The Society of Thoracic Surgeons (STS) has issued a statement on the controversy surrounding EXCEL, commenting that “that the final interpretation regarding the outcomes of the EXCEL study should wait until an independent analysis of all aspects of the EXCEL study has been performed”. It adds such an analysis will “provide our best opportunity to “get it right” for the benefit of our patients—now and in the future”.
According to the statement, the STS has been monitoring “with keen interest” the controversy in the medical literature and the lay press regarding studies (i.e. EXCEL and NOBLE) that have compared coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) for the management of left main disease. The statement notes: “The EXCEL and NOBLE studies draw slightly different conclusions regarding the rate of major adverse cardiac and cerebrovascular events at five-year follow-up. The scientific community and a number of medical organisations have raised questions regarding the EXCEL study, specifically questioning trial design, methodology (particularly the definitions of myocardial injury endpoints), statistical analyses, and final conclusions.” It adds: “Any final conclusions drawn from the EXCEL trial will not only affect the actions of physicians, surgeons, regulatory agencies, and third-party payers but, more importantly, they will seriously impact the health and well being of our patients and their families for years to come.”
However, because of the “potentially profound consequences” of the findings of EXCEL—the statement explains—the STS believes that the final interpretation of the EXCEL should, therefore, wait until an independent review of all aspects of the EXCEL study has been conducted.
Prior to the STS statement, the Cardiovascular Research Foundation (CRF) announced that it has commissioned an independent review of the data. Furthermore, the American Association for Thoracic Surgery (AATS) called for all of the EXCEL data to “be made publicly available for analysis and interpretation. The European Association of Cardio-Thoracic Surgeons (EACTS)—who sparked the current debate when it withdrew its support from the European recommendations on left main disease because of concerns it has about EXCEL—has also reached out to EXCEL investigators to “offer assistance” in resolving concerns raised about data from the trial.
The STS statement concludes that an independent analysis is the “best opportunity” to ensure the optimal treatment of patients now and in the future.