NATICK, Mass. and CHICAGO, April 1, 2008 BostonScientific Corporation (NYSE: BSX) today announced results from a pooledanalysis of patients from its TAXUS IV and TAXUS V randomized clinical trials.The analysis compared the safety and efficacy of the TAXUS(R) Express(TM)Paclitaxel-Eluting Coronary Stent System in diabetic versus non-diabeticpatients. Results demonstrated that despite the known increased rates ofmortality and restenosis for diabetics versus non-diabetics in patients withcardiovascular disease(1), the TAXUS Stent had comparable levels of late lossand target lesion revascularization (TLR) across these patient populations.The study also showed no significant differences in target vesselrevascularization (TVR), stent thrombosis, or myocardial infarction (MI),after adjustments were made for differences in other baseline characteristicsbetween patients with or without diabetes. Analysis of the data was presentedby Gregg W. Stone, M.D., of the Columbia University Medical Center in NewYork, at the SCAI Annual Scientific Sessions in Partnership with the ACC/i2Summit in Chicago.
"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