A biodegradable polymer sirolimus-eluting stent (BP-SES) was noninferior to currently-used second-generation drug-eluting stents (DES) in terms of target lesion failure (TLF) at one year in patients undergoing PCI for chronic or acute coronary syndromes, based on findings from the TARGET-IV NA trial presented at TCT 2024 and published in JACC. However, researchers noted that longer-term follow-up is needed to determine whether the findings impact efficacy and safety in this patient group.

The prospective, multicenter trial randomized 1,720 patients from North America and Europe to receive either BP-SES (n=860 patients, 1,057 lesions) or second-generation DES (n=860 patients, 1,084 lesions). The mean age of participants was 66 years and 74% were male. In addition, a total of 61% patients presented with stable coronary disease, 32% had unstable angina, and 7% had NSTEMI or recent STEMI.

The primary endpoint – the rate of TLF at 12 months – was noninferior between the BP-SES and control groups (3.4% vs. 3.3%, respectively). Cardiac death, myocardial infarction, and stent thrombosis rates were similar between the two groups. Angiographic follow-up was available in 104 patients and 128 (94.1%) lesions. At 13 months, the powered secondary endpoint of mean in-stent late lumen loss was 0.1490.263 mm for BP-SES and 0.3270.463 mm for control. Additionally, an optical coherence tomography substudy that included 37 patients (42 lesions) found no difference in mean neointimal hyperplasia thickness between groups at 13 months.

"DESs have become the default therapy for patients undergoing PCI," write Robert W. Yeh, MD, FACC, et al. "…Our findings in TARGET-IV NA showed excellent clinical outcomes in both randomized groups, with primary outcome event rates lower than those reported in previous studies."