Long-term safety and efficacy with paclitaxel-eluting stents: 5-year final results of the TAXUS IV clinical trial (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent).

OBJECTIVES: The pivotal TAXUS IV (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent) trial evaluated the long-term safety and effectiveness of the paclitaxel-eluting stent (PES) compared with an otherwise identical bare-metal stent (BMS) in a relatively uncomplicated population of patients with a single de novo lesion in a native coronary vessel, treated between March and July 2002. BACKGROUND: Long-term follow-up is required to determine whether the early safety and efficacy of drug-eluting stents are maintained. METHODS: The primary end point of this prospective, randomized, double-blind trial was 9-month ischemia-driven target vessel revascularization (TVR) for PES versus the BMS control. Follow-up was complete in 1,230 (95.1%) of 1,294 randomized evaluable patients at 5 years. RESULTS: Compared with BMS, PES significantly reduced TVR at 9 months (12.1% vs. 4.7%; p < 0.0001); this benefit was maintained through 5 years (27.4% vs. 16.9%; p < 0.0001), given comparable TVR rates for BMS and PES between years 1 and 5 (4.1%/year vs. 3.3%/year; respectively, p = 0.16). Similar patterns were observed for composite major adverse cardiac events (MACE) (32.8% BMS vs. 24.0% PES, p = 0.0001 at 5 years). Stent thrombosis was comparable for PES and BMS at 9 months (0.8% BMS vs. 0.8% PES; p = 0.98) and at 5 years (2.1% BMS vs. 2.2% PES, p = 0.87). The overall revascularization benefits of PES were consistent across multiple subgroups, including sex, diabetes, left anterior descending artery lesion location, reference vessel diameter, lesion length, and multiple stents. CONCLUSIONS: These 5-year results demonstrate the long-term safety and sustained efficacy of PES compared with BMS in patients with noncomplex lesions. (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent; NCT00292474).

Percutaneous placement of a low-profile stent-graft device for aortic dissections.

PURPOSE: The use of stent-grafts has proved to be safe and effective treatment for complicated aortic dissections but usually requires surgical cutdown to accommodate large-profile devices. Preliminary results of the use of a low-profile design that allows percutaneous access are presented. MATERIALS AND METHODS: Fifteen patients with aortic dissection were treated with use of a low-profile stent-graft. Dissection types included Stanford type A (n = 6) and type B (n = 9). The procedures were performed with use of Perclose devices to achieve hemostasis. The stent-graft device was composed of Gianturco stents connected with longitudinal wire struts covered with radially expanded polytetrafluoroethylene. The delivery sheath sizes were 14-20 F. RESULTS: In 87% of patients (13 of 15), the entry tear was excluded completely. Successful femoral closures were achieved in 93% of patients (14 of 15) with use of the suture-mediated devices. In 7% of patients (one of 15), surgical closure of the femoral arteries was required. The rate of pseudoaneurysm occurrence was 7% (one of 15). Hospitalization ranged from 1 to 30 days with a mean duration of 6.5 days. The 30-day mortality rate was 27% (four of 15). In the remaining 11 patients, entry tear sites were excluded and, on follow-up CT examinations, there was thrombosis and retraction of the false lumen and enlargement of the true lumen. CONCLUSION: Preliminary results of the use of a low-profile stent-graft device to treat aortic dissections show that, in most patients, it can be used with a suture-mediated device without surgical exposure of the common femoral artery.