) (m 2 ) | 2.0 | 1.9, 2.2 | — | 1.8 | 1.7, 2.0 | — | 2.0 | 1.9, 2.1 | — | 1.9 | 1.8, 2.0 | — |
Family History of AAA | — | — | 11.6% | — | — | 6.0% | — | — | 14.2% | — | — | 5.3% |
Smoker | — | — | — | — | — | — | — | — | ||||
Never | — | — | 5.6% | — | — | 5.9% | — | — | 5.3% | — | — | 5.7% |
Previous | — | — | 59.3% | — | — | 59.6% | — | — | 55.4% | — | — | 54.7% |
Current | — | — | 35.1% | — | — | 34.5% | — | — | 39.4% | — | — | 39.4% |
Hypertension | — | — | 54.9% | — | — | 39.7% | — | — | 57.8% | — | — | 39.0% |
Chronic lung disease | — | — | 21.2% | — | — | 10.3% | — | — | 23.0% | — | — | 9.0% |
Stroke | — | — | 12.7% | — | — | 2.1% | — | — | 12.0% | — | — | 4.3% |
Diabetes mellitus | — | — | 9.9% | — | — | 3.0% | — | — | 9.7% | — | — | 2.5% |
Embolism | — | — | 1.8% | — | — | 0.8% | — | — | 0.9% | — | — | 0.7% |
Ischemic Heart Disease | — | — | 50.3% | — | — | 29.8% | — | — | 52.7% | — | — | 29.5% |
History of MI | — | — | 26.9% | — | — | 19.9% | — | — | 30.4% | — | — | 16.0% |
History of Cancer | — | — | 17.1% | — | — | 5.7% | — | — | 15.3% | — | — | 6.6% |
DVT | — | — | 6.4% | — | — | — | — | — | 5.6% | — | — | — |
AAA diameter (cm) | 4.7 | 4.3, 5.0 | — | 4.5 | 4.3, 4.9 | — | 4.7 | 4.3, 5.1 | — | 4.6 | 4.3, 5.0 | — |
Cholesterol (mg/dL) | ||||||||||||
Total | 212.0 | 185, 235 | — | 235.5 | 208, 266 | — | 212.0 | 183, 236 | — | 235.5 | 204, 262 | — |
HDL | 37.0 | 32, 45 | — | 41.9 | 33, 57 | — | 36.0 | 31, 45 | — | 40.5 | 34, 49 | — |
LDL | 136.0 | 115, 160 | — | 154.9 | 127, 185 | — | 136.0 | 115, 163 | — | 151.5 | 126, 180 | — |
Creatinine (mg/dL) | 1.1 | 1.0, 1.3 | — | 1.2 | 1.0, 1.3 | — | 1.1 | 1.0, 1.3 | — | 1.2 | 1.0, 1.3 | — |
Forced expiratory volume in one second (L) | 2.6 | 2.1, 2.9 | — | 2.1 | 1.6, 2.6 | — | 2.5 | 2.1, 2.9 | — | 2.2 | 1.7, 2.7 | — |
Previous CABG/PCI | — | — | 24.3% | — | — | 5.9% | — | — | 24.8% | — | — | 5.2% |
Aspirin | — | — | 48.7% | — | — | 28.8% | — | — | 47.8% | — | — | 13.0% |
Beta-blocker | — | — | 14.8% | — | — | 15.6% | — | — | 16.9% | — | — | 14.7% |
Anti-arrhythmic | — | — | 12.5% | — | — | 0.4% | — | — | 12.1% | — | — | 0.5% |
Cholesterol lowering | — | — | 21.0% | — | — | 2.5% | — | — | 20.8% | — | — | 3.4% |
Hypertension lowering | — | — | 52.9% | — | — | 45.4% | — | — | 59.9% | — | — | 42.1% |
Had AAA Repair | — | — | 61.6% | — | 62.4% | — | — | 92.6% | — | — | 92.4% | |
AAA rupture | — | — | 2.1% | — | 3.6% | — | — | 0.4% | — | — | 1.1% | |
Time until surgery – if had surgery (Days) | 819 | 439, 1252 | — | 588 | 322, 1032 | — | 31 | 21, 41 | — | 52 | 33, 90 | — |
Outcome | ||||||||||||
Survival status | ||||||||||||
Alive | — | — | 78.5% | — | — | 71.4% | — | — | 74.9% | — | — | 71.8% |
Dead | — | — | 21.5% | — | — | 28.6% | — | — | 25.1% | — | — | 28.2% |
AAA related death Total Pop | — | — | 3.4% | — | — | 6.6% | — | — | 3.3% | — | — | 5.7% |
Death within 30 days of surgery | — | — | 1.1% | — | — | 7.0% | — | — | 1.9% | — | — | 5.6% |
Time to death or censoring (Days surviving) | 1805 | 1362, 2316 | — | 1373 | 1156, 1813 | — | 1754 | 1347, 2281 | — | 1544 | 1172, 1981 | — |