SAN FRANCISCO, CA — The biolimus-eluting stent with a biodegradable polymer (Nobori, Terumo) is statistically noninferior to the zotarolimus-eluting coronary stent (Resolute Integrity, Medtronic) with regard to the primary end point of major adverse cardiac events (MACE) at 12 months, according to a head-to-head comparison presented yesterday at TCT 2013 .

The trial, known as SORT-OUT VI , is unique in that "all-comers" were included in the study, and despite this, event rates were extremely low in both arms. At 12 months, the rate of cardiac death, MI, and target lesion revascularization was 5.3% in patients treated with the zotarolimus-eluting stent and 5.1% among those who received the biolimus-eluting stent (p=0.006 for noninferiority).

Lead investigator Dr Bent Raungaard (Aalborg University Hospital, Denmark) presented the results of the 1502 patients who received the zotarolimus-eluting stent and the 1497 who received the biolimus-eluting stent. Patients in the trial were well-matched, and approximately 18% had diabetes, which is low but in line with other Scandinavian population–based studies. Stable angina was the leading indication for PCI, while17% to 19% had a ST-segment-elevation MI (STEMI) and approximately 30% of patients had unstable angina/NSTEMI prior to PCI.

In the trial, there was no follow-up angiography or study-related patient contact, so all events were clinical/patient-driven, said Raungaard. When presenting the results to the media and during the late-breaking clinical-trials sessions, Raungaard said that the primary-end-point curves, MACE at 12 months, were virtually identical.

Current Generation of Stents Is Pretty Good

Dr Bent Raungaard

While Raungaard interpreted the results positively, Dr Alexander Lansky (Yale University School of Medicine, New Haven, CT) focused on the near-superimposable events curves, a finding that might suggest the biodegradable polymer doesn't really make much of difference on outcomes.

Like the others who commented on the results, however, Lansky noted how difficult it is to conduct comparative stent trials, given the excellent results with the comparator stents. Similarly, Dr Gregg Stone (Columbia University, New York) said that with these difficulties, one option, rather than designing a 10 000-patient mega-trial to tease out small differences, might be to assess higher-risk patients. In doing so, researchers might be able find differences between stents. Dr Sunil Rao (Duke University Medical Center, Durham, NC) made a similar statement but also emphasized the safety of stents used now in clinical practice.

"I think what's clear is that the current generation of drug-eluting stents that we're using appears to be incredibly safe," said Rao. "If you look at the time that's elapsed since 2006, when we first realized the issue of late stent thrombosis, it's really a remarkable advance in device technology. I think it's very, very reassuring."

One of the advantages of the biodegradable polymer, said Rao, would be to reduce very late stent thrombosis, such as events that occur beyond one year. As the TCT panel noted during the press conference, the polymer in the stent is fully dissolved after about nine months, so follow-up of the SORT-OUT VI patients beyond one year is critical. Raungaard said that further follow-up is planned.

Raungaard reports no conflicts of interest.


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