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

초록

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 (29.2412.17 versus 32.2713.84 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.

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