Biodegradable Polymer- versus Durable Polymer-Coated Sirolimus-Eluting Stents: The Final 5-Year Outcomes of the I-LOVE-IT 2 Trial.

AIMS: This analysis presents the final 5-year results of the I-LOVE-IT 2 trial, a noninferiority study comparing BP- sirolimus-eluting stent (SES) with DP-SES in patients with coronary artery disease. METHODS AND RESULTS: Overall, 2737 Chinese patients eligible for coronary stenting were treated with BP- or DP-SES in a 2:1 ratio. Patients who were randomized to BP-SES group were additionally re-randomized to receive either 6-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, or clinically indicated target lesion revascularization). At five years, 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 patient-oriented composite endpoint (PoCE: all-cause death, all MI and any revascularization) (HR: 1.03, 95% CI: 0.86 to 1.23), or definite/probable ST (HR: 1.11, 95% CI: 0.70 to 1.77). Cumulative events also were similar between 6-month DAPT and 12-month DAPT groups after BP-SES implantation. CONCLUSIONS: I-LOVE-IT 2 has shown that the 5-year safety and efficacy of BP-SES and DP-SES were similar, as were those between 6-month and 12-month of DAPT after BP-SES implantations.