Dr Patrick Serruys (Thorax Center, Rotterdam, the Netherlands) presented early results from the Arterial Revascularization Therapies Study II (ARTS II), comparing outcomes of 606 registry patients treated with a sirolimus-eluting stent with those of the PCI (n=600) and CABG (n=605) patients from the original ARTS I study. Serruys pointed out that the patients receiving a sirolimus-eluting stent today are generally higher risk than those enrolled in the original ARTS trial: for example, the number of diabetics was higher in the ARTS II group, 26.2%, compared with 15.9% in the CABG group from ARTS I and 18.7% in the PCI group from ARTS I. As well, the proportion of patients treated for three-vessel disease and the number of lesions per patient was higher in the ARTS II group. In the preliminary results, major adverse cardiovascular and cerebrovascular events (MACCE) were lower in the ARTS II group at 2.8% than in either the ARTS I-CABG (4.1%) or ARTS I-PCI (8.2%) patients.

Dr Serruys said, "I think it's fair to say that the number of treated vessels and lesions has increased with respect to ARTS I. However, the clinical success rate has remained the same. The overall MACCE rate of ARTS II is now equivalent to the surgical arm of ARTS I and seems to be a promising preamble to upcoming randomized trials such as FREEDOM and SYNTAX."

Presenting the 8-month data from the multi-center, non-randomized, historically controlled study in patients with de novo coronary artery lesions in small vessels (2.25 mm - 2.75 mm) with long lesions (15-30 mm) treated with the CYPHER Stent (SVELTE).

Dr Eduardo Sousa (Institute Dante Pazzanese, Sao Paulo, Brazil) reported that in-stent lesion loss and in-lesion late loss were significantly lower in the SVELTE cohort than in the SIRIUS bare-metal stent cohort and comparable to the SIRIUS Cypher cohort. Binary restenosis was also dramatically lower in both the SVELTE and SIRIUS Cypher cohort, compared with the binary restenosis rates in the SIRIUS bare-metal stent cohort. Clinically, target lesion revascularization was significantly lower in the patients in the SVELTE group compared with the SIRIUS control group.

"The current data are consistent with previous trials conducted with the Cypher sirolimus-eluting stent," Sousa concluded. "This is yet another piece of evidence of the powerful effect of this stent."

Commenting on the results of the TROPICAL Study comparing the CYPHER Stent to intravascular brachytherapy (low dose radiation), for the treatment of in-stent restenosis, principal investigator Professor Franz-Josef Neumann, Medical Clinic, Herz-Zentrum, Bad Krozingen, Germany, said: "In the treatment of in-stent restenosis, the CYPHER Sirolimus-eluting Stents provided an average in-lesion late loss of <0.1mm."

" Compared with the treatment of in-stent restenosis, brachytherapy, the CYPHER Stent substantially reduced angiographic restenosis and the need for target vessel revascularisation (repeat treatment)," he added.

TROPICAL: Angiographic outcomes at six months

Clinically, the sirolimus-eluting stent group also had fewer adverse events at follow-up.

TROPICAL: Nonhierarchical event rate at six months