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

EuroIntervention 2021;16:e1518-e1526. DOI: 10.4244/EIJ-D-19-00865

1. General Hospital of Northern Theater Command, Shenyang, China; 2. Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China; 3. Affiliated Tangdu Hospital of the Air Force Medical University, Xi'an, China; 4. Fourth Affiliated Hospital of Harbin Medical University, Harbin, China; 5. Affiliated Changhai Hospital of the Navy Medical University, Shanghai, China; 6. Affiliated Xijing Hospital of the Air Force Medical University, Xi'an, China; 7. Jilin University First Hospital, Changchun, China

Aims: 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.

Methods and results: 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.

Conclusions: 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. 

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