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Randomized comparison of novel biodegradable polymer and durable polymer‐coated cobalt‐chromium sirolimus‐eluting stents: Three‐Year Outcomes of the I‐LOVE‐IT 2 Trial
Author(s) -
Song Lei,
Li Jing,
Guan Changdong,
Jing Quanmin,
Lu Shuzheng,
Yang Lixia,
Xu Kai,
Yang Yuejin,
Xu Bo,
Han Yaling
Publication year - 2018
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.27465
Subject(s) - medicine , target lesion , clinical endpoint , stent , sirolimus , randomized controlled trial , myocardial infarction , surgery , cardiology , percutaneous coronary intervention
Objectives We aimed to compare the long‐term outcomes of the novel biodegradable polymer cobalt‐chromium sirolimus‐eluting stent (BP‐SES) versus the durable polymer sirolimus‐eluting stent (DP‐SES) in the I‐LOVE‐IT2 trial. Backgrounds Comparisons of the long‐term safety and efficiency of the BP‐DES versus the DP‐DES are limited. Methods A total of 2,737 patients eligible for coronary stenting were randomized to the BP‐SES or DP‐SES group at a 2:1 ratio. The primary endpoint of target lesion failure (TLF) was defined as a composite of cardiac death, target vessel myocardial infarction (MI), or clinically indicated target lesion revascularization. Results A three‐year clinical follow‐up period was available for 2,663 (97.3%) patients. There were no significant differences in TLF (8.9% vs. 8.6%, P = 0.81), patient‐oriented composite endpoint (PoCE) (15.2% vs.14.5%, P = 0.63), or individual components between the BP‐SES and DP‐SES. Definite/probable stent thrombosis (ST) was low and similar at 3 years (0.8% vs. 1.0%, P = 0.64). Landmark analysis of 1–3 years showed that the TLF (2.7% vs. 2.6%, P = 0.81), PoCE (6.2% vs. 5.1%, P = 0.28), and definite/probable ST (0.4% vs. 0.4%, P = 1.00) were comparable between the 2 arms. Conclusions In this prospective randomized trial, the BP‐SES showed similar clinical results versus the DP‐SES in terms of safety and efficacy outcomes over a 3‐year follow‐up period.