Protocol for a randomised controlled trial for Treatment in Thoracic Aortic Aneurysm: Surgery versus Surveillance (TITAN: SvS)

Ming Hao Guo, Jehangir J Appoo, George A Wells, Michael Chu, Maral Ouzounian, Jacqueline Fortier, Munir Boodhwani, Ming Hao Guo, Jehangir J Appoo, George A Wells, Michael Chu, Maral Ouzounian, Jacqueline Fortier, Munir Boodhwani

Abstract

Introduction: Ascending thoracic aortic aneurysm (ATAA) is an asymptomatic condition that can lead to catastrophic events of rupture or dissection. Current guidelines are based on limited retrospective data and recommend surgical intervention for ATAA with a diameter of greater or equal to 5.5 cm. Treatment in Thoracic Aortic Aneurysm: Surgery versus Surveillance is the first prospective, multicentre, randomised controlled trial that compares outcomes of patients undergoing early elective ascending aortic surgery to patients undergoing medical surveillance.

Methods and analysis: Patients between the ages of 18 and 80 with an asymptomatic ATAA between 5.0 cm and 5.4 cm in diameter are eligible for randomisation to early surgery or surveillance. Patients in the surgery group will be followed at 1 month after discharge, then annually for a minimum of 2 years and up to 5 years. Patients in the surveillance group will be followed annually from their index clinic visit for a minimum of 2 years and up to 5 years. The primary outcome is all-cause mortality at follow-up. A sample size of 618 subjects (309 in each group) will achieve an 80% power at a 0.047 significance level.

Ethics and dissemination: This study has received Ottawa Health Science Network Research Ethics Board approval (Protocol 20180007-01H), which was most recently updated on 25 November 2020. The Research Ethics Board have granted approval to the study at 14 participating institutions, including the Ottawa Health Science Network Research Ethics Board. On completion of data analysis, the result of the trial will be presented at national and international conferences, and published in relevant journals, regardless of the finding of the trial.

Trial registration number: NCT03536312.

Keywords: cardiac surgery; surgery; vascular medicine.

Conflict of interest statement

Competing interests: Dr Ououznian is on the North American Advisory Board (consultant position) for Medtronic Inc; Dr Michael Chu receives Speaker’s honoraria from Medtronic, Edwards Lifesciences, Boston Scientific, Terumo Aortic, and Abbott Vascular.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Treatment in Thoracic Aortic Aneurysm: Surgery versus Surveillance recruitment flowsheet.

References

    1. Hagan PG, Nienaber CA, Isselbacher EM, et al. . The International registry of acute aortic dissection (IRAD): new insights into an old disease. JAMA 2000;283:897–903. 10.1001/jama.283.7.897
    1. Pape LA, Awais M, Woznicki EM, et al. . Presentation, Diagnosis, and Outcomes of Acute Aortic Dissection: 17-Year Trends From the International Registry of Acute Aortic Dissection. J Am Coll Cardiol 2015;66:350–8. 10.1016/j.jacc.2015.05.029
    1. Davies RR, Goldstein LJ, Coady MA, et al. . Yearly rupture or dissection rates for thoracic aortic aneurysms: simple prediction based on size. Ann Thorac Surg 2002;73:17–28. 10.1016/S0003-4975(01)03236-2
    1. Hiratzka LF, Bakris GL, Beckman JA, et al. . 2010 ACCF/AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/SVM guidelines for the diagnosis and management of patients with thoracic aortic disease: a report of the American College of cardiology Foundation/American heart association Task force on practice guidelines, American association for thoracic surgery, American College of radiology, American stroke association, society of cardiovascular Anesthesiologists, Society for cardiovascular angiography and interventions, society of interventional radiology, society of thoracic surgeons, and Society for vascular medicine. Circulation 2010;121:e266–369. 10.1161/CIR.0b013e3181d4739e
    1. Erbel R, Aboyans V, Boileau C, et al. . 2014 ESC guidelines on the diagnosis and treatment of aortic diseases: document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The task force for the diagnosis and treatment of aortic diseases of the European Society of cardiology (ESC). Eur Heart J 2014;35:2873–926. 10.1093/eurheartj/ehu281
    1. Boodhwani M, Andelfinger G, Leipsic J, et al. . Canadian cardiovascular Society position statement on the management of thoracic aortic disease. Can J Cardiol 2014;30:577–89. 10.1016/j.cjca.2014.02.018
    1. Appoo JJ, Bozinovski J, Chu MWA, et al. . Canadian cardiovascular Society/Canadian Society of cardiac Surgeons/Canadian Society for vascular surgery joint position statement on open and endovascular surgery for thoracic aortic disease. Can J Cardiol 2016;32:703–13. 10.1016/j.cjca.2015.12.037
    1. Guo MH, Appoo JJ, Saczkowski R, et al. . Association of mortality and acute aortic events with ascending aortic aneurysm: a systematic review and meta-analysis. JAMA Netw Open 2018;1:e181281. 10.1001/jamanetworkopen.2018.1281
    1. Mori M, Shioda K, Wang X, Fort Lauderdale . Comtemporary characteristics and risk profiles for proximal thoracic aortic surgeries for aortic Aneurym: analysis of the STS national ACSD. Society of Thoracic Surgeons Annual Meeting 2018, Florida, USA, 2018.
    1. Pape LA, Tsai TT, Isselbacher EM, et al. . Aortic diameter >or = 5.5 cm is not a good predictor of type A aortic dissection: observations from the International Registry of Acute Aortic Dissection (IRAD). Circulation 2007;116:1120–7. 10.1161/CIRCULATIONAHA.107.702720
    1. Mansour AM, Peterss S, Zafar MA, et al. . Prevention of aortic dissection suggests a diameter shift to a lower aortic size threshold for intervention. Cardiology 2018;139:139–46. 10.1159/000481930
    1. Rylski B, Blanke P, Beyersdorf F, et al. . How does the ascending aorta geometry change when it dissects? J Am Coll Cardiol 2014;63:1311–9. 10.1016/j.jacc.2013.12.028
    1. Chaikof EL, Brewster DC, Dalman RL, et al. . SVS practice guidelines for the care of patients with an abdominal aortic aneurysm: Executive summary. J Vasc Surg 2009;50:880–96. 10.1016/j.jvs.2009.07.001
    1. Ashton HA, Buxton MJ, Day NE, et al. . The multicentre aneurysm screening study (mass) into the effect of abdominal aortic aneurysm screening on mortality in men: a randomised controlled trial. Lancet 2002;360:1531–9. 10.1016/s0140-6736(02)11522-4
    1. Lederle FA, Wilson SE, Johnson GR, et al. . Immediate repair compared with surveillance of small abdominal aortic aneurysms. N Engl J Med 2002;346:1437–44. 10.1056/NEJMoa012573
    1. Norman PE, Jamrozik K, Lawrence-Brown MM, et al. . Population based randomised controlled trial on impact of screening on mortality from abdominal aortic aneurysm. BMJ 2004;329:1259. 10.1136/bmj.38272.478438.55
    1. , Powell JT, Brady AR, et al. , United Kingdom Small Aneurysm Trial Participants . Long-Term outcomes of immediate repair compared with surveillance of small abdominal aortic aneurysms. N Engl J Med 2002;346:1445–52. 10.1056/NEJMoa013527
    1. Scott RAP, Bridgewater SG, Ashton HA. Randomized clinical trial of screening for abdominal aortic aneurysm in women. Br J Surg 2002;89:283–5. 10.1046/j.0007-1323.2001.02014.x
    1. Barthel FM-S, Babiker A, Royston P, et al. . Evaluation of sample size and power for multi-arm survival trials allowing for non-uniform accrual, non-proportional hazards, loss to follow-up and cross-over. Stat Med 2006;25:2521–42. 10.1002/sim.2517
    1. Mok SCM, Ma W-G, Mansour A, et al. . Twenty-Five year outcomes following composite graft aortic root replacement. J Card Surg 2017;32:99–109. 10.1111/jocs.12875
    1. Cheung K, Boodhwani M, Chan K-L, et al. . Thoracic aortic aneurysm growth: role of sex and aneurysm etiology. J Am Heart Assoc 2017;6:e003792. 10.1161/JAHA.116.003792
    1. Chung J, Stevens L-M, Ouzounian M, et al. . Sex-Related differences in patients undergoing thoracic aortic surgery. Circulation 2019;139:1177–84. 10.1161/CIRCULATIONAHA.118.035805
    1. Peterss S, Charilaou P, Dumfarth J, et al. . Aortic valve disease with ascending aortic aneurysm: impact of concomitant root-sparing (supracoronary) aortic replacement in nonsyndromic patients. J Thorac Cardiovasc Surg 2016;152:791–8. 10.1016/j.jtcvs.2016.05.020

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