Effect of Age on Survival Between Open Repair and Surveillance for Small Abdominal Aortic Aneurysms




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





  • Immediate open repair offers no greater survival benefit compared with surveillance for patients with asymptomatic small (4.0 to 5.5 cm) AAAs.



  • 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.



  • 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.



  • 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.



Table 1

Characteristics of the study cohort: 2,226 patients randomized to either immediate open repair or surveillance in the Aneurysm Detection and Management (ADAM) and United Kingdom Small Aneurysm Trial (UKSAT)












































































































































































































































































































































































































































































































































































































































































































Variable Surveillance n = 1094 Open Repair n = 1132
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

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Dec 1, 2016 | Posted by in CARDIOLOGY | Comments Off on Effect of Age on Survival Between Open Repair and Surveillance for Small Abdominal Aortic Aneurysms

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