In response to continued discussion on the validity of the conclusions of the EXCEL trial comparing coronary stenting to coronary bypass surgery, The American Association for Thoracic Surgery (AATS) has released a statement calling for the release of all trial data to help surgeons and patients make informed choices based on sound analysis.
AATS statement on transparency of clinical research data
The American Association for Thoracic Surgery (AATS) is made up of over 1,400 of the foremost academic cardiothoracic surgeons in the world. The AATS Board of Directors has noted, with concern, allegations raised in a BBC news report about the validity of the conclusions of the EXCEL trial which compared coronary stenting to coronary artery bypass surgery in patients with left main coronary artery stenosis.
We note also the response of the European Association for Cardiothoracic Surgery (EACTS), which has withdrawn their support for the Left Main Chapter of the joint 2018 EACTS – ESC (European Society of Cardiology) Clinical Guidelines for Myocardial Revascularization.
The possibility that some patients may have been wrongly advised or treated as a result of current recommendations, which may have been influenced due to incomplete reporting of available data from the EXCEL trial, is a serious matter.
Our membership holds the veracity and transparency of data as fundamental tenets of clinical research trials; if any member of the treating heart teams, oversight committees, trial investigators, or peer reviewers raise potential serious issues regarding trial data presentation or interpretation, then the best way forward is the public release of all trial data for an independent analysis to confirm that the original trial conclusions are valid.
This is particularly true for industry sponsored trials of previously approved devices which are not subject to Government oversight, to reassure the public and physician community that conflicts of interest or unconscious bias has not influenced substantially the design, conduct, reporting, or interpretation of such studies.
The AATS agrees with others that all of the data should be made publicly available for analysis and interpretation, as a way to resolve the current controversy around the EXCEL trial, in order to provide patients with the best possible counsel and informed consent.
Vaughn A. Starnes, MD, President and David R. Jones, MD, Secretary