Mar. 26, 2007 While research shows that drug-eluting stents effectively reduce restenosis and revascularization compared to bare-metal stents, questions and controversy surrounding the safety and efficacy of drug-eluting stents continue to dominate discussions and headlines. A study presented at the American College of Cardiology's Innovation in Intervention: i2 Summit surveys the safety and efficacy of the second generation Xience™V Everolimus Eluting Coronary Stent System (EES), compared to the current gold standard paclitaxel-eluting stent (PES), to determine if it offers similar or enhanced outcomes.
Although Xience™V EES has demonstrated favorable results in pilot studies, the SPIRIT-III trial is the first large trial to study the system directly against the leading drug-eluting stent. The trial was conducted at 65 United States sites and enrolled 1,002 patients with coronary lesions in up to two coronary arteries. Patients were randomized in a 2:1 ratio to stent implantation with either Xience™V or PES. Patient outcomes were evaluated using angiography (use of X-rays to study the blood vessels) and intravascular ultrasound (IVUS -- use of a tiny ultrasound probe inserted into the coronary arteries to measure plaque).
Nine months after being implanted, patients treated with the XIENCE V stent compared to PES had similar rates of target vessel failure (7.2% vs. 9.0% respectively), but a strong trend toward fewer ischemic-driven target lesion revascularization procedures (2.6% vs. 5.0%). The rates of death, MI and stent thrombosis were similar with both stents. As a result, there were fewer major adverse cardiac events (MACE) at nine months in patients treated with the XIENCE V stent compared to PES (4.6% vs. 8.1%). At eight month angiographic follow-up, the XIENCE-V stent also significantly decreased in-segment late loss (0.14 mm vs. 0.28 mm) and the follow-up diameter stenosis (18.8% vs. 22.8%), which resulted in a strong trend toward reduced binary restenosis (4.7% vs. 8.9%).
"Drug-eluting stents continue to evolve, with enhanced drugs, polymers and delivery systems that will result in improved outcomes for patients with coronary artery disease," said Gregg W. Stone. M.D., of Columbia University Medical Center and lead author of the study. "The SPIRIT III trial demonstrates that the XIENCE V stent decreases angiographic restenosis and improves overall freedom from adverse events at nine months after implantation compared to the previously most widely used drug-eluting stent."
Dr. Stone will present the results of the "Clinical, Angiographic and IVUS Results from the Pivotal United States Randomized SPIRIT-III Trial of the Xience™V Everolimus Eluting Coronary Stent System in Patients With Coronary Artery Disease" Innovation in Intervention: i2 Summit is an annual meeting for practicing cardiovascular interventionalists sponsored by the American College of Cardiology in partnership with the Society for Cardiovascular Angiography and Interventions.
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