The EXCEL and NOBLE studies draw slightly different conclusions regarding the rate of major adverse cardiac and cerebrovascular events at 5-year follow-up. The scientific community and a number of medical organizations have raised questions regarding the EXCEL study, specifically questioning trial design, methodology (particularly the definitions of myocardial injury endpoints), statistical analyses, and final conclusions.
STS has a longstanding commitment to the assessment and improvement of quality clinical care in patients with cardiovascular disease. 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 wellbeing of our patients and their families for years to come.
Given such potentially profound consequences, the Society believes 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 is our expectation that objective re-evaluation of the trial data, methodology, and conclusions by expert trialists, clinicians and statisticians will resolve the controversy and provide the optimal clinical roadmap for patients with left main coronary disease.
STS believes that such an analysis will provide our best opportunity to “get it right” for the benefit of our patients—now and in the future.
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