An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with acute type A aortic dissection (ATAAD) and malperfusion syndrome (MPS). Objectives: The present study aimed to investigate the difference in all-cause mortality after optimized treatment strategies (OTS) versus traditional treatment strategies (TTS) for ATAAD patients with MPS. Background: The mortality of ATAAD with MPS is high. However, the management strategies of MPS patients still not to be confirmed. Compare with TTS, OTS as a strategy for ATAAD patients with MPS might have be beneficial results.
A total of 236 subjects with ATAAD complicated with MPS who met inclusion criteria and do not have any exclusion criterion will be randomized to optimized treatment strategies (OTS) group and traditional treatment strategies (TTS) group. 1. Patients randomized to OTS group will be treated with optimized treatment strategies. The optimized strategies based on 6-hour threshold from symptom onset. For malperfused patients with symptom onset within 6 hours, central repair will be performed immediately. Additional stenting will be used in patients with persistent malperfusion. For malperfused patients with symptom onset beyond 6 hours, individualized delayed central repair according to the different types of MPS will be performed after organ function improved and the patient could tolerate central repair. 2. Patients randomized to TTS group will treated with traditional treatment strategies. Immediate central repair will performed for patients with coronary and cerebral malperfusion syndrome. However, for patients with mesenteric and lower extremity malperfusion syndrome, interventional therapy will be administered through fenestration and/or stenting to first alleviate organ ischemia. Once the patients had a resolution of organ failure, corrective open aortic repair will be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
236
The optimized strategies based on 6-hour threshold from symptom onset. For malperfused patients with symptom onset within 6 hours, central repair will be performed immediately. Additional stenting will be used in patients with persistent malperfusion. For malperfused patients with symptom onset beyond 6 hours, individualized delayed central repair according to the different types of MPS will be performed after organ function improved and the patient could tolerate central repair.
Immediate central repair will be performed for patients with coronary and cerebral malperfusion syndrome. However, for patients with mesenteric and lower extremity malperfusion syndrome, interventional therapy will be administered through fenestration and/or stenting to first alleviate organ ischemia. Once the patients had a resolution of organ failure, corrective open aortic repair will be performed.
Xiamen Cardiovascular Hospital at Xiamen University
Xiamen, Fujian, China
Operative Mortality (OM)
Patients who died within 30 days
Time frame: 30-day
Rate of composite of Major Adverse Events (MAE)
Number of participants with MAE which will include the composite rate of low cardiac output syndrome, new cerebrovascular accident, intestinal ischemia, lower limb necrosis, multiple organ failure according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
Time frame: 30-day
Rate of composite of Major Adverse Pulmonary Events (MAPE)
Number of participants with MAPE which will include the composite rate of intubation \>48 hours, pneumonia, reintubation, tracheostomy according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
Time frame: 30-day
Rate of reintervention
The number of participants who will require reoperation for distal aorta
Time frame: 3 year
Mid-term survival
The secondary endpoint of the study is the evaluation of mid-term survival
Time frame: 3 year
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