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"The five-year TAXUS IV follow-up study of the TAXUS Express Stent clearlydemonstrates long-term safety, with similar rates of death, myocardialinfarction, and stent thrombosis across a broad cross section of patients andlesions and with no new cases of stent thrombosis between years four andfive," said Gregg W. Stone, M.D., of Columbia University Medical Center andthe Cardiovascular Research Foundation, New York, the Principal Investigatorfor the TAXUS IV clinical trial. "The TAXUS IV data combined with the TAXUSII results presented in September clearly add to the growing body of evidencereinforcing the long-term safety of TAXUS paclitaxel-eluting stents."
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The results of TAXUS IV reaffirm the long-term safety of the TAXUS Stentas demonstrated by an excellent five-year safety profile. Rates of all death(10.0% vs. 11.2%, p=0.49), cardiac death (4.4% vs. 4.5%, p=0.85), and alldeath and Q-wave myocardial infarction (10.9% vs. 12.0%, p=0.57) werenumerically lower in the TAXUS Stent group compared to the BMS group. Thefive-year rates of cardiac death and Q-wave myocardial infarction wereidentical between the TAXUS Stent and the control BMS (5.3% vs. 5.3%, p=0.96).Using the broader ARC definition of definite/probable, the TAXUS IV trialreported no cases of stent thrombosis between years four and five for theTAXUS Stent and one incidence of stent thrombosis for the BMS control group(0.0% vs. 0.2%, p=0.50), with a cumulative rate of stent thrombosis ratethrough five years being identical -- 2.5% for the TAXUS Stent and 2.5% forBMS (p=0.94).
"With the recent reversal of the SCAAR study, positive results from theOntario database and excellent five-year data reported for TAXUS II and nowTAXUS IV, the TAXUS Stent System has firmly established an outstanding long-term safety and efficacy record as evidenced by clinical trial data nowreporting out to five years," said Paul LaViolette, Chief Operating Officer ofBoston Scientific. "Also noteworthy is that the slow-release paclitaxel-eluting TAXUS Stent continues to demonstrate its effectiveness in preventingrestenosis, or additional procedures, out to five years across a wide varietyof patients and lesions."
The TAXUS IV five-year results support the long-term effectiveness of theTAXUS Stent with marked target lesion revascularization (TLR) reduction acrossa broad cross section of patients and lesions. When compared to BMS, theTAXUS Stent reduced the five-year rates of TLR by 56% (9.1% vs. 20.5%,p<0.0001), target vessel revascularization (TVR) by 38% (16.9% vs. 27.4%,p<0.0001), and major adverse cardiac events (MACE) by 27% (24.0% vs. 32.8%,p=0.0001). The rate of patients living free of TLR events was 90.9% at fiveyears for the TAXUS group compared to 79.5% for the BMS control group(p<0.0001). The rate of patients living free of TVR events was 83.1% at fiveyears for the TAXUS group compared to 72.6% for the BMS control group(p<0.0001).
TAXUS IV is a randomized, double-blind pivotal trial designed to assessthe safety and efficacy of a paclitaxel-eluting coronary stent system inreducing restenosis in de novo lesions 10-28 mm in length and 2.5-3.75 mm indiameter. The study, which enrolled 1,326 patients at 73 sites in the Uni
