Abbott announced on 16 June the initiation of SPIRIT PRIME, a clinical trial to study the performance of the company’s next-generation Xience Prime Everolimus Eluting Coronary Stent System, currently an investigational device, for the treatment of coronary artery disease. Results from SPIRIT PRIME will be used to support the regulatory filing for Xience Prime in the United States. The first patient was enrolled at Hillcrest Medical Center in Tulsa, Oklahoma, by Rajesh Chandwaney.
Xience Prime utilises the same well-studied drug and proven biocompatible polymer as Xience V Everolimus Eluting Coronary Stent System. In addition, it offers a novel stent design and a modified delivery system designed for greater flexibility and improved deliverability. Xience Prime uses cobalt chromium technology, which allows for very thin struts while maintaining strength to support the vessel as well as excellent visibility under X-ray during the stent implantation procedure. Xience Prime is based upon the proven design of the Multi-Link family of stents, which is the most widely used stent platform in the world – with more than 2 million implants worldwide according to Abbott. The company expects to launch Xience Prime in a broad size matrix with sizes up to 38mm in Europe later this year.
“Xience Prime carries the same successful drug and polymer as the Xience V stent. Its stent platform and delivery balloon are designed to be highly deliverable, and as such, Xience Prime has the potential to simplify procedures in challenging cases,” said Marco A Costa, professor of medicine, director of the Interventional Cardiology Center, and director of the Center for Research and Innovation, Harrington-McLaughlin Heart and Vascular Institute, University Hospitals Case Medical Center, Case Western Reserve University in Cleveland, Ohio, and principal investigator of the SPIRIT PRIME trial. “Xience V is used routinely in my practice, and I look forward to studying the enhanced features and sizes of Abbott’s next-generation drug eluting stent, Xience Prime.”
The SPIRIT PRIME study is a prospective, multicentre, non-randomised trial designed to study Xience Prime in 500 patients at 75 hospital centres. Patients may receive a maximum of two stents in separate vessels. SPIRIT PRIME will have two arms: the Core Size arm will follow 400 patients who will be treated with a stent from 2.25mm to 4mm in diameter and from 8mm to 28mm in length, and the Long Lesion arm will follow 100 patients who will receive a stent from 2.5mm to 4mm in diameter and either 33mm or 38mm in length.
The primary endpoint is major adverse cardiac events, a composite measure of cardiac death, myocardial infarction and target lesion revascularisation at one year.
In the SPIRIT family of trials, Xience V demonstrated superiority to Boston Scientific’s Taxus Paclitaxel Eluting Coronary Stent System in two randomised clinical trials. In the SPIRIT II trial, Xience V demonstrated a statistically significant 69% reduction of in-stent late loss at six months compared to Taxus. In the SPIRIT III trial, Xience V demonstrated a statistically significant 50% reduction of in-segment late loss at eight months compared to Taxus. Long-term results further reinforce the excellent clinical outcomes, with Xience V demonstrating an 88% reduction in cardiac death and a 57% reduction in major adverse cardiac events compared to Taxus at three years in the SPIRIT II trial. At two years in the SPIRIT III trial, Xience V demonstrated a 45% reduction in the risk of cardiac events compared to Taxus.