title: Five-year clinical outcomes in patients with diabetes mellitus treated with polymer-free sirolimus- and probucol-eluting stents versus second-generation zotarolimus-eluting stents: a subgroup analysis of a randomized controlled trial.
abstract: Improved outcomes in patients with diabetes mellitus undergoing percutaneous coronary intervention remain an unmet clinical need. We assessed the long-term efficacy and safety of novel polymer-free sirolimus- and probucol-eluting stent in diabetic patients enrolled in intracoronary stenting and angiographic results: test efficacy of sirolimus- and probucol-eluting versus zotarolimus-eluting stents 5 trial.
  
  
  
  In a pre-specified subgroup analysis, outcomes of diabetic patients treated with a sirolimus- and probucol-eluting stent or a second-generation zotarolimus-eluting stent were compared. The primary endpoint was a device-oriented composite outcome comprising cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularization (TLR) at 5-year follow-up. Event-free survival was assessed using the Kaplan-Meier method. Hazard ratios (HR) and 95 % confidence intervals (CI) were estimated from univariate Cox proportional hazards models.
  
  
  
  A total of 870 patients with diabetes mellitus were treated with either a sirolimus- and probucol-eluting stent (n = 575) or a second-generation zotarolimus-eluting stent (n = 295). At 5 years, the rate of device-oriented composite endpoint was comparable between the sirolimus- and probucol-eluting stent and the second-generation zotarolimus-eluting stent (32.9 versus 33.4 %, HR 0.88, 95 % CI 0.76-1.26). No significant differences were observed between the sirolimus- and probucol-eluting stent and the second-generation zotarolimus-eluting stent groups in the incidence of cardiac death (15.6 versus 16.7 % HR 0.92, 95 % CI 0.63-1.32), target-vessel MI (4.6 versus 6.6 %, HR 0.73, 95 % CI 0.40-1.34), and TLR (18.6 versus 18.8 %, HR 1.00, 95 % CI, 0.72-1.41). The rate of definite or probable stent thrombosis was low and similar in both groups (2.5 versus 2.6 %, HR 1.02, 95 % CI, 0.41-2.52).
  
  
  
  In patients with diabetes the long-term efficacy and safety of a polymer-free sirolimus- and probucol-eluting stent were comparable to a second-generation durable polymer zotarolimus-eluting stent. Trial registration ClinicalTrials.gov NCT00598533. Registered 10 January 2008.
authors: Deutsches Herzzentrum München, Technische Universität München, Lazarettstraße 36, Munich, Germany.
authors: Yukinori
authors: Y
authors: Harada
authors: Deutsches Herzzentrum München, Technische Universität München, Lazarettstraße 36, Munich, Germany.
authors: Roisin
authors: R
authors: Colleran
authors: Deutsches Herzzentrum München, Technische Universität München, Lazarettstraße 36, Munich, Germany.
authors: Sebastian
authors: S
authors: Kufner
authors: Deutsches Herzzentrum München, Technische Universität München, Lazarettstraße 36, Munich, Germany.
authors: Daniele
authors: D
authors: Giacoppo
authors: Deutsches Herzzentrum München, Technische Universität München, Lazarettstraße 36, Munich, Germany.
authors: Tobias
authors: T
authors: Rheude
authors: Deutsches Herzzentrum München, Technische Universität München, Lazarettstraße 36, Munich, Germany.
authors: Jonathan
authors: J
authors: Michel
authors: Deutsches Herzzentrum München, Technische Universität München, Lazarettstraße 36, Munich, Germany.
authors: Salvatore
authors: S
authors: Cassese
authors: 1. medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, Munich, Germany.
authors: Tareq
authors: T
authors: Ibrahim
authors: 1. medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, Munich, Germany.
authors: Karl-Ludwig
authors: KL
authors: Laugwitz
authors: Deutsches Herzzentrum München, Technische Universität München, Lazarettstraße 36, Munich, Germany.
authors: Adnan
authors: A
authors: Kastrati
authors: Deutsches Herzzentrum München, Technische Universität München, Lazarettstraße 36, Munich, Germany. byrne@dhm.mhn.de.
authors: Robert A
authors: RA
authors: Byrne
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002318:Cardiovascular Diseases / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000209:etiology / Q000628:therapy; D003328:Coronary Thrombosis / Q000209:etiology / Q000628:therapy; D003925:Diabetic Angiopathies / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000628:therapy; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011341:Probucol / Q000008:administration & dosage* / Q000009:adverse effects; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D019233:Retreatment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D010975:Platelet Aggregation Inhibitors; C489443:zotarolimus; D011341:Probucol; D020123:Sirolimus
keywords: Diabetes; Drug-Eluting Stent; Probucol; Sirolimus; Zotarolimus