Barcelona, Spain - Physicians at this year's EuroPCR meeting had the chance to glimpse some of the first randomized clinical data on so-called "active" stents that promote vessel healing while reducing the risk of antiproliferative reactions, without carrying polymers or drugs that have been blamed for an increased risk of stent thrombosis.

Whether such stents end up competing directly with blockbuster drug-eluting stents (DES) or end up as niche products in people who cannot take dual antiplatelet therapy remains to be seen, experts say.

The Genous stent is an antibody-coated bare-metal stent designed to capture a patient's own endothelial progenitor cells (EPCs) to accelerate the natural healing process after stent placement and to modulate smooth-muscle-cell growth. Stent developers believe the stent would be particularly attractive to patients who cannot take extended dual antiplatelet therapy or who may be at particularly high risk for stent thrombosis.

Investigators for the e-Healing multicenter first-in-human registry of the Genous stent (OrbusNeich) and for the TRIAS-HR randomized pilot study comparing the Genous stent with the Taxus stent presented new data here at the meeting. The e-Healing registry, led by Dr Sigmund Silber (Dr Müller Hospital, Munich, Germany) and Dr Robbert de Winter (Academic Medical Center, Amsterdam, the Netherlands) had, as of late March 2008, enrolled almost 5000 patients at 144 sites. In an interim analysis of 1640 patients who have completed 12-month follow-up, investigators report that rates of cardiac death, MI, and target lesion revascularization (TLR) are low and comparable with rates seen in the early Taxus registry studies. Importantly, a low rate of stent thrombosis was seen despite patients taking just one month of dual antiplatelet therapy.

e-Healing registry: 12-month results

May 14, 2008

Shelley Wood

Two-year follow-up for both trials was presented here at the EuroPCR 2008 meeting.

Presenting the two-year results for SPIRT III, Dr Gregg Stone (Columbia University, New York, NY) showed that the gap separating MACE and target-vessel-failure (TVF) rates in patients treated with the everolimus-eluting Xience V stent vs the paclitaxel-eluting Taxus stent has continued to widen between 12 and 24 months, favoring the Xience everolimus-eluting stent. One-year results for the study, recently published in the Journal of the American Medical Association [1], suggested that the newer device was statistically superior to the Taxus for MACE, but for TVF (any cardiac events in the treated vessel) showed only a trend in favor of the Xience V. But at two years, the difference between the groups was statistically significant, Stone reported Tuesday. MACE rates were reduced by 45%, while TVF was reduced by 32%. Rates of target lesion revascularization (TLR) and stent thrombosis were also numerically lower for the Xience V stent.Two-year clinical results for SPIRIT III

Further probing of the MACE end point showed that while death and cardiac death rates were not significantly different between the two groups, MI rates showed a strong trend in favor of the Xience V, and all-cause death/MI events combined just reached statistical significance, again favoring the Xience V. The trial was not, however, powered to demonstrate a difference in clinical events, Stone clarified.

Intriguingly, an analysis of stent-thrombosis rates for both stents, based on timing of dual antiplatelet therapy discontinuation, suggested that there were fewer stent thrombosis "episodes" after six months in Xience V-treated patients who had discontinued their meds than in Taxus-treated patients who had stopped dual antiplatelet therapy. The observation "is potentially important and deserves further study," Stone commented.

Available in Europe since early 2006, the Xience V stent received the thumbs-up from an FDA advisory panel last year but has not yet been granted marketing approval in the US.

Dr Bernard Chevalier (Centre Cardiologique du Nord, Saint-Denis, France) presented late results for the phase 1 and 2 NOBORI study of Terumo's stent by the same name. The Nobori stent uses the S-stent platform, a biodegradable polymer, and Biolimus A9; the device received CE Mark approval in Europe earlier this year. In the phase 1 study, the Nobori was compared with the Taxus Express stent, while in phase 2, the comparator stent was the Taxus Liberté; two-year data were available only for the 85 Nobori-treated patients/35 Taxus-treated patients in the phase 1 study.

According to Chevalier, the NOBORI I trial met its clinical end point of noninferiority in terms of in-stent late loss in both phase 1 and 2 of the study, with most angiographic results at nine months showing statistical superiority of the Nobori stent. Although the numbers of patients and events at two years were too small to be statistically meaningful, the rates of TLR and TVF were numerically lower in the Nobori-treated patients. Of note, there were no stent thromboses out to two years for the Nobori stent, despite the fact that only 25% of patients remained on dual antiplatelet therapy at this time.Two-year clinical results for NOBORI

Discussing the results following their presentation, Dr Evelyn Regar (Erasmus Medical Center, Rotterdam, the Netherlands) suggested that the next-generation DES seem to be, albeit at an early stage, superior to their predecessors. "The new-generation DES, Nobori and Xience V, showed sustained efficacy and safety results over two-year follow-up and proved superior in their respective primary trial end points," she said. While the trend favoring reduced stent thrombosis for the newer stents in both trials is "reassuring," Regar reminded the audience that none of the trials to date have been powered to address the question of stent thrombosis.

Bro JJ,

           No harm trying or listen to him..... If so coincidence tat the price move according to pattern then is good.... If din move, we had nothing to lose right???? hee

           But I also think that there is nothing about so call 'pattern" especially in stocks.....We shall see and monitor closely next week which is short by one day ( 4 trading day only).

           Let's hope the assumption is correct... chiong ar!!!!!