TCT: Extra-Thin Biodegradable Stents Show Promise

WASHINGTON -- Two thin-strut biodegradable polymer stents matched a traditional durable stent in terms of safety and efficacy, according to a large randomized trial in the Netherlands.

At 1 year, target vessel failure occurred in 5.4% of patients who received a durable zotarolimus-eluting Resolute Integrity stent, compared to 4.7% with the everolimus- and sirolimus-eluting biodegradable stentss (Synergy and Orsiro stents, respectively; P-value for non-inferiority<0.0001 for both).

Other event rates were low and similar among patients, according to the investigators of the BIO-RESORT trial led by Clemens von Birgelen, MD, PhD, of the Thoraxcentrum Twente in Enschede, Netherlands:

• Cardiac death (0.9% for each of the three stents)
• Clinically indicated target vessel revascularization (2.0% for Synergy versus 2.3% for Orsiro versus 2.6% for Resolute Integrity, log-rank P not significant)
• Target vessel-related MI (2.1% versus 2.2% versus 2.7, log-rank P not significant)
• Definite stent thrombosis (0.3% for all)

Von Birgelen reported the data at the annual Transcatheter Cardiovascular Therapeutics meeting. Findings were simultaneously published online in The Lancet.

"Use of all three drug-eluting stents for the treatment of a complex all-comers population resulted in favorable 1-year clinical outcomes," von Birgelen concluded.

He and his co-investigators randomized patients (n=3,514) in an all-comers population who received one of three stents from 2012 to 2015: the Synergy (n=1,172), Resolute Integrity (n=1,173), or Orsiro (n=1,169). Outcomes were evaluated at 12 months.

Importantly, acute coronary syndromes accounted for 70% of cases, which were all encountered in four Dutch centers. More than 70% of targeted lesions were complex.

"Considering the complex study population in BIO-RESORT, which included many patients with increased clinical, lesion-related, or procedural risk, the event rates were remarkably low and represent at 1 year an excellent safety signal for the stents assessed," von Birgelen and colleagues wrote.

"I'm blown away. This makes you feel good about PCI these days," said Paul Teirstein, MD, of Scripps Clinic in La Jolla, Calif., at a TCT press conference. He called the 2% failure rates "amazing" across the board and an indication that it will become harder to justify bypass surgery in place of PCI in the future.

Yet Dean J. Kereiakes, MD, of The Christ Hospital in Cincinnati, noted that it was too early to say anything about very late outcomes.

"These are good stats. The field is moving forward," he said, but suggested that a benefit for these biodegradable products over durable stents -- if any -- would be incremental.

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