SAN DIEGO – Positive results of the LEADERS FREE II trial in patients with high bleeding risk undergoing percutaneous coronary intervention may pave the way for approval of a new drug-coated stent in the United States and possibly spell the end for bare-metal stents.
The stent studied – a polymer-free umirolimus-coated stent – is currently marketed in Europe as BioFreedom (Biosensors International). It outperformed a very similar bare-metal stent (Gazelle, manufactured by Biosensors Interventional Technologies) in the randomized LEADERS FREE trial, which was conducted outside the United States (). The single-arm LEADERS FREE II ( ) trial was undertaken to confirm those findings, assess their generalizability in a North American population, and obtain data to support regulatory approval of the stent in the United States, explained presenting author , a professor of medicine and member in the Duke Clinical Research Institute, Duke University, Durham, N.C. All patients received drug-coated stents because it was considered unethical to randomize any to bare-metal stents after the preceding trial. As in that trial, all patients received 1 month of dual-antiplatelet therapy.
Compared with the 1,211 propensity-matched patients treated with bare metal stents in the LEADERS FREE trial, the 1,203 patients treated with drug-coated stents in the LEADERS FREE II trial had a 33% lower risk of primary safety events (a composite of cardiac death and myocardial infarction) and a 37% lower risk of primary efficacy events (clinically driven target lesion revascularization) at 1 year, according to the study’s main results. Secondary outcomes were all similar or better with the drug-coated stents.
“This study demonstrates reproducibility of the randomized LEADERS FREE findings showing superior safety … and superior effectiveness … of the drug-coated stent over the bare-metal stent,” Dr. Krucoff said. “This study also, by enrolling more than half of patients in North America, supports the generalizability of the findings to patients on both sides of the Atlantic.”