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Ghione, Matteo; Wykrzykowska, Joanna J.; Windecker, Stephan; Serruys, Patrick W.; Buszman, Pawel; Linke, Axel; Sohn, Hae Young; Corti, Roberto; Antoni, Diethmar; Wijns, William; Estevez-Loureiro, Rodrigo; Morice, Marie-Claude; Es, Gerrit-Anne van; Geuns, Robert Jan van; Juni, Peter; Eerdmans, Pedro; Vries, Ton de; Konik, Stephanie; Di Mario, Carlo (2016): Five-year outcomes of chronic total occlusion treatment with a biolimus A9-eluting biodegradable polymer stent versus a sirolimus-eluting permanent polymer stent in the LEADERS all-comers trial. In: Cardiology Journal, Vol. 23, No. 6: pp. 626-636
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Background: Few data are available on long-term follow-up of drug-eluting stents in the treatment of chronic total occlusion (CTO). The LEADERS CTO sub-study compared the long-term results in CTO and non-CTO lesions of a Biolimus A9 (TM)-eluting stent (BES) with a sirolimus-eluting stent (SES). Methods: Among 1,707 patients enrolled in the prospective, multi-center, all-comers LEADERS trial, 81 with CTOs were treated with either a BES (n = 45) or a SES (n = 36). The primary endpoint was the occurrence of major adverse cardiac events (MACE): cardiac death, myocardial infarction (MI) and clinically-indicated target vessel revascularization (TVR). Results: At 5 years, the rate of MACE was numerically higher in the CTO group than in the non-CTO group (29.6% vs. 23.3%;p = 0.173), with a significant increase in the incidence of target lesion revascularization (TLR) (21.0 vs. 12.6;p = 0.033), but no difference in stent thrombosis (ST). Patients with CTO receiving a BES demonstrated a lower incidence of MACE (22.2% vs. 38.9%;p = 0.147) with a significant reduction in TLR compared to patients receiving a SES (11.1% vs. 33.3%, p = 0.0214) with an incidence similar to that observed in the non-CTO group treated with BES (11.6%). Definite ST at 5 years nearly halved in the BES group (4.4% vs. 8.3%, p = 0.478) with no ST in the BES group after the first year (0% vs. 8.3%, p for interaction = 0.009). Conclusions: The use of a BES showed a reduction in MACE, TVR, TLR, and ST over time in the CTO subset with similar outcome as for non-CTO lesions.