Patients suffering from acute coronary syndromes who are high risks for bleeding during angioplasty do much better and exhibit fewer complications when a polymer-free biolimus-A drug-coated stent is used versus a bare metal stent, according to a new study.
Results from a sub-study of the Leaders Free trial was recently reported at the EuroPCR 2016 gathering. The trial studied the use of a polymer-free and carrier-free drug-coated stent that transfers umirolimus (biolimus A9), a highly lipophilic analogue of sirolimis, into the blood vessel wall over the span of a month.
Previous studies indicated that at least one in 6 patients undergoing angioplasty to treat narrowed coronary arteries of the heart were at a high risk of bleeding. Those patients are typically treated with bare-metal stents in conjunction with one month of dual antiplatelet therapy to reduce the risk of bleeding. However, researchers said, that carries a higher risk of a recurrence of narrowing of the artery following the procedure.
“The most important take-home message is that using a BA9-coated stent plus one month of dual antiplatelet therapy not only improves the efficacy of PCI (angioplasty) in patients with ACS (acute coronary syndromes) and high risk of bleeding compared to use of bare metal stent, but also increases safety with less cardiac death, myocardial infarction and stent thrombosis,” Dr. Christoph Naber, lead author, told News Medical. “Current guidelines may need to be revised and bare metal stents can no longer be recommended for these patients.”
At the one-year follow-up of the study, patients that got the drug-coated stent had less than half the rate of clinically driven target lesion revascularization compared to those who got a bare metal stent. They also has a significantly lower risk of complications, that include a composite of death due to cardiac failure and stent thrombosis.