title: Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trials.
abstract: OBJECTIVE
  The efficacy of durable polymer drug-eluting stents (DES) is delivered at the expense of delayed healing of the stented vessel. Biodegradable polymer DES aim to avoid this shortcoming and may potentially improve long-term clinical outcomes, with benefit expected to accrue over time. We sought to compare long-term outcomes in patients treated with biodegradable polymer DES vs. durable polymer sirolimus-eluting stents (SES).
  
  
  RESULTS
  We pooled individual patient data from three large-scale multicentre randomized clinical trials (ISAR-TEST 3, ISAR-TEST 4, and LEADERS) comparing biodegradable polymer DES with durable polymer SES and assessed clinical outcomes during follow-up through 4 years. The efficacy endpoint of interest was target lesion revascularization and the safety endpoint of interest was definite stent thrombosis. Out of 4062 patients included in the present analysis, 2358 were randomly assigned to treatment with biodegradable polymer DES (sirolimus-eluting, n= 1501; biolimus-eluting, n= 857) and 1704 patients to durable polymer SES. No heterogeneity across the trials was observed in analyses of the primary and secondary endpoints. At 4 years, the risk of target lesion revascularization was significantly lower among patients treated with biodegradable polymer DES vs. durable polymer SES (hazard ratio 0.82, 95% CI 0.68-0.98, P= 0.029). In addition, the risk of stent thrombosis was significantly reduced with biodegradable polymer DES vs. durable polymer SES (hazard ratio 0.56, 95% CI 0.35-0.90, P= 0.015), driven by a lower risk of very late stent thrombosis (hazard ratio 0.22, 95% CI 0.08-0.61, P= 0.004). In keeping with this, in landmark analysis between 1 and 4 years, the incidence of myocardial infarction was lower for patients treated with biodegradable polymer DES vs. durable polymer SES (hazard ratio 0.59, 95% CI 0.73-0.95, P= 0.031).
  
  
  CONCLUSIONS
  Biodegradable polymer DES improve safety and efficacy compared with durable polymer SES during long-term follow-up to 4 years.
authors.affiliation: Department of Cardiology,  Bern University Hospital, Bern,  Switzerland.
authors.forename: Giulio G
authors.initials: GG
authors.lastname: Stefanini
authors.forename: Robert A
authors.initials: RA
authors.lastname: Byrne
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Antoinette
authors.initials: A
authors.lastname: de Waha
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
authors.forename: Steffen
authors.initials: S
authors.lastname: Massberg
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.forename: Albert
authors.initials: A
authors.lastname: Schömig
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D053208:Kaplan-Meier Estimate; D008297:Male; D015337:Multicenter Studies as Topic; D009203:Myocardial Infarction / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic; D020123:Sirolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D020123:Sirolimus