EXCEL: EACTS reaches out to trial investigators to “resolve concerns”, as CRF commissions independent review

349

The European Association of Cardio-Thoracic Surgeons (EACTS) has issued a statement reaching out to EXCEL investigators to “offer assistance” in resolving concerns raised about data from the trial. In a letter sent to the principal investigators, EACTS recommends that individual patient data be made available “for independent analysis” by the Institute of Clinical Trials and Methodology at University College London (London, UK), which it describes as a “very reputable group of trial scientists with considerable international skills and experience in the field”.

Meanwhile, the Cardiovascular Research Foundation (CRF) has announced that it has commissioned an independent review of the data. The CRF statement affirmed its commitment to clinical research “using high academic and operational standards”, adding: “We fully support the balanced and transparent presentation and dissemination of all clinical trial results.”

The CRF statement explains that, although the society was engaged by the sponsor of the EXCEL trial to organise the independent Clinical Endpoint Committee (CEC) and to perform specific analytical and other related services, it played no part in conducting the trial. The foundation also offers “to assist the relevant societies and medical academies to ensure a comprehensive review of available data from the EXCEL trial. Dr Gregg Stone (who is not an employee of CRF) continues to be involved with the organisation.”

EACTS has also offered to assist a review of the EXCEL findings: “We recognise that, given the concerns that have been raised, you may be appointing a separate group to look again at the EXCEL results. If this is the case … we recommend that EACTS is directly involved to provide the independence and the breadth of expertise that this exercise deserves.” Signed by secretary general Domenico Pagano, EACTS’ letter endorses the involvement of the European Society of Cardiology (ESC) as both “desirable and appropriate”, and says that “urgent action is required to re-establish the validity of the EXCEL trial in order to provide safe clinical recommendations”.

In December 2019, the EACTS Council withdrew its support for the recommendations on left main coronary artery disease of the 2018 joint ESC-EACTS Myocardial Revascularisation Guidelines, following concerns raised in a BBC Newsnight investigation about the validity of EXCEL’s findings. EACTS then invited the ESC “to work with us jointly to consider the evidence available and develop updated recommendations as a matter of urgency”. The EACTS statement says it has yet to receive a response from the ESC.


LEAVE A REPLY

Please enter your comment!
Please enter your name here