Type B Aortic Dissection
Conditions
Keywords
TEVAR
Brief summary
The goal of this clinical trial is to determine whether an upfront invasive strategy of TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy with surveillance for deterioration in patients with uncomplicated type B aortic dissection.
Detailed description
The study will be a prospective, pragmatic, randomized clinical trial of the comparative effectiveness of an initial strategy for the treatment of uncomplicated type B aortic dissection (uTBAD). Patients with uTBAD and no prior history of aortic intervention will be randomized within 48 hours to 6 weeks after index admission to one of the two initial strategies. Follow-up will be ascertained via a centralized call center and ascertainment of medical records, as well as remote blood pressure monitoring. Recommendations regarding medical therapy will be made to enrolling centers and feedback on the quality of medical care given, however, all subsequent care, with the exception of aortic interventions, will be at the discretion of the responsible clinical care team. Aortic interventions will allowable only as per protocol.
Interventions
PROCEDURETEVAR
Thoracic endovascular aortic repair
OTHERGuideline directed medical therapy and surveillance of dissection
Routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.
Sponsors
Duke University
The University of Texas Health Science Center, Houston
State University of New York - Downstate Medical Center
Oregon Health and Science University
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 21 years 2. Patients with a Stanford type B aortic dissection not involving the aorta at or proximal to the innominate artery, without rupture and/or malperfusion syndrome (renal, mesenteric, or extremity) who are within 48 hours to 6 weeks after start of index admission for their type B dissection 3. Ability to provide written informed consent 4. Investigator believes anatomy is suitable for TEVAR
Exclusion criteria
1. Ongoing systemic infection 2. Pregnant or planning to become pregnant in the next 3 months 3. Life expectancy related to non-aortic conditions \< 2 years 4. Unwilling or unable to comply with all study procedures 5. Known patient history of genetic aortopathy 6. Penetrating Aortic Ulcer without concomitant uTBAD 7. Intramural hematoma without concomitant uTBAD 8. Iatrogenic (traumatic) aortic dissection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death or major aortic complications (MAC) | Last follow-up timepoint. Differential follow-up with median of about 4 years | The primary endpoint is a composite of all-cause death or major aortic complications (MAC). MACs are defined as: * Aortic rupture * Malperfusion syndrome * New aortic tear requiring intervention, * Retrograde aortic dissection, * Dependence on outpatient dialysis (chronic) * Major amputation (above ankle) * Tracheostomy * fistula formation (e.g., aorto-esophageal, aorto-tracheal) * Spinal Cord Ischemia with paralysis or paresis * Stroke * AD-related intervention in either group defined as: * Open TAA/TAAA Repair * Fenestrated and/or Branched Endovascular Repair of TAAA * Repeat TEVAR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life, as measured by the Abdominal Aortic Aneurysm Quality of Life questionnaire (AAAQol) | Last follow-up timepoint. Differential follow-up with median of about 4 years | An adapted version of the AAAQol survey and the PROMIS-16 will be used to assess general and aortic specific quality of life. The AAAQol questionnaire was specifically developed and validated on patients with abdominal aortic aneurysms and measures both the physical and emotional impact of either 1) having an abdominal aortic aneurysm or 2) having surgical or endovascular therapy for an abdominal aortic aneurysm. This metric has been shown to be valid and responsive in abdominal aortic aneurysm. While it has not been tested in aortic dissection, its questions assess the same domains shown to be significantly impacted in patients with aortic dissection. |
| Cumulative incidence of cardiovascular (CV) hospitalizations | Last follow-up timepoint. Differential follow-up with median of about 4 years | CV hospitalization will be defined as hospitalization \>/= 24 hours for any cardiovascular cause. |
| Mean number of cardiovascular (CV) hospitalizations | Last follow-up timepoint. Differential follow-up with median of about 4 years | CV hospitalization will be defined as hospitalization \>/= 24 hours for any cardiovascular cause. |
| Incidence of cardiovascular death | Last follow-up timepoint. Differential follow-up with median of about 4 years | Death from any cardiovascular cause. |
| Incidence of all-cause death | Last follow-up timepoint. Differential follow-up with median of about 4 years | Death from any case |
| Cumulative incidence of major aortic complications (MAC) | Last follow-up timepoint. Differential follow-up with median of about 4 years | Composite endpoint. MACs are defined as: • Aortic rupture • Malperfusion syndrome • New aortic tear requiring intervention, • Retrograde aortic dissection, • Dependence on outpatient dialysis (chronic) • Major amputation (above ankle) • Tracheostomy • fistula formation (e.g., aorto-esophageal, aorto-tracheal) • Spinal Cord Ischemia with paralysis or paresis • Stroke • AD-related intervention in either group defined as: - Open TAA/TAAA Repair - Fenestrated and/or Branched Endovascular Repair of TAAA - Repeat TEVAR |
| Incidence of stroke | Last follow-up timepoint. Differential follow-up with median of about 4 years | Defined as a focal neurological deficit that could be attributed to a vascular territory and lasted \>24 hours or was associated with a new lesion on computed tomography scan or magnetic resonance imaging. |
| Incidence of paraplegia or paraparesis | Last follow-up timepoint. Differential follow-up with median of about 4 years | Defined as including: 1) flaccid paraplegia (no lower extremity movement), or lower extremity movement without gravity, or lower extremity movement with gravity, or standing with assistance or walking with assistance. |
| Incidence of vascular access injury requiring surgical repair | Last follow-up timepoint. Differential follow-up with median of about 4 years | Defined as any open surgical procedure to treat a vascular injury at the site of vascular access for a previous endovascular procedure. |
| Incidence of aortobronchial / aortoesophageal fistula | Last follow-up timepoint. Differential follow-up with median of about 4 years | Defined as fistulous connection between the aorta and bronchus as confirmed by chest imaging or direct visualization (surgical or bronchoscopic). Aortoesophageal fistula is defined as a fistulous connection between the aorta and the esophagus as confirmed by chest imaging or direct visualization (surgical or endoscopically). |
| Incidence of retrograde type A dissection | Last follow-up timepoint. Differential follow-up with median of about 4 years | Defined as any new ascending arch, or descending dissection contiguous with and proximal to the original presenting anatomy as confirmed by imaging. |
| Incidence of aortic-related death | Last follow-up timepoint. Differential follow-up with median of about 4 years | Aortic-related death will be defined as death within 30 days of 1) diagnosis of aortic dissection 2) any aortic intervention or 3) ruptured aortic aneurysm. |
| Number of days alive and out of the hospital | Last follow-up timepoint. Differential follow-up with median of about 4 years | Defined as the number of days alive minus the number of days in the hospital over 4 years (primary analysis). |
| Incidence of secondary percutaneous interventions after TEVAR | Last follow-up timepoint. Differential follow-up with median of about 4 years | Any secondary percutaneous intervention after TEVAR |
Countries
Canada, United States
Contacts
CONTACTMegan Roebuck, M.S.
CONTACTKady-Ann Steen-Burrell, Ph.D.
PRINCIPAL_INVESTIGATORManesh R Patel, M.D.
Duke University
PRINCIPAL_INVESTIGATORFiras F Mussa, M.D.
The University of Texas at Houston
PRINCIPAL_INVESTIGATORPanos Kougias, M.D.
The State University of New York at Downstate
PRINCIPAL_INVESTIGATORSreekanth Vemulapalli, M.D.
Duke University
PRINCIPAL_INVESTIGATORSean O'Brien, Ph.D.
Duke University
Outcome results
None listed