Efficacy and safety of a second-generation biodegradable polymer sirolimus-eluting stent: One-year results of the CREDIT 2 trial.

Abstract:

AIMS:We performed a multicenter, randomized controlled trial to determine the noninferiority of a novel biodegradable polymer drug-eluting stent (BP-DES), the EXCEL 2 stent, to the first-generation BP-DES, the EXCEL stent. METHODS AND RESULTS:Patients (n = 419) scheduled to undergo percutaneous coronary intervention (PCI) were randomized to receive either the EXCEL 2 stent (n = 208) or the EXCEL stent (n = 211) from 15 Chinese centers. At 9 months, primary endpoint in-stent late loss (LL) difference was -0.03 mm (95% confidence interval: -0.09 mm to 0.04 mm) between the EXCEL 2 group (0.14 ± 0.26 mm) and the EXCEL group (0.16 ± 0.36 mm), demonstrating the noninferiority of EXCEL 2 to EXCEL in terms of in-stent LL (P for noninferiority < .0001). Besides, target lesion failure (TLF) was statistically lower in EXCEL 2 group compared with EXCEL through 1 year (HR [95%CI] = 0.45 [0.20,0.98], Plog-rank  = .04). Definite/probable ST was observed in 0.0% vs 1.9% (P = .12) of EXCEL 2 vs EXCEL-treated subjects. CONCLUSIONS:The second-generation BP-DES (EXCEL 2) was noninferior to the first-generation BP-DES (EXCEL) for the primary endpoint of in-stent LL at 9 months. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT02057978.

journal_name

Cardiovasc Ther

authors

Xu K,Han Y,Xu B,Yang Y,Wang G,Li H,Sun Y,Tao L,Wang H,Yuan Z,Liu H,Liu J,Jia Y,Ma G,Fu G,Li X,Li S,Wang S,Pu K,CREDIT 2 Investigators.

doi

10.1111/1755-5922.12327

subject

Has Abstract

pub_date

2018-06-01 00:00:00

pages

e12327

issue

3

eissn

1755-5914

issn

1755-5922

journal_volume

36

pub_type

杂志文章,多中心研究,随机对照试验
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