EuroPCR

EuroPCR

Issue: July 2013
Perspective from Alexandre Abizaid, MD, PhD
Perspective from Ashok Seth, MD
May 22, 2013
2 min read
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BIOFLOW-II: Biodegradable polymer DES noninferior to durable polymer DES at 9 months

Issue: July 2013
Perspective from Alexandre Abizaid, MD, PhD
Perspective from Ashok Seth, MD
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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.