US Enrollment Begins in Abbott Vascular's Global EXCEL Trial

October 4, 2011—Abbott Vascular (Santa Clara, CA) announced that it has begun enrolling patients in the United States 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, multicenter, randomized trial designed to assess the safety and efficacy of Abbott's Xience Prime/Xience V everolimus-eluting coronary stent systems compared to coronary artery bypass grafting (CABG) in select patients with unprotected left main coronary artery disease.

According to Abbott Vascular, 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 CABG in these patients. The trial will enroll more than 2,600 patients at up to 165 medical centers in 18 countries from regions across the globe, including the United States, Europe, Asia Pacific, Canada, and Latin America. Select patients who have unprotected left main disease will be randomized 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 3 years, with all randomized patients having reached a minimum of 2 years of follow-up.

Abbott Vascular noted that a multidisciplinary team of surgeons and cardiologists is leading the EXCEL trial. The Principal Investigators are Joseph Sabik, MD; Gregg W. Stone, MD; Patrick W. Serruys, MD; and A. Pieter Kappetein, MD.

“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,” commented Dr. Sabik. “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.”

Dr. Stone added, “EXCEL will examine the differences between stenting and surgery in a select patient population. The EXCEL trial, which is the largest study to date to randomize 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.”

The company advised that Xience Prime is commercially available only in countries that recognize CE Mark approval. In the United States, Xience Prime is an investigational device and is not available for sale. 

The Xience V is marketed in the United States, Europe, Asia, and other international markets. Xience V is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions ≤ 28 mm) with reference vessel diameters of 2.25 to 4.25 mm, stated Abbott Vascular.