Drug-coated stent bests bare metal in patients with high bleeding risk

September 23, 2018|Hematology and Oncology

REPORTING FROM TCT 2018

Parsing the findings

When asked whether the Food and Drug Administration should approve this stent and whether he would use it for his patients, Dr. Krucoff gave a “yes, but …” reply. “The but here is, we have a lot to learn in this area. These are patients who by and large have been excluded from every pivotal drug-eluting stent study and every pivotal dual-antiplatelet study,” he elaborated. It is therefore unclear, for example, how the stent will perform as more are treated and what the optimal duration of dual-antiplatelet therapy is. Nonetheless, given that these patients make up a sizable share of the PCI [percutaneous coronary intervention] population and that some centers still commonly use bare-metal stents, “I think bringing this stent forward with a label for 30 days [of dual-antiplatelet therapy] in high bleeding risk patients is a yes.”

“To me, the main driving factor for an expeditious [approval] process is, if you put a conservatively critical eye to this, you could say that LEADERS FREE alerts us to a safety signal [about] our intuitive behavior practice of putting bare-metal stents in patients who we know are at high bleeding risk, so we are only going to treat them with 30 days of dual-antiplatelet therapy. There is actually a safety signal that we are potentially doing harm, based on at least one look at this,” Dr. Krucoff added. “There is no question, I think FDA decisions are primarily driven by safety concerns. The unusual thing here is, it’s not a safety concern as a defect in the device, it’s a safety concern relative to our current practice.”

In fact, it may be time to retire bare-metal stents altogether, according to Antonio Colombo, MD, director of the Cardiac Cath Lab and Interventional Cardiology Unit at the Columbus and San Raffaele Hospital, Milan, and a visiting professor of medicine at Columbia University Medical Center, New York. “I think the results are very provocative. We did a survey in Italy, and the use of bare-metal stents in the last 3 years has been 1.3%. It’s very low but still not zero. So with this data, I really wonder, should we pull out bare-metal stents from the market? Is it ethical to put in a bare-metal stent if you have this [other] stent available?” he asked.

That percentage is in double digits in the United States, noted Sunil V. Rao, MD, a professor of medicine and member in the Duke Clinical Research Institute. “It’s pretty remarkable how often bare-metal stents are being used in the U.S., so for the U.S. market, this [new] option is actually a very attractive one. We have a lot of debates in our own practice about whether we should be putting in bare-metal stents, and often we are directed to do so by noninvasive cardiologists who are not necessarily up to speed on the latest data,” he commented. “It’s a very provocative question to ask whether we should take our bare-metal stents off the shelf, and it’s going to become a particularly acute question when and if this stent gets approved.”