Second generation drug-eluting stents have lower frequency of thrombotic complications and in-stent restenosis. While clinical results have significantly improved, having a 2-3% annual rate of these complications within the first year after angioplasty is still worrisome.
This resulted in the development of stents with struts <70 µm (ultrathin), with bioresorbable polymer and abluminal cover. Stents with ultrathin struts have shown superiority compared with stents with thin struts in terms of treated lesion failure (TLF) after 1 year.
Other tools currently used to diminish stent thrombosis and/or restenosis are intravascular ultrasound (IVUS)- and optical coherence tomography (OCT)-guided angioplasty.
The objective of this prospective, multicenter, randomized, non-inferiority study was to examine whether using biodegradable polymer ultrathin sirolimus-eluting stents (60-80 µm; BP-SES) vs. durable polymer thin everolimus-eluting stents (81 µm; DP-EES) implanted using IVUS or OCT has an impact on TLF at 1 year.
The primary endpoint (PEP) was TLF at 1 year, defined as a composite of cardiovascular death, treated vessel-related acute myocardial infarction (AMI), and clinically driven treated lesion revascularization (TLR). The secondary endpoint (SEP) was a composite of all-cause mortality, total acute myocardial infarction, revascularizations of any kind, stroke, bleeding, and stent thrombosis.
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The study included 1440 patients, who were randomized as follows: 722 to the BP-SES arm, and 718 to the DP-EES arm. Mean patient age was 70 years old, and most subjects were male. The most frequent clinical presentation was stable angina, while 14% experienced acute coronary syndromes (ACS). The most used anti-thrombotic medications were aspirin and prasugrel. The anterior descending artery was the artery most frequently treated, and the mean SYNTAX score was 11. There were no differences between groups in terms of angiographic and procedural characteristics.
The TLF rate after one year was 6% in the BP-SES arm and 5.7% in the DP-EES arm (p = 0.04 for noninferiority; p = 0.845 for superiority). There were no significant differences in the SEP.
Conclusion
BP-SES is noninferior to DP-EES in terms of TLF at 1 year when implantation is guided by IVUS or
Dr. Andrés Rodríguez
Member of the Editorial Board of SOLACI.org.
Original Title: Ultrathin, Biodegradable-Polymer Sirolimus-Eluting Stent vs Thin, Durable-Polymer Everolimus-Eluting Stent.
Reference: Masato Nakamura, MD et al J Am Coll Cardiol Intv 2022;15:1324–1334.
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