TAXUS Clinical Trials: TCT Recap

Gregg W. Stone, MD
Gregg W. Stone, MD
Dr. Stone, at the recent TCT Conference, findings were presented on a variety of TAXUS Clinical Trials. What trials did you report on, and what were some of the overall findings? At TCT my colleagues and I delivered extensive long-term TAXUS Clinical Trial data, particularly the highly anticipated two-year results from the TAXUS II European pivotal trial and the two-year results from the TAXUS IV U.S. pivotal trial. The TAXUS II and TAXUS IV Clinical Trials data demonstrated remarkable consistency in measures of safety and efficacy across patients, lesions and time. Once patients were past a six- or nine-month threshold, the TLR, TVR, MACE* and late loss rates were consistently low, all the way out to two years. Can you summarize some of the specific data from the TAXUS II Clinical Trial? In TAXUS II Clinical Trial, the two-year MACE rate was 14.2% for the combined slow-release (SR) and moderate-release (MR*) TAXUS® Stent group, compared with 24.6% for the combined bare metal stent (BMS) control group. In-stent late loss was measured at 26% for the TAXUS Stent group, compared with 54% for the control group. The angiographic data showed stable late loss out to two years with a sustained statistical benefit over the control group. The study reported a TLR rate of 5.5% for the SR arm and 3.9% for the MR arm, compared with 15% for the control group. This included eight new TLR events (percutaneous coronary intervention, or PCI) between one and two years in the control group, compared to one new event in the SR group, and no new events in the MR group. What about the two-year results from the TAXUS IV Clinical Trial? In the TAXUS IV Clinical Trial, TLR at two years was measured at 5.6% for the TAXUS Stent group vs. 17.4 for the control group. TVR at two years with the TAXUS Stent was 10.6% vs. 21.1% for the control group. MACE at two years with the TAXUS Stent was 14.7% compared to the control group’s 24.9%. What are the primary take-aways from the longer term TAXUS® results? The highlight of TCT relative to the TAXUS Stent was the emergence of extensive long-term clinical trial data showing the durability of this drug-eluting stent in preventing restenosis, as well as its safety. The now very complete data from the TAXUS Clinical Trials have demonstrated the long-term efficacy of the TAXUS Paclitaxel-Eluting Coronary Stent across patients, lesions and time. So, we’ve concluded that 1) the TAXUS Stent markedly reduces clinical restenosis, resulting in reduced rates of repeat percutaneous intervention; 2) this stent shows similar results in a wide range of complex patients and lesions and 3) at two years’ follow-up, the incremental benefits of having received the TAXUS Stent rather than a BMS continue to increase, with no evidence of late catch-up. Based on these data, what can interventional cardiologists tell their patients about the TAXUS Express2 Paclitaxel-Eluting Coronary Stent? The data are very robust and I would say that the best message we can give our patients is that the consistency of results across patient and lesion types significantly increases our confidence in this therapy. The TAXUS trial data sound very positive at two years. What's ahead in TAXUS Clinical Trials? Yes, based on these data, physicians should feel quite comfortable at this point. Going forward, I’m encouraged by Boston Scientific’s commitment to conducting and supporting large, multi-center randomized trials, which further increases confidence. There are two exciting new TAXUS studies coming up. SYNTAX is a new randomized trial starting in a couple of months that will study multi-vessel, multi-lesion cases the most complex patients. This will be a true real world trial with very few exclusion factors. Also, in two months we’ll begin enrolling for the HORIZONS AMI trial, which will explore optimal anti-thrombotic therapies and also test whether the TAXUS Stent will safely reduce the one-year rate of ischemia-driven TVR. HORIZONS will be conducted by the Cardiovascular Research Foundation with a grant from Boston Scientific. Is there any information that is helpful to physicians as they continue to use this technology? Yes, good stenting techniques continue to be important with DES. Using what we call the 4Ps can help ensure positive outcomes. Pre-dilate to prepare the lesion and allow the stent to expand fully Pressure to ensure good apposition-inflate to 14-16 atmospheres (atm) to fully expand the stent Pause to allow for balloon deflation; let the balloon deflate and fold fluoroscopically according to the DFU before pulling it out Position-monitor the guide catheter to avoid unplanned catheter advancement, (diving or sucking in). Sponsored by Boston Scientific Corporation. * TLR = Target Lesion Revascularization; TVR = Target Vessel Revascularization; MACE = Major Adverse Cardiac Events, including death, myocardial infarction (MI; Q-wave and non Q-wave) and TLR. * The TAXUS® Express2 Moderate-Release Stent is not approved for sale and the safety and efficacy of this device have not been established.