Stent Reduces MACE by 55 Percent


September 21, 2007

September 21, 2007-The CYPHER Sirolimus-eluting Coronary Stent reduced by more than half the rate of major adverse cardiac events (MACE) compared to the Taxus Stent in small coronary vessels, according to data appearing this week in the Journal of the American College of Cardiology.

In a randomized controlled trial of more than 1,000 patients, the CYPHER Stent reduced MACE by 55 percent (10.4 percent vs. 21.4 percent; p=0.004), mainly driven by a 69 percent reduction of target lesion revascularization (TLR) (6.0 percent vs. 17.7 percent; p=0.001) compared with the Taxus Stent at two years. There were no significant differences between the two stents with respect to death, cardiac death or heart attack at two years. In this study, reference diameter of vessels ranged from <2.75 vs. >2.75 mm.

In large and mixed coronary vessels, the differences between the CYPHER Stent and the Taxus Stent were less pronounced, although numerically lower with the CYPHER stent. In these two patient groups, rates of MACE (large: 10.4 percent vs. 13.1 percent; p=0.33; mixed: 16.7 percent vs. 18.0 percent; p=0.83) and TLR (large: 6.9 percent vs. 8.6 percent; p=0.47; mixed: 16.7 percent vs. 15.4 percent; p=0.86) were similar.

In the United States, the CYPHER Stent is currently approved for use in native coronary arteries with a diameter of >2.50mm and <3.50mm.

The SIRTAX study is an independent, randomized, 1,012 patient comparison of the CYPHER Stent with the Taxus Stent for coronary revascularization. It included not only patients with angina but also a large percentage of patients who were suffering from an acute heart attack (myocardial infarction) at the time of stent placement, a patient group not currently within the approved U.S. indications.

In the subgroup analysis, the investigators studied the impact of vessel size on angiographic and long-term clinical outcomes after PCI. The study analyzed 503 patients who received the CYPHER Stent and 509 patients who received the Taxus Stent.

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