J Cardiovasc Interv.  2025 Apr;4(2):130-141. 10.54912/jci.2024.0034.

Ultrathin Bioresorbable Polymer Sirolimus-Eluting Orsiro Stents for Complex Percutaneous Coronary Intervention

• Jeon HS
• Kim SY
• Lee JH
• Lee JW
• Youn YJ
• Yang HM
• Woo SI
• Yoo SY
• Lee J
• Shin SH
• Ahn SG

• KMID: 2566687
• DOI: http://doi.org/10.54912/jci.2024.0034

Abstract

Background
The long-term efficacy and safety of Orsiro biodegradable polymer-coated sirolimus-eluting stents in patients undergoing percutaneous coronary intervention (PCI) has been established. Since complex PCI is becoming increasingly common, this study evaluated the efficacy and safety of Orsiro stents in complex PCI.
Methods
The bioresorbable polymer sirolimus-eluting stents in a complex percutaneous coronary intervention population (BIO-REAL) registry is a prospective, single-arm, observational trial designed to evaluate the clinical outcomes of patients who receive Orsiro Biodegradable polymer drug-eluting stents implantation during complex PCI at 6 centers in the Republic of Korea. Complex PCI involves treating conditions such as multivessel disease, diffuse lesions, chronic total occlusion lesions, bifurcated lesions, small vessels, calcified lesions, in-stent restenosis (ISR) lesions, ostial lesions, or left main lesions. The primary endpoint of this study is the device-oriented composite outcome (DOCO), which includes cardiac death, target vessel-related myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) at 12 months.
Results
The study included 784 patients presenting with 1,098 lesions. The average age of the participants was 66.7 ± 10.8 years, with 74.6% being male. The primary endpoint was reached in 3.3% of the patients, consisting of a cardiac death rate of 2.2%, a target vesselrelated MI rate of 0.6%, and a TLR rate of 0.9%. Incidence of the primary endpoint was notably higher among patients with acute MI, diabetes mellitus (DM), or chronic kidney disease (CKD). Regarding complex PCI components, the DOCO rate was elevated in cases involving ISR lesions (6.8%) and those with moderate-to-severe calcification (4.1%).
Conclusions
The Orsiro stent demonstrated optimal efficacy and safety at 12 months in patients undergoing complex PCI. Outcomes were less favorable in patients with acute MI, DM, or CKD undergoing complex PCI. Additionally, ISR and calcified lesions were associated with an increased risk of unfavorable outcomes following PCI.

Keyword

Drug-eluting stents; Percutaneous coronary intervention; Polymers