One-Stop Hybrid Versus Conventional Surgery for Acute Type A Aortic Dissection: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 140
- Locations
- 2
- Primary Endpoint
- Incidence of the Composite Endpoint of 30-day Mortality, Stroke, and Acute Kidney Injury (Stage 2 or 3)
Study Overview
Brief Summary
This is a prospective, randomized controlled trial designed to compare the clinical efficacy and short-term outcomes of one-stop hybrid surgery versus conventional total arch replacement with frozen elephant trunk (FET) in patients with acute Stanford Type A Aortic Dissection. The study evaluates differences in perioperative metrics, postoperative complications, 30-day survival, aortic remodeling, and quality of life.
Detailed Description
Stanford Type A Aortic Dissection (TAAD) is a life-threatening condition requiring urgent surgical repair. This study tests the hypothesis that a one-stop hybrid surgery protocol is superior to conventional repair. 140 patients with acute TAAD were randomized to one of two groups. The experimental group received a one-stop hybrid surgery, which combines open total arch replacement using a standard branched surgical graft with the antegrade deployment of a separate stent graft, performed under moderate hypothermia. The active comparator group underwent conventional total arch replacement using an integrated frozen elephant trunk (FET) hybrid prosthesis, performed under deep hypothermic circulatory arrest. The study's main objective is to compare key clinical outcomes between the two surgical strategies, including a primary composite endpoint of 30-day mortality, stroke, and acute kidney injury, to provide evidence on the optimal surgical approach for this high-risk population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-70 years.
- •Diagnosis of acute TAAD (symptom onset <72 hours) confirmed by imaging, with dissection involving the aortic arch requiring total arch replacement.
- •Relative hemodynamic stability, defined as a systolic blood pressure >90 mmHg without high-dose vasopressor support (norepinephrine >0.1 µg/kg/min).
- •Provision of informed consent.
Exclusion Criteria
- •Age >70 years.
- •Stanford type B or non-dissection pathologies.
- •Life-threatening comorbidities prohibitive of major cardiac surgery (e.g., advanced multiorgan failure from other causes, active malignancy).
- •Absolute contraindications to surgery.
- •History of previous ascending aorta or aortic arch surgery.
- •Inability to provide informed consent.
Arms & Interventions
Experimental: Hybrid Group (n=70)
Patients were randomized to undergo one-stop hybrid surgery, which included total aortic arch replacement with a standard 4-branched artificial vascular graft combined with antegrade stent grafting of the proximal descending aorta, performed in a single stage under moderate hypothermia (approx. 28°C).
Intervention: One-Stop Hybrid Surgery (Procedure)
Active Comparator: Conventional Group (n=70)
Patients were randomized to undergo conventional total arch replacement using an integrated frozen elephant trunk (FET) hybrid prosthesis. The procedure was performed under deep hypothermic circulatory arrest (target temperature 23°C-25°C).
Intervention: Conventional Total Arch Replacement with Frozen Elephant Trunk (Procedure)
Outcomes
Primary Outcomes
Incidence of the Composite Endpoint of 30-day Mortality, Stroke, and Acute Kidney Injury (Stage 2 or 3)
Time Frame: Within 30 days post-procedure
A composite outcome measure including all-cause mortality, any new focal neurological deficit lasting \>24 hours and confirmed by imaging (stroke), and acute kidney injury defined as Stage 2 or 3 by KDIGO criteria. The measure is the percentage of patients in each group who experience at least one of these events.
Incidence of the Composite Endpoint of 30-day Mortality, Stroke, and Acute Kidney Injury (Stage 2 or 3)
Time Frame: Within 30 days post-procedure
A composite outcome measure including all-cause mortality, any new focal neurological deficit lasting \>24 hours and confirmed by imaging (stroke), and acute kidney injury defined as Stage 2 or 3 by KDIGO criteria. The measure is the percentage of patients in each group who experience at least one of these events.
Secondary Outcomes
- All-Cause Mortality at 30 Days(Within 30 days post-procedure)
- Incidence of Postoperative Stroke(Within 30 days post-procedure)
- Incidence of Stage ≥2 Acute Kidney Injury (AKI)(Within 30 days post-procedure)
- Operative Metrics(Intraoperative)
- Duration of Mechanical Ventilation(During the postoperative hospital stay (up to 30 days post-procedure))
- Incidence of Other Major Postoperative Complications(During hospital stay (up to 30 days post-procedure))
- Change in Aortic Morphology Score(1 Month Post-procedure, 3 Months Post-procedure)
- Change in Quality of Life(3 Months Post-procedure)
- Incidence of Endoleak(1 Month Post-procedure, 3 Months Post-procedure)
- Incidence of Cardiovascular Events(Through study completion (3 months))
- Length of Intensive Care Unit (ICU) Stay(During the postoperative hospital stay (up to 30 days post-procedure))
- Total Postoperative Hospital Stay(During the postoperative hospital stay (up to 30 days post-procedure))
- All-Cause Mortality at 30 Days(Within 30 days post-procedure)
- Incidence of Postoperative Stroke(Within 30 days post-procedure)
- Incidence of Stage ≥2 Acute Kidney Injury (AKI)(Within 30 days post-procedure)
- Operative Metrics(Intraoperative)
- Duration of Mechanical Ventilation(During the postoperative hospital stay (up to 30 days post-procedure))
- Incidence of Other Major Postoperative Complications(During hospital stay (up to 30 days post-procedure))
- Change in Aortic Morphology Score(1 Month Post-procedure, 3 Months Post-procedure)
- Change in Quality of Life(3 Months Post-procedure)
- Incidence of Endoleak(1 Month Post-procedure, 3 Months Post-procedure)
- Incidence of Cardiovascular Events(Through study completion (3 months))
- Length of Intensive Care Unit (ICU) Stay(During the postoperative hospital stay (up to 30 days post-procedure))
- Total Postoperative Hospital Stay(During the postoperative hospital stay (up to 30 days post-procedure))
Investigators
Qi Hu
Principal investigator
The First Hospital of Hebei Medical University