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Intensive blood pressure control in patients with acute type B aortic dissection (RAID): study protocol for
Jian-Cang Zhou1, Nan Zhang2, Zhong-Heng Zhang3,4
1Department of Critical Care Medicine, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou 310016, China.
Insights
This study investigates the optimal blood pressure target for acute type B aortic dissection (ABAD). Lowering blood pressure to <120 mmHg may reduce adverse outcomes compared to <140 mmHg.
Area of Science:
- Cardiovascular Medicine
- Vascular Surgery
- Critical Care
Background:
- Blood pressure control is crucial for acute type B aortic dissection (ABAD).
- Current guidelines recommend a target below 140/90 mmHg, but optimal levels remain debated.
- Lowering blood pressure may reduce dissection propagation but risks compromising organ perfusion.
Purpose of the Study:
- To determine the optimal blood pressure target for patients with ABAD.
- To investigate whether intensive blood pressure control (<120 mmHg) is superior to conventional control (<140 mmHg).
Main Methods:
- Multi-center randomized controlled trial involving 360 patients with new-onset ABAD and hypertension.
- Randomization to intensive (<120 mmHg) or conventional (<140 mmHg) blood pressure control.
- Primary outcome: composite in-hospital adverse events (death, paralysis, renal failure).
Main Results:
- Interim analysis will be performed.
- Secondary outcomes include aortic size, ischemia, mortality, and intervention rates.
Conclusions:
- The study aims to optimize treatment strategies for aortic dissection.
- Results will inform clinical guidelines on blood pressure management in ABAD.
Background:
Blood pressure control is an essential therapy for patients with acute type B aortic dissection (ABAD) and should be maintained throughout the entire treatment. Thus, vast majority current guidelines recommend control the blood pressure to lower than 140/90 mmHg. Theoretically, a much lower target may further decrease the risk of propagation of dissection. However, some argued that too lower blood pressure would compromise the organ perfusion. Thus, there is no unanimous optimal target for blood pressure in patients with ABAD so far. The present study aimed to investigate the optimal blood pressure target for patients with ABAD, in the hope that the result would optimize the treatment of aortic dissection (AD).
Methods:
The study is a multi-center randomized controlled clinical trial. Study population will include patients with new diagnosed ABAD and hypertension. Blocked randomization was performed where intensive blood pressure control (<120 mmHg) with conventional blood pressure control (<140 mmHg) were allocated at random in a ratio of 1:1 in blocks of sizes 4, 6, 8, and 10 to 360 subjects. Interim analysis will be performed. The primary outcome is a composite in-hospital adverse outcome, including death, permanent paraplegia or semi- paralysis during the hospitalization, and renal failure requiring hemodialysis at discharge. While the secondary outcomes include the aortic size, lower extremity or visceral ischemia, retrograde propagation into aortic arch or ascending aorta, mortality in 6 months and 1 year, intensive care unit (ICU) length of stay, total length of hospital stay, creatinine level, and surgical or endovascular intervention.
Ethics And Dissemination:
The study was approved by the institutional review board of Sir Run Run Shaw Hospital (approval number: 20160920-9). Informed consent will be obtained from participants or their next-of-kin. The results will be published in a peer-reviewed journal and shared with the worldwide medical community.
Trial Registration:
NCT03001739 (https://register.clinicaltrials.gov/).
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