TAXUS II. In 2002, we released our six-month data from TAXUS II, which tested the effects of both the slow- and moderate-release platforms. The results were very promising. TAXUS II is a 536-patient, 15-country, randomized, double-blind, controlled study of the safety and efficacy of a TAXUS paclitaxel-eluting coronary stent, in which two sequential cohorts of patients with standard risk, de novo coronary artery lesions were treated. The slow-release formulation cohort reported an in-stent binary restenosis rate of 2.3 percent and an in-segment binary restenosis rate of 5.5 percent. The moderate-release formulation cohort reported an in-stent binary restenosis rate of 4.7 percent and an in-segment binary restenosis rate of 8.6 percent. The rates for the control group were 19 percent for in-stent binary restenosis and 22 percent for in-segment binary restenosis. In-segment includes the stent length plus 5mm on either end of the stent. The six-month MACE rates for TAXUS II were 19.8 percent for the control versus 8.5 percent for the slow-release formulation cohort and 7.8 percent for the moderate-release formulation cohort.

In comparing TAXUS I and II, we saw notable consistency between our clinical endpoints, our IVUS endpoints, and our Quantitative Coronary Angiography endpoints. This consistency is more important than any single trial on its own merits because the combination of preclinical work and early clinical consistency indicates a high degree of probability that subsequent clinical trials will perform similarly.