Considering target lesion failure (TLF) outcomes at 1-year follow-up during the TARGET-IV study, the Firehawk biodegradable polymer sirolimus-eluting stent (BP-SES) is noninferior to the currently used second-generation drug-eluting stents (DESs). These data were presented by Olivier F. Bertrand, MD, PhD, of the Quebec Heart and Lung Institute, Canada, in a late-breaking trial session at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 conference in Washington, DC, on Wednesday. Despite their benefits, durable polymers carry the risk of delayed healing and inhibition of reendothelialization. The BP-SES (MicroPort) delivers a third of the drug dose of other DESs and “has a fully biodegradable sirolimus-containing polymer coating localized to recessed abluminal grooves on the stent surface,” the authors of this study wrote. The TARGET-IV NA study — a prospective, multicenter, single-blind, 1:1 randomized noninferiority trial — examined the differences in outcomes between the BP-SES and second-generation DESs in North America and Europe. TLF at 1-year was the primary endpoint of this study: a composite of cardiac death, target vessel-related myocardial infarction [MI] or ischemia-driven TLF). The primary intention-to-treat analysis tested noninferiority using an absolute margin of 3.85% and 1-sided alpha of 0.025. Secondary endpoints were examined in a substudy using optical coherence tomography (OCT; mean neointial hyperplasia thickness) and an additional angiography substudy (in-stent late lumen loss). A total of 1,720 patients (mean age=66 years, 74% male) with 2,159 lesions were randomly assigned to BP-SES (n=860, 1,057 lesions, mean age=65.3 years, 74.4% male) or second-generation DES (n=860, 1,084 lesions, mean age=65.8 years, 73.6% male). The BP-SES TLF rate (3.4%) at 1-year was noninferior to the DES TLF 1-year rate (3.3%) (absolute risk difference=0.13%, upper bound 97.5% confidence interval [CI]=2.03, pnoninferiority<0.0001). Rates of cardiac death, MI and stent thrombosis were similar between groups. In the OCT substudy, 37 patients (42 lesions) had no difference in the substudy’s primary endpoint at 13 months (pnoninferiority=0.01) Follow-up angiography results were available in 104 patients (97.2% enrolled in angiographic substudy) and 128 lesions. The secondary endpoint of mean in-stent late lumen loss was 0.149 ± 0.263 mm for the BS-SES group and 0.327 ± 0.436 mm for the DES group at 13-months (pnoninferiority<0.0001). Some limitations of this study included lower-than-expected event rates, 5-year follow-up is needed to understand late TLF and stent thrombosis outcomes, lack of baseline intravascular imaging data and the exclusion of patients with ST-segment myocardial infarction (MI) limits the generalizability to the STEMI population. Overall, the BP-SES was noninferior to the second-generation DESs currently in use, in terms of 1-year TLF. Image Caption: Olivier F. Bertrand, MD, PhD, speaks during a news conference Wednesday at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC. Image Credit: Bailey G. Salimes/CRTonline.org