A novel, polymer-free amphilius-eluting stent known as the “Cre8” was proven noninferior to the latest-generation permanent polymer drug-eluting stent in the first large-scale trial of its kind, according to research presented at the Cardiovascular Research Foundation’s 30th annual TCT conference in San Diego this week.
The ReCre8 trial, which comprised 1,532 all-comer percutaneous coronary intervention (PCI) patients from three medical centers across Europe, tested the efficacy of Alvimedica’s Cre8 stent against Medtronic’s established Resolute Integrity ZES. Lead investigator Pieter R. Stella, MD, PhD, said the newer device aimed to reduce complications associated with earlier-generation drug-eluting stents—especially the risk of thrombosis that’s been linked to polymer stents.
Stella and his team recruited patients over an almost three-year period, after which half were randomized to the polymer-free amphilimus-eluting stent (PF-AES) and half to the durable polymer zotarolimus-eluting stent (PP-ZES). Forty percent of patients were troponin-positive at presentation, and 60 percent were troponin negative.
Patients with troponin-positive acute coronary syndromes were treated with 12 months of dual antiplatelet therapy (DAPT), Stella said, while their low-risk counterparts were assigned to one month of DAPT.
The researchers identified their primary endpoint of target lesion failure as cardiac death, target-vessel MI or target-lesion revascularization at 12 months, with a secondary endpoint of net adverse clinical events. Target lesion failure ultimately occurred in 6.2 percent of the PF-AES group and 5.6 percent of the PP-ZES group, with a risk difference of 0.5 percent.
Stella said the secondary endpoint was met by 12.2 percent of the PF-AES cohort and 11.6 percent of the PP-ZES group at the one-year mark, with consistent results across all subgroups.
It’s a start, but Stella said physicians will likely want to wait for three-year ReCre8 data before using the stent in everyday practice. Information collected at three years could shed further light on target lesion failure outcomes.
“ReCre8 is the first randomized clinical trial of its kind, and found that polymer-free amphilimus-eluting stents are shown to be clinically noninferior to latest-generation zotarolimus-eluting stents in terms of target-lesion failure at 12 months in an all-comers PCI population,” Stella, head of interventional cardiology and manager of the Research Division, Heart & Lungs at University Medical Center Utrecht, the Netherlands, said in a release. “Although further study is warranted, one-month DAPT following these latest-generation drug-eluting stents in troponin-negative patients may be safe regarding stent thrombosis, especially in non-complex lesions.”
Results of the study were published in the AHA journal Circulation Sept. 22.