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BIOFLOW-II: Biodegradable polymer DES noninferior to durable polymer DES at 9 months
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PARIS — Nine-month results from the BIOFLOW-II trial provide evidence that a biodegradable polymer drug-eluting stent performs similar to a durable polymer DES with regard to in stent late loss and clinical event rates.
Stephan Windecker, MD, researcher with the Bern University Hospital, Switzerland, presented data on the prospective, multicenter, randomized controlled BIOFLOW-II trial. The trial compared the Orsiro sirolimus-eluting stent (Biotronik; n=298), which features a biodegradable polymer, with the Xience Prime everolimus-eluting stent (Abbott; n=154) in 452 patients with a single de novo lesion in up to two coronary arteries; most of the lesions were found in the left anterior descending artery, according to Windecker.
At 9 months, follow-up was available in 98% of patients. Nearly identical results were reported between the stents in terms of in stent (Orsiro, 0.10± 0.32 vs. Xience Prime, 0.11 ± 0.29; P=.99) and in segment (Orsiro, 0.09 ± 0.35 vs. Xience Prime, 0.09 ± 0.33; P= .86) late loss. No significant differences were reported in minimum luminal diameter, diameter stenosis or binary restenosis. Similar rates of target lesion failure (P=.47) and the individual endpoints of cardiac death (P=.40), target vessel MI (P=.95) and target lesion revascularization (P=.66) were also observed.
These results, Windecker said during his presentation, “will need to be extended to larger randomized trials powered for clinical endpoints, including more complex patients.”
One of the limitations of note, in fact, Windecker said, was that the study was not adequately powered to detect differences in clinical event rates; however, an oncoming clinical trial powered for clinical endpoints directly comparing the two stent platforms has just completed enrollment.
The BIOFLOW-II trial will continue to follow patients for up 5 years. – by Brian Ellis
For more information:
Windecker S. LBCT 2. Presented at: EuroPCR; May 21-24, 2013; Paris.
Disclosure: Windecker reports receiving institutional grant/research support from Abbott, Biosensors, Biotronik, Boston Scientific, Cordis, Edwards Lifesciences, Medtronic and St. Jude Medical.
Perspective
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Alexandre Abizaid, MD, PhD
A next-generation stent like this one with very few struts could potentially cause less injury to the vessel wall. It makes me wonder whether we have truly achieved the state of the art. I think we should keep searching for this “holy grail.”
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Ashok Seth, MD
An ideal stent could be one with a cobalt chromium thin strut platform, a biodegradable polymer and a limus drug. All of these components get incorporated into this Orsiro stent. The hypothesis with a stent like this is that the biodegradable polymer will gradually degrade over 1 to 2 years leaving behind a bare-metal stent. This would have potential long-term advantages of low rates of very late stent thrombosis, low restenosis rates and the ability to withdraw or cease dual antiplatelet therapy, if required.
In this study, what was demonstrated was that this new Orsiro stent had identical low late loss compared with Xience Prime. The important aspect is that the good results of Xience, in terms of short- and long-term safety and efficacy, provide us with robust 5-year data of extremely low stent thrombosis rates, making it very difficult to design a study that would be able to show the superiority of any new stent concepts and its potential advantage. BIOFLOW-II had a very select inclusion criteria looking at late loss, but needs a powerful clinical endpoint. However, the next study which has been completed and is an all-comer study powered for clinical endpoints I suspect will demonstrate noninferiority toward Xience. It would be extremely difficult to demonstrate superiority of the potential advantages even in an all-comers study. So even if proven to be noninferior, the potential advantages may make this stent an attractive and favored option in “real-world” patients.
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