An abluminal groove-filled biodegradable polymer sirolimus-eluting stent (FIREHAWK) may be as safe and effective as a durable polymer everolimus-eluting coronary stent (XIENCE) at two-year follow up, according to results from the TARGET All Comer study presented May 22 at EuroPCR in Paris and simultaneously published in JACC: Cardiovascular Interventions.

Bo Xu, MD, et al., analyzed 1,653 patients that were randomly assigned to either undergo implantation of the FIREHAWK or XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization.

Results showed that at two-year follow up, the incidence of target lesion failure was 8.7 percent in the FIREHAWK vs. 8.6 percent in the XIENCE group. The event rates of individual components of the primary endpoint were also found to be comparable for the two groups.

Furthermore, the researchers discovered that landmark analyses between one- and two-year follow up revealed no statistically significant difference of target lesion failure for the FIREHAWK vs. XIENCE stent. However, they found that beyond one year, very late definite or probable stent thrombosis occurred in three patients in the FIREHAWK group and seven patients in the XIENCE group.

In an accompanying editorial comment, Michael Joner, MD, and Salvatore Cassese, MD, PhD, note that "by now, we must realize that the ambition to detect incremental clinical benefit of one drug-eluting stent over the other is slowly but surely fading with contemporary clinical trial design." They add, "Yet, our mission to improve patient care will hopefully drive innovation and guide us into a novel era of personalized medicine with well-adapted clinical, scientific and financial incentives."

Keywords: Drug-Eluting Stents, Sirolimus, Polymers, Incidence, Motivation, Myocardial Infarction, Stents, Thrombosis, Patient Care

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