Real polymer-free sirolimus- and probucol-eluting versus biodegradable polymer sirolimus-eluting stents for obstructive coronary artery disease: DKPLUS-Wave 1, a multicenter, randomized, prospective trial.

Abstract

BACKGROUND:

Polymer-free sirolimus- and probucol-eluting stents (Real Dual drug-eluting stents [DES]) is as effective as first-generation DES in treating coronary artery stenosis. It is unknown whether sirolimus-eluting stents containing biodegradable polymer (Excel) would be superior to real Dual DES. This study aimed to investigate the difference in target vessel revascularization (TVR) at 12 months in patients with coronary artery disease treated by the implantation of Dual DES or Excel stents.

METHODS:

Three hundred and forty-six patients with de novo coronary artery disease were recruited from six centers in China and randomly assigned to either the Dual DES or the Excel group. The primary endpoint was the occurrence of TVR at 12 months. The secondary endpoint was angiographic in-stent restenosis and late lumen loss at 13 months. Stent thrombosis (ST) served as the safety endpoint. Dual anti-platelet therapy (DAPT) was prescribed for 6 months.

RESULTS:

Clinical follow-up for 12 months and repeat angiography at 13 months were available in 100% and >90% of patients, respectively. The ISR and in-stent late loss were significantly different between the Excel (3.1%, 0.09 ± 0.11 mm) and the Dual DES (19.5%, 0.36 ± 0.32 mm, P < 0.001, P < 0.001, respectively) groups. The TVR (3.5%) in the Excel group was significantly less than in the Dual DES group (13.9%, P = 0.001). The ST rate beyond 12 months in the Dual DES group was 0%, and this was 1.2% in the Excel group (P = 0.499).

CONCLUSIONS:

The Excel stent was statistically superior to the Dual DES in terms of restenosis, late loss, and TVR for long lesions.

• Authors: Shao-Liang Chen, Fei Ye, Jun-Jie Zhang, Jian-Jun Zou, Xue-Song Qian, Feng Li, Song Yang, Zhen Ge, Shou-Jie Shan, Xiao-Bo Li, Tian Xu, Jing Kan, Ling Lin, Ya-Ling Han
• Journal: Cardiovascular therapeutics (Cardiovasc Ther) Vol. 31 Issue 4 Pg. 193-200 (Aug 2013) ISSN: 1755-5922 [Electronic] England
• PMID: 22954234 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2012 John Wiley & Sons Ltd.

Chemical References

• Cardiovascular Agents
• Platelet Aggregation Inhibitors
• Polymers
• Probucol
• Sirolimus

Topics

• Absorbable Implants
• Aged
• Cardiovascular Agents (adverse effects)
• Chi-Square Distribution
• China
• Coronary Angiography
• Coronary Artery Disease (diagnosis, mortality, therapy)
• Coronary Restenosis (etiology, prevention & control)
• Coronary Thrombosis (etiology, prevention & control)
• Disease-Free Survival
• Drug Therapy, Combination
• Drug-Eluting Stents
• Female
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Percutaneous Coronary Intervention (adverse effects, instrumentation, mortality)
• Platelet Aggregation Inhibitors (therapeutic use)
• Polymers
• Probucol (administration & dosage)
• Prospective Studies
• Prosthesis Design
• Sirolimus (administration & dosage)
• Time Factors
• Treatment Outcome