[TCT2007]TRIAS HR Pilot Trial: Genous EPC-capturing Stent Feasible

Six-month clinical outcomes were similar between Genous and Taxus for treatment ofhigh-risk restenosis lesions.

Six-month clinical and angiographic outcomes from the TRIAS HR Pilot Study suggestthat the Genous endothelial progenitor cell-capturing stent may be a practical option for treatingcoronary artery stenosis and lesions at high risk for restenosis.

Robbert J. deWinter, MD, PhD, presented pilot data that compared the Genous stent (OrbusNeich) with the Taxus stent (Boston Scientific). No differences between the two were statistically significant. The underpowered pilot study will be followed by a larger, multicenter trial.

The Genous stent uses EPC-capturing technology and enhances endothelialization, according to
deWinter, of the University of Amsterdam in The Netherlands. The technology produces accelerated healing, protects against thrombus, minimizes restenosis, and has an improved safety profile over current DES, he said (Figure 1).

Pilot data

At 6 months, clinical outcomes including death, MI, repeat PCI, CABG and TVF were similar between groups (Figure 2).

Outcomes for high-risk restenosis lesions were also similar between the two stents, deWinter said.
Forty-four percent of patients who received the Genous stent were taking clopidogrel at 6 months compared with 73% who received the Taxus stent. Most patients in both groups reported no angina.

Fourteen percent of patients treated with Taxus required repeat non-TVR compared with 3.2% of patients treated with the Genous stent.

Total follow-up for the TRIAS HR Pilot Study is 5 years.

Critical appraisal

Cindy L. Grines, MD, director, Cardiac Cath Laboratories and Interventional Cardiology Fellowship Program at William Beaumont Hospital in Royal Oak, Mich., presented a critical appraisal of the TRIAS HR Pilot Study.

Overall, the pilot data are promising, Grines said. Compared with DES, the EPC-capturing stent offers several potential benefits: It quickly establishes normal endothelium, requires a shorter duration of clopidogrel therapy, may reduce cost as well as bleeding, and seems to decrease the risk of stent thrombosis.

Grines voiced several concerns about the trial including the fact that the Genous stent was used in fewer patients with diabetes, was employed in more vessels that were 2.8 mm or greater, and that the study was not blinded and had a small sample size.