First generation versus second generation drug‐eluting stents for the treatment of bifurcations: 5‐year follow‐up of the LEADERS all‐comers randomized trial. Issue 7 (9th December 2015) - Grundeken, Maik J.
Abstract : Background: Historically, percutaneous coronary intervention (PCI) of bifurcation lesions was associated with worse procedural and clinical outcomes when compared with PCI of non‐bifurcation lesions. Newer generation drug‐eluting stents (DES) might improve long‐term clinical outcomes after bifurcation PCI. Methods and Results: The LEADERS trial was a 10‐center, assessor‐blind, non‐inferiority, all‐comers trial, randomizing 1, 707 patients to treatment with a biolimus A9 TM ‐eluting stent (BES) with an abluminal biodegradable polymer or a sirolimus‐eluting stent (SES) with a durable polymer (ClinicalTrials.gov Identifier: NCT00389220). Five‐year clinical outcomes were compared between patients with and without bifurcation lesions and between BES and SES in the bifurcation lesion subgroup. There were 497 (29%) patients with at least 1 bifurcation lesion (BES = 258; SES = 239). At 5‐year follow‐up, the composite endpoint of cardiac death, myocardial infarction (MI) and clinically‐indicated (CI) target vessel revascularization (TVR) was observed more frequently in the bifurcation group (26.6% vs. 22.4%, P = 0.049). Within the bifurcation lesion subgroup, no differences were observed in (cardiac) death or MI rates between BES and SES. However, CI target lesion revascularization (TLR) (10.1% vs. 15.9%, P = 0.0495), and CI TVR (12.0% vs. 19.2%, P = 0.023) rates were significantly lower in the BES group. Definite/probable stent thrombosis (ST) rate was numerically lower in the BES group (3.1% vs. 5.9%, P = 0.15). Very late (>1 year) definite/probable ST rates trended to be lower with BES (0.4% vs. 3.1%, P = 0.057). Conclusions: In the treatment of bifurcation lesions, use of BES led to superior long‐term efficacy compared with SES. Safety outcomes were comparable between BES and SES, with an observed trend toward a lower rate of very late definite/probable ST between 1 and 5 years with the BES. © 2015 Wiley Periodicals, Inc.