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Randomized Controlled Trial Multicenter Study Comparative Study
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.
- 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, and Ya-Ling Han.
- Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
- Cardiovasc Ther. 2013 Aug 1;31(4):193-200.
BackgroundPolymer-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.MethodsThree 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.ResultsClinical 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).ConclusionsThe Excel stent was statistically superior to the Dual DES in terms of restenosis, late loss, and TVR for long lesions.© 2012 John Wiley & Sons Ltd.
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