CRF Commissions Review of Controversial EXCEL Trial

Patrice Wendling

January 06, 2020

The Cardiovascular Research Foundation (CRF) has authorized an independent review to examine its role in the EXCEL trial of left main coronary artery disease.

The nonprofit was engaged at the outset of the EXCEL trial by the trial sponsor, Abbott Medical Devices, to organize the independent Clinical Endpoint Committee and to perform specific analytical and other related services.

Questions were raised in 2018 about the protocol definition of myocardial infarction (MI), but the debate took a very public turn last month after a BBC Newsnight report alleged the investigators deliberately withheld critical data on rates of MI under the Third Universal Definition and downplayed worse longer-term mortality with percutaneous coronary intervention (PCI) versus bypass surgery. Concerns were also raised about possible investigator conflicts of interest.

"Because of our commitment to excellence, we have commissioned an independent review of the matter," CRF told theheart.org | Medscape Cardiology in a statement.

The review will only address CRF's role in the study, not the EXCEL results themselves, CRF spokesperson Judy Romero said.

She declined to say who is conducting the review, noting this is confidential information.

The investigators responded within days to the BBC claims with an 11-page document, but have vowed not to debate the trial with the media or on social media.

EXCEL coprincipal investigator Gregg Stone, Icahn School of Medicine at Mount Sinai, New York City, has been a very public and staunch defender of the trial but has also taken criticism for his presentation of the 5-year EXCEL results at TCT 2019, the CRF's annual scientific symposium.

There is no change to Stone's role as a CRF faculty member and codirector of Medical Research and Education at CRF, Romero said.

The CRF statement says "We fully support the balanced and transparent presentation and dissemination of all clinical trial results" and notes it is also "available to assist the relevant societies and medical academies to ensure a comprehensive review of available data from the EXCEL trial."

Following the BBC report, the European Association for Cardio-Thoracic Surgery (EACTS) took the unprecedented step of withdrawing its support for the left main chapter of the 2018 EACTS–European Society of Cardiology (ESC) clinical revascularization guidelines based on the EXCEL 3-year results. For its part, ESC stood by the document.

The American Association for Thoracic Surgery, however, issued a statement echoing calls for the public release of all trial data for independent analysis to confirm that the conclusions, including relative equivalence for stents and surgery, are valid.

The Society of Thoracic Surgeons (STS) has yet to weigh in with a formal statement on the trial or the guidelines. EXCEL coprincipal investigator Joseph Sabik III, MD, Cleveland Clinic, Ohio, is currently serving as secretary on the STS board of directors.

STS surgeon leaders are "actively discussing" the matter and will "continue their conversation" during the STS annual meeting later this month in New Orleans, STS spokesperson Jennifer Bagley told theheart.org | Medscape Cardiology via email.

Stone, Sabik, and fellow coprincipal investigator A. Pieter Kappetein, MD, PhD, a Medtronic vice president, chief medical officer of the company's structural heart business, and a surgeon at Erasmus Medical Center, Rotterdam, the Netherlands, had at press time yet to respond to queries from theheart.org | Medscape Cardiology regarding the independent review.

Coprincipal investigator Patrick Serruys, MD, PhD, Imperial College London, said only that the queries would be discussed at a steering committee meeting over this past weekend.

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, join us on Twitter and Facebook.

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