Saturday, March 24, 2007

Second generation drug-eluting stent system challenges current gold standard

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 today 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. 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.
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).

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