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Catheter Cardiovasc Interv. 2018 Feb 15;91(S1):608-616. doi: 10.1002/ccd.27465. Epub 2018 Jan 11.

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 information

1
Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.
2
Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China.
3
Catheterization Laboratory, Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.
4
Department of Cardiology, Affiliated Anzhen Hospital of Capital Medical University, Beijing, China.
5
Department of Cardiology, Kunming General Hospital of Chengdu Military Region, Kunming, China.

Abstract

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.

KEYWORDS:

biodegradable polymer; drug-eluting stent; durable polymer; sirolimus-eluting stent

PMID:
29322619
DOI:
10.1002/ccd.27465
[Indexed for MEDLINE]

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