title: Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial.
abstract: OBJECTIVE
  This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial.
  
  
  BACKGROUND
  The LEADERS trial is the first randomized study to evaluate biodegradable polymer-based drug-eluting stents (DES) against durable polymer DES.
  
  
  METHODS
  The LEADERS trial was a 10-center, assessor-blind, noninferiority, "all-comers" trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The primary endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary endpoints included extending the primary endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat.
  
  
  RESULTS
  At 5 years, the BES was noninferior to SES for the primary endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority <0.0001, p for superiority = 0.069). The BES was associated with a significant reduction in the more comprehensive patient-orientated composite endpoint of all-cause death, any MI, and all-cause revascularization (297 [35.1%] vs. 339 [40.4%], RR: 0.84 [95% CI: 0.71 to 0.98], p for superiority = 0.023). A significant reduction in very late definite ST from 1 to 5 years was evident with the BES (n = 5 [0.7%] vs. n = 19 [2.5%], RR: 0.26 [95% CI: 0.10 to 0.68], p = 0.003), corresponding to a significant reduction in ST-associated clinical events (primary endpoint) over the same time period (n = 3 of 749 vs. n = 14 of 738, RR: 0.20 [95% CI: 0.06 to 0.71], p = 0.005).
  
  
  CONCLUSIONS
  The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220).
authors: Thoraxcenter, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands. p.w.j.c.serruys@erasmusmc.nl
authors: Patrick W
authors: PW
authors: Serruys
authors: Vasim
authors: V
authors: Farooq
authors: Bindu
authors: B
authors: Kalesan
authors: Ton
authors: T
authors: de Vries
authors: Pawel
authors: P
authors: Buszman
authors: Axel
authors: A
authors: Linke
authors: Thomas
authors: T
authors: Ischinger
authors: Volker
authors: V
authors: Klauss
authors: Franz
authors: F
authors: Eberli
authors: William
authors: W
authors: Wijns
authors: Marie Claude
authors: MC
authors: Morice
authors: Carlo
authors: C
authors: Di Mario
authors: Roberto
authors: R
authors: Corti
authors: Diethmar
authors: D
authors: Antoni
authors: Hae Y
authors: HY
authors: Sohn
authors: Pedro
authors: P
authors: Eerdmans
authors: Tessa
authors: T
authors: Rademaker-Havinga
authors: Gerrit-Anne
authors: GA
authors: van Es
authors: Bernhard
authors: B
authors: Meier
authors: Peter
authors: P
authors: Jüni
authors: Stephan
authors: S
authors: Windecker
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D054855:Drug-Eluting Stents; D005060:Europe; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality / Q000517:prevention & control; D016017:Odds Ratio; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011108:Polymers; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D011108:Polymers; C518022:umirolimus; D020123:Sirolimus
keywords: ACS; ARC; Academic Research Consortium; BES; BMS; CI; DES; KM; Kaplan-Meier; MACE; MI; PCI; POCE; RR; SES; ST; ST-segment elevation myocardial infarction; STEMI; TVR; acute coronary syndrome; bare-metal stent(s); biodegradable polymer; biolimus-eluting stent(s); confidence interval; drug-eluting stent(s); drug-eluting stents; durable polymer; major adverse cardiac events; myocardial infarction; patient-oriented composite endpoint; percutaneous coronary intervention; rate ratio(s); sirolimus-eluting stent(s); stent thrombosis; target vessel revascularization