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January 7, 2020

EACTS Seeks to Collaborate With EXCEL Investigators to Resolve Trial Data Concerns

January 7, 2020—The European Association for Cardio-Thoracic Surgery (EACTS) announced that its Secretary General, Professor Domenico Pagano, MD, on behalf of the EACTS Council, has written to the principal investigators of the EXCEL trial to offer assistance to resolve concerns that have been raised about the trial. Prof. Pagano’s email (available online here) was sent to Gregg Stone, MD; Pieter Kappetein, MD; Patrick Serryus, MD; and Joseph Sabik, MD.

In December 2019, the EACTS Council withdrew its support for the recommendations on left main coronary artery disease from the joint 2018 EACTS/European Society of Cardiology (ESC) Clinical Guidelines for Myocardial Revascularization in response to the report of the United Kingdom’s BBC Newsnight investigation on the EXCEL trial.

The EACTS Council has invited the ESC to work jointly with EACTS to consider the evidence available and develop updated recommendations.

According to the society, EACTS has highlighted the importance of making the individual patient data available for independent analysis. In the interests of patient safety, urgent action is required to re-establish the validity of the EXCEL trial in order to provide safe clinical recommendations, stated the society.

EACTS also suggested that the data be made available to the Institute of Clinical Trials and Methodology at University College London, in London, United Kingdom, to independently reanalyze the EXCEL data.

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