Event rates from the 2,487 patients in ARRIVE 1 showed improvement from year one to year two with lower rates of all death (2.2%, 5.7% cumulative), Q-wave MI (0.3%, 0.9% cumulative), TAXUS-related TVR (2.5%, 7.6% cumulative) and ARC defined stent thrombosis (0.8%, 2.5% cumulative). The two-year event rates for expanded use patients were comparable to the simpler (TAXUS IV-like) patients with single stent lesions, including ARC stent thrombosis which was equivalent for complex and simple lesion patients at 0.8%.
In the medication-requiring diabetic sub-population (2,054 patients), diabetics had higher rates of death at two years compared to non-diabetics (8.3% vs. 4.6%) but no increase in TAXUS-related TVR (7.6% for both groups). The cumulative rates of Q-wave MI at two years were 0.6% for diabetic patients and 1.0% for non-diabetics. Two-year ARC defined stent thrombosis was 3.2% for diabetics and 2.3% for non-diabetics.
"ARRIVE represents the largest reported series of drug-eluting stent patients in selected high-risk subgroups," said John M. Lasala, M.D., PhD, Professor of Medicine, Washington University School of Medicine. "Considering the complexity of patients studied, the ARRIVE data indicate acceptable TAXUS- related incidence rates observed at one year and favorable safety and performance at two years. The data show consistent outcomes in high-risk patient groups representing a broad spectrum of procedural complexity seen in real-world practice."
"Our extensive ARRIVE registries provide valuable insight into the benefits of the TAXUS Stent in real-world drug-eluting stent use," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "The results are helpful in identifying low frequency TAXUS stent-related events and provide information on expanded use in complex patient populations."
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|SOURCE Boston Scientific Corporation|
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