April 1, 2008 - Despite the known increased rates of mortality and restenosis for diabetics versus non-diabetics in patients with cardiovascular disease, the TAXUS Stent had comparable levels of late loss and target lesion revascularization (TLR) across these patient populations, according to results from TAXUS IV and TAXUS V randomized clinical trials.
The analysis compared the safety and efficacy of the TAXUS Express Paclitaxel-Eluting Coronary Stent System in diabetic versus non-diabetic patients.
The study also showed no significant differences in target vessel revascularization (TVR), stent thrombosis or myocardial infarction (MI), after adjustments were made for differences in other baseline characteristics between patients with or without diabetes. Analysis of the data was presented by Gregg W. Stone, M.D., of the Columbia University Medical Center in New York, at the SCAI Annual Scientific Sessions in Partnership with the ACC/i2 Summit in Chicago.
"The TAXUS IV/V diabetic subset data indicated that the TAXUS Stent mitigated the impact of diabetes as a risk factor for restenosis following stenting procedures in the patients studied," said Dr. Stone. "Diabetic patients treated with TAXUS Stents compared to bare-metal stents had significantly improved event-free survival, particularly important in high-risk patients with diabetes."
The pooled analysis included angiographic outcomes at nine months and clinical outcomes at three years among 338 diabetic patients and 901 non-diabetic patients treated with the TAXUS Stent from the TAXUS IV and V clinical trials. Nine-month angiographic outcomes showed equivalent in-segment late loss (0.27mm vs. 0.31mm, p=0.28) and binary restenosis (14.3 percent vs. 15.1 percent, p=0.83) in diabetics and non-diabetics, respectively.
At three years, TLR was similar for diabetic and non-diabetic patients (12.4 percent vs. 10.1 percent, p=0.25), despite significant baseline differences and increased comorbidity risk in diabetic patients. TVR was higher in diabetics (21.4 percent vs. 15.7 percent, p=0.017), due to an increase in remote TVR events (outside the stented segment), which is an indicator of the more aggressive background disease progression in diabetics. Three-year rates of stent thrombosis under Protocol definition (0.9 percent vs. 1.3 percent, p=0.63) and ARC Definite/Probable (1.6 percent vs. 1.9 percent, p=0.73) were similar, even without multivariate adjustment.
The TAXUS IV/V analysis also compared 338 diabetic patients treated with the 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 in diabetic patients treated with the TAXUS Stent compared to BMS, consistent with results seen in other high-risk patient groups. The TAXUS Stent showed comparable safety to BMS in diabetics, with no significant differences in death (7.3 percent vs. 7.1 percent, p=0.91), cardiac death (4.6 percent vs. 2.7 percent, p=0.23), MI (6.5 percent vs. 6.6 percent, p=0.83) or ARC Definite/Probable stent thrombosis (1.6 percent vs. 1.5 percent, p=1.00) in TAXUS and BMS, respectively.
The safety and effectiveness of the TAXUS Express Stent has not been established in patients with diabetes in the United States.
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