A risk-adjusted and anatomically stratified cohort comparison study of open surgery, endovascular techniques and medical management for juxtarenal aortic aneurysms-the UK COMPlex AneurySm Study (UK-COMPASS): a study protocol

Shaneel R. Patel; David C. Ormesher; Samuel R. Smith; Kitty H. F. Wong; Paul Bevis; Colin D. Bicknell; Jonathan R. Boyle; John A. Brennan; Bruce Campbell; Andrew Cook; Alastair P. Crosher; Rui V. Duarte; Murray M. Flett; Carrol Gamble; Richard J. Jackson; Maciej T. Juszczak; Ian M. Loftus; Ian M. Nordon; Jai V. Patel; Kellie Platt; Eftychia-Eirini Psarelli; Peter C. Rowlands; John V. Smyth; Theodoros Spachos; Leigh Taggart; Claire Taylor; Srinivasa Rao Vallabhaneni

doi:10.1136/bmjopen-2021-054493

A risk-adjusted and anatomically stratified cohort comparison study of open surgery, endovascular techniques and medical management for juxtarenal aortic aneurysms-the UK COMPlex AneurySm Study (UK-COMPASS): a study protocol

Shaneel R. Patel, David C. Ormesher, Samuel R. Smith, Kitty H. F. Wong, Paul Bevis, Colin D. Bicknell, Jonathan R. Boyle, John A. Brennan, Bruce Campbell, Andrew Cook, Alastair P. Crosher, Rui V. Duarte, Murray M. Flett, Carrol Gamble, Richard J. Jackson, Maciej T. Juszczak, Ian M. Loftus, Ian M. Nordon, Jai V. Patel, Kellie PlattEftychia-Eirini Psarelli, Peter C. Rowlands, John V. Smyth, Theodoros Spachos, Leigh Taggart, Claire Taylor, Srinivasa Rao Vallabhaneni (Lead / Corresponding author)

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Abstract

Introduction: In one-third of all abdominal aortic aneurysms (AAAs), the aneurysm neck is short (juxtarenal) or shows other adverse anatomical features rendering operations more complex, hazardous and expensive. Surgical options include open surgical repair and endovascular aneurysm repair (EVAR) techniques including fenestrated EVAR, EVAR with adjuncts (chimneys/endoanchors) and off-label standard EVAR. The aim of the UK COMPlex AneurySm Study (UK-COMPASS) is to answer the research question identified by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme: 'What is the clinical and cost-effectiveness of strategies for the management of juxtarenal AAA, including fenestrated endovascular repair?'

Methods and analysis: UK-COMPASS is a cohort study comparing clinical and cost-effectiveness of different strategies used to manage complex AAAs with stratification of physiological fitness and anatomical complexity, with statistical correction for baseline risk and indication biases. There are two data streams. First, a stream of routinely collected data from Hospital Episode Statistics and National Vascular Registry (NVR). Preoperative CT scans of all patients who underwent elective AAA repair in England between 1 November 2017 and 31 October 2019 are subjected to Corelab analysis to accurately identify and include every complex aneurysm treated. Second, a site-reported data stream regarding quality of life and treatment costs from prospectively recruited patients across England. Site recruitment also includes patients with complex aneurysms larger than 55 mm diameter in whom an operation is deferred (medical management). The primary outcome measure is perioperative all-cause mortality. Follow-up will be to a median of 5 years.

Ethics and dissemination: The study has received full regulatory approvals from a Research Ethics Committee, the Confidentiality Advisory Group and the Health Research Authority. Data sharing agreements are in place with National Health Service Digital and the NVR. Dissemination will be via NIHR HTA reporting, peer-reviewed journals and conferences.

Trial registration number: ISRCTN85731188.

Original language	English
Article number	e054493
Number of pages	8
Journal	BMJ Open
Volume	11
Issue number	11
Early online date	30 Nov 2021
DOIs	https://doi.org/10.1136/bmjopen-2021-054493
Publication status	Published - 30 Nov 2021

Keywords

clinical trials
protocols & guidelines
vascular surgery

ASJC Scopus subject areas

General Medicine

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Patel, S. R., Ormesher, D. C., Smith, S. R., Wong, K. H. F., Bevis, P., Bicknell, C. D., Boyle, J. R., Brennan, J. A., Campbell, B., Cook, A., Crosher, A. P., Duarte, R. V., Flett, M. M., Gamble, C., Jackson, R. J., Juszczak, M. T., Loftus, I. M., Nordon, I. M., Patel, J. V., ... Vallabhaneni, S. R. (2021). A risk-adjusted and anatomically stratified cohort comparison study of open surgery, endovascular techniques and medical management for juxtarenal aortic aneurysms-the UK COMPlex AneurySm Study (UK-COMPASS): a study protocol. BMJ Open, 11(11), Article e054493. https://doi.org/10.1136/bmjopen-2021-054493

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title = "A risk-adjusted and anatomically stratified cohort comparison study of open surgery, endovascular techniques and medical management for juxtarenal aortic aneurysms-the UK COMPlex AneurySm Study (UK-COMPASS): a study protocol",

abstract = "Introduction: In one-third of all abdominal aortic aneurysms (AAAs), the aneurysm neck is short (juxtarenal) or shows other adverse anatomical features rendering operations more complex, hazardous and expensive. Surgical options include open surgical repair and endovascular aneurysm repair (EVAR) techniques including fenestrated EVAR, EVAR with adjuncts (chimneys/endoanchors) and off-label standard EVAR. The aim of the UK COMPlex AneurySm Study (UK-COMPASS) is to answer the research question identified by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme: 'What is the clinical and cost-effectiveness of strategies for the management of juxtarenal AAA, including fenestrated endovascular repair?'Methods and analysis: UK-COMPASS is a cohort study comparing clinical and cost-effectiveness of different strategies used to manage complex AAAs with stratification of physiological fitness and anatomical complexity, with statistical correction for baseline risk and indication biases. There are two data streams. First, a stream of routinely collected data from Hospital Episode Statistics and National Vascular Registry (NVR). Preoperative CT scans of all patients who underwent elective AAA repair in England between 1 November 2017 and 31 October 2019 are subjected to Corelab analysis to accurately identify and include every complex aneurysm treated. Second, a site-reported data stream regarding quality of life and treatment costs from prospectively recruited patients across England. Site recruitment also includes patients with complex aneurysms larger than 55 mm diameter in whom an operation is deferred (medical management). The primary outcome measure is perioperative all-cause mortality. Follow-up will be to a median of 5 years.Ethics and dissemination: The study has received full regulatory approvals from a Research Ethics Committee, the Confidentiality Advisory Group and the Health Research Authority. Data sharing agreements are in place with National Health Service Digital and the NVR. Dissemination will be via NIHR HTA reporting, peer-reviewed journals and conferences.Trial registration number: ISRCTN85731188.",

keywords = "clinical trials, protocols & guidelines, vascular surgery",

author = "Patel, {Shaneel R.} and Ormesher, {David C.} and Smith, {Samuel R.} and Wong, {Kitty H. F.} and Paul Bevis and Bicknell, {Colin D.} and Boyle, {Jonathan R.} and Brennan, {John A.} and Bruce Campbell and Andrew Cook and Crosher, {Alastair P.} and Duarte, {Rui V.} and Flett, {Murray M.} and Carrol Gamble and Jackson, {Richard J.} and Juszczak, {Maciej T.} and Loftus, {Ian M.} and Nordon, {Ian M.} and Patel, {Jai V.} and Kellie Platt and Eftychia-Eirini Psarelli and Rowlands, {Peter C.} and Smyth, {John V.} and Theodoros Spachos and Leigh Taggart and Claire Taylor and Vallabhaneni, {Srinivasa Rao}",

note = "Funding: Health Technology Assessment Programme (Award ID: 15/153/02). {\textcopyright} Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.",

year = "2021",

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language = "English",

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Patel, SR, Ormesher, DC, Smith, SR, Wong, KHF, Bevis, P, Bicknell, CD, Boyle, JR, Brennan, JA, Campbell, B, Cook, A, Crosher, AP, Duarte, RV, Flett, MM, Gamble, C, Jackson, RJ, Juszczak, MT, Loftus, IM, Nordon, IM, Patel, JV, Platt, K, Psarelli, E-E, Rowlands, PC, Smyth, JV, Spachos, T, Taggart, L, Taylor, C & Vallabhaneni, SR 2021, 'A risk-adjusted and anatomically stratified cohort comparison study of open surgery, endovascular techniques and medical management for juxtarenal aortic aneurysms-the UK COMPlex AneurySm Study (UK-COMPASS): a study protocol', BMJ Open, vol. 11, no. 11, e054493. https://doi.org/10.1136/bmjopen-2021-054493

A risk-adjusted and anatomically stratified cohort comparison study of open surgery, endovascular techniques and medical management for juxtarenal aortic aneurysms-the UK COMPlex AneurySm Study (UK-COMPASS): a study protocol. / Patel, Shaneel R.; Ormesher, David C.; Smith, Samuel R. et al.
In: BMJ Open, Vol. 11, No. 11, e054493, 30.11.2021.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - A risk-adjusted and anatomically stratified cohort comparison study of open surgery, endovascular techniques and medical management for juxtarenal aortic aneurysms-the UK COMPlex AneurySm Study (UK-COMPASS)

T2 - a study protocol

AU - Patel, Shaneel R.

AU - Ormesher, David C.

AU - Smith, Samuel R.

AU - Wong, Kitty H. F.

AU - Bevis, Paul

AU - Bicknell, Colin D.

AU - Boyle, Jonathan R.

AU - Brennan, John A.

AU - Campbell, Bruce

AU - Cook, Andrew

AU - Crosher, Alastair P.

AU - Duarte, Rui V.

AU - Flett, Murray M.

AU - Gamble, Carrol

AU - Jackson, Richard J.

AU - Juszczak, Maciej T.

AU - Loftus, Ian M.

AU - Nordon, Ian M.

AU - Patel, Jai V.

AU - Platt, Kellie

AU - Psarelli, Eftychia-Eirini

AU - Rowlands, Peter C.

AU - Smyth, John V.

AU - Spachos, Theodoros

AU - Taggart, Leigh

AU - Taylor, Claire

AU - Vallabhaneni, Srinivasa Rao

N1 - Funding: Health Technology Assessment Programme (Award ID: 15/153/02). © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

PY - 2021/11/30

Y1 - 2021/11/30

N2 - Introduction: In one-third of all abdominal aortic aneurysms (AAAs), the aneurysm neck is short (juxtarenal) or shows other adverse anatomical features rendering operations more complex, hazardous and expensive. Surgical options include open surgical repair and endovascular aneurysm repair (EVAR) techniques including fenestrated EVAR, EVAR with adjuncts (chimneys/endoanchors) and off-label standard EVAR. The aim of the UK COMPlex AneurySm Study (UK-COMPASS) is to answer the research question identified by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme: 'What is the clinical and cost-effectiveness of strategies for the management of juxtarenal AAA, including fenestrated endovascular repair?'Methods and analysis: UK-COMPASS is a cohort study comparing clinical and cost-effectiveness of different strategies used to manage complex AAAs with stratification of physiological fitness and anatomical complexity, with statistical correction for baseline risk and indication biases. There are two data streams. First, a stream of routinely collected data from Hospital Episode Statistics and National Vascular Registry (NVR). Preoperative CT scans of all patients who underwent elective AAA repair in England between 1 November 2017 and 31 October 2019 are subjected to Corelab analysis to accurately identify and include every complex aneurysm treated. Second, a site-reported data stream regarding quality of life and treatment costs from prospectively recruited patients across England. Site recruitment also includes patients with complex aneurysms larger than 55 mm diameter in whom an operation is deferred (medical management). The primary outcome measure is perioperative all-cause mortality. Follow-up will be to a median of 5 years.Ethics and dissemination: The study has received full regulatory approvals from a Research Ethics Committee, the Confidentiality Advisory Group and the Health Research Authority. Data sharing agreements are in place with National Health Service Digital and the NVR. Dissemination will be via NIHR HTA reporting, peer-reviewed journals and conferences.Trial registration number: ISRCTN85731188.

AB - Introduction: In one-third of all abdominal aortic aneurysms (AAAs), the aneurysm neck is short (juxtarenal) or shows other adverse anatomical features rendering operations more complex, hazardous and expensive. Surgical options include open surgical repair and endovascular aneurysm repair (EVAR) techniques including fenestrated EVAR, EVAR with adjuncts (chimneys/endoanchors) and off-label standard EVAR. The aim of the UK COMPlex AneurySm Study (UK-COMPASS) is to answer the research question identified by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme: 'What is the clinical and cost-effectiveness of strategies for the management of juxtarenal AAA, including fenestrated endovascular repair?'Methods and analysis: UK-COMPASS is a cohort study comparing clinical and cost-effectiveness of different strategies used to manage complex AAAs with stratification of physiological fitness and anatomical complexity, with statistical correction for baseline risk and indication biases. There are two data streams. First, a stream of routinely collected data from Hospital Episode Statistics and National Vascular Registry (NVR). Preoperative CT scans of all patients who underwent elective AAA repair in England between 1 November 2017 and 31 October 2019 are subjected to Corelab analysis to accurately identify and include every complex aneurysm treated. Second, a site-reported data stream regarding quality of life and treatment costs from prospectively recruited patients across England. Site recruitment also includes patients with complex aneurysms larger than 55 mm diameter in whom an operation is deferred (medical management). The primary outcome measure is perioperative all-cause mortality. Follow-up will be to a median of 5 years.Ethics and dissemination: The study has received full regulatory approvals from a Research Ethics Committee, the Confidentiality Advisory Group and the Health Research Authority. Data sharing agreements are in place with National Health Service Digital and the NVR. Dissemination will be via NIHR HTA reporting, peer-reviewed journals and conferences.Trial registration number: ISRCTN85731188.

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KW - vascular surgery

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Patel SR, Ormesher DC, Smith SR, Wong KHF, Bevis P, Bicknell CD et al. A risk-adjusted and anatomically stratified cohort comparison study of open surgery, endovascular techniques and medical management for juxtarenal aortic aneurysms-the UK COMPlex AneurySm Study (UK-COMPASS): a study protocol. BMJ Open. 2021 Nov 30;11(11):e054493. Epub 2021 Nov 30. doi: 10.1136/bmjopen-2021-054493

A risk-adjusted and anatomically stratified cohort comparison study of open surgery, endovascular techniques and medical management for juxtarenal aortic aneurysms-the UK COMPlex AneurySm Study (UK-COMPASS): a study protocol

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