TCT: Steady-Release DES Matches Resolute Shorter-Term

WASHINGTON -- Bucking the trend toward disappearing scaffolds and eliminating polymers, a novel metallic stent, which elutes rapamycin-analogue ridaforolimus and has a super durable polymer coating designed to resist peeling and other distortions, did well against a standard Resolute stent in the BIONICS trial.

Both the BioNIR stent and zotarolimus-eluting comparator had a target lesion failure rate -- a composite of cardiac death, target vessel myocardial infarction (MI), and ischemia-driven target lesion revascularization -- of 5.3% at 12 months, which met noninferiority criteria for the primary endpoint.

Stent thrombosis rates were also comparable between devices, reported David E. Kandzari, MD, of Piedmont Heart Institute in Atlanta, at the Transcatheter Cardiovascular Therapeutics (TCT) meeting.

But the stent didn't quite match up to Resolute on device success, defined as a final residual stenosis of less than 50% without need for additional stents or device malfunction (98.3% vs 99.5%, P=0.004).

The 1,919 patients randomized in the "more-comers" international trial had symptomatic coronary artery disease, including non-ST-segment elevation MI, chronic total occlusion, and other complex lesions, but not severe left ventricular dysfunction with an ejection fraction less than 30%, cardiogenic shock, hemodynamic instability, prior history of stent thrombosis, or inability to adhere to dual antiplatelet therapy.

"The reason that's important is that most approval trials historically have been in what we call 'vanilla' lesion and patient subsets, and then when the device is approved with device efficacy it gets applied in a broad patient population," noted Ajay Kirtane, MD, of New York-Presbyterian/Columbia Medical Center in New York City, who commented as moderator of a TCT press conference at which the results were presented. "For clinicians out there, it's encouraging" to see such trials.

Notably, the trial and another initiated at the same time were both the first-in-human experience and the support for regulatory clearance.

Also unique, "this drug-eluting stent is manufactured under less conventional methods" -- cut out with lasers from a sheet of metal, sprayed with drug, then rolled and laser welded -- "and this method confers greater reproducibility and efficiency that may translate to substantial cost savings," Kandzari said at the press conference.

Price is a major obstacle to adoption, commented Michael Mack, MD, of The Heart Hospital Baylor Plano Research Center in Plano, Texas. Mack is a surgeon who runs a cardiovascular service line for a major healthcare system and thus has some role in choosing stents used there.

"To a large extent, stents have been commoditized and price is a major deciding factor for what's adopted in clinical practice right now," he noted. "If we look at the new stents that have been approved in the last couple years, the adoption rate is relatively low because of the price point associated with it."

Furthermore, Neal Kleiman, MD, of Houston Methodist Hospital, speaking as a discussant at a press conference, called the results "impressive" but pointed out that "it's going to be very difficult to find new stents that are better" given the low risks with current stents.

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