The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

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

DOI: 10.4244/EIJ-D-19-00865

1. General Hospital of Northern Theater Command, Shenyang, China, 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 Haerbin Medical University, Haerbin, China
5. Affiliated Changhai Hospital of the Navy Medical University, Shanghai, China
6. Affiliated Xijing Hospital of the Air Force Medical University
7. Jilin University First Hospital
8. NO. 960 Hospital of PLA, Jinan, China
9. Pingdu People’s Hospital, Pingdu, China
10. NO. 463 Hospital of PLA, Shenyang, China
11. Xinxiang Central Hospital, Xinxiang, China
12. NO. 252 Hospital of PLA, Baoding, China
13. Cangzhou Central Hospital, Cangzhou, China
14. Shengjing Hospital, Shenyang, China
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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.

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