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Efficacy and Safety of preoperative Controlling Heart Rate in Patients with Acute Type A Aortic Dissection (ESCORT):
Guangyu Liu1, De Wang2, Yanmin Yang3
1Anaesthesiology Centre, Chinese Academy of Medical Sciences and Peking Union Medical College Fuwai Hospital, Beijing, China.
Insights
The ESCORT trial investigates optimal preoperative heart rate control for acute Stanford Type A aortic dissection. This randomized controlled trial aims to provide evidence-based guidance for managing heart rate in high-risk patients.
Area of Science:
- Cardiovascular Surgery
- Clinical Trials
- Medical Research
Background:
- Acute Stanford Type A aortic dissection (AD) is a life-threatening emergency with high mortality.
- Current guidelines for preoperative heart rate control (≤60 bpm) lack high-level evidence.
- Factors like heart rate and contractility influence AD progression.
Purpose of the Study:
- To determine the optimal preoperative heart rate target for patients with acute Stanford Type A AD.
- To provide high-level evidence from a randomized controlled trial (RCT) to inform clinical guidelines.
- To address the evidence gap in current consensus-driven recommendations.
Main Methods:
- A multicenter, single-blind RCT involving 680 adult patients with acute Stanford Type A AD.
- Patients randomized into low (55-65 bpm) and standard (75-85 bpm) heart rate target groups.
- Esmolol used as primary agent for protocol-directed medication to achieve target heart rates.
Main Results:
- Primary outcome: rate of major adverse cardiovascular events within 30 days post-surgery.
- Secondary outcomes: clinical, economic, and biochemical measures.
- The study is designed to yield statistically significant results to guide clinical practice.
Conclusions:
- The ESCORT study is a large-scale RCT investigating optimal preoperative heart rate control in acute Type A AD.
- Results have the potential to fill evidence gaps and influence the standard of care.
- Findings will be disseminated through publications and conferences to inform the medical community.
Introduction:
Aortic dissection (AD) is a life-threatening cardiovascular emergency with a high mortality rate, and acute Stanford Type A AD is the most dangerous form, often requiring surgical intervention. Factors contributing to the progression of AD include increased heart rate, blood pressure and the rate of ventricular contraction (dP/dt). While heart rate control is a cornerstone of preoperative management for AD per existing guidelines, the recommended target (eg, ≤60 bpm in American Heart Association 2010) is consensus-driven (Level C) and thus not grounded in high-level evidence. The ESCORT (Efficacy and Safety of preoperative Controlling heart Rate in patients with acute Type A aortic dissection) trial is designed to address this critical gap by providing high-level evidence from a randomised controlled trial to define the optimal preoperative heart rate target.
Methods And Analysis:
The study is a multicentre, single-blind, RCT involving adult patients diagnosed with acute (Stanford Type A) AD, scheduled for aortic arch prosthetic vascular replacement and elephant trunk stent implantation surgery. 680 patients will be randomised into two groups: low heart rate target group (55-65 beats per minute) and standard heart rate target group (75-85 beats per minute). The intervention involves protocol-directed medication to achieve the target heart rates, with esmolol as the primary recommended agent. The primary outcome measure is the rate of major adverse cardiovascular event within 30 days after surgery, and secondary outcomes include various clinical, economic and biochemical measures.
Discussion:
The ESCORT study is the large-scale RCT to investigate the optimal preoperative heart rate control in patients with acute type A AD. The results of this study have the potential to fill the evidence gap in current clinical guidelines and provide evidence-based support for clinical management. The findings may influence the standard of care by either endorsing lower heart rate targets or providing alternative guidance for managing heart rate in this high-risk patient population. The study's results will be disseminated through publications and presentations at both national and international conferences, ensuring that the results are accessible to the medical community and relevant patient organisations.
Ethics And Dissemination:
This study, including the study protocol (version 1.3, 3 December 2022), was approved by the Ethics Committee of Fuwai Hospital, CAMS and PUMC (approval number: 2022-1886). Additional approvals were obtained from the ethics committees of participating subcentres (approval numbers are listed in the main text). The findings will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences.
Trial Registration Number:
ChiCTR2300067811.
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