TEVAR + BMT for Aortic Dissection

(ACUTE-B Trial)

Recruiting at 1 trial location

Overseen By Kristofer M Charlton-Ouw, MD, FACS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must be taking: Intravenous antihypertensives

Disqualifiers: Type A dissection, Chronic dissection, Aneurysm, 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: Unknown

Duration: 5 years

436 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for individuals recently diagnosed with uncomplicated acute type B aortic dissection, a serious condition involving a tear in the inner layer of the aorta. The study compares the effectiveness of the best medical therapy (BMT) alone versus BMT combined with thoracic endovascular aortic repair (TEVAR), a minimally invasive procedure to fix the tear. Ideal participants have received this diagnosis within the last 30 days, manage their pain and blood pressure with up to three medications, and have not experienced complications such as organ problems or severe pain. As an unphased trial, this study allows participants to contribute to important research that could improve treatment options for future patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have their pain and blood pressure controlled with up to three intravenous antihypertensive medications, which suggests that some medication adjustments might be necessary.

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

Research has shown that thoracic endovascular aortic repair (TEVAR) is generally safe and well-tolerated. Studies indicate that patients undergoing TEVAR for uncomplicated type B aortic dissection tend to have positive outcomes. For example, one study found survival rates of 100% after one year, 97.1% after three years, and 92.6% after five years, suggesting that TEVAR maintains its safety over time.

Another study reported excellent results both shortly after the procedure and in the long term, with few complications. Most patients recover well and experience minimal issues after treatment, though complications, while rare, can occur.

Overall, the evidence suggests that TEVAR is a promising treatment option with a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatment combining thoracic endovascular aortic repair (TEVAR) with the best medical therapy (BMT) for aortic dissection because it offers a potentially more comprehensive approach than BMT alone. Unlike the standard care that typically relies on managing blood pressure and symptoms with medication, TEVAR provides a minimally invasive method to directly repair the aorta. This dual approach not only aims to stabilize the condition medically but also structurally supports the aorta, potentially reducing the risk of complications and improving long-term outcomes.

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

Research has shown that thoracic endovascular aortic repair (TEVAR) effectively treats aortic dissection. One study found that 83% of patients who underwent TEVAR were alive after 10 years, with 92.3% surviving without aortic-related issues. Another study revealed that TEVAR had a significantly lower death rate within 30 days compared to medication alone. Long-term studies reported survival rates of 92.5% at 1 year, 84.1% at 5 years, and still high at 10 years. In this trial, one group of participants will receive TEVAR in addition to the best medical therapy (BMT), while another group will receive BMT alone. These findings suggest that combining TEVAR with the best medical care could improve outcomes for patients with uncomplicated acute type B aortic dissection. ^{4 6 7 8 9}

Who Is on the Research Team?

Kristofer M Charlton-Ouw, MD, FACS

Principal Investigator

University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a recent (≤30 days old) uncomplicated acute type B aortic dissection, who've been stabilized and can follow the study plan. It's not for those with complicated cases, other health trials soon, severe kidney issues, recent major health events like heart attacks or strokes, pregnant/breastfeeding women, or certain genetic disorders.

Inclusion Criteria

Meets criteria for inclusion in the National Death Index and Social Security Death Master File

Adequate imaging, e.g., CT with contrast (chest + abdomen+ pelvis) is available prior to enrollment

I was diagnosed with a specific type of aortic dissection within the last 30 days and it's not causing severe complications.

Exclusion Criteria

I'm sorry, but I'm not familiar with the term "complicated ABAD." It seems to be a specific medical term or acronym that I'm not aware of. If you could provide more context or details, I'd be happy to help rewrite the criterion in simpler language.

My anatomy is not suitable for a specific type of vascular surgery.

I have not had a stroke in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly allocated to either best medical therapy (BMT) alone or BMT with thoracic endovascular aortic repair (TEVAR)

5 years

Follow-up

Participants are monitored for safety, effectiveness, and quality of life changes after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• BMT
• BMT+TEVAR

Trial Overview

The study compares two treatments for acute type B aortic dissection: standard best medical therapy (BMT) alone versus BMT combined with thoracic endovascular aortic repair (TEVAR). Participants will be randomly assigned to one of these treatment groups.

How Is the Trial Designed?

Group I: BMT+TEVAR Experimental Treatment 1 Intervention

Patients in this group will be managed with thoracic endovascular aortic repair (TEVAR) in addition to the best medical therapy (BMT)

Group II: BMT Alone Active Control 1 Intervention

Patients in this group will be managed with the best medical therapy (BMT) alone

BMT+TEVAR is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as TEVAR for:

• Thoracic aortic aneurysm
• Type B aortic dissection
• Penetrating atherosclerotic ulcers of thoracic aorta

Approved in United States as TEVAR for:

• Descending thoracic aortic aneurysms
• Type B aortic dissections

Approved in Canada as TEVAR for:

• Thoracic aortic aneurysm
• Type B aortic dissection

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

Thoracic endovascular aortic repair (TEVAR) did not show a significant advantage in 30-day mortality rates compared to best medical therapy (BMT) for treating uncomplicated type B aortic dissection (TBAD), indicating similar short-term safety profiles.

While TEVAR did not significantly improve 1- or 2-3 year survival rates compared to BMT, there was a trend towards better 4- or 5-year survival with TEVAR, suggesting potential long-term benefits that require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracic endovascular aortic repair or best medical therapy for uncomplicated type B aortic dissection? A meta-analysis. Yang, J., Shi, Y., Jiang, J.[2022]

In a study of 90 patients with acute uncomplicated type B aortic dissection, combining thoracic endovascular aortic repair (TEVAR) with Best Medical Therapy (BMT) significantly improved long-term survival rates compared to BMT alone.

The study found that patients receiving the combined treatment had a higher incidence of false lumen thrombosis, indicating a more favorable outcome in managing the condition, with both groups reaching median survival after 24 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular Repair of the Thoracic Aorta Combined with Drug Therapy in Acute Uncomplicated Type B Aortic Dissection. Wei, L., Meng, Y., Zhang, G., et al.[2023]

In a study of 357 patients with acute uncomplicated type B aortic dissection, those who underwent thoracic endovascular aortic repair (TEVAR) had a significantly lower risk of late death and fewer aortic ruptures compared to those receiving best medical treatment (BMT) over a 5-year period.

Although TEVAR had higher early adverse event rates, it showed better long-term outcomes, with 91.9% freedom from all-cause mortality and 94.1% freedom from aortic-related mortality at 5 years, suggesting it may be the preferred treatment option for improving outcomes in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of mid-term outcomes of endovascular repair and medical management in patients with acute uncomplicated type B aortic dissection. Xiang, D., Kan, X., Liang, H., et al.[2022]

In a study of 338 patients with uncomplicated type B acute aortic dissection, those treated with thoracic endovascular aortic repair (TEVAR) experienced significantly lower all-cause mortality compared to those receiving best medical treatment (BMT).

TEVAR also resulted in fewer aortic-related adverse events than BMT, indicating it may be a more effective intervention for improving long-term outcomes in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular Repair Compared With Medical Management of Patients With Uncomplicated Type B Acute Aortic Dissection. Qin, YL., Wang, F., Li, TX., et al.[2022]

Thoracic endovascular aortic repair (TEVAR) for complicated acute and chronic type B aortic dissections showed a 100% primary technical success rate, with low in-hospital and 30-day complication rates (2% for death and paraplegia).

While TEVAR is effective, it requires more secondary interventions and imaging follow-up compared to traditional open surgery, with a composite reintervention rate of 23.4% during a median follow-up of 7.1 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midterm results for endovascular repair of complicated acute and chronic type B aortic dissection. Parsa, CJ., Schroder, JN., Daneshmand, MA., et al.[2022]

In a study of 140 patients with stable type B aortic dissection, thoracic endovascular aortic repair (TEVAR) did not significantly improve 2-year survival rates compared to optimal medical therapy alone, with survival rates of 95.6% for medical therapy versus 88.9% for TEVAR.

While TEVAR showed a significant improvement in aortic remodeling (91.3% of patients experienced positive changes) compared to only 19.4% in the medical treatment group, it was associated with a higher incidence of neurological adverse events, indicating that the procedure may carry risks without clear survival benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized comparison of strategies for type B aortic dissection: the INvestigation of STEnt Grafts in Aortic Dissection (INSTEAD) trial. Nienaber, CA., Rousseau, H., Eggebrecht, H., et al.[2022]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36690933/

Long-term outcomes of thoracic endovascular aortic repair ...

The overall 10-years survival rate was 83% (6 of 48), and the aortic-related survival rate was 92.3% (3 of 48). Conclusions: TEVAR is a safe and ...

2.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.122.026914

Long‐Term Outcomes of Chronic Type B Aortic Dissection ...

This study aimed to analyze the 5-year clinical outcomes of thoracic endovascular aortic repair of chronic type B aortic dissection.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2589004223024367

Article Long-term survival and risk analysis of thoracic ...

The cumulative overall survival rates for the thoracic endovascular aortic repair group at 1 year, 5 years, and 10 years were 92.5%, 84.1%, and ...

4.

jvascsurg.org

jvascsurg.org/article/S0741-5214(22)02105-X/fulltext

Outcomes of thoracic endovascular aortic repair for ...

The study reported 3-year all-cause mortality (18%, 4%, and 24%), dissection-related mortality (12%, 4%, and 9%), and aortic reintervention ...

5.

bmcsurg.biomedcentral.com

bmcsurg.biomedcentral.com/articles/10.1186/s12893-024-02555-4

Efficacy of thoracic endovascular aortic repair versus medical ...

Results. Thirty-two cohort studies including 150,836 patients were included. TEVAR was associated with a significantly lower 30-day mortality ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10682288/

Long-term survival and risk analysis of thoracic ...

The cumulative overall survival rates for the thoracic endovascular aortic repair group at 1 year, 5 years, and 10 years were 92.5%, 84.1%, and ...

7.

frontiersin.org

frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2024.1442800/full

Safe and favorable prognosis of thoracic endovascular ...

Short-and long-term outcomes of TEVAR for uncomplicated TBAD with a small aortic aneurysm were excellent, with few postoperative complications.

8.

jvascsurg.org

jvascsurg.org/article/S0741-5214(23)00438-X/fulltext

Safety and efficacy of thoracic endovascular aortic repair ...

The overall cumulative survival rates were 100% at 1 year, 97.1% at 3 years, and 92.6% at 5 years. Four of 52 patients (7.7%) developed ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12282756/

Outcomes following extended thoracic endovascular aortic ...

This study evaluated the short- to longer-term safety and efficacy of extended thoracic endovascular aortic repair for Type B aortic dissection.