title: Polymer-free sirolimus- and probucol-eluting versus new generation zotarolimus-eluting stents in coronary artery disease: the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting versus Zotarolimus-eluting Stents (ISAR-TEST 5) trial.
abstract: BACKGROUND
  Durable polymer coatings have been implicated in mid- and long-term adverse events after drug-eluting stent implantation. A polymer-free dual-drug sirolimus- and probucol-eluting stent and a new generation permanent polymer zotarolimus-eluting stent are recently developed technologies demonstrating encouraging results.
  
  
  RESULTS
  In a clinical trial with minimal exclusion criteria, we randomly assigned 3002 patients to treatment with sirolimus- and probucol-eluting stents versus zotarolimus-eluting stents. The trial was designed to demonstrate noninferiority of the sirolimus- and probucol-eluting stents. The primary end point was the combined incidence of cardiac death, target-vessel-related myocardial infarction, or target-lesion revascularization at 1-year follow-up. Follow-up angiography was scheduled at 6 to 8 months. The sirolimus- and probucol-eluting stent was noninferior to the zotarolimus-eluting stent in terms of occurrence of the primary end point (13.1% versus 13.5%, respectively, P(noninferiority)=0.006; hazard ratio=0.97, 95% confidence interval, 0.78 to 1.19; P(superiority)=0.74). The incidence of definite/probable stent thrombosis was low in both groups (1.1% versus 1.2%, respectively; hazard ratio=0.91 [95% confidence interval, 0.45 to 1.84], P=0.80). With regard to angiographic efficacy, there were no differences between the sirolimus- and probucol-eluting stent and the zotarolimus-eluting stent in terms of either in-segment binary angiographic restenosis (13.3% versus 13.4% respectively; P=0.95) or in-stent late luminal loss (0.31±0.58 mm versus 0.29±0.56 mm, respectively; P=0.46).
  
  
  CONCLUSIONS
  In this large-scale study powered for clinical end points, a polymer-free sirolimus- and probucol-eluting stent was noninferior to a new generation durable polymer-based zotarolimus-eluting stent out to 12 months.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier NCT 00598533.
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany. massberg@idi.havard.edu
authors.forename: Steffen
authors.initials: S
authors.lastname: Massberg
authors.forename: Robert A
authors.initials: RA
authors.lastname: Byrne
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.forename: Stefanie
authors.initials: S
authors.lastname: Schulz
authors.forename: Jürgen
authors.initials: J
authors.lastname: Pache
authors.forename: Jörg
authors.initials: J
authors.lastname: Hausleiter
authors.forename: Tareq
authors.initials: T
authors.lastname: Ibrahim
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Fusaro
authors.forename: Ilka
authors.initials: I
authors.lastname: Ott
authors.forename: Albert
authors.initials: A
authors.lastname: Schömig
authors.forename: Karl-Ludwig
authors.initials: KL
authors.lastname: Laugwitz
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation* / Q000379:methods / Q000706:statistics & numerical data; D000924:Anticholesteremic Agents / Q000627:therapeutic use; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy; D054855:Drug-Eluting Stents / Q000009:adverse effects / Q000706:statistics & numerical data*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality; D011108:Polymers / Q000009:adverse effects / Q000737:chemistry; D011341:Probucol / Q000627:therapeutic use*; D011474:Prosthesis Design; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D007166:Immunosuppressive Agents; D011108:Polymers; C489443:zotarolimus; D011341:Probucol; D020123:Sirolimus