103
Views
7
CrossRef citations to date
0
Altmetric
Review

Standardization of outcome measures in clinical trials of pharmacological treatment for abdominal aortic aneurysm

, , , &
Pages 1251-1260 | Published online: 10 Jan 2014

References

  • Kent KC, Zwolak RM, Egorova NN et al. Analysis of risk factors for abdominal aortic aneurysm in a cohort of more than 3 million individuals. J. Vasc. Surg. 52(3), 539–548 (2010).
  • Moll FL, Powell JT, Fraedrich G et al.; European Society for Vascular Surgery. Management of abdominal aortic aneurysms clinical practice guidelines of the European society for vascular surgery. Eur. J. Vasc. Endovasc. Surg. 41(Suppl. 1), S1–S58 (2011).
  • Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation 106(25), 3143–3421 (2002).
  • Golledge J, Norman PE. Atherosclerosis and abdominal aortic aneurysm: cause, response, or common risk factors? Arterioscler. Thromb. Vasc. Biol. 30(6), 1075–1077 (2010).
  • Klink A, Hyafil F, Rudd J et al. Diagnostic and therapeutic strategies for small abdominal aortic aneurysms. Nat. Rev. Cardiol. 8(6), 338–347 (2011).
  • Lederle FA, Johnson GR, Wilson SE et al. Yield of repeated screening for abdominal aortic aneurysm after a 4-year interval. Aneurysm Detection and Management Veterans Affairs Cooperative Study Investigators. Arch. Intern. Med. 160(8), 1117–1121 (2000).
  • Singh K, Bønaa KH, Jacobsen BK, Bjørk L, Solberg S. Prevalence of and risk factors for abdominal aortic aneurysms in a population-based study: the Tromsø Study. Am. J. Epidemiol. 154(3), 236–244 (2001).
  • Wilson CT, Fisher E, Welch HG. Racial disparities in abdominal aortic aneurysm repair among male Medicare beneficiaries. Arch. Surg. 143(5), 506–510 (2008).
  • Hobbs SD, Sam RC, Bhatti A et al. The low incidence of surgery for non-cardiac vascular disease in UK Asians may be explained by a low prevalence of disease. Eur. J. Vasc. Endovasc. Surg. 32(5), 494–499 (2006).
  • Chaikof EL, Brewster DC, Dalman RL et al.; Society for Vascular Surgery. The care of patients with an abdominal aortic aneurysm: the Society for Vascular Surgery practice guidelines. J. Vasc. Surg. 50(Suppl. 4), S2–S49 (2009).
  • Baxter BT, Terrin MC, Dalman RL. Medical management of small abdominal aortic aneurysms. Circulation 117(14), 1883–1889 (2008).
  • Thompson AR, Cooper JA, Ashton HA, Hafez H. Growth rates of small abdominal aortic aneurysms correlate with clinical events. Br. J. Surg. 97(1), 37–44 (2010).
  • Mofidi R, Goldie VJ, Kelman J, Dawson AR, Murie JA, Chalmers RT. Influence of sex on expansion rate of abdominal aortic aneurysms. Br. J. Surg. 94(3), 310–314 (2007).
  • Grootenboer N, Bosch JL, Hendriks JM, van Sambeek MR. Epidemiology, aetiology, risk of rupture and treatment of abdominal aortic aneurysms: does sex matter? Eur. J. Vasc. Endovasc. Surg. 38(3), 278–284 (2009).
  • Brown PM, Zelt DT, Sobolev B. The risk of rupture in untreated aneurysms: the impact of size, gender, and expansion rate. J. Vasc. Surg. 37(2), 280–284 (2003).
  • Solberg S, Singh K, Wilsgaard T, Jacobsen BK. Increased growth rate of abdominal aortic aneurysms in women. The Tromsø study. Eur. J. Vasc. Endovasc. Surg. 29(2), 145–149 (2005).
  • Schermerhorn ML, Giles KA, Sachs T et al. Defining perioperative mortality after open and endovascular aortic aneurysm repair in the US Medicare population. J. Am. Coll. Surg. 212(3), 349–355 (2011).
  • Schermerhorn ML, O’Malley AJ, Jhaveri A, Cotterill P, Pomposelli F, Landon BE. Endovascular vs. open repair of abdominal aortic aneurysms in the Medicare population. N. Engl. J. Med. 358(5), 464–474 (2008).
  • Lederle FA, Freischlag JA, Kyriakides TC et al.; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial. JAMA 302(14), 1535–1542 (2009).
  • Brewster DC, Cronenwett JL, Hallett JW Jr, Johnston KW, Krupski WC, Matsumura JS; Joint Council of the American Association for Vascular Surgery and Society for Vascular Surgery. Guidelines for the treatment of abdominal aortic aneurysms. Report of a subcommittee of the Joint Council of the American Association for Vascular Surgery and Society for Vascular Surgery. J. Vasc. Surg. 37(5), 1106–1117 (2003).
  • Sakalihasan N, Limet R, Defawe OD. Abdominal aortic aneurysm. Lancet 365(9470), 1577–1589 (2005).
  • Thompson SG, Ashton HA, Gao L, Scott RA; Multicentre Aneurysm Screening Study Group. Screening men for abdominal aortic aneurysm: 10 year mortality and cost effectiveness results from the randomised Multicentre Aneurysm Screening Study. BMJ 338, b2307 (2009).
  • Lederle FA, Wilson SE, Johnson GR et al.; Aneurysm Detection and Management Veterans Affairs Cooperative Study Group. Immediate repair compared with surveillance of small abdominal aortic aneurysms. N. Engl. J. Med. 346(19), 1437–1444 (2002).
  • Vega de Ceniga M, Gomez R, Estallo L, Rodriguez L, Baquer M, Barba A. Growth rate and associated factors in small abdominal aortic aneurysms. Eur. J. Vasc. Endovasc. Surg. 31(3), 231–236 (2006).
  • McGloughlin TM, Doyle BJ. New approaches to abdominal aortic aneurysm rupture risk assessment: engineering insights with clinical gain. Arterioscler. Thromb. Vasc. Biol. 30(9), 1687–1694 (2010).
  • Malkawi AH, Hinchliffe RJ, Xu Y, Holt PJ, Loftus IM, Thompson MM. Patient-specific biomechanical profiling in abdominal aortic aneurysm development and rupture. J. Vasc. Surg. 52(2), 480–488 (2010).
  • Doyle BJ, Corbett TJ, Callanan A, Walsh MT, Vorp DA, McGloughlin TM. An experimental and numerical comparison of the rupture locations of an abdominal aortic aneurysm. J. Endovasc. Ther. 16(3), 322–335 (2009).
  • Venkatasubramaniam AK, Mehta T, Chetter IC et al. The value of abdominal examination in the diagnosis of abdominal aortic aneurysm. Eur. J. Vasc. Endovasc. Surg. 27(1), 56–60 (2004).
  • De Bruin JL, Baas AF, Buth J et al.; DREAM Study Group. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N. Engl. J. Med. 362(20), 1881–1889 (2010).
  • Vogel TR, Cantor JC, Dombrovskiy VY, Haser PB, Graham AM. AAA repair: sociodemographic disparities in management and outcomes. Vasc. Endovascular Surg. 42(6), 555–560 (2008).
  • Greenhalgh RM, Brown LC, Powell JT, Thompson SG, Epstein D, Sculpher MJ; United Kingdom EVAR Trial Investigators. Endovascular versus open repair of abdominal aortic aneurysm. N. Engl. J. Med. 362(20), 1863–1871 (2010).
  • Franks SC, Sutton AJ, Bown MJ, Sayers RD. Systematic review and meta-analysis of 12 years of endovascular abdominal aortic aneurysm repair. Eur. J. Vasc. Endovasc. Surg. 33(2), 154–171 (2007).
  • Lovegrove RE, Javid M, Magee TR, Galland RB. A meta-analysis of 21,178 patients undergoing open or endovascular repair of abdominal aortic aneurysm. Br. J. Surg. 95(6), 677–684 (2008).
  • Conrad MF, Adams AB, Guest JM et al. Secondary intervention after endovascular abdominal aortic aneurysm repair. Ann. Surg. 250(3), 383–389 (2009).
  • Paravastu SC, Ghosh J, Murray D, Farquharson FG, Serracino-Inglott F, Walker MG. A systematic review of open versus endovascular repair of inflammatory abdominal aortic aneurysms. Eur. J. Vasc. Endovasc. Surg. 38(3), 291–297 (2009).
  • Lederle FA, Johnson GR, Wilson SE et al.; Veterans Affairs Cooperative Study #417 Investigators. Rupture rate of large abdominal aortic aneurysms in patients refusing or unfit for elective repair. JAMA 287(22), 2968–2972 (2002).
  • Brady AR, Thompson SG, Fowkes FG, Greenhalgh RM, Powell JT; UK Small Aneurysm Trial Participants. Abdominal aortic aneurysm expansion: risk factors and time intervals for surveillance. Circulation 110(1), 16–21 (2004).
  • Brown LC, Powell JT. Risk factors for aneurysm rupture in patients kept under ultrasound surveillance. UK Small Aneurysm Trial Participants. Ann. Surg. 230(3), 289–296 (1999).
  • Landon BE, O’Malley AJ, Giles K, Cotterill P, Schermerhorn ML. Volume-outcome relationships and abdominal aortic aneurysm repair. Circulation 122(13), 1290–1297 (2010).
  • Renapurkar RD, Setser RM, O’Donnell TP et al. Aortic volume as an indicator of disease progression in patients with untreated infrarenal abdominal aneurysm. Eur. J. Radiol. 81(2), e87–e93 (2012).
  • Parr A, Jayaratne C, Buttner P, Golledge J. Comparison of volume and diameter measurement in assessing small abdominal aortic aneurysm expansion examined using computed tomographic angiography. Eur. J. Radiol. 79(1), 42–47 (2011).
  • Kauffmann C, Tang A, Therasse E et al. Measurements and detection of abdominal aortic aneurysm growth: accuracy and reproducibility of a segmentation software. Eur. J. Radiol. 81(8), 1688–1694 (2011).
  • Hahne JD, Arndt C, Herrmann J, Schönnagel B, Adam G, Habermann CR. Follow-up of abdominal aortic aneurysm after endovascular aortic repair: comparison of volumetric and diametric measurement. Eur. J. Radiol. 81(6), 1187–1191 (2012).
  • Wever JJ, Blankensteijn JD, Th M Mali WP, Eikelboom BC. Maximal aneurysm diameter follow-up is inadequate after endovascular abdominal aortic aneurysm repair. Eur. J. Vasc. Endovasc. Surg. 20(2), 177–182 (2000).
  • Beales L, Wolstenhulme S, Evans JA, West R, Scott DJ. Reproducibility of ultrasound measurement of the abdominal aorta. Br. J. Surg. 98(11), 1517–1525 (2011).
  • Dugas A, Therasse E, Kauffmann C et al. Reproducibility of abdominal aortic aneurysm diameter measurement and growth evaluation on axial and multiplanar computed tomography reformations. Cardiovasc. Intervent. Radiol. 35(4), 779–787 (2012).
  • Foo FJ, Hammond CJ, Goldstone AR et al. Agreement between computed tomography and ultrasound on abdominal aortic aneurysms and implications on clinical decisions. Eur. J. Vasc. Endovasc. Surg. 42(5), 608–614 (2011).
  • Kauffmann C, Tang A, Dugas A, Therasse É, Oliva V, Soulez G. Clinical validation of a software for quantitative follow-up of abdominal aortic aneurysm maximal diameter and growth by CT angiography. Eur. J. Radiol. 77(3), 502–508 (2011).
  • Sprouse LR 2nd, Meier GH 3rd, Parent FN, DeMasi RJ, Glickman MH, Barber GA. Is ultrasound more accurate than axial computed tomography for determination of maximal abdominal aortic aneurysm diameter? Eur. J. Vasc. Endovasc. Surg. 28(1), 28–35 (2004).
  • Pol JA, Truijers M, van der Vliet JA et al. Impact of dynamic computed tomographic angiography on endograft sizing for endovascular aneurysm repair. J. Endovasc. Ther. 16(5), 546–551 (2009).
  • Iezzi R, Di Stasi C, Dattesi R et al. Proximal aneurysmal neck: dynamic ECG-gated CT angiography–conformational pulsatile changes with possible consequences for endograft sizing. Radiology 260(2), 591–598 (2011).
  • van Prehn J, Vincken KL, Sprinkhuizen SM et al. Aortic pulsatile distention in young healthy volunteers is asymmetric: analysis with ECG-gated MRI. Eur. J. Vasc. Endovasc. Surg. 37(2), 168–174 (2009).
  • Aggarwal S, Qamar A, Sharma V, Sharma A. Abdominal aortic aneurysm: a comprehensive review. Exp. Clin. Cardiol. 16(1), 11–15 (2011).
  • Lederle FA. The natural history of abdominal aortic aneurysm. Acta Chir. Belg. 109(1), 7–12 (2009).
  • Schlösser FJ, Tangelder MJ, Verhagen HJ et al.; SMART study group. Growth predictors and prognosis of small abdominal aortic aneurysms. J. Vasc. Surg. 47(6), 1127–1133 (2008).
  • Kurvers H, Veith FJ, Lipsitz EC et al. Discontinuous, staccato growth of abdominal aortic aneurysms. J. Am. Coll. Surg. 199(5), 709–715 (2004).
  • Ashton HA, Buxton MJ, Day NE et al.; Multicentre Aneurysm Screening Study Group. The Multicentre Aneurysm Screening Study (MASS) into the effect of abdominal aortic aneurysm screening on mortality in men: a randomised controlled trial. Lancet 360(9345), 1531–1539 (2002).
  • Bown MJ, Jones GT, Harrison SC et al. CARDIoGRAM Consortium; Global BPgen Consortium; DIAGRAM Consortium; VRCNZ Consortium. Abdominal aortic aneurysm is associated with a variant in low-density lipoprotein receptor-related protein 1. Am. J. Hum. Genet. 89(5), 619–627 (2011).
  • Krishna SM, Dear AE, Norman PE, Golledge J. Genetic and epigenetic mechanisms and their possible role in abdominal aortic aneurysm. Atherosclerosis 212(1), 16–29 (2010).
  • Saratzis A, Abbas AA, Kiskinis D, Melas N, Saratzis N, Kitas GD. Abdominal aortic aneurysm: a review of the genetic basis. Angiology 62(1), 18–32 (2011).
  • Harrison SC, Holmes MV, Agu O, Humphries SE. Genome wide association studies of abdominal aortic aneurysms – biological insights and potential translation applications. Atherosclerosis 217(1), 47–56 (2011).
  • Reeps C, Essler M, Pelisek J, Seidl S, Eckstein HH, Krause BJ. Increased 18F-fluorodeoxyglucose uptake in abdominal aortic aneurysms in positron emission/computed tomography is associated with inflammation, aortic wall instability, and acute symptoms. J. Vasc. Surg. 48(2), 417–423 (2008).
  • Menezes LJ, Kotze CW, Hutton BF et al. Vascular inflammation imaging with 18F-FDG PET/CT: when to image? J. Nucl. Med. 50(6), 854–857 (2009).
  • Kotze CW, Groves AM, Menezes LJ et al. What is the relationship between 18F-FDG aortic aneurysm uptake on PET/CT and future growth rate? Eur. J. Nucl. Med. Mol. Imaging 38(8), 1493–1499 (2011).
  • Xu XY, Borghi A, Nchimi A et al. High levels of 18F-FDG uptake in aortic aneurysm wall are associated with high wall stress. Eur. J. Vasc. Endovasc. Surg. 39(3), 295–301 (2010).
  • Xiong J, Wang SM, Zhou W, Wu JG. Measurement and analysis of ultimate mechanical properties, stress-strain curve fit, and elastic modulus formula of human abdominal aortic aneurysm and nonaneurysmal abdominal aorta. J. Vasc. Surg. 48(1), 189–195 (2008).
  • Vande Geest JP, Dillavou ED, Di Martino ES et al. Gender-related differences in the tensile strength of abdominal aortic aneurysm. Ann. NY Acad. Sci. 1085, 400–402 (2006).
  • Dorfmann A, Wilson C, Edgar ES, Peattie RA. Evaluating patient-specific abdominal aortic aneurysm wall stress based on flow-induced loading. Biomech. Model. Mechanobiol. 9(2), 127–139 (2010).
  • Scholtes VP, de Vries JP, Catanzariti LM et al. Biobanking in atherosclerotic disease, opportunities and pitfalls. Curr. Cardiol. Rev. 7(1), 9–14 (2011).
  • de Kleijn DP, Moll FL, Hellings WE et al. Local atherosclerotic plaques are a source of prognostic biomarkers for adverse cardiovascular events. Arterioscler. Thromb. Vasc. Biol. 30(3), 612–619 (2010).
  • Hurks R, Hoefer IE, Vink A et al. Aneurysm-express: human abdominal aortic aneurysm wall expression in relation to heterogeneity and vascular events – rationale and design. Eur. Surg. Res. 45(1), 34–40 (2010).
  • Flondell-Sité D, Lindblad B, Kölbel T, Gottsäter A. Cytokines and systemic biomarkers are related to the size of abdominal aortic aneurysms. Cytokine 46(2), 211–215 (2009).
  • Takagi H, Manabe H, Kawai N, Goto SN, Umemoto T. Circulating matrix metalloproteinase-9 concentrations and abdominal aortic aneurysm presence: a meta-analysis. Interact. Cardiovasc. Thorac. Surg. 9(3), 437–440 (2009).
  • Hellenthal FA, Buurman WA, Wodzig WK, Schurink GW. Biomarkers of AAA progression. Part 1: extracellular matrix degeneration. Nat. Rev. Cardiol. 6(7), 464–474 (2009).
  • Hellenthal FA, Buurman WA, Wodzig WK, Schurink GW. Biomarkers of abdominal aortic aneurysm progression. Part 2: inflammation. Nat. Rev. Cardiol. 6(8), 543–552 (2009).
  • Hellenthal FA, Geenen IL, Teijink JA, Heeneman S, Schurink GW. Histological features of human abdominal aortic aneurysm are not related to clinical characteristics. Cardiovasc. Pathol. 18(5), 286–293 (2009).
  • Golledge J, Tsao PS, Dalman RL, Norman PE. Circulating markers of abdominal aortic aneurysm presence and progression. Circulation 118(23), 2382–2392 (2008).
  • Golledge AL, Walker P, Norman PE, Golledge J. A systematic review of studies examining inflammation associated cytokines in human abdominal aortic aneurysm samples. Dis. Markers 26(4), 181–188 (2009).
  • Golledge J, Muller R, Clancy P, McCann M, Norman PE. Evaluation of the diagnostic and prognostic value of plasma D-dimer for abdominal aortic aneurysm. Eur. Heart J. 32(3), 354–364 (2011).
  • Guessous I, Periard D, Lorenzetti D, Cornuz J, Ghali WA. The efficacy of pharmacotherapy for decreasing the expansion rate of abdominal aortic aneurysms: a systematic review and meta-analysis. PLoS ONE 3(3), e1895 (2008).
  • Miyake T, Morishita R. Pharmacological treatment of abdominal aortic aneurysm. Cardiovasc. Res. 83(3), 436–443 (2009).
  • Schouten O, van Laanen JH, Boersma E et al. Statins are associated with a reduced infrarenal abdominal aortic aneurysm growth. Eur. J. Vasc. Endovasc. Surg. 32(1), 21–26 (2006).
  • Hackam DG, Thiruchelvam D, Redelmeier DA. Angiotensin-converting enzyme inhibitors and aortic rupture: a population-based case–control study. Lancet 368(9536), 659–665 (2006).
  • Thompson A, Cooper JA, Fabricius M, Humphries SE, Ashton HA, Hafez H. An analysis of drug modulation of abdominal aortic aneurysm growth through 25 years of surveillance. J. Vasc. Surg. 52(1), 55–61.e2 (2010).
  • Lindeman JH, Abdul-Hussien H, van Bockel JH, Wolterbeek R, Kleemann R. Clinical trial of doxycycline for matrix metalloproteinase-9 inhibition in patients with an abdominal aneurysm: doxycycline selectively depletes aortic wall neutrophils and cytotoxic T cells. Circulation 119(16), 2209–2216 (2009).
  • Dodd BR, Spence RA. Doxycycline inhibition of abdominal aortic aneurysm growth: a systematic review of the literature. Curr. Vasc. Pharmacol. 9(4), 471–478 (2011).
  • Schanzer A, Greenberg RK, Hevelone N et al. Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair. Circulation 123(24), 2848–2855 (2011).
  • Lederle FA. Abdominal aortic aneurysm – open versus endovascular repair. N. Engl. J. Med. 351(16), 1677–1679 (2004).
  • Lederle FA. Endovascular repair of abdominal aortic aneurysm – round two. N. Engl. J. Med. 352(23), 2443–2445 (2005).
  • Assar AN. Pharmacological therapy for patients with abdominal aortic aneurysm. Expert Rev. Cardiovasc. Ther. 7(8), 999–1009 (2009).
  • Curci JA. Digging in the “soil” of the aorta to understand the growth of abdominal aortic aneurysms. Vascular 17(Suppl. 1), S21–S29 (2009).
  • Michel JB, Martin-Ventura JL, Egido J et al. FAD EU consortium. Novel aspects of the pathogenesis of aneurysms of the abdominal aorta in humans. Cardiovasc. Res. 90(1), 18–27 (2011).
  • Svensjö S, Björck M, Gürtelschmid M, Djavani Gidlund K, Hellberg A, Wanhainen A. Low prevalence of abdominal aortic aneurysm among 65-year-old Swedish men indicates a change in the epidemiology of the disease. Circulation 124(10), 1118–1123 (2011).
  • Lederle FA, Johnson GR, Wilson SE et al. The aneurysm detection and management study screening program: validation cohort and final results. Aneurysm Detection and Management Veterans Affairs Cooperative Study Investigators. Arch. Intern. Med. 160(10), 1425–1430 (2000).
  • Powell JT, Sweeting MJ, Brown LC, Gotensparre SM, Fowkes FG, Thompson SG. Systematic review and meta-analysis of growth rates of small abdominal aortic aneurysms. Br. J. Surg. 98(5), 609–618 (2011).
  • Wilson KA, Woodburn KR, Ruckley CV, Fowkes FG. Expansion rates of abdominal aortic aneurysm: current limitations in evaluation. Eur. J. Vasc. Endovasc. Surg. 13(6), 521–526 (1997).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.