Dr. Martin B. Leon Announced the Latest TARGET I Randomized Controlled Trial Data to the World
Miami, America, 23 October, 2012--At the Next-Generation DES and Bioabsorbable Scaffolds forum of TCT, Dr. Martin B. Leon, professor of Columbia University Medical Center, chairman of TCT, and the principal co-investigator of TARGET, presented the latest primary endpoint data of Firehawk® TARGET I Randomized Controlled Trial ("RCT"). Firehawk® Rapamycin Target Eluting Coronary Stent ("Firehawk®") is the third generation drug-eluting stent system designed and manufactured exclusively by MicroPort Medical. The clinical results approved that Firehawk® is safe and effective. Furthermore it also indicated the feasibility and advantage of the "Target Release" feature on Firehawk®.
TARGET I RCT had enrolled 460 patients (229 inFirehawk® and 231 inXience V). The RCT has a non-inferiority design with the primary endpoint of the in-stent late lumen loss at 9 months. Angiographic follow-up at 9 months (88.9% follow-up rate) showed that the primary endpoint of the RCT was achieved by 0.13±0.24mm in late lumen loss for Firehawk® and 0.13±0.18mm for Xience V. The non-inferiority is achieved. Furthermore, in the 1 year clinical follow up, there is no evidence of in-stent thrombosis for both Firehawk® and Xience V, and the rate of TLF is 2.2% for both arms.
Dr. Leon pointed out the fact that the unique design of Firehawk® enables lower dosage of drug concentration while maintaining the same efficacy and safety feature that were observed in the previous generation of DES.
At the end of discussions, Dr. Alan Yang, Director of Stanford University Medical Center and the host of this forum, commented on the relationship between polymer degradation time and antiplatelet therapy. Even though the complete polymer degradation time is more than 6 months for Firehawk®, it is still possible to stop anitiplatelet therapy earlier. Since the polymer is only located in the grooves of the abluminal surface, the risk for the remaining polymer to cause late thrombosis is minimized. It would not be a concern for shortening antiplatelet therapy.
Dr. Bo Xu MD, Director of Fu Wai Hospital and National Center for Cardiovascular Diseases of China, agreed with Dr. Alan Yang's opinion. He also mentioned that OCT follow up for Firehawk® FIM study at 4-month indicated endothelial cell coverage is as high as 96.2% which is very impressive.
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