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No stent thrombosis reported
No stent thrombosis reported in final TAXUS II results
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THE FINAL five-years results from the TAXUS II trial and two registries have, according to investigators, confirmed the ‘positive’ and ’sustained benefit’ of the of Taxus Liberte and Taxus drug-eluting stent systems. The results were announced at the European Society of Cardiology (ESC) congress in Vienna, Austria.
TAXUS II TAXUS II is a randomised, double-blind, controlled study of 536 patients in 15 countries designed to evaluate the safety and efficacy of a Taxus paclitaxel-eluting coronary stent, in which two sequential cohorts of patients with standard risk, de novo coronary artery lesions were treated with different dose formulations. The efficacy advantage of the Taxus stent seen at six months was maintained through the five years following stent implantation, with the commercialised slow-release (SR) version of the Taxus stent reducing Target Lesion Revascularisation (TLR) by 44% vs. BMS (Taxus SR 10.3%, BMS 18.4%, p=0.0003). Safety of the Taxus stent was also maintained with Major Adverse Cardiac Events (MACE) for the Taxus SR stent showing a 35% reduction over the BMS (Taxus SR 20.4%, BMS 27.6%, p=0.01). The overall myocardial infarction (MI) rate for the Taxus SR stent was 4.7% as compared to 7.1 in the bare metal group (Taxus SR 4.7%, BMS 7.1%, p=NS). The results also showed no additional stent thrombosis between years four and five, while the BMS control experienced one stent thrombosis during this same period. This marks the third consecutive year of TAXUS II follow-up with no stent thrombosis seen in the TAXUS stent patient group. “Long-term results from TAXUS II reinforce the safety of paclitaxel-eluting stent technology and provide encouraging data regarding late and very late stent thrombosis out to five years,” said Professor Sigmund Silber, who presented the TAXUS II results. “In this trial, the data revealed that the Taxus paclitaxel-eluting stent maintained its efficacy benefits and had no thrombosis between years four and five while the bare metal control had one additional thrombosis. These results warrant important consideration and possible further study if seen as an indication of longer-term trends.”
TAXUS OLYMPIA According to the sponsor, the global, prospective TAXUS OLYMPIA registry is the world’s largest drug-eluting stent registry and plans to enrol up to 26,000 patients from more than 400 centres worldwide. OLYMPIA is designed to analyse real-world clinical outcomes data for Boston Scientific’s second-generation Taxus Liberte paclitaxel-eluting stent system in the treatment of patients with coronary artery disease. One-year results from the European and Intercontinental launch phases of the OLYMPIA registry (sponsored by Boston Scientific) revealed a low overall 3.9% rate of Taxus Liberte stent related cardiac events. The registry has enrolled nearly 23,000 patients and these results were based on the first 7,124 patient cohort. The 3.9% rate of related cardiac events, including cardiac death (1.1%), myocardial infarction (0.9%), and stent related re-intervention of the target vessel (2.5%). The one-year stent thrombosis rate was 0.8%, which is consistent with safety data from other drug-eluting stent registries. In the diabetic subset (2,380 patients), OLYMPIA reported a low 4.4% rate of overall stent related cardiac events, including cardiac death (1.9%), and myocardial infarction (0.8%). Stent related re-interventions (2.3%) and stent thrombosis (0.7%) were both lower for the high-risk diabetic patient group than the rates for the overall population. The OLYMPIA European and Intercontinental launch phases consisted of diverse and high-risk patient populations, reflecting complex usage patterns in ‘realworld’ clinical practices. A majority of patients exhibited complex lesions or clinical characteristics, including, multi-vessel disease (57.7%), prior myocardial infarction (MI) (37.3%), acute MI (17.8%), multiple stents (32.9%), type B2/C lesions (56.6%) and diabetes (33.4%). Of the first 7,124 patients enrolled, 92.5% (6,593 patients) were available for evaluation at one year. Patients with a single vessel treated with only one Taxus Liberte stent were considered simple use patients and comprised 27.6% of the total. Complex use patients comprised 72.4% of the population (5,157 patients) and included patients with acute MI, small vessels, long lesions, in-stent restenosis, and bifurcations, representing lesions not studied in the TAXUS IV and TAXUS ATLAS pivotal randomised controlled trials. Despite the higher complexity, patients in this group demonstrated an overall Taxus Liberte stent related cardiac event rate of 4.6% and a stent thrombosis rate of 1.0%. “The OLYMPIA registry continues to show impressive results, especially given the high degree of complex patient and lesions from real-world practice,” said Dr Martyn Thomas, Director of Invasive Cardiology, Kings College Hospital, London, and one of the coordinating investigators of the registry. “The data show consistency with initial results and with data from other TAXUS clinical trials and registries, offering further evidence that the Taxus Liberte stent system continues to show positive safety outcomes in real-world use.” The Taxus Liberte stent is an investigational device and is not for sale in the US.
TAXUS WOMAN Also at the ESC, results were also announced results from the TAXUS WOMAN study, a gender specific analysis of the TAXUS II, IV, V and VI trials assessing the efficacy data of the Taxus paclitaxel-eluting coronary stent in women undergoing coronary revascularisation. The study found paclitaxel-eluting stents to have similar clinical outcomes in women and men, despite the higher risk profile in women patients. The TAXUS II, IV, V and VI trials evaluated the performance of the Taxus paclitaxel-eluting stent (PES) compared to a bare metal stent (BMS) control in patients with coronary artery disease. The TAXUS WOMAN study analysed pooled results of the women enrolled in these TAXUS trials and compared them with the corresponding endpoints in men. Of the 3,445 patients enrolled in the TAXUS trials between June 2001 and March 2004, 955 (27.7%) were women. Of these women, 480 received PES and 475 received BMS. Of the 2,490 men enrolled, 1,238 received PES and 1,252 received BMS. As compared to men, women were older (mean age 65.4 +/- 10.9 years vs. 61.0 +/- 10.4 years), had smaller body surface area (1.80 +/- 0.19m2 vs. 2.05 +/- 0.20m2), had more diabetes (30.4% vs. 21.0%), had more hypertension (78.0% vs. 65.1%), had smaller vessels (pre-procedure reference vessel diameter 2.63 +/- 0.46mm vs. 2.78 +/- 0.52mm), and had more history of coronary artery disease (62.2% vs. 54.7%) (p for all <0.001). There were no other significant differences in baseline demographics, lesion or procedural characteristics between the PES and BMS groups in both genders. Results show that the Taxus stent maintained its advantage in preventing repeat procedures compared to the BMS control, while showing no significant differences in outcomes based on gender. At one year, the unadjusted rate of target lesion revascularisation (TLR) in the PES-treated group was 8.1% in women vs. 6.7% in men (p=0.297), while in the BMStreated group, the unadjusted TLR rate at one year was 17.5% in women vs. 16.4% in men (p=0.613). At three years, the data showed continued low TLR rates in both women and men treated with PES (10.7% in women vs. 8.8% in men, with no difference between men and women, p=0.301). Comparable results in safety outcomes were seen for women, showing no differences in major adverse cardiac event (MACE) rates at one year. MACE rates in the PES group were 15.6% for women vs. 13.2% for men (p=0.214), while MACE rate in BMS group were 24.0% for women vs. 21.7% for men (p=0.332). “This study of data from the TAXUS trials offers encouraging news for women with coronary artery disease,” said Dr Ghada Mikhail, Consultant Cardiologist, St Mary’s Hospital Trust, London, UK. “Previous trials and registries have demonstrated a less favourable clinical outcome in women compared to men when undergoing coronary revascularisation with BMS. That difference has been previously explained by the smaller vessels and higher risk profile seen in women. These data show, however, that the Taxus paclitaxel-eluting coronary stent works equally well in women, maintaining its anti-restenotic efficacy advantages and positive safety profile relative to BMS.”
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