Original Investigation
Zotarolimus-Eluting Versus Bare-Metal Stents in Uncertain Drug-Eluting Stent Candidates

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Abstract

Background

The use of drug-eluting stents (DES) in patients at high risk of bleeding or thrombosis has not been prospectively studied; limited data are available in patients who have a low restenosis risk.

Objectives

This study sought to compare a hydrophilic polymer-based, second-generation zotarolimus-eluting stent (ZES) with a unique drug fast-release profile versus bare-metal stents (BMS) under similar durations of dual-antiplatelet therapy (DAPT).

Methods

We randomly assigned 1,606 patients with stable or unstable symptoms, and who on the basis of thrombotic bleeding or restenosis risk criteria, qualified as uncertain candidates for DES, to receive ZES or BMS. DAPT duration was on the basis of patient characteristics, rather than stent characteristics, and allowed for a personalized 1-month dual antiplatelet regimen. The primary endpoint was the risk of 1-year major adverse cardiovascular events (MACE), which included death, myocardial infarction (MI), or target vessel revascularization (TVR).

Results

Median DAPT duration was 32 days (interquartile range [IQR]: 30 to 180 days) and did not differ between the groups. In the ZES group, 140 patients (17.5%) reached the primary endpoint, compared with 178 patients (22.1%) in the BMS group (hazard ratio: 0.76; 95% confidence interval: 0.61 to 0.95; p = 0.011) as a result of lower MI (2.9% vs. 8.1%; p < 0.001) and TVR rates (5.9% vs.10.7%; p = 0.001) in the ZES group. Definite or probable stent thrombosis was also significantly reduced in ZES recipients (2.0% vs. 4.1%; p = 0.019).

Conclusions

Compared with BMS, DES implantation using a stent with a biocompatible polymer and fast drug-eluting characteristics, combined with an abbreviated, tailored DAPT regimen, resulted in a lower risk of 1-year MACE in uncertain candidates for DES implantation. (Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS] Study; NCT01385319)

Key Words

drug-eluting stent(s)
dual-antiplatelet therapy
high bleeding risk
high thrombotic risk
zotarolimus-eluting stent(s)

Abbreviations and Acronyms

BMS
bare-metal stent(s)
CI
confidence interval
DAPT
dual antiplatelet therapy
DES
drug-eluting stent(s)
HR
hazard ratio
IQR
interquartile range
MACE
major adverse cardiovascular event(s)
MI
myocardial infarction
TVR
target vessel revascularization
ZES
zotarolimus-eluting stent(s)

Cited by (0)

The study is an investigator-driven clinical trial, which received funding from Medtronic through an unrestricted grant to the Consorzio Ferrara Ricerche, which employed dedicated personnel for data monitoring, data management, event adjudication, and independent statistical analysis.

Dr. Valgimigli has received honoraria for lectures/advisory board and research grants from Merck, Iroko, Eli Lilly, and Medtronic; honoraria for advisory board and lectures from The Medicines Company, Eli Lilly Co., Daiichi Sankyo, Inc., St. Jude, and Abbott Vascular; and fees for lectures from Cordis, CID, and Terumo. Dr. Patialiakas has received grants from the Hellenic Cardiological Society and the Hellenic Institution of Cardiology. Dr. McFadden has received fees from Abbott Vascular and Medtronic for Clinical Event Committee adjudications. Dr. Colangelo is a consultant for Abbott. Dr. Roffi has received institutional research grants from Abbott Vascular, Medtronic, Boston Scientific, Biotronik, and Biosensor. Dr. Ferlini has received consulting honoraria from Abbott Vascular and Eli Lilly. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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