Conference Coverage

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


Key clinical point: The polymer-free umirolimus (Biolimus A9)–coated stent is superior to the bare-metal stent in patients at high bleeding risk when used with a month of dual-antiplatelet therapy.

Major finding: The drug-coated stent reduced 1-year risks of the composite of cardiac death and MI by 33% and clinically driven target lesion revascularization by 37% when compared with matched controls.

Study details: A single-arm trial of 1,203 patients at high bleeding risk undergoing PCI who were given drug-coated stents with 1 month of dual-antiplatelet therapy who were compared with 1,211 propensity-matched historical control patients given bare-metal stents (LEADERS FREE II trial).

Disclosures: Dr. Krucoff has various affiliations/financial relationships with Abbott Vascular, Biosensors, Boston Scientific, CSI, Medtronic, OrbusNeich, and Terumo. The trial was sponsored by Biosensors.



– 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.

Dr. Mitchell W. Krucoff, professor of medicine and a member in the Duke Clinical Research Institute, Duke University, Durham, N.C. Susan London/MDedge News

Dr. Mitchell W. Krucoff

Findings were reported in a late-breaking session and press conference at the Transcatheter Cardiovascular Therapeutics annual meeting.

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 (N Engl J Med. 2015 Nov 19;373[21]:2038-47). The single-arm LEADERS FREE II (NCT02843633) 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 Mitchell W. Krucoff, MD, 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.”


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