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Final follow-up of the Multicentre Aneurysm Screening Study (MASS) randomized trial of abdominal aortic aneurysm screening.

ABSTRACT: The long-term effects of abdominal aortic aneurysm (AAA) screening were investigated in extended follow-up from the UK Multicentre Aneurysm Screening Study (MASS) randomized trial.A population-based sample of men aged 65-74 years were randomized individually to invitation to ultrasound screening (invited group) or to a control group not offered screening. Patients with an AAA (3·0 cm or larger) detected at screening underwent surveillance and were offered surgery after predefined criteria had been met. Cause-specific mortality data were analysed using Cox regression.Some 67 770 men were enrolled in the study. Over 13 years, there were 224 AAA-related deaths in the invited group and 381 in the control group, a 42 (95 per cent confidence interval 31 to 51) per cent reduction. There was no evidence of effect on other causes of death, but there was an overall reduction in all-cause mortality of 3 (1 to 5) per cent. The degree of benefit seen in earlier years of follow-up was slightly diminished by the occurrence of AAA ruptures in those with an aorta originally screened normal. About half of these ruptures had a baseline aortic diameter in the range 2·5-2·9 cm. It was estimated that 216 men need to be invited to screening to save one death over the next 13 years.Screening resulted in a reduction in all-cause mortality, and the benefit in AAA-related mortality continued to accumulate throughout follow-up.ISRCTN37381646 (http://www.controlled-trials.com).

SUBMITTER: Thompson SG

PROVIDER: S-EPMC3569614 | biostudies-literature | 2012 Dec

REPOSITORIES: biostudies-literature

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Final follow-up of the Multicentre Aneurysm Screening Study (MASS) randomized trial of abdominal aortic aneurysm screening.

Thompson S G SG Ashton H A HA Gao L L Buxton M J MJ Scott R A P RA

The British journal of surgery 20121003 12

<h4>Background</h4>The long-term effects of abdominal aortic aneurysm (AAA) screening were investigated in extended follow-up from the UK Multicentre Aneurysm Screening Study (MASS) randomized trial.<h4>Methods</h4>A population-based sample of men aged 65-74 years were randomized individually to invitation to ultrasound screening (invited group) or to a control group not offered screening. Patients with an AAA (3·0 cm or larger) detected at screening underwent surveillance and were offered surge ...[more]

PMID: 23034729

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Project description:BackgroundCurcumin, a popular herbal supplement from the plant turmeric, has prevented ischemic reperfusion and toxin-induced injury in many animal studies and a single-centre randomized human trial. We sought to test whether perioperative oral curcumin (compared with placebo) affects the inflammatory response and risk of postrepair complications after elective abdominal aortic aneurysm repair in humans.MethodsWe conducted a parallel-group, randomized, placebo-controlled trial of patients from 10 hospitals in Canada who were scheduled to undergo elective repair of an unruptured abdominal aortic aneurysm (November 2011 to November 2014). Patients in the treatment group received perioperative oral curcumin (2000-mg doses 8 times over 4 d). Patients, health care providers and local research staff were unaware of the treatment assignment. The primary outcomes were median concentrations of 4 bio markers indicating injury and inflammation (postoperative urine interleukin-18 and perioperative rise in serum creatinine, plasma N-terminal pro-B-type natriuretic peptide and plasma high-sensitivity C-reactive protein).ResultsBaseline characteristics were similar in the 2 groups (606 patients overall; median age 76 yr). More than 85% of patients in each group took more than 80% of their scheduled capsules. Neither curcumin nor placebo significantly affected any of the 4 biomarkers (p > 0.05 for all comparisons). Regarding the secondary outcomes, there was a higher risk of acute kidney injury with curcumin than with placebo (17% v. 10%, p = 0.01), but no between-group difference in the median length of hospital stay (5 v. 5 days, p > 0.9) or the risk of clinical events (9% v. 9%, p = 0.9).InterpretationCurcumin had no beneficial effects when used in elective abdominal aortic aneurysm repair. These findings emphasize the importance of testing turmeric and curcumin before espousing their health benefits, as is currently done in the popular media.Trial registrationClinicalTrials.gov, no. NCT01225094.

Project description:OBJECTIVE:To assess the cost effectiveness of ultrasound screening for abdominal aortic aneurysms. DESIGN:Primary analysis: four year cost effectiveness analysis based directly on results from a randomised controlled trial in which patients were individually allocated to invitation to ultrasound screening (intervention) or to a control group not offered screening. Secondary analysis: projection of the data, based on conservative assumptions, to indicate likely cost effectiveness at 10 years. SETTING:Four centres in the United Kingdom. Screening delivered in primary care settings with follow up and surgery offered in the main hospitals Participants: Population based sample of 67 800 men aged 65-74 years. MAIN OUTCOME MEASURES:Mortality from and costs (screening, follow up, elective and emergency surgery) related to abdominal aortic aneurysm; cost per life year gained. RESULTS:Over four years there were 47 fewer deaths related to abdominal aortic aneurysms in the screening group than in the control group, but the additional costs incurred were pound 2.2m. After adjustment for censoring and discounted at 6% the mean additional cost of the screening programme was pound 63.39 ($97.77, euro;100.48) (95% confidence interval pound 53.31 to pound 73.48) per patient. The hazard ratio for abdominal aortic aneurysm was 0.58 (0.42 to 0.78). Over four years the mean incremental cost effectiveness ratio for screening was pound 28 400 ( pound 15 000 to pound 146 000) per life year gained, equivalent to about pound 36 000 per quality adjusted life year. After 10 years this figure is estimated to fall to around pound 8000 per life year gained. CONCLUSIONS:Even at four years the cost effectiveness of screening for abdominal aortic aneurysms is at the margin of acceptability according to current NHS thresholds. Over a longer period the cost effectiveness will improve substantially, the predicted ratio at 10 years falling to around a quarter of the four year figure.

Dataset Information

Final follow-up of the Multicentre Aneurysm Screening Study (MASS) randomized trial of abdominal aortic aneurysm screening.

Publications

Final follow-up of the Multicentre Aneurysm Screening Study (MASS) randomized trial of abdominal aortic aneurysm screening.

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