Maik J Grundeken1, Joanna J Wykrzykowska1, Yuki Ishibashi2, Scot Garg3, Ton de Vries4, Hector M Garcia-Garcia2,4, Yoshinobu Onuma2,4, Robbert J de Winter1, Pawel Buszman5, Axel Linke6, Thomas Ischinger7, Volker Klauss8, Franz Eberli9, Roberto Corti10, William Wijns11, Marie-Claude Morice12, Carlo di Mario13, Bernhard Meier14, Peter Jüni15, Ashkan Yazdani16, Samuel Copt16, Stephan Windecker14, Patrick W Serruys17. 1. Heartcenter, Academic Medical Center, Amsterdam, The Netherlands. 2. Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. 3. East Lancashire Hospitals NHS Trust, Blackburn, United Kingdom. 4. Cardialysis BV, Rotterdam, The Netherlands. 5. American Heart of Poland, Ustroń, Poland. 6. Herzzentrum Leipzig, Leipzig, Germany. 7. Kardiologie Im Zentrum, Munich, Germany. 8. Kardiologie Innenstadt, Munich, Germany. 9. Department of Cardiology, Triemli Spital, Zurich, Switzerland. 10. University Hospital Zurich, Zurich, Switzerland. 11. Department of Cardiology, Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium. 12. Institut Hospitalier Jacques-Cartier, Institut Cardiovasculaire Paris-Sud, Massy, France. 13. Royal Brompton Hospital, London, United Kingdom. 14. Department of Cardiology, University of Bern, Bern, Switzerland. 15. Department of Cardiology/University of Bern, CTU Bern and Institute of Social and Preventive Medicine, Bern, Switzerland. 16. Biosensors Europe SA, Morges, Switzerland. 17. International Centre for Circulatory Health, NHLI, Imperial College London, London, the United Kingdom.
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 biolimusA9(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.
RCT Entities:
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.
Authors: Dobrin Vassilev; Niya Mileva; Carlos Collet; Pavel Nikolov; Kiril Karamfiloff; Vladimir Naunov; Jeroen Sonck; Irinka Hristova; Despina Georgieva; Gianluca Rigatelli; Ghassan S Kassab; Robert J Gil Journal: Int J Cardiol Heart Vasc Date: 2021-12-29