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Medical Device Daily Senior Staff Writer

Interventional cardiologists aiming to tackle the dual problem of in-stent restenosis and stent thrombosis associated with the use of stents have found a potential remedy by combining drug-eluting and pro-healing technologies.

Alan Yean Yip Fong, MD, of the Sarawak General Hospital (Malaysia) presented six-month clinical follow-up data from 50 patients in the Paclitaxel-eluting balloon and bio-engineered progenitor cell-attracting stainless steel stent in percutaneous treatment of coronary artery stenosis (POTENT) registry last week during the World Congress of Cardiology Scientific Sessions 2010 in Beijing.

POTENT, an investigator-initiated, single-center study, evaluated the combination of pre-dilation with a Paclitaxel drug-eluting balloon catheter, the SeQuent Please from B. Braun Melsungen (Berlin), followed by implantation of the Genous Bio-engineered R stent from OrbusNeich (Hong Kong) for the percutaneous treatment of coronary artery stenosis.

In the six-month clinical follow-up of the 50 patients in the study, the rate of major adverse cardiac events (MACE) was 6%, and the rate of clinical driven target lesion revascularization (TLR) was 4%. In an optional nine-month angiographic follow-up of 35 patients, no patients exhibited binary restenosis, the investigators reported.

"We are very encouraged by the low MACE and binary restenosis rates, which are comparable to other stenting strategies and demonstrate the potential for combining drug-eluting and pro-healing technologies," said Tiong-Kiam Ong, MD, of the Sarawak General Hospital and principal investigator of the study. "This therapeutic strategy could be a potent remedy for the dual problem of in-stent restenosis and stent thrombosis."

While the POTENT study was independent from the companies that make the devices, David Camp, VP of corporate development for OrbusNeich, told Medical Device Daily that the goal of the investigators was to find a safer way to treat patients that they would otherwise treat with a drug-eluting stent.

"I think most physicians, even though they recognize that drug-eluting stent technology has a tremendous impact on restenosis, they also recognize that it comes with a price, long-term dual antiplatelet therapy (DAPT) because otherwise you get these stent thrombosis events that can lead to death in approximately half the patients," Camp said.

In the POTENT registry, 32% of patients were diabetic, 86% were male, 58% had a previous heart attack and the mean age of the study population was 56. Of the lesions treated, 46% were type B2/C lesions. The patients received a pre-loading of DAPT at least six hours prior to the percutaneous coronary intervention, and the DAPT was continued for three months. There were no in-hospital or 30-day MACE reported. There was one case of late stent thrombosis.

David Kujawa, director of strategic marketing for OrbusNeich, told MDD that while DAPT was prescribed for three-months following the percutaneous coronary intervention in the POTENT registry, the investigators said those patients would have been on DAPT for at least 12 months if they had been treated just with a drug-eluting stent. Significantly reducing the use of the therapy will have a cost-saving impact, as well as provide the patient with the freedom of future treatment options. He noted that requiring dual antiplatelet therapy makes it "very risky" for patients to undergo any kind of surgery, even something as minor as dental surgery.

"Anything with a drug-eluting balloon is kind of a hot topic right now," Camp said.

Similar, more preliminary results, from the POTENT study were presented in Paris about a month ago, Camp said, which generated a lot of interest in the potential of this therapy strategy. He said he expects OrbusNeich will hear from more clinicians interested in the technology as a result of the recent presentation in Beijing.

According to OrbusNeich, Genous is its endothelial progenitor cell (EPC) capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices, such as stents. The technology consists of an antibody surface coating that attracts EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis. The Genous Bio-engineered R stent has been commercially available in more than 60 countries since 2005, the company noted. The Genous stent has been proven as a safe, effective alternative to drug-eluting stents, according to the company, and is supported by data from more than 5,000 patients in company-sponsored clinical studies.

"The Genous stent is actually the only bio-engineered stent in the world right now," Camp said. He explained that the problem with most drug-eluting stents is that they are good at reducing restenosis, but the devices have a high rate of late-stent thrombosis because the stent is not healing.

"All our technology is doing is accelerating the healing process," Camp said.

The company noted that there is a growing body of evidence from multiple clinical studies that the Genous stent is effective for patients who are non-responsive to or cannot tolerate long-term dual antiplatelet therapy.

"We're not against Plavix but we want the physician to have a choice," Camp said, adding that some patients cannot tolerate long-term dual antiplatelet therapy for various reasons, either because they have a non-cardiac surgery scheduled, or they have gastrointestinal bleeding, or they simply do not respond to Plavix. "Genous by itself is a very powerful tool for the interventional cardiologist," he said.

Amanda Pedersen, 229-471-4212

Published  June 23, 2010

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