Randomized Trials in Cardiac Surgery: Why and How.

Objectives: Randomized clinical trials (RCTs) are the gold standard for comparative effectiveness. However, they face unique challenges in cardiac surgery. The objective of this work is to summarize the challenges of RCTs in cardiac surgery, describe efforts employed in recent years to mitigate these impediments and outline the future opportunities for increased RCT adoption in the specialty.

Methods: This review was conducted as an expert analysis on the existing state of RCTs in cardiac surgery based on expert discussion at a dedicated session during the 2024 Annual Meeting of the European Association for Cardio-Thoracic Surgery (EACTS). Different trial-support infrastructures, such as the Randomized Comparison of the Clinical Outcomes of Single versus Multiple Arterial Grafts (ROMA) Network, the Cardiothoracic Surgical Trials Network (CTSN), the Global Cardiovascular Research Funders Forum (GCRFF) and the UK Model, and their respective mechanisms for overcoming RCT barriers were described in detailed. Models were selected due to specific author involvement and knowledge. Future directions were postulated based on current trends.

Results: Despite heterogeneous structures, the described models largely aimed to increased cardiac RCTs through improved trial participation, either via increased trainees, expanded stakeholders or focused patient recruitment, facilitating funding and fostering wider collaboration.

Conclusions: RCTs are a key component for clinical advancement yet have been underutilized in cardiac surgery. Recent endeavours have reduced the multifactorial barriers associated with cardiac surgery RCTs and intentional future efforts are necessary for continued cardiac advancement.