Efficacy and Safety of preoperative Controlling Heart Rate in Patients with Acute Type A Aortic Dissection (ESCORT): protocol for a randomised controlled trial

INTRODUCTION: ype 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.