Biodegradable stents: Revolutionary potential for children with congenital heart defects

Two-year data from the BASKET-PROVE II trial that demonstrated a biodegradable-polymer drug-eluting stent was noninferior to a durable-polymer drug-eluting stent and superior to a thin-strut bare-metal stent were presented in November at the American Heart Association Scientific Sessions. This study supports prior studies that have demonstrated a strong argument for use of biodegradable stents in coronary disease, particularly when coupled with studies that demonstrated restored vasoreactivity after stent degradation, and other advantages of nonpermanence of a vascular scaffold.

The untold aspect of this story is that while a battle ensues between two competing therapeutic modalities, there is a population for which this technology has no competitor. The biodegradable stents are a fascinating development and represent an enormous financial investment by the companies that develop them. Fortunately, it appears that it is a gamble that will pay off. Unfortunately, the financial considerations limit the applicability of this important advance.

John P. Breinholt

An unmet need

The population of which I speak are children with congenital heart disease. While biodegradable stents represent an evolution in coronary therapy, it could be a revolutionary development for children born with complex heart defects.

An infant born with coarctation of the aorta, for example, will require a surgery, sometimes urgent surgery, during the first week of life. If the defect is mild and only requires intervention as a teenager or if a prior surgical repair recurs, we have stents that can be used off-label (specifically, biliary stents) to successfully address the defect. For the infants, we cannot offer the same because while they grow, a bare metal stent does not grow, and the biliary stents are too long and large for infant blood vessels. The stents that would work in infants cannot be dilated to “adult size,” precluding their use. In summary, we have no present therapy to offer.

A biodegradable stent would address this unmet need, but that stent does not exist, and may not exist. The stent in question would need to be developed for this patient population, which would be another large financial investment, but the number of patients it would treat would be far fewer than the potential recipients of the biodegradable coronary stents.

In other words, this would not be a profitable venture although the impact in pediatric interventional cardiology would be immeasurable. It would change the way we treat this disease, and potentially others, and pave the way toward better interventions than what are utilized today.

I have spoken with several developers of the biodegradable stents. They understand the need, they recognize the potential of this product, but fear it will never go further because it is not financially sustainable.

Questions remain

How do you do the “right thing” and pioneer a new therapy when the realities of business get in the way?
Are there ways for our adult interventional colleagues to leverage their position in this market to help us acquire this technology?
How can we make this happen?

Reference:

Ghimire G. EuroIntervention. 2009;4:481-484.

John P. Breinholt, MD, is a pediatric interventional cardiologist and division director of pediatric cardiology at the University of Texas Health Science Center at Houston. Breinholt is currently participating in the SCAI Emerging Leader Mentorship (ELM) Program and serves as co-chair of the Interventional Career Development (ICD) Subcommittee.

Disclosure: Breinholt reports no relevant financial disclosures.