Surgery vs Surveillance for Thoracic Aortic Aneurysm

(TITAN:SvS Trial)

Recruiting at 30 trial locations

Overseen By Alice Black

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Previous cardiac surgery, Connective tissue disease, Genetic aortopathies, Inflammatory arteritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

610 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best treatment for individuals with an enlarged ascending aorta. It aims to determine whether early thoracic aortic surgery or regular check-ups (surveillance) is more beneficial for patients with an aorta measuring between 5.0 and 5.5 cm. Patients will either undergo surgery to replace the aorta or receive close monitoring with regular scans to assess which approach is safer and more effective. This study targets individuals with an ascending aortic aneurysm (a bulge in the artery wall) within that size range. The results will guide doctors in choosing the best treatment for this condition. As an unphased trial, it offers patients the chance to contribute to significant research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that thoracic aortic surgery is generally safe when planned in advance. In past studies, about 3 out of every 100 people undergoing elective surgery on the ascending aorta did not survive, which is considered a relatively low risk for such a major operation.

Most patients handle the surgery well, with a low chance of complications afterward. While all surgeries carry some risk, many doctors consider these risks acceptable to prevent a potentially life-threatening aorta rupture. These statistics can help individuals weigh the benefits and risks when considering joining a trial or undergoing the surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two very different approaches to managing thoracic aortic aneurysms: active surgical intervention and careful monitoring. The surgical option offers a direct intervention by repairing the aneurysm, potentially preventing life-threatening complications. On the other hand, the surveillance approach allows doctors to track the aneurysm's progression through regular CT scans, reserving surgery for when it becomes absolutely necessary. This trial could reveal valuable insights into the effectiveness and safety of immediate surgery versus a more conservative, watchful waiting strategy, potentially reshaping how patients with thoracic aortic aneurysms are treated in the future.

What evidence suggests that this trial's treatments could be effective for thoracic aortic aneurysm?

This trial will compare surgery with surveillance for thoracic aortic aneurysm. Research has shown that surgery on the chest's main artery can lower the risk of serious health issues for people with enlarged arteries. Although surgery may pose more immediate risks, it can reduce the long-term risk of death. For example, those who undergo surgery often experience fewer strokes and other major problems than those who do not. This suggests that early surgery might be more effective at preventing dangerous artery issues than surveillance alone. Overall, surgery could lead to a longer life and fewer complications for individuals with an enlarged main artery in the chest. ^{6 7 8 9 10}

Who Is on the Research Team?

Jehangir Appoo, MD

Principal Investigator

University of Calgary

Munir Boodhwani, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

This trial is for adults aged 18-79 with an ascending aortic aneurysm measuring between 5.0 and 5.4 cm, who can provide informed consent and commit to follow-up. It excludes those unfit for surgery, with certain medical conditions or previous cardiac surgeries, pregnant women, or those with rapid aneurysm growth.

Inclusion Criteria

My aortic aneurysm is between 5.0cm and 5.4cm in size.

My aortic aneurysm is being monitored and will be eligible for the trial once it reaches 5.0 cm.

Exclusion Criteria

I am pregnant or planning to become pregnant.

I am unable to understand or sign the consent form.

You have a known connective tissue disease, such as Marfan syndrome, Loey-Dietz syndrome, or Turner syndrome.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Randomization and Pre-treatment

Patients are randomized to either the early surgery group or the surveillance group. Baseline assessments and pre-randomization evaluations are conducted.

10-12 weeks

1 visit (in-person)

Treatment/Surveillance

Patients in the surgery group undergo elective aortic surgery, while those in the surveillance group are monitored with CT scans and medical therapy.

2 years

Annual visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment or surveillance, with assessments of mortality and acute aortic events.

2 years

Annual visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Thoracic Aortic Surgery

Trial Overview

The TITAN SvS trial randomly assigns patients to either early elective surgery to replace the enlarged part of the aorta or close monitoring (surveillance). The goal is to see which approach better reduces death and aortic tearing/rupture after two years.

How Is the Trial Designed?

Group I: Surgery/Treatment Arm Experimental Treatment 1 Intervention

Patients in the Operative Registry will have thoracic aortic surgery

Group II: Surveillance Arm Active Control 1 Intervention

Patients in the Non-Operative Registry will be followed in clinic annually with a CT scan to monitor the status of their ascending aortic aneurysm, until the end of the study, the occurrence of an aortic event, or death.

Thoracic Aortic Surgery is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Thoracic Aortic Surgery for:

• Thoracic aortic aneurysm
• Ascending aortic aneurysm
• Descending thoracic aortic aneurysm

Approved in European Union as Thoracic Aortic Surgery for:

• Thoracic aortic aneurysm
• Ascending aortic aneurysm
• Descending thoracic aortic aneurysm

Approved in Canada as Thoracic Aortic Surgery for:

• Thoracic aortic aneurysm
• Ascending aortic aneurysm
• Descending thoracic aortic aneurysm

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Collaborator

Trials

26

Recruited

6,300+

Hamilton General Hospital

Collaborator

Trials

2

Recruited

1,700+

Montreal Heart Institute

Collaborator

Trials

125

Recruited

85,400+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

McGill

Collaborator

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

Thoracic endovascular aortic repair (TEVAR) has shown reduced early morbidity and mortality rates compared to traditional open surgical repair for various thoracic aortic diseases, based on multiple case-series studies and reviews.

However, there is insufficient high-quality clinical data to demonstrate an improvement in long-term overall survival for patients undergoing TEVAR, highlighting the need for more rigorous randomized-controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracic endovascular aortic repair--indications and evidence. Cao, CQ., Bannon, PG., Shee, R., et al.[2022]

In a study of 150 patients undergoing either endovascular repair (TEVAR) or open surgical repair (OSR) for thoracic aortic aneurysms, TEVAR was found to have lower total costs from admission to discharge (£34,020) compared to OSR (£45,875), despite higher initial procedure costs due to device expenses.

While TEVAR had lower postoperative costs and shorter hospital stays, its follow-up costs over 12 months were slightly higher (£5,206) compared to OSR (£5,039), mainly due to hospital readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Costs of endovascular and open repair of thoracic aortic aneurysms. Gray, J., McCarthy, A., Samarakoon, D., et al.[2023]

Thoracic endovascular aortic repair (TEVAR) significantly reduces early complications such as all-cause mortality at 30 days (odds ratio 0.44) and paraplegia (odds ratio 0.42) compared to open surgical repair, based on a meta-analysis of 42 studies involving 5,888 patients.

TEVAR also leads to fewer cardiac complications, transfusions, and shorter hospital stays, although there is no significant difference in long-term outcomes like stroke or mortality beyond one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular aortic repair versus open surgical repair for descending thoracic aortic disease a systematic review and meta-analysis of comparative studies. Cheng, D., Martin, J., Shennib, H., et al.[2018]

In a study of 759 patients over 50 years old undergoing repair for descending thoracic aortic aneurysms, operative mortality rates were similar for both thoracic endovascular aortic repair (TEVAR) and open surgery, at 6.5% and 7.6% respectively.

However, TEVAR was associated with a significantly worse 5-year survival rate (54.2% compared to 65.6% for open repair) and a higher rate of aortic-related reinterventions (23.1% vs. 14.3%), suggesting potential long-term complications and the need for further procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes after endovascular or open repair for degenerative descending thoracic aortic aneurysm using linked hospital data. von Allmen, RS., Anjum, A., Powell, JT.[2014]

In a study of 72 patients undergoing thoracic endovascular aortic repair (TEVAR) over 13 years, the procedure showed promising survival rates with 93% at one month, 88% at one year, and 63% at five years, indicating its efficacy for treating thoracic aorta disorders.

The study reported a low complication rate, with only 7% of patients experiencing mortality within 30 days, primarily due to vascular issues, and emphasized the importance of considering revascularization of the left subclavian artery to prevent complications like subclavian steal syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of the Endovascular Management of Thoracic Aortic Pathology. Bell, D., Bassin, L., Neale, M., et al.[2015]

In a study of 3,705 patients with intact descending thoracic aortic aneurysms, TEVAR (thoracic endovascular aortic repair) was associated with lower early postoperative mortality compared to open surgical repair, making it a safer initial treatment option.

While open surgical repair showed a lower risk of needing further interventions later on, TEVAR resulted in better overall survival rates at 9 years, suggesting it should be the preferred method for treating these aneurysms in Medicare beneficiaries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular Versus Open Repair of Intact Descending Thoracic Aortic Aneurysms. Chiu, P., Goldstone, AB., Schaffer, JM., et al.[2020]

TEVAR (thoracic endovascular aortic repair) shows significantly lower early mortality and fewer complications like stroke and renal failure compared to open surgical repair (OSR) for thoracic aortic aneurysms, based on a systematic review of 15 studies.

However, OSR has a lower rate of re-intervention in the mid-to-long term, and long-term survival outcomes are inconsistent, indicating that the choice between TEVAR and OSR should consider individual patient factors and preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of endovascular versus open surgical repair for thoracic aortic aneurysm: a systematic review and meta-analysis. Mahboub-Ahari, A., Sadeghi-Ghyassi, F., Heidari, F.[2022]

TEVAR is a safe and effective treatment for thoracic aorta diseases, showing excellent long-term survival rates, especially in patients with traumatic aortic injury, where no late deaths occurred.

Long-term survival rates vary based on the type of aortic pathology, with patients who had previous type-A dissection treatment showing the lowest survival rate (50% at 5 years), while those with aneurysmatic aortic disease had a 55% survival rate at 5 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes and Risk Factors Analysis for Patients Undergoing Thoracic Endovascular Aorta Repair (TEVAR), According to the Aortic Pathologies. Gallo, M., van den Berg, JC., Torre, T., et al.[2023]

In a study of 50 patients who underwent open repair after thoracic endovascular aortic repair (TEVAR), the most common reasons for the subsequent surgery included type 1 endoleaks and retrograde aortic dissection, indicating that these complications can arise from TEVAR.

The open repair procedures were performed safely, with a low hospital mortality rate of 6% and no strokes reported, suggesting that while these surgeries are complex, they can lead to good early outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open aortic repair after prior thoracic endovascular aortic repair. Roselli, EE., Abdel-Halim, M., Johnston, DR., et al.[2014]

In a study of 8967 patients undergoing elective repair of thoracic aortic aneurysms, endovascular repair (TEVAR) was associated with a 46% lower risk of death compared to open repair, highlighting its safety and efficacy.

Patients who underwent TEVAR also experienced significantly fewer postoperative complications, including neurologic (48% lower odds), cardiac (76% lower odds), and respiratory complications (62% lower odds), making it a preferable option for surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open versus endovascular repair of thoracic aortic aneurysms: a Nationwide Inpatient Sample study. Hughes, K., Guerrier, J., Obirieze, A., et al.[2014]

Thoracic endovascular aortic repair (TEVAR) is increasingly used for treating thoracic aortic conditions, especially in younger patients who will require long-term postoperative monitoring.

There is ongoing debate about the best methods and frequency of surveillance after TEVAR due to challenges like the inaccessibility of the thoracic aorta for ultrasound, risks of radiation exposure, and complications from contrast use in imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of mandatory lifelong annual surveillance after thoracic endovascular repair. Wong, S., Mastracci, TM., Katsargyris, A., et al.[2012]

In a study of 66 patients undergoing thoracic endovascular aortic repair (TEVAR), the procedure demonstrated acceptable mortality (10.61% at 30 days) and reintervention rates (21.21%), suggesting it is a feasible option for treating complex thoracic aortic diseases.

Underweight patients faced significantly higher risks of complications and endoleak compared to those with higher body mass index, indicating that body weight may influence postoperative outcomes in TEVAR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Clinical Impact of Thoracic Endovascular Aortic Repair in the Management of Thoracic Aortic Diseases. Molano, F., Rey Chaves, CE., Conde, D., et al.[2023]

In a study of 16 patients undergoing thoracic endovascular aortic repair (TEVAR), the procedure achieved a primary technical success rate of 93.75%, with complete exclusion of the aneurysm in 15 patients and no operative mortality.

Despite some complications, including four perioperative strokes (with three patients fully recovering), the intermediate-term outcomes were positive, suggesting that TEVAR could be safely extended to treat a wider range of thoracic aortic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracic EndoVascular Stent Graft Repair for Aortic Aneurysm. Kim, JT., Yoon, YH., Lim, HK., et al.[2022]

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sciencedirect.com

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