TAXUS(R) Stent Demonstrates Similar Outcomes in Diabetic Patients Compared to Non-diabetics in Pooled Analysis of TAXUS IV and V Trials
"The TAXUS IV/V diabetic subset data indicated that the TAXUS Stentmitigated the impact of diabetes as a risk factor for restenosis followingstenting procedures in the patients studied," said Dr. Stone. "Diabeticpatients treated with TAXUS Stents compared to bare-metal stents hadsignificantly improved event-free survival, particularly important inhigh-risk patients with diabetes."
The pooled analysis included angiographic outcomes at nine months andclinical outcomes at three years among 338 diabetic patients and 901non-diabetic patients treated with the TAXUS Stent from the TAXUS IV and Vclinical trials. Nine-month angiographic outcomes showed equivalentin-segment late loss (0.27mm vs. 0.31mm, p=0.28) and binary restenosis (14.3%vs. 15.1%, p=0.83) in diabetics and non-diabetics, respectively.
At three years, TLR was similar for diabetic and non-diabetic patients(12.4% vs. 10.1%, p=0.25), despite significant baseline differences andincreased comorbidity risk in diabetic patients. TVR was higher in diabetics(21.4% vs. 15.7%, p=0.017), due to an increase in remote TVR events (outsidethe stented segment), which is an indicator of the more aggressive backgrounddisease progression in diabetics. Three-year rates of stent thrombosis underProtocol definition (0.9% vs. 1.3%, p=0.63) and ARC Definite/Probable (1.6%vs. 1.9%, p=0.73) were similar, even without multivariate adjustment.
The TAXUS IV/V analysis also compared 338 diabetic patients treated withthe TAXUS Stent versus 336 diabetic patients treated with bare-metal stents(BMS). Three-year rates of TVR and TLR were reduced by roughly 50 percent indiabetic patients treated with the TAXUS Stent compared to BMS, consistentwith results seen in other high-risk patient groups. The TAXUS Stent showedcomparable safety to BMS in diabetics, with no significant differences indeath (7.3% vs. 7.1%, p=0.91), cardiac death (4.6% vs. 2.7%, p=0.23), MI (6.5%vs. 6.6%, p=0.83) or ARC Definite/Probable stent thrombosis (1.6% vs. 1.5%,p=1.00) in TAXUS and BMS, respectively.
"We are pleased to see that TLR in TAXUS patients -- an importantindicator of TAXUS efficacy -- showed no significant difference betweendiabetic and non-diabetic patients in these studies," said Paul LaViolette,Chief Operating Officer at Boston Scientific. "This analysis is consistentwith data we recently announced from our ARRIVE 1 and 2 real-world registries,showing that the TAXUS Stent effectively neutralized the impact of diabetes asa risk factor for restenosis in the patients studied."
The growing diabetic subset accounts for more than one-quarter of allcoronary interventional procedures in the United States. Diabetes isgenerally associated with an increased risk of cardiovascular events andpatients with diabetes are more likely th
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