A Medical Device Daily

Abbott (Abbott Park, Illinois) reported enrollment of the first patient in its SPIRIT IV clinical trial for the continued evaluation of the safety and efficacy of the Xience V everolimus-eluting coronary stent system for the treatment of coronary artery disease in a more complex patient population.

Xience V received CE-mark approval earlier this year. The system utilizes the Multi-Link Vision coronary stent platform, which Abbott acquired from Guidant (Indianapolis) as part of the latter's acquisition by Boston Scientific (Natick, Massachusetts) earlier this year.

Abbott acquired the vascular intervention and endovascular solutions businesses of Guidant in April as part of the requirements for regulatory approval of the Guidant-Boston Sci deal. Abbott noted in its announcement of start of the SPIRIT IV trial that Guidant has been “the predominant U.S. market leader in metallic stents since the introduction of the company's first stent system in 1997.”

“SPIRIT IV has been designed to enroll a broader patient group, including patients with multi-vessel coronary artery disease requiring multi-vessel stenting,” said Gregg Stone, MD, of Columbia University Medical Center and the Cardiovascular Research Foundation (both New York), principal investigator for the trial. “Preliminary results from clinical studies of the Xience V stent have been promising.”

The study will enroll about 1,125 patients at some 40 U.S. sites. The single-blinded trial allows for the treatment of up to three de novo native coronary artery lesions, with a maximum of two lesions per vessel, and in some cases, lesions that are located at areas of bifurcation.

The Xience V stent system will be randomized 2:1 to Boston Scientific's Taxus Express2 paclitaxel-eluting stent system. The primary endpoint of the trial is ischemia-driven target vessel failure at 270 days. Patients will be followed out five years.

John Capek, PhD, president of cardiac therapies for Abbott Vascular (Redwood City, California), said, “SPIRIT IV will allow us to increase our understanding about the potential of Xience V as a next-generation drug-eluting stent for physicians caring for the patients with challenging coronary artery disease.”

Six-month data on the Xience stent system from the SPIRIT II trial will be presented Sept. 5 during the European Society of Cardiology meeting in Barcelona, Spain.

The SPIRIT III pivotal study has completed enrollment of 1,002 patients in the randomized U.S. portion of the trial. Enrollment in the 4.0 mm and Japan arms of the non-randomized portion of the SPIRIT III clinical trial was temporarily suspended earlier this year, but is expected to resume “in the near future,” the company said.