Dr Patrick Serruys (Thorax Center, Rotterdam, the Netherlands) said that this multi-centre study involving 191 patients from 10 sites in 7 countries is a non-randomized dose-ranging registry to determine the optimal dose and kinetic release profile of paclitaxel on a new stent designed specifically for drug delivery. The primary endpoint was a composite MACE at 4 months. Secondary endpoints were angiographic late loss, rate of binary restenosis, diameter stenosis by QCA at 4 months, neointimal tissue volume by IVUS at 4 months and both technical and procedural success.

* six formulations of paclitaxel :
D1 10 ¥ìg / 5 days - bidirectional
D2 10 ¥ìg /10 days - mural
D3 10 ¥ìg /10 days - bidirectional
D4 10 ¥ìg /30 days - mural
D5 30 ¥ìg /30 days - mural
D6 30 ¥ìg /10 days - bidirectional

At baseline the patients median age was 59 years (male 70%). Risk factors or co-morbidities included history of smoking (76%), diabetes (19%), hypertension (53%), dyslipidemia (66%), prior MI (38%), prior CABG (3%) and prior PCI (12%). The majority of lesions were Type A and B1 (77%) with Type B2 (21%) and Type C (2%) by ACC Classification. The mean lesion length was 11.60 mm ± 2.71 mm (a percent stenosis of 80.4% ± 12.8%). Final diameter stenosis was 4.3% ± 5.2%. Post dilation occurred in 60% of cases. Technical success was achieved in 95% and procedural success was achieved in 93% of cases. The 30-day MACE rate was 4.2% (all TLR) and clinical outcomes in 191 patients at 4 months included death (0%), Non-Q wave MI (1.6%), Stent thrombosis (0.5%).

Dr Serruys said "The safety profile of this system - using an erodable polymer and delivering 100% of the drug in the nominal elution period - is within the accepted standards." Although the doses used were substantlially less than with TAXUS paclitaxel stents, the inhibtion of neo-intimal hyperplasia was inversly related to the rate of release. Currently the two best doses (D4 and D5) are under further investigation in the Euro-STAR trial from which the 4 month results will be followed up with 12 month IVUS and QCA data.