The Wavering Lifecycle of Drug-eluting Stents

July 7, 2014
Jeannette Y. Wick, RPh, MBA, FASCP

When patients with diabetes or metabolic syndrome experience acute cardiac events, the subject of stents often arises.

When patients with diabetes or metabolic syndrome experience acute cardiac events, the subject of stents often arises.

Since the late 1980s, 3 kinds of stents — bare metal stents (BMSs), drug-eluting stents (DESs), and the new generation of biodegradable DESs — have been used to treat stenosis. Although DESs seem to have lower rates of restenosis than BMSs, they increase the risk of very late stent thrombosis, which principally occurs when clinicians curtail antiplatelet therapy for at-risk patients or those nonadherent to such therapy.

Periodic research findings on adverse events associated with DESs have influenced surgeons’ decisions to implant the stents, which has created a zigzag pattern of use in the United States.

A team of physicians and statisticians from the New York University School of Medicine and the Medical College of Wisconsin recently set out to identify trends in DES use over the years. To do so, they analyzed data from the 2001-2011 Nationwide Inpatient Sample for patients undergoing percutaneous coronary intervention (PCI) and published their results in the International Journal of Cardiology.

Throughout the study period, 8,150,763 PCI procedures were performed. DES use peaked in 2005, when a DES was placed in 89% of all patients, including those with a low risk of restenosis, high risk of stent thrombosis, or bleeding. The authors indicated DES use appeared somewhat indiscriminate during this time, because even those with an increased risk of bleeding at a rate of 88% received a DES.

According to the researchers, a series of presentations at the European Society of Cardiology (ESC) Scientific Session in 2006 that suggested DESs were associated with significantly more stent thrombosis, death, and myocardial infarction (MI) tempered surgeons’ enthusiasm over the stents, as they reported a steep drop in DES use in 2007.

Also in 2007, a US Food and Drug Administration (FDA) Advisory Panel released a statement indicating a small yet significant risk of late stent thrombosis with DES use, though it also endorsed the devices for use in the lesion subsets for which they were originally approved. In the subsequent years, DES implantation climbed progressively, and by 2011, its use topped 73%. Although the use of DESs increased in subgroups of patients at risk for restenosis, it decreased in those at risk for thrombosis or bleeding, as well as in those at risk for discriminant care, such as Medicaid patients.

Nevertheless, the authors noted the stents’ lifecycle of unbridled enthusiasm, false sense of security, rude awakening, resetting of expectations, and persistent mistrust is typical of many products.