Your feedback is appreciated on 411114003 |Drug coated stent (product)| and its subtype 411191007 |Drug eluting stent (product)|. Are these duplicates? If not, is there enough clinical distinction to keep them as separate concepts? Can examples be provided of a drug-coated stent that is not also considered a drug-eluting stent?
*Because these two are both specified as drug, the presence or absence of other non-drug coatings such as polymers, silicon carbide, etc., are irrelevant.
From the GMDN, Drug-coated-metal coronary artery stent:
A non-bioabsorbable, metallic tubular mesh structure covered with a drug directly on the metal surface (i.e., not eluted by a polymer or carbon coating), designed to be implanted via a delivery catheter into a de novo or restenotic native coronary artery, during a percutaneous coronary intervention (PCI), to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug is intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation; neither polymers nor antibody coating are included. Disposable devices associated with implantation may be included.
GMDN breaks down the drug-eluting stents by the coating that the drug elutes from, but Drug-eluting coronary artery stent, carbon-coated:
A non-bioabsorbable metal tubular mesh structure covered with a biocompatible film of pure carbon (polymer free) and loaded with a drug, designed to be implanted via a delivery catheter into a de novo or restenotic native coronary artery, during a percutaneous coronary intervention (PCI), to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug is intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation, and is loaded into and released from carbon-coated reservoirs on the external surface of the stent to facilitate maximum drug delivery to the vessel wall. Disposable implantation devices may be included.
From the point of GMDN / regulatory drug-coated is not the same as drug-eluting.
Just to add, I think the drug-eluting ones are designed to release drug into the blood vessel wall, where as the drug coated ones are acting on the surface of stent and / or the blood flowing past.
That being said, I don’t think cardiologists are that concerned about the specifics of the name and probably lump them together and only care about the drug instead of the of the technology used.
So if I understand GMDN’s stance correctly, a drug-eluting stent cannot be a drug-coated stent, so 411191007 |Drug eluting stent (product)| would not be a subtype of 411114003 |Drug coated stent (product)| but a sibling?
That would fit with the GMDN definitions of these devices. They are not the same and aren’t subtypes of each other as far as GMDN are concerned. Making them siblings would make sense.
I would agree that there is now a distinction between drug-eluting and drug coated stents and they should be siblings. However, if the latter is an advancement of the polymer stent then the term we have in SNOMED for Drug-coated stent pre-dates this new technology/terminology. Furthermore the definitions above are specific to the type of stent e.g. Drug-coated-metal coronary artery stent. I am unsure if we can consistently apply this distinction in terminology to other stent types, e.g. ureteral stents? So maybe the terms ‘drug-eluting stent’ and ‘drug coated stent’ are too broad and ambiguous to be clinically useful?
Other way round, I’m 95% sure the drug-coated stents came much earlier than the drug-eluting stents.
I do agree these concepts:
411191007 |Drug eluting stent (product)|
411114003 |Drug coated stent (product)|
are more like groupers as I agree clinically you should be using and know you’re using something more specific.
I’m less certain if there is a need or requirement for the generic concepts a targets in the modelling of other concepts, most likely procedure concepts.
I think the drug-coated heparin stents are mid-1990s. The first drug-eluting stent (sirolimus) was 2002.
Hi Stuart,
I was thinking more the newer products that are labelled as drug coated due to changes in technology and the move away from polymers e.g https://www.biosensors.com/intl/biofreedom - BioFreedom™ is a polymer- and carrier-free Drug Coated Stent with BA9™ (DCS).
The strict classification as either a drug-eluting or a drug coated stent may becomes less clear due to the potential uniqueness of the newer products entering the market and how regulatory agencies and companies name their products. The literature I have looked at is not overly consistent especially when bringing into the mix other types of stents.
However, before making any changes we would assess the impact. And this would depend on whether the group feels there is a clinically relevant issue with these groupers. As you said, clinicians will know their products.
I think one thing we have clarified is that drug-coated and drug-eluting are not duplicates in accordance with GMDN definitions for coronary stents and one is not a subtype of the other given the discussions.