In results from a substudy of the LEADERS trial presented at Transcatheter Cardiovascular Therapeutics 2009, the rates of major adverse coronary events (MACE) in patients with long lesions were equivalent between those implanted with biolimus-eluting stents (BES) and those treated with SES.
Previous studies have shown that PES are inferior to SES for treatment of long lesions, said Joanna J. Wykrzykowska, MD, of Erasmus Medical Center (Rotterdam, The Netherlands). “This is the first report of a drug-eluting stent other than Cypher (Cordis/Johnson & Johnson; Miami Lakes, FL) performing relatively well in long lesions,” Dr. Wykrzykowska said in an interview. Biolimus is a semisynthetic analogue of sirolimus; in the Biomatrix stent (Biosensors International; Singapore) it is paired with a biodegradable polylactic acid polymer.
BES and SES Mostly Equivalent
For the study, Dr. Wykrzykowska and colleagues randomized 1,707 “all-comer” patients to treatment with BES or SES. The researchers performed a stratified post-hoc analysis of angiographic outcomes at 9 months and clinical outcomes at 1 year for vessels with lesion lengths = 20 mm vs. > 20 mm. Baseline clinical characteristics of patients with long lesions (153 treated with BES and 151 with SES) were similar to those with shorter lesions (592 treated with BES and 619 with SES), except for a higher incidence of acute MI in the short-lesion group.
Overall, late luminal loss was greater for long lesions than for short lesions. However, among patients with long lesions, late loss was similar between patients receiving BES (0.32 ± 0.69 mm) and SES (0.24 ± 0.57 mm; P = 0.59). Likewise, rates of binary in-stent restenosis were also similar between those who received BES (16.7%) and those who received SES (10.3%; P = 0.12).