title: Long-term outcomes of biodegradable polymer versus durable polymer drug-eluting stents in patients with diabetes a pooled analysis of individual patient data from 3 randomized trials.
abstract: BACKGROUND
  There is ongoing debate on the optimal drug-eluting stent (DES) in diabetic patients with coronary artery disease. Biodegradable polymer drug-eluting stents (BP-DES) may potentially improve clinical outcomes in these high-risk patients. We sought to compare long-term outcomes in patients with diabetes treated with biodegradable polymer DES vs. durable polymer sirolimus-eluting stents (SES).
  
  
  METHODS
  We pooled individual patient-level data from 3 randomized clinical trials (ISAR-TEST 3, ISAR-TEST 4 and LEADERS) comparing biodegradable polymer DES with durable polymer SES. Clinical outcomes out to 4 years were assessed. The primary end point was the composite of cardiac death, myocardial infarction and target-lesion revascularization. Secondary end points were target lesion revascularization and definite or probable stent thrombosis.
  
  
  RESULTS
  Of 1094 patients with diabetes included in the present analysis, 657 received biodegradable polymer DES and 437 durable polymer SES. At 4 years, the incidence of the primary end point was similar with BP-DES versus SES (hazard ratio = 0.95, 95% CI = 0.74-1.21, P = 0.67). Target lesion revascularization was also comparable between the groups (hazard ratio = 0.89, 95% CI = 0.65-1.22, P = 0.47). Definite or probable stent thrombosis was significantly reduced among patients treated with BP-DES (hazard ratio = 0.52, 95% CI = 0.28-0.96, P = 0.04), a difference driven by significantly lower stent thrombosis rates with BP-DES between 1 and 4 years (hazard ratio = 0.15, 95% CI = 0.03-0.70, P = 0.02).
  
  
  CONCLUSIONS
  In patients with diabetes, biodegradable polymer DES, compared to durable polymer SES, were associated with comparable overall clinical outcomes during follow-up to 4 years. Rates of stent thrombosis were significantly lower with BP-DES.
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany. Electronic address: dewaha@dhm.mhn.de.
authors.forename: Antoinette
authors.initials: A
authors.lastname: de Waha
authors.forename: Giulio G
authors.initials: GG
authors.lastname: Stefanini
authors.forename: Lamin A
authors.initials: LA
authors.lastname: King
authors.forename: Robert A
authors.initials: RA
authors.lastname: Byrne
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Sebastian
authors.initials: S
authors.lastname: Kufner
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods*; D003324:Coronary Artery Disease / Q000628:therapy*; D048909:Diabetes Complications; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011108:Polymers; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013927:Thrombosis / Q000209:etiology; D016896:Treatment Outcome
chemical_list: D011108:Polymers; C518022:umirolimus; D020123:Sirolimus
keywords: Biodegradable polymer; Biolimus A9; Diabetes mellitus; Drug-eluting stent; Meta-analysis; Stent thrombosis