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Safety and efficacy of 6‐month versus 12‐month dual antiplatelet therapy in patients after implantation of multiple biodegradable polymer‐coated sirolimus‐eluting coronary stents: Insight from the I‐LOVE‐IT 2 trial
Author(s) -
Qi Jing,
Li Yi,
Li Jing,
Jing Quanmin,
Xu Kai,
Gao Chuanyu,
Ma Likun,
Zhang Zhi,
Xu Bo,
Han Yaling
Publication year - 2017
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.26947
Subject(s) - medicine , target lesion , clinical endpoint , sirolimus , myocardial infarction , stent , stroke (engine) , incidence (geometry) , cardiology , surgery , clinical trial , percutaneous coronary intervention , mechanical engineering , physics , optics , engineering
Objective This study sought to compare the clinical outcomes of 6‐month versus 12‐month dual antiplatelet therapy (DAPT) in patients receiving multiple biodegradable polymer‐coated sirolimus‐eluting stents (BP‐SES) implants. Background The clinical outcomes for patients who undergo multiple BP‐SES implantation with different DAPT durations are uncertain. Methods In the I‐LOVE‐IT 2 trial, 907 patients treated with multiple BP‐SES (total stent number ≥2) were assigned to receive 6‐month ( n = 440) or 12‐month ( n = 467) DAPT. The primary endpoint was 12‐month target lesion failure (TLF), which is a composite of cardiac death, target vessel myocardial infarction (MI) or clinically indicated target lesion revascularization. The major secondary endpoints were 12‐month net adverse clinical events, a composite of all causes of death, MI, stroke, any revascularization and bleeding. Results The number of stents per patient between the 6‐month and 12‐month DAPT group was similar (2.4 ± 0.7 vs. 2.4 ± 0.7, P = 0.47). The incidence of 12‐month TLF was comparable in the 6‐month and 12‐month DAPT groups (9.3% vs.7.5%, Log‐rank P = 0.33). However, landmark analysis showed that 12‐month DAPT, compared to 6‐month DAPT, was associated with a significantly lower risk of TLF (4.8% vs. 2.4%, Log‐rank P = 0.049) at a cost of a slightly increased risk of all bleeding events (0.5% vs. 1.7%, Log‐rank P = 0.07) between 6 and 12 months. Conclusions In patients treated with multiple BP‐SES, 6‐ and 12‐month DAPT had similar impacts on 12‐month clinical outcomes. Additionally, 12‐month DAPT might reduce TLF between 6 and 12 months at the cost of a slightly increased risk of all bleeding events. © 2017 Wiley Periodicals, Inc.