Polymer-free amphilimus-eluting stents (PF-AES) are non-inferior to permanent-polymer zotarolimus-eluting stents (PP-ZES) in terms of target-lesion failure at 12 months, according to the results of the ReCre8 study, presented by Pieter R. Stella, MD, Ph.D. (University Medical Center, Utrecht, the Netherlands) at TCT 2018. The results for the first RCT comparing PF-AES versus latest generation PP ZES in an all-comers PCI population were simultaneously published in Circulation.
Polymer-free amphilimus-eluting stents (PF-AES) represent a novel elution-technology in the present era of drug-eluting stents. In a prospective, multicenter, randomized, non-inferiority trial, performed in an all-comers population requiring percutaneous coronary intervention spanning three European sites, the clinical safety and efficacy of PF-AES were compared to latest-generation permanent-polymer zotarolimus-eluting stents (PP-ZES). Randomization in a 1:1 ratio to either PP-ZES or PF-AES was performed following stratification for troponin-status and diabetes. Based on troponin level at the time of randomization, troponin-positive patients were treated with 12 months dual antiplatelet therapy (DAPT), whereas troponin-negative patients were treated with 1 month of DAPT. The primary endpoint of target-lesion failure was defined as cardiac death, target vessel myocardial infarction, or target lesion revascularization at 12-months as analyzed by modified intention-to-treat (80% power, and a 3∙5% non-inferiority margin).
“While PF-AES is non-inferior to PP-ZES in regard to the primary endpoint of target-lesion failure at 12 months follow-up, a future dedicated trial on PF-AES in diabetic patients is required in order to explore the efficacy of this novel drug-eluting technology in this specific subgroup.”- Dr. Pieter Stella, M.D.
A total of 1532 patients were randomized and 1491 of them were treated with the assigned stent and were available for follow-up. The primary endpoint occurred in 5.6% and 6∙2% of the patients receiving PP-ZES and PF-AES respectively. The investigators found that PF-AES were clinically non-inferior to PP-ZES (risk difference 0∙5%, upper limit one-sided 95% confidence interval 2∙6%, p non-inferiority 0∙0086). Additionally, cardiac death occurred in 10 (1∙3%) vs. 10 patients (1∙3%, p-value for difference 1∙00), target-vessel myocardial infarction occurred in 18 (2∙4%) vs. 17 patients (2∙3%, p-value for difference 0∙87), and target-lesion revascularization occurred in 22 (2∙9%) vs. 20 patients (2∙6%, p-value for difference 0∙75) for PF-AES as compared to PP-ZES. Low rates of stent thrombosis were observed using these latest-generation drug-eluting stents, even with short duration of DAPT. Findings regarding the secondary endpoint and pre-specified subgroups were generally consistent with that of the primary endpoint.
“I don’t know what it all means. I think it probably just means that the competitive world is going to be big on which DES you choose and it’s going to really become all about pricing. Don’t you think that’s a good thing? If there’s a lot of competition, the driver of the prices will go down.”- Dr. Roxana Mehran, M.D.
Highlighting the clinical implications of the results on behalf of the ReCre8 Study investigators, Pieter Stella stated, “While PF-AES is non-inferior to PP-ZES in regard to the primary endpoint of target-lesion failure at 12 months follow-up, a future dedicated trial on PF-AES in diabetic patients is required in order to explore the efficacy of this novel drug-eluting technology in this specific subgroup.”
When questioned on the meaning of the results of all these stent wars at TCT 2018, in an interview with Dr. C. Michael Gibson, Dr. Roxana Mehran commented, “I don’t know what it all means. I think it probably just means that the competitive world is going to be big on which DES you choose and it’s going to really become all about pricing. Don’t you think that’s a good thing? If there’s a lot of competition, the driver of the prices will go down.”
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