On 4 October, Abbott announced it has begun US patients’ enrolment in the EXCEL (Evaluation of Xience Prime or Xience V versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial.
EXCEL is a global, prospective, multicentre, randomised trial to assess the safety and efficacy of the Xience Prime/Xience V everolimus eluting coronary stent systems, compared to coronary artery bypass grafting (CABG), or surgery, in select patients with unprotected left main coronary artery disease.
The first US patient was enrolled into the EXCEL trial at Turkey Creek Medical Center in Knoxville, USA, by Michael L Maggart, cardiothoracic surgeon, and Malcolm T Foster, interventional cardiologist.
The EXCEL trial will evaluate “unprotected” patients with left main disease who have not received grafts to these arteries to determine whether coronary stenting can be an alternative to bypass surgery in these patients.
“With the advancement of technology and expertise, coronary stenting might have potential as an alternative to coronary bypass surgery for select patients with left main disease,” said Joseph Sabik, chairman, Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, and a principal investigator of the EXCEL trial. “Although surgery has traditionally been the standard of care in patients with left main disease, the goal of the EXCEL trial is to evaluate Xience as a potential new treatment option for select patients with this high-risk condition.”
“EXCEL will examine the differences between stenting and surgery in a select patient population,” said Gregg W Stone, professor of medicine at Columbia University Medical Center and NewYork-Presbyterian Hospital and a principal investigator of the EXCEL trial. “The EXCEL trial, which is the largest study to date to randomise patients with left main disease to either coronary stenting or surgery, is designed to answer whether one of these therapies is preferred in these high-risk patients, thus helping physicians determine appropriate treatment choices in patients with left main disease.”
About the EXCEL trial
The trial will enrol more than 2,600 patients at up to 165 medical centres in 18 countries from regions across the globe, including the USA, Europe, Asia Pacific, Canada and Latin America. Select patients who have unprotected left main disease will be randomised to receive a drug eluting stent (Xience Prime or Xience V) or CABG. The primary endpoint of the study is the composite measure of all-cause mortality, myocardial infarction, or stroke at a median follow-up duration of three years, with all randomised patients having reached a minimum of two years’ follow-up. In addition to Sabik and Stone, the following are also principal investigators of the EXCEL trial: Patrick W Serruys, professor of interventional cardiology; and A Pieter Kappetein, associate professor of Cardio-thoracic Surgery, both at the Thoraxcentre, Erasmus Medical Center, Rotterdam, The Netherlands.