Comparison of biolimus A9-eluting (Nobori) and everolimus-eluting (Promus Element) stents in patients with de novo native long coronary artery lesions: a randomized Long Drug-Eluting Stent V trial.

Abstract

BACKGROUND:

Procedural and clinical outcomes still remain unfavorable for patients with long coronary lesions who undergo percutaneous coronary intervention. The current study, therefore, evaluated 2 innovative drug-eluting stents for the management of long-lesion coronary artery disease.

METHODS AND RESULTS:

This randomized, multicenter, prospective trial, called the Long Drug-Eluting Stent (LONG-DES) V trial, compared the biodegradable polymer-based biolimus A9-eluting stent (BES) and the durable polymer-based platinum chromium everolimus-eluting stent (PtCr-EES) in 500 patients with long (≥ 25 mm) coronary lesions. The primary end point of the trial was in-segment late luminal loss at the 9-month angiographic follow-up. The BES and PtCr-EES groups had similar baseline characteristics, with a slightly shorter lesion length in the BES group versus the PtCr-EES group (29.24 ± 12.17 versus 32.27 ± 13.84 mm; P = 0.016). In-segment late luminal loss was comparable between the 2 groups at the 9-month angiographic follow-up (BES, 0.14 ± 0.38 versus PtCr-EES, 0.11 ± 0.37 mm; difference, 0.031; 95% confidence interval, -0.053 to 0.091; P = 0.03 for a noninferiority margin of 0.11, P = 0.45 for superiority), as was in-stent late luminal loss (0.20 ± 0.41 versus 0.24 ± 0.38 mm; P = 0.29). The incidence of in-segment (6.1% versus 4.9%; P = 0.63) and in-stent (3.7% versus 4.9%; P = 0.59) binary restenosis was also similar between the groups. There was no significant between-group difference in the rate of composite outcome of death, myocardial infarction, and target vessel revascularization (41, 16.7% in BES versus 42, 16.5% in PtCr-EES; P=0.94).

CONCLUSIONS:

BES and PtCr-EES implantation showed analogous angiographic and clinical outcomes for patients with de novo long coronary lesions.

CLINICAL TRIAL REGISTRATION URL:

http://www.clinicaltrials.gov. Unique identifier: NCT01186120.

• Authors: Jong-Young Lee, Duk-Woo Park, Young-Hak Kim, Jung-Min Ahn, Won-Jang Kim, Soo-Jin Kang, Seung-Whan Lee, Cheol Whan Lee, Seong-Wook Park, Sung-Cheol Yun, Tae-Hyun Yang, Bong-Ki Lee, Nae-Hee Lee, Joo-Young Yang, Won-Yong Shin, Hun Sik Park, Kee-Sik Kim, Seung Ho Hur, Sung Yun Lee, Jong-Seon Park, Yun Seok Choi, Seung Uk Lee, Sung-Ho Her, Seung-Jung Park
• Journal: Circulation. Cardiovascular interventions (Circ Cardiovasc Interv) Vol. 7 Issue 3 Pg. 322-9 (Jun 2014) ISSN: 1941-7632 [Electronic] United States
• PMID: 24823426 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 American Heart Association, Inc.

Chemical References

• Everolimus
• umirolimus
• Sirolimus

Topics

• Aged
• Coronary Angiography
• Coronary Artery Disease (mortality, therapy)
• Coronary Restenosis (epidemiology)
• Drug-Eluting Stents (adverse effects)
• Everolimus
• Female
• Follow-Up Studies
• Humans
• Incidence
• Male
• Middle Aged
• Myocardial Infarction (epidemiology)
• Percutaneous Coronary Intervention (methods)
• Prospective Studies
• Single-Blind Method
• Sirolimus (adverse effects, analogs & derivatives)
• Survival Rate
• Thrombosis (epidemiology)
• Treatment Outcome