Heart patients with coronary artery stents often face the prospect of getting another one when the artery re-clogs from scar tissue. But a new treatment can head off that prospect, and a Northern Virginia center was part of its development.
The treatment is called the AGENT Drug-Coated Balloon, and Inova Schar Heart and Vascular was part of the clinical trial that led to Food and Drug Administration approval in March.
Dr. Wayne Batchelor, the system director of interventional cardiology at Inova Schar Heart and Vascular, describes a stent as “a metal scaffold that’s put in a blocked artery that opens up the artery and restores blood flow to the heart.” But he explains that “the Achilles heel of stents has been recurrence of scar tissue inside the stent.” Even though the stent pushes aside the plaque that clogs arteries, scar tissue can build up inside the stent and plug the artery back up.
Some years ago, researchers developed what’s called drug-eluting stents — stents coated with the kind of medication that helps prevent the formation of scar tissue — and that helps, but it still happens in 5 to 10 percent of stent cases, Batchelor says.
“It can be a vexing problem,” he says, and the previous solution was to put in another stent. That can work, but a “stent sandwich” (Batchelor’s term) starts to produce wear and tear on the artery itself.
That’s where the AGENT balloon comes in. Developed by Boston Scientific, it’s a drug-eluting balloon that opens up the artery and leaves another drug to prevent the formation of more scar tissue.
Inova Schar participated in a randomized trial to test out the new technique, and the results have been encouraging. The FDA has approved the use of the balloon, and “because we were participants in the trial, we got our hands on the balloon early, and have used it in several patients thus far with very good success,” Batchelor says.
Since the device was approved, Inova has treated four or five patients with the balloon “with 100 percent success.”
“Of course,” he warns, “we’ll have to let time play out to make sure that they don’t come back with scar tissue. But the technique is very straightforward. It’s very similar to what we normally do for these procedures, and it can be done with a very high level of safety for our patients, and we’re confident that it’ll translate into an important reduction in recurrence.”
The downsides or potential side effects are “no more than there are for any other standard angioplasty or coronary stent procedures,” Batchelor says.
“We’re already using the balloons in our usual care of patients. The only difference here is, instead of following it with placement of a stent, if we balloon and get a good result, the drug is delivered,” he says.
‘Pretty Significant’
Batchelor emphasizes that the technique is only for people who already have stents who are experiencing another narrowing of an artery. It doesn’t replace stents altogether — at least not yet.
“In the future, there are going to be trials set up and designed to see if this should move to the position of even replacing stents,” Batchelor says. “Right now, it’s only for stents that have developed scar tissue and recurrence, but there are some concepts that support the idea of potentially using this upfront and avoiding a stent. But we’re not there yet.”
Still, where they are is pretty exciting. Schar does close to 2,000 stent procedures a year, Batchelor estimated, so that 5 to 10 percent of patients who need another procedure really adds up. “[And] when you multiply that by the U.S. population and the worldwide population, it turns out to be pretty significant numbers of patients who could benefit from this.”
Batchelor put in a plug for Schar, noting that the leadership and administration help put it in a position to take part in these sorts of trials, which, as in the case of AGENT, leads to early adoption of new treatments: “We take pride in being a high-level research institute, and use that to supplement our excellent clinical practice and allow some novel therapies to patients who are in need.”
Feature image, lenetsnikolai/stock.adobe.com
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