Long-term data presented from Abbott's Spirit II clinical trial demonstrated that the clinical advantages of the Xience V Everolimus Eluting Coronary Stent System continued to increase between two and three years compared to the Taxus Express2 Paclitaxel-Eluting Coronary Stent System/Taxus Liberte Paclitaxel-Eluting Coronary Stent System (Taxus). Both Taxus Express2 (73 per cent of lesions) and Taxus Liberte (27 per cent of lesions) were used as controls in the Spirit II trial. The data also showed that patients treated with Xience V continue to experience fewer heart attacks, deaths or repeat procedures at the target lesion compared to patients treated with Taxus out to three years. The results from the Spirit II trial were presented during the Summit at the American College of Cardiology's 58th annual scientific session in Orlando, Florida.
Between two and three years, Abbott's market-leading Xience V maintained a low cardiac death rate of 0.5 per cent, while the observed cardiac death rate for Taxus more than tripled during the same time period (1.3 per cent at two years vs 4.2 per cent at three years). Similarly, Xience V maintained a low, single-digit rate of major adverse cardiac events (MACE) between two and three years (6.4 percent at two years vs. 6.4 per cent at three years), while the observed MACE rate with Taxus increased approximately 40 per cent between two and three years (10.5 per cent at two years vs 14.9 per cent at three years). MACE is an important composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, heart attack (myocardial infarction or MI), or ischemia-driven target lesion revascularization (ID-TLR driven by lack of blood supply).
In addition, the Spirit II results demonstrated that Xience V continues to outperform Taxus, with Xience V showing continued clinical benefits at three years, including an 88 per cent reduction in the risk of cardiac death and a 57 per cent reduction in the risk of MACE.
"In the clinical outcomes that matter most, such as heart attack, repeat procedure at the target lesion or death, Xience V demonstrated a consistent reduction compared to TAXUS out to three years," said Patrick W Serruys, professor of Interventional Cardiology at Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands, and principal investigator of the Spirit II clinical trial. "What's even more impressive is that the clinical differences between Xience V and Taxus continue to widen between two and three years, confirming the long-term safety and efficacy of Xience V."
"The data from the Spirit family of trials continue to prove that Xience V is an excellent option for patients. Physicians have embraced this technology, as demonstrated by the market-leading position of Xience V around the world," said John Capek, executive vice president, Medical Devices, Abbott. "Our next-generation drug eluting stent in development, Xience Prime, builds upon the outstanding body of clinical evidence from the Spirit family of clinical trials, while the new stent design and its delivery system build upon the excellent performance of the Vision cobalt chromium platform, improving deliverability and helping physicians treat difficult lesions."
Xience V is the market-leading drug eluting stent platform, with 50 per cent share in the United States, and market-leading share around the world.
Abbott's next-generation Xience Prime Everolimus Eluting Coronary Stent System utilizes the same drug and polymer as Abbott's market-leading Xience V stent and builds upon the proven design of the Multi-Link family of stents. Xience Prime features a new stent design and delivery system that are designed to make it more flexible for improved deliverability. Abbott plans to make Xience Prime available in an expanded size matrix with lengths up to 38 mm. The company expects to launch Xience Prime in Europe later this year.