Chinese Firehawk Stent Performs Well Against Xience in All-Comers Study

PARIS, France—A head-to-head study of a new drug-eluting stent developed in China shows the device compares favorably with the Xience everolimus-eluting stent (Abbott Vascular).

Among 1,653 “all-comers” patients, the rate of the primary endpoint of target lesion failure was 5.9% with Xience and 6.1% with the Firehawk cobalt-chromium, sirolimus-eluting stent (MicroPort), a difference that met the study’s criteria for noninferiority, according to results presented last week at EuroPCR 2018.

Lead investigator Andreas Baumbach, MD (Queen Mary University and Barts Health Center, London, England), called Firehawk a “classic, workhorse stent.” He said the device has large cells for good side-branch access and excellent radial force. A thin-strut device at just 86 µm, the Firehawk has abluminal grooves to contain the bioresorbable polymer. The drug is released over 90 days, while the polymer is fully resorbed within 9 months. 

Unlike other drug-eluting stents, Firehawk has a low dosage of sirolimus, containing about one-third the amount released by similar devices.

“The targeted principle seems to work—it just has the drug where it needs the drug,” Baumbach told TCTMD. “It’s a very clever design. From looking at the field, it’s really interesting, because I think this is a stent that can compete.”

From a regulatory perspective, the TARGET-All Comers study, which was conducted at 21 centers, is the first Europe-based drug-eluting stent trial of Chinese technology, said Baumbach. The Firehawk stent was approved for European use in 2015, and TARGET-All Comers is a postmarketing study designed to further test safety and effectiveness.  

Regarding the components of the primary endpoint, there were no differences in rates of cardiac death, target-vessel MI, or ischemia-driven target lesion revascularization among patients treated with Xience and those treated with Firehawk.

There was no difference between groups in stent thrombosis (1.2% in each arm at 12 months) or in late lumen loss among a small subset of patients who underwent planned angiography at 13 months.

Robert Byrne, MBBCh, PhD (Deutsches Herzzentrum München, Germany), said Firehawk is similar to others his group has tested in the past, such as stents tested in the ISAR clinical trials. With its thin struts, abluminal grooves, and biodegradeable DL-polylactic acid polymer, the Firehawk stent has “tried and tested” features, he told TCTMD.

Previous studies, most of which were conducted in China, have shown the device performs well and is associated with good clinical outcomes, said Baumbach. He added that they plan to follow patients in TARGET-All Comers for 5 years.