Newly approved cardiac stent may provide alternative for some patients

There is a concern that cardiac stents are overused.

In fact, a study published in the Journal of the American Medical Association in 2011 found that only 50 percent of stent procedures reflected in the National Cardiovascular Data Registry,  were categorized as appropriate. Back in 2015, a pilot program won grant money from the Centers for Medicare and Medicaid Services to understand how physicians make decisions on stenting and other cardiovascular procedures and lay the ground for proper physician education and change.

While value-based care models are making their way into cardiac care, one company in San Antonio, Texas believes that it’s nanocoated stent will appeal to physicians who are looking for alternatives to drug-eluting stents for patients with high risk of bleeding.

CeloNova Biosciences, whose Cobra PzF Nano Coated stent is coated with a thin biocompatible polymer, announced Wednesday that the Food and Drug Administration has approved the device.

One of the device’s chief attractions is that patients need to be on dual anti-platelet therapy for a much shorter period of time following the stenting, said Dennert Ware, executive chairman and acting CEO of CeloNova, in a phone interview prior to the approval. The company’s approval announcement said the DAPT therapy needs to continue for a minimum of 30 days.

Compare that to drug-eluting stents, where DAPT therapy continues for 6-to-12 months following the procedure. For bare metal stents, the period is lower — one month.

CeloNova’s Cobra stent is made of cobalt chromium with a proprietary Polyzene-F nano-thin polymer. Data presented to FDA for approval found that stent thrombosis — a complication of stenting — was non-existent 9 months after the Cobra was inserted.

Device thrombosis occurs when a thrombus or blood clot suddenly forms in a stented coronary artery impeding blood flow and is a life-threatening complication. Where Cobra had no stent thrombosis, Abbott’s Xience stent, considered the best-in-class drug-eluting stent, has a stent thrombosis rate of 0.7 percent at one year.

The pivotal trial enrolled 296 patients from 35 centers in the U.S. and abroad. The Xience data comes from a much larger trial that pitted Abbott’s bioresorbable stent against Xience, also an Abbott stent.

CeloNova’s Ware believes it’s important to highlight the low thrombosis rate.

“It’s better than DES for certain patients because our safety record — that is our thrombosis record — is very very good and far superior to  DES,” he declared. “It also has very good TLR and that is much better than a bare metal stent and nearly as good DES.”

Who are those certain patients that can benefit from the newly approved Cobra? Those that have a high risk of bleeding.

“What often happens is that people who require a stent are also people who are older and have comorbidites,” Ware explained. “That increases the probability of bleeding and in those cases we offer a far superior alternative, a choice the doctor can make to keep the patient safe.”

The principal investigator in the trial echoed Ware.

“There continues to be an unmet clinical need for patients who may not be candidates for drug-eluting stents or longer term dual antiplatelet therapy,” said Dr. Donald Cutlip, principal investigator and professor of medicine at Beth Israel Deaconess Medical Center and Harvard Medical School, in the news release announcing the FDA approval.“Given the observed low rates of stent thrombosis and target lesion revascularization that need to be confirmed in future studies, the COBRA PzF stent system may hold potential unique benefit for these patients.”

The low stent thrombosis is because of the biocompatible nature of the polymer nanocoating.

“It is the biocompatibility, the selectivity of that surface for attracting proteins and rejecting proteins so that the proteins that tend to initiate a thrombosis are the ones that are repelled and the proteins that tend to get good healing are attracted,” Ware explained.

Currently, per the company’s news release, CeloNova is studying the stent in the COBRA REDUCE trial, which began enrollment in February 2016. This randomized controlled trial will test whether the stent can help reduce bleeding as compared to drug-eluting stents, by “shortening the duration of DAPT to 14 days in patients who are at high-risk for bleeding and require treatment for coronary artery disease.”

FDA just gave the nod, but the Cobra stent is already approved and sold in Europe and the Middle East.

Source: bandit2523, Getty Images, and CeloNova Biosciences