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WASHINGTON -- A novel polymer-free drug-eluting stent (DES) used with just 1 month of a dual antiplatelet regimen remained safer and became even more effective than a bare-metal stent (BMS) for high bleeding risk patients with additional follow-up in the LEADERS FREE trial.

The previously-reported 1-year safety advantage of the BioFreedom stent over the Gazelle BMS was maintained at 2 years (cardiac death, myocardial infarction, or definite or probable stent thrombosis HR 0.8, P=0.039), , of the Hôpital de la Tour in Geneva, and colleagues found.

The from a HR favoring the DES of 0.5 to now 0.54 at 2 years (6.8% vs 12.0%, P<0.0001), the group reported here at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting and simultaneously online in the Journal of the American College of Cardiology.

For these high bleeding risk patients, major bleed rates were similar over 2 years between groups, and the mortality risk from them -- which was equivalent of that from a thrombotic event -- was likewise similar for the two treatment groups.

The advantage of the new drug-coated stent came as a surprise last year, but a "delight" this year, , of Houston Methodist Hospital, commented on a discussion panel at a TCT press conference for the day's late-breaking clinical trials.

"Remember that when you select a group that's at high risk for bleeding, you're also selecting a group at high risk for thrombotic events," he said. "I'm very happy to see this."

Despite these and other recent results going against BMS for the last niches of their use, the panel was split on whether there is still a rationale for BMS in the clinic.

None at all, argued , of Christ Hospital in Cincinnati.

"You've got really outdated U.S. guidelines, that have perpetuated the use of BMS," he said, questioning the European members of the panel on whether they have used any at all recently, to which the answer was none this year. "And the reason is," Kereiakes continued, "every one of these -- ZEUS, LEADERS FREE in [acute coronary syndromes], LEADERS FREE whole trial, will be at [the European Society of Cardiology meeting] next year -- the theme is overwhelming. BMS have increased stent thrombosis rates."

"I personally would beg to differ with that," said , of New York-Presbyterian/Columbia University Medical Center in New York City. "There's a very marginal difference, the difference between whether it's 4 weeks and 3 months. It's small but it's for very, very selected patients."

"Remember we don't have BioFreedom here in the United States," added Kirtane. "In the U.S. population, it's a little bit irresponsible right now to say there's no reason for bare-metal stents."

, of Scripps Clinic in La Jolla, Calif., too said he hadn't used any BMS this year but added, "I can kind of see where I might. If my patient needed an operation, even in 3 weeks, I would use a bare-metal stent."

The trial included 2,432 high bleeding risk patients who were ages 75 or older, had a need for prolonged oral anticoagulation, had renal failure, had planned major surgery, had low hemoglobin or recent transfusion, and cancer in the prior 3 years.

They were randomized to stenting with the Gazelle BMS or BioFreedom stent, which fully releases within 30 days the highly-lipophilic sirolimus analog drug coated onto the metal scaffold without a polymer, leaving it much like a bare metal stent after that point.

While the comparator in LEADERS FREE is not a contemporary stent in common use, Kirtane suggested that the safety results would likely generalize to the newer-generation BMS.

The Gazelle and BioFreedom stents both have stainless steel, 120-micron thick struts. "You could argue that the restenosis rate of such struts may be higher than thinner bare-metal stent struts," Urban said. "For efficacy, yes, you could argue maybe the results would have been somewhat different if we had thin-strut stents. For safety, ... there's not much data out there to suggest that thin strut stents are safer on bare-metal stents."

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