Nagoya, Japan - New pilot-trial data suggest that the "prohealing" Genous (OrbusNeich) stent, designed to recruit endothelial progenitor cells to the inner surface of the stent to stimulate natural endothelialization of the stented section, may reduce major adverse cardiac events (MACE) and stent-thrombosis risk, compared with drug-eluting stents (DES).

Dr Federico Piscione (Federico II University of Naples, Italy) presented results from the 257-patient study during the 2008 Japanese Society of Interventional Cardiology annual meeting. For the study, the 257 consecutive, relatively high-risk patients received either the Genous stent or a Taxus or Cypher stent and were then followed for a mean of 13 months. To heartwire, Piscione clarified that patients were not actually randomized; rather, one physician performed only DES implantation, while two others performed Genous stent implantation exclusively. Patients themselves were not blinded to stent choice.

At follow-up, MACE rates were statistically lower for the Genous stent, while rates of MACE components individually—cardiac death, MI, and repeat PCI—were all numerically lower, as compared with the DES group.

No stent thromboses occurred in the Genous-treated patients; stent thrombosis occurred at a rate of 5.8% in the DES-treated patients. Of note, DES-treated patients received dual antiplatelet therapy for 12 months, while Genous-treated patients received just one month of dual antiplatelet therapy, followed by aspirin thereafter.

"Our preliminary results suggest that Genous endothelial progenitor cell capturing coronary stent deployment in a consecutive series of high-risk patients is safe and effective, with a similar in-hospital MACE incidence and a better long-term clinical outcome when compared with DES," Piscione and colleagues concluded.

The stent-thrombosis results from Piscione et al's study appear consistent with observations by de Winter et al, reported by heartwire, who found MI rates to be numerically higher in the Taxus stent—hinting at increased stent thrombosis—than in the Genous in the TRIAS HR study. But in contrast to Piscione and colleagues, the number of repeat revascularizations was also higher with the Genous in the TRIAS HR pilot study.

Asked about the difference by heartwire, Piscione suggested that an emphasis on optimal stent deployment likely contributed to low rates of repeat PCI in their study. Investigators used pre- and post-PCI angiography, paid special attention to selecting the best stent length and diameter, and performed high-pressure postdilatation as a "default procedure," he said. Results of randomized trials, including one now under way in Europe, will help provide answers as to how the Genous stacks up against approved DES.

In his presentation, Piscione also presented results on 22 patients who received Genous stents prior to noncardiac surgery or endovascular aortic repair. In all patients, antiplatelet therapy was stopped during the perioperative period—an average of five days—and thienopyridines were not restarted after surgery. Up to one-month postsurgery, however, no MACE events, including stent thromboses, had occurred.

"According to our findings, the endothelial progenitor cell capture technology applied to the Genous stent might offer a new, important, safe, and feasible therapeutic strategy for patients needing to undergo 'lifesaving' or nondeferrable major noncardiac surgery early after a coronary stent deployment," Piscione et al concluded.