Analysis of SPIRIT and COMPARE Data Supports Abbott Vascular's Xience V

April 3, 2011—Abbott Vascular (Santa Clara, CA) announced that Dean J. Kereiakes, MD, presented 2-year results on the safety and efficacy of the company's Xience V everolimus-eluting coronary stent system compared to Taxus Liberté and Taxus Express² paclitaxel-eluting coronary stent systems (Boston Scientific Corporation, Natick, MA) at the American College of Cardiology's (ACC) 60^th annual scientific session in New Orleans.

The pooled analysis of the SPIRIT II, SPIRIT III, SPIRIT IV, and COMPARE trials reinforces the positive clinical performance of Xience V, the company stated; this analysis was performed independently of the company.

Abbott Vascular sponsored and conducted the SPIRIT trials. SPIRIT IV included 3,690 patients. Many of these patients presented with multiple medical complexities, including more than 1,100 patients with diabetes, as well as patients with small vessels, long lesions, and multiple lesions. The COMPARE study was a physician-initiated trial involving 1,800 patients with complex vascular disease. Taxus Liberté was the control in COMPARE, and Taxus Express² was the control in SPIRIT II, SPIRIT III, and SPIRIT IV.

According to the company, predictors of artery restenosis, cardiac death, or heart attack were evaluated out to 2 years in nearly 7,000 patients from the SPIRIT II, III, IV, and COMPARE clinical trials. The data demonstrated that use of Xience V resulted in significantly lower clinical event rates after a stent procedure. In the pooled analysis, Xience V showed a 36% reduction in the risk of major adverse cardiac events (MACE) compared to Taxus (7.3% for Xience V vs 11.1% for Taxus; P < .001). MACE is defined as cardiac death, myocardial infarction (MI), or ischemia-driven target lesion revascularization (ID-TLR).

The pooled analysis data of Xience V versus Taxus also demonstrated reductions of risk for heart attack of 47% (2.9% vs 5.5%; P < .001), for cardiac death or heart attack of 40% (4% vs 6.6%; P < .001), for ID-TLR of 36% (4.1% vs 6.6%; P < .001), for definite or probable stent thrombosis as defined by Academic Research Consortium of 70% (0.7% vs 2.3%; P < .0001)

“Xience V consistently demonstrated low adverse cardiac event rates in trial after trial,” commented Dr. Kereiakes. “The SPIRIT II, III, IV, and COMPARE pooled analysis suggests that Xience V reduced the occurrence of adverse events compared to patients treated with the Taxus stent. The low event rates demonstrated by Xience V in these trials are especially impressive given the complexity of patients in the SPIRIT IV and COMPARE trials and confirm that the results seen with Xience V in earlier randomized clinical trials are consistent with clinical practice.”