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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,100
Thoracic endovascular aortic repair
Routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.
All-cause death or major aortic complications (MAC)
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
Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Quality of Life, as measured by the Abdominal Aortic Aneurysm Quality of Life questionnaire (AAAQol)
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.
Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Cumulative incidence of cardiovascular (CV) hospitalizations
CV hospitalization will be defined as hospitalization \>/= 24 hours for any cardiovascular cause.
Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Mean number of cardiovascular (CV) hospitalizations
CV hospitalization will be defined as hospitalization \>/= 24 hours for any cardiovascular cause.
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University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGHonorhealth
Phoenix, Arizona, United States
RECRUITINGMemorial Care Long Beach Medical Center
Long Beach, California, United States
RECRUITINGKeck Medical Center of USC
Los Angeles, California, United States
RECRUITINGUniversity of California San Diego
San Diego, California, United States
WITHDRAWNUniversity of California
San Francisco, California, United States
RECRUITINGStanford University Medical Center
Stanford, California, United States
WITHDRAWNUniversity of Colorado Denver
Aurora, Colorado, United States
RECRUITINGMemorial Hospital Central
Colorado Springs, Colorado, United States
RECRUITINGHartford Hospital
Hartford, Connecticut, United States
RECRUITING...and 52 more locations
Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Incidence of cardiovascular death
Death from any cardiovascular cause.
Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Incidence of all-cause death
Death from any case
Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Cumulative incidence of major aortic complications (MAC)
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
Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Incidence of stroke
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.
Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Incidence of paraplegia or paraparesis
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.
Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Incidence of vascular access injury requiring surgical repair
Defined as any open surgical procedure to treat a vascular injury at the site of vascular access for a previous endovascular procedure.
Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Incidence of aortobronchial / aortoesophageal fistula
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).
Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Incidence of retrograde type A dissection
Defined as any new ascending arch, or descending dissection contiguous with and proximal to the original presenting anatomy as confirmed by imaging.
Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Incidence of aortic-related death
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.
Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Number of days alive and out of the hospital
Defined as the number of days alive minus the number of days in the hospital over 4 years (primary analysis).
Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Incidence of secondary percutaneous interventions after TEVAR
Any secondary percutaneous intervention after TEVAR
Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years