Who was the control group for DIRECT STENT?
The control group for direct stenting was from the TAXUS ATLAS workhorse patient population that received the TAXUS Libert© stent. In the TAXUS ATLAS workhorse trial, predilation was mandatory. There were 247 patients treated with direct stenting versus 543 patients in the predilation control group. What was important about the DIRECT STENT trial? The TAXUS Libert© stent was delivered in 97.6% of the patients where it was attempted. Ultimately, there was successful delivery in 100% of patients, meaning a few patients needed some predilation in order to deliver the stent. The key number is the percentage of patients who were able to receive direct stenting without needing any predilation. If you look at other direct stenting trials, our percentage is actually a very high number. What about TVR and TLR in direct stenting with the Libert©? Very interesting findings. Compared to the predilation control, the TLR rates were reduced by 63% with direct stenting. Obviously because of the large
