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JACC Cardiovasc Interv. 2013 Jul;6(7):664-70. doi: 10.1016/j.jcin.2013.03.001. Epub 2013 Mar 21.

Zotarolimus- and paclitaxel-eluting stents in an all-comer population in China: the RESOLUTE China randomized controlled trial.

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1
Fu Wai Hospital, National Center for Cardiovascular Diseases of China, Beijing, China.

Abstract

OBJECTIVES:

This study sought to compare clinical outcomes and angiographic findings using the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Santa Rosa, California) versus the Taxus Liberte paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Massachusetts) in an all-comer Chinese population.

BACKGROUND:

Concerns regarding restenosis risk led to new-generation drug-eluting stents (DES) designed for use in patients with complex clinical or lesion characteristics. In-stent late lumen loss (LLL) is a measure of restenosis risk.

METHODS:

Patients with an indication for treatment with a DES were randomized in a 1:1 ratio to placement of at least 1 R-ZES or PES with minimal exclusions. The primary endpoint was angiographic in-stent LLL at 9 months post-procedure. Clinical endpoints at 12 months are compared between the 2 stents.

RESULTS:

A total of 198 patients received a R-ZES, and 202 patients received a PES. Most patients were male; 25.8% and 29.2% of R-ZES and PES patients, respectively, had diabetes. Over 70% of lesions in both cohorts were American College of Cardiology/American Heart Association lesion classification Type B2 and C (B2/C). In-stent LLL was 0.16 ± 0.38 mm for R-ZES and 0.33 ± 0.52 mm for PES at 9 months (p < 0.001; 95% confidence interval [CI]: -0.26 to -0.08). The rates of clinically driven target lesion revascularization were 1.5% for R-ZES and 7.0% for PES (p = 0.011). The rate of target lesion failure was 5.6% for R-ZES and 11% for PES (p = 0.068).

CONCLUSIONS:

In an all-comers Chinese population, 9-month in-stent LLL was significantly less with R-ZES compared with PES, which was reflected in lower revascularization rates at 12 months for the R-ZES patients. Results are consistent with previous clinical trials of the R-ZES in all-comer populations. (Resolute Zotarolimus-Eluting Stent Versus the Taxus Liberte Paclitaxel-Eluting Stent for Percutaneous Coronary Intervention in China [R-China RCT]; NCT01334268).

KEYWORDS:

%DS; CI; China; DES; LLL; MI; MLD; PES; R-ZES; Resolute zotarolimus-eluting stent; Resolute zotarolimus-eluting stent(s); TLF; TLR; TVF; TVMI; TVR; all-comer population; confidence interval; drug-eluting stent; drug-eluting stent(s); late lumen loss; minimal lumen diameter; myocardial infarction; paclitaxel-eluting stent; paclitaxel-eluting stent(s); percent diameter stenosis; randomized controlled trial; target lesion failure; target lesion revascularization; target vessel failure; target vessel myocardial infarction; target vessel revascularization

PMID:
23523240
DOI:
10.1016/j.jcin.2013.03.001
[Indexed for MEDLINE]
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