Biodegradable polymer-coated versus durable polymer-coated sirolimus-eluting stents: the final 5-year outcomes of the I-LOVE-IT 2 trial

• Published in: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology Vol. 16; no. 18; p. e1518
• Main Authors: Xu, Kai, Xu, Bo, Guan, Changdong, Jing, Quanmin, Zheng, Qiangsun, Li, Xueqi, Zhao, Xianxian, Wang, Haichang, Zhao, Xuezhong, Li, Yi, Li, Jing, Yang, Yuejin, Han, Yaling
• Format: Journal Article
• Language: English
• Published: France 02.04.2021
• Subjects: Absorbable Implants; Cardiovascular Agents - adverse effects; Coronary Artery Disease - surgery; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention - adverse effects; Polymers; Risk Factors; Sirolimus - therapeutic use; Treatment Outcome
• ISSN: 1969-6213
• DOI: 10.4244/EIJ-D-19-00865

This analysis presents the final five-year results of the I-LOVE-IT 2 trial, a non-inferiority study comparing a biodegradable polymer (BP) sirolimus-eluting stent (SES) with a durable polymer (DP) SES in patients with coronary artery disease. Overall, 2,737 Chinese patients eligible for coronary stenting were treated with BP-SES or DP-SES in a 2:1 ratio. Patients who were randomised to the BP-SES group were additionally re-randomised to receive either six-month or 12-month dual antiplatelet therapy (DAPT) in a 1:1 ratio. The primary endpoint was 12-month target lesion failure (TLF: cardiac death, target vessel myocardial infarction (MI), or clinically indicated target lesion revascularisation). At five years, the overall follow-up rate was 90.8%, and the cumulative incidence of TLF as the primary endpoint was similar between BP-SES and DP-SES (hazard ratio [HR] 1.01, 95% confidence interval [CI]: 0.79 to 1.28), as was that for the patient-oriented composite endpoint (PoCE: all-cause death, all MI and any revascularisation) (HR 1.03, 95% CI: 0.86 to 1.23), or definite/probable stent thrombosis (ST) (HR 0.91, 95% CI: 0.70 to 1.77). Cumulative events were also similar between the six-month DAPT and 12-month DAPT groups after BP-SES implantation. I-LOVE-IT 2 showed that the five-year safety and efficacy of BP-SES and DP-SES were similar, as were those between six months and 12 months of DAPT after BP-SES implantation.