Firehawk Stent Still Holds Up Well to Xience at 2 Years: TARGET All Comers

PARIS, France—Firehawk, a sirolimus-eluting stent featuring abluminal grooves and a biodegradable polymer, matches the safety and efficacy of the Xience everolimus-eluting stent over 2 years of follow-up, according to updated results from the TARGET All Comers trial released today at EuroPCR 2019.

The device, which is manufactured in China and received CE Mark approval in 2015, has recessed abluminal grooves that allow controlled release of sirolimus, such that 90% of the drug is released by 90 days. Its polymer degrades within 6 to 9 months. Xience, meanwhile, has a durable polymer and releases nearly all of its everolimus within 120 days.

Firehawk “is designed to minimize polymer burden and reduce drug concentrations in the vessel wall,” said Bo Xu, MD (Fu Wai Hospital, Beijing, China), lead investigator of the trial, dubbed TARGET AC. One-year findings from the trial were presented at EuroPCR 2018. The latest results were simultaneously published online in JACC: Cardiovascular Interventions.

TLF Similar, Stent Thrombosis Rare

TARGET AC, a multicenter, noninferiority trial conducted at 21 sites in 10 European countries, randomized 1,653 all-comers patients with symptomatic CAD or asymptomatic CAD plus objective evidence of ischemia to receive either Firehawk (Shanghai MicroPort Medical Group) or Xience (Abbott Vascular). Nearly 9% were undergoing primary PCI for STEMI. In all, 94.5% of the cohort either completed 2-year follow-up or died during that time span.

By 2 years, the primary endpoint of TLF (defined as cardiac death, target-vessel MI, or ischemia-driven TLR) was almost identical with Firehawk and Xience at 8.7% and 8.6%, respectively, as were its individual components. A patient-oriented composite endpoint (all-cause death, any MI, and any revascularization) occurred in 19.3% of the Firehawk group and 17.8% of the Xience group (P = 0.46).

Landmark analyses at 1 year and 2 years again showed no differences for TLF between the two study arms. Very late definite/probable stent thrombosis was rare, occurring in 0.4% of Firehawk patients and 0.9% of Xience patients beyond 1 year (P = 0.34).

There was no evidence of a clinical advantage for Firehawk, Xu et al observe in their paper. “Continued follow-up is required to address a potential benefit of the Firehawk stent, and the TARGET All Comers study will continue to evaluate clinical outcomes up to 5 years,” they say.

Discussant Manel Sabaté, MD, PhD (Institut Clinic Cardiovascular, Barcelona, Spain), said that despite the good news of equivalence between the two devices, the bad news is that events continue to accrue between 1 and 2 years irrespective of stent type. For stent thrombosis, in particular, it might be useful to identify which patients might benefit from prolonged dual antiplatelet therapy (DAPT), he suggested, asking what was known about this in TARGET AC.

Xu said the researchers are planning to look further at the relationship between DAPT and outcomes, but that the data haven’t been fully analyzed. Duration of therapy in TARGET AC was guideline-based.

One thing not addressed here is the possibility of less DAPT, Ziyad Ghazzal, MD (American University of Beirut Medical Center, Lebanon), added. “Of course, it would be interesting to see if those new stents can allow us, in certain subsets of patients, to shorten DAPT duration.”

Two large randomized trials regarding DAPT duration and Firehawk are ongoing in China, Xu reported.

Market Disruption?

That Firehawk is made in China isn’t inconsequential, Michael Joner, MD, and Salvatore Cassese, MD, PhD (both from Deutsches Herzzentrum München, Munich, Germany), assert in an editorial accompanying the paper.

“Together with India, China is expected to be one of the largest international stent markets in the years to come; for instance, percutaneous coronary intervention hospitalizations in China observed a 21-fold growth over a 10-year period without plateauing. Based on their impressive domestic numbers, Chinese and Indian stent manufacturers have recently funded a plethora of head-to-head trials investigating novel DES technologies against benchmark DES,” they say.

Often designed to test noninferiority, these trials are done to get regulatory approval and rarely provide new clinical insights, Joner and Cassese observe. “Rather, they are potentially disruptive regarding market share.

“Indeed, the novel DES manufactured in China and India are cheaper than those of Western countries' market leaders,” they continue, predicting that “once these novel DES gain the regulatory approval on both sides of the Atlantic and enter the Western countries' market, even a small price difference would be of certain relevance and may play a critical role in selection of the DES platform to be implemented in daily practice.”