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SAN FRANCISCO -- A novel stent specifically designed to meet the needs of the substantial number of coronary artery disease patients who have a high-risk of bleeding halved the risk of clinically-driven target lesion revascularization compared to a bare metal stent.

The primary endpoint of clinically-driven target lesion revascularization (TLR) came out at a rate of 5.1% with the biolimus-eluting BioFreedom polymer-free stent versus 9.8% for patients treated with a bare metal stent (hazard ratio 0.50, 95% CI 0.56-0.91 P<0.001), said Philip M. Urban, MD, director of Interventional Cardiology at La Tour Hospital in Geneva, Switzerland.

For the primary safety endpoint of cardiac death, myocardial infarction or stent thrombosis at 390 days in the intention-to-treat analysis, 112 patients of 1,221 patients in the BioFreedom arm reached that endpoint versus 145 of the 1,211 patients in the bare-metal stent arm -- or 9.4% versus 12.9% (P<0.0001 for non-inferiority and 0.005 for superiority).

Urban reported results of the LEADERS FREE trial during a late-breaking clinical trials session at the Transcatheter Cardiovascular Therapeutics meeting here, and the findings were also simultaneously published in the

The conundrum facing cardiologists treating CAD patients at high bleeding risk is that the most effective device for treating CAD is a drug-eluting stent, but current recommendations for use of those devices include dual antiplatelet therapy (DAPT) for up to 12 months -- a daunting prospect for patients at high-risk for bleeding. The alternative is a bare metal stent, which requires only 30 days of DAPT.

The BioFreedom stent fully releases its highly lipophilic sirolimus analog drug from the metal scaffold into the vessel wall within 30 days without any polymer coating, leaving it much like a bare metal stent after the first month.

Thus, the concept of this DES "offered the appeal of getting your cake and eating it too," said , of Saint Joseph's Heart and Vascular Institute in Atlanta, who was not involved in the study.

King told 麻豆传媒 that he believed there was a real need for a device such as the BioFreedom stent, and he predicted that it could become the favored stent in high bleeding risk patients.

He estimated that 15% of CAD patients were high bleeding risk and Urban put the number at 20% of CAD patients, but of the University of Missouri-Kansas City School of Medicine, said a recent , "found that 40% were high bleeding risk."

Urban said the study recruited patients who met a number of criteria for high bleeding risk -- two-thirds were age 75 or older, a third were taking oral anticoagulants, and 17% to 20% had renal failure. "One-third of the patients were on triple therapy (oral anticoagulant, clopidogrel, and aspirin)," he said.

The efficacy advantage of the BioFreedom stent was driven by a difference in MI -- 6.1% versus 8.9% -- and, to a lesser extent, the difference in stent thrombosis: 2.0% versus 2.2%.

But bleeding was a risk in both treatment arms: 7.2% of the BioFreedom and 7.3% of bare metal stent patients experienced serious bleeding events and overall bleeding rates, which included minor bleeding events, were 18.1% in the BioFreedom group versus 19.1% for the bare metal, Urban said.

Urban said the "device success rate was 97%, so we can say that the device delivers very nicely."

, of the Mayo Clinic in Rochester, Minn., told 麻豆传媒 that the LEADERS FREE findings were encouraging, but he didn't see an immediate clinical implication.

"We are going to stent patients who need stenting, even if the bleeding risk is high," Gersh said. Nonetheless, he agreed that there was an undeniable appeal to a DES that only required short-term dual antiplatelet therapy.

BioFreedom is available in Europe and has also received conditional IDE approval to conduct a U.S.-based clinical trial as a possible first step toward FDA approval.