Abbott Vascular Presents 3-Year SPIRIT II Data at ACC

March 29, 2009—Abbott Vascular (Santa Clara, CA) announced that long-term data presented from the company's SPIRIT II clinical trial demonstrated that the clinical advantages of the Xience V everolimus-eluting coronary stent system continued to increase between 2 and 3 years compared to Boston Scientific Corporation's (Natick, MA) Taxus Express² paclitaxel-eluting coronary stent system and the Taxus Liberté paclitaxel-eluting coronary stent system. Both Taxus Express² (73% of lesions) and Taxus Liberté (27% 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 myocardial infarctions, deaths, or repeat procedures at the target lesion compared to patients treated with the Taxus device out to 3 years. The results from the SPIRIT II trial were presented by Patrick W. Serruys, MD.

SPIRIT II is a prospective, multicenter, randomized, single-blind, controlled clinical trial comparing Xience V to Taxus in 300 patients (223 Xience V patients, 77 Taxus patients) with either one or two de novo native coronary artery lesions. Patients from Europe, India, and New Zealand were enrolled in the trial between July 5, 2005 and November 15, 2005. The primary endpoint of the SPIRIT II trial was in-stent late loss at 6 months, wherein Xience V demonstrated superiority to Taxus with a statistically significant 69% reduction in late loss (mean, 0.11 mm for Xience V vs 0.36 mm for Taxus).

Between 2 and 3 years, Abbott's Xience V maintained a cardiac death rate of 0.5% compared to the observed cardiac death rate for Taxus, which more than tripled during the same time period from 1.3% at 2 years to 4.2% at 5 years, based on Kaplan-Meier estimates. Similarly, Xience V maintained a low single-digit rate of major adverse cardiac events (MACE) between 2 and 3 years (6.4% at 2 years and 6.4% at 3 years), while the observed MACE rate with Taxus increased approximately 40% from 10.5% at 2 years to 14.9% at 3 years. MACE is defined as cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization. In addition, the SPIRIT II results demonstrated Xience V's continued clinical benefits at 3 years, including an 88% reduction in the risk of cardiac death and a 57% reduction in the risk of MACE.

According to Abbott Vascular, in the 300-patient SPIRIT II trial, Xience V demonstrated the following results at 3 years, in which event rates are based on Kaplan-Meier estimates and P values are for descriptive purposes only:

• An 88% reduction in the risk of cardiac death compared to Taxus (0.5% for Xience V vs 4.2% for Taxus; P = .024).
• A 57% reduction in the risk of MACE compared to Taxus (6.4% vs 14.9%; P = .029).
• An observed 52% reduction in the risk of myocardial infarction compared to Taxus (3.3% vs 6.8%; P = .2).
• An observed 56% reduction in the risk of ischemia-driven target lesion revascularization compared to Taxus (4.2% vs 9.4%; P = .092).
• No stent thrombosis between 2 and 3 years with Xience V and a low rate of stent thrombosis from 0 to 3 years per Academic Research Consortium definition of definite/probable stent thrombosis (0.9% vs 2.8%; P = .27).

Abbott Vascular also supplies a private-label version of Xience V to Boston Scientific that is marketed as the Promus everolimus-eluting coronary stent system.