The one-year pooled Arrive data confirmed the known higher mortality rate for diabetics versus non-diabetics with cardiovascular disease, but showed that the Taxus Stent had similarly low rates of stent-related cardiac death, myocardial infarction (MI), stent thrombosis, and major cardiac events (MCE) across those two patient subsets. The study also showed similar rates of target vessel re-intervention (TVR) and Taxus-related TVR in indicated patients per the EU label, whether or not they had diabetes.
The results showed diabetic patients had the well-known higher overall adjusted one-year mortality rate than patients without diabetes (3.7% versus 2.3%, respectively, p=0.016), with the difference being driven by the cardiac death rate (2.3% versus 1.2%, p=0.014), and reflecting the more advanced cardiac disease associated with diabetes. However, this difference was not related to the Taxus Stent as the Taxus Stent-related cardiac death rates at one-year were comparable in diabetics and non-diabetics, respectively (1.0% versus 0.7%, p=0.29) in this patient population.
Additionally, Taxus Stent-related MCE rates (cardiac death, MI, and re-intervention) at one year were comparable (5.7% versus 5.6%, p=0.80), as was the incidence of Taxus Stent-related MI (1.6% versus 1.2%, p=0.26), in both groups. Stent thrombosis at one year was low and showed no significant difference between diabetics and non-diabetics under protocol definition (1.5% versus 1.3%, p=0.59) or ARC Definite/Probable (1.7% versus 1.2%, p=0.29). Unadjusted one-year rates of Taxus Stent-related cardiac death, TAXUS Stent-related MCE, Taxus Stent-related MI, and protocol-defined stent thrombosis showed no differences between the two populations, suggesting that the safety profile is comparable for the two groups despite increased underlying risk in patients with diabetes.
Additionally, the Arrive analysis confirmed that the Taxus Stent maintained comparable re-intervention rates in the diabetic and non-diabetic patient populations in Arrive 1 and 2. Rates of one-year TVR, whether adjusted or unadjusted, were similar between the patient groups (6.1% versus 6.0%, p=0.80, adjusted).