Company Enrolls First Patient into SPIRIT PRIME Trial in the United States.
Abbott today announced 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 into the SPIRIT PRIME clinical trial at Hillcrest Medical Center in Tulsa, Okla., by Rajesh Chandwaney, M.D.
XIENCE PRIME utilizes the same well-studied drug and proven biocompatible polymer as Abbott’s market-leading 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. The company expects to launch XIENCE PRIME in a broad size matrix with sizes up to 38 mm 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, M.D., Ph.D., FACC, FSCAI, 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, multi-center, nonrandomized trial designed to study XIENCE PRIME in 500 patients at 75 hospital centers. 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 2.25 mm to 4.0 mm in diameter and from 8 mm to 28 mm in length, and the Long Lesion arm will follow 100 patients who will receive a stent from 2.5 mm to 4.0 mm in diameter and either 33 mm or 38 mm in length. The primary endpoint is major adverse cardiac events (MACE), which is a composite measure of cardiac death, heart attack (myocardial infarction) and repeat procedure of the treated lesion (target lesion revascularization) at one year.
“Based upon the market-leading technology of XIENCE V, XIENCE PRIME will be available in a greater breadth of sizes, and is designed to provide improved deliverability,” said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “SPIRIT PRIME is expected to build upon the superior outcomes from the SPIRIT family of clinical trials, and the initiation of the study represents Abbott’s commitment to bringing important advances in drug eluting stent technology to clinicians and their patients.”
In the SPIRIT family of trials, XIENCE V demonstrated superiority to Boston Scientific’s TAXUS® Paclitaxel Eluting Coronary Stent System in two randomized clinical trials. In the SPIRIT II trial, XIENCE V demonstrated a statistically significant 69 percent reduction of in-stent late loss (a measure of vessel re-narrowing) at six months compared to TAXUS. In the SPIRIT III trial, XIENCE V demonstrated a statistically significant 50 percent reduction of in-segment late loss (a measure of vessel re-narrowing) at eight months compared to TAXUS. Long-term results further reinforce the excellent clinical outcomes, with XIENCE V demonstrating an 88 percent reduction in cardiac death and a 57 percent reduction in MACE compared to TAXUS at three years in the SPIRIT II trial. At two years in the SPIRIT III trial, XIENCE V demonstrated a 45 percent reduction in the risk of MACE compared to TAXUS. Across the SPIRIT family of trials, Abbott plans to study more than 20,500 patients treated with everolimus eluting stents.
In addition to SPIRIT PRIME, Abbott’s robust vascular research program includes clinical trials in coronary artery disease and peripheral artery disease. Key products in the vascular pipeline include: the MULTI-LINK 8™ Coronary Stent System, a next-generation frontline balloon dilatation catheter, a fully bioabsorbable drug eluting coronary device, and the Omnilink Elite™ Peripheral Stent System.
The MULTI-LINK 8 Coronary Stent System, the next-generation frontline balloon dilatation catheter, the fully bioabsorbable drug eluting device and the Omnilink Elite Peripheral Stent System are in development and are not available for sale.
XIENCE PRIME currently is an investigational device in the United States and not available for sale.