Firehawk Stent Meets Noninferiority to Xience in Symptomatic CAD

Patrice Wendling

May 31, 2018

PARIS — A novel sirolimus-eluting stent developed in China is on par with the workhorse Xience everolimus-eluting stent (Abbott Vascular), according to results of TARGET All Comers, the first European-based, real-world trial of a Chinese drug-eluting stent.

Among 1653 patients with symptomatic coronary artery disease, the primary endpoint of target lesion failure (TLF) at 12 months reached 6.1% with the Firehawk (MicroPort) stent and 5.9% with Xience, which met the study's noninferiority margin of 3.5% (P = .004).

There were no significant differences between the two stents in the individual TLF components of cardiac death (1.2% vs 0.9%), target vessel MI (4.5% vs 3.9%), or ischemia-driven target lesion revascularization (1.2% vs 2.4%), co-principal investigator Andreas Baumbach, MD, Queen Mary University, London, United Kingdom, reported at the Congress of the European Association of Percutaneous Cardiovascular Intervention (EuroPCR) 2018.

The cobalt chromium Firehawk stent features a thin 86-μm strut with abluminal grooves containing a biodegradable polymer and sirolimus, he explained. About 90% of the drug is released within 90 days.

Prior trials in China have reported on the safety and efficacy of the Firehawk, which was approved for use in Europe in 2015.

For the TARGET All Comers trial, investigators at 21 centers in Europe and the United Kingdom randomly assigned 823 patients to Firehawk and 830 patients to Xience. The mean age was 64.9 years and 65.3 years, respectively, and three fourths of patients were male.

About 55% of all patients had stable angina and the rest were treated for unstable ST-segment MI (STEMI) or non-STEMI. Analysis of TLF rates for these subgroups has yet to be completed, Baumbach said.

An average of 1.7 stents were implanted in each group, with postdilation performed in about half of all cases. About 80% of lesions were classified as B2 or C.

The technical success rate was 92.4% for Firehawk and 94.8% for Xience. The difference was statistically significant (P = .025) and was due to the full array of Firehawk stent lengths not being available at the time of the study, Baumbach said.

At 12 months, the rate of definite stent thrombosis was identical in both groups at 1.2%.

A quantitative coronary angiography substudy showed no difference in late lumen loss at 13 months among 71 patients treated with Firehawk and 66 patients treated with Xience (0.17 mm vs 0.11 mm; P for noninferiority = .024).

"In a population with broad angiographic inclusion and clinical characteristics, treatment with the Firehawk is as safe and effective as with the Xience family of stents," Baumbach said in the late-breaking trial session.

Following the presentation, an audience member questioned the 3.5% noninferiority margin. Panelist Robert Byrne, MD, Deutsches Herzzentrum, Munich, Germany, took up the point, noting that they assumed a TLF rate of 7% and actually got quite close to it.

"One of the issues we're having in practice is that the event rates are lower than we suppose, so this is definitely positive," he said. "But what do you think about the 3.5% as the noninferiority margin?"

Baumbach replied that the noninferiority margin is in line with that used in other trials and that the expected event rates are "very close to what was planned, and as you can see from the results in the absolute difference, we're very comfortable that this is noninferior."

Panelist Julinda Mehilli, MD, Munich University Clinic, Germany, asked about the importance of the Firehawk in everyday practice, given the availability of several other drug-eluting stents, such as the Synergy everolimus-eluting bioabsorable polymer stent (Boston Scientific) and the cobalt chromium Ultimaster sirolimus-eluting stent (Terumo Interventional).

"What kind of special features is this stent offering to us, maybe special mechanical features to use it in routine practice or to use it in a special population?" she asked.

Baumbach replied, "I think the unique point is that there is not really a unique point; this is a classic workhorse stent…. This is a stent that has all the features for everyday use, with large cells for good side branch access, good radial force, and now very good safety and efficacy data."

Baumbach reports receiving grants/research support from Abbott and honoraria/consulting fees from Keystone Heart, MicroPort, Sinomed, and Stentys.

Congress of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) 2018. Presented May 23, 2018.

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