BACKGROUND: Limited evidence exists regarding the long-term performance of polymer-free (PF) drug-eluting stents (DES) in comparison to permanent polymer DES. This study investigated the 5-year efficacy and safety of a PF @entity3446 -eluting stent (PF-SES) versus a permanent polymer @entity1311 -eluting stent (PES) in the setting of the Intracoronary Stenting and Angiographic Restenosis-Test Equivalence Between Two Drug-Eluting Stents (ISAR-TEST) randomized trial. METHODS AND RESULTS: A total of 450 @entity1 undergoing percutaneous coronary intervention were randomized to receive either PF-SES (Yukon, Translumina; n = 225) or PES (Taxus, Boston Scientific; n = 225). Clinical follow-up was performed to 5 years after enrollment. The endpoints were major adverse @entity299 (MACE), @entity75 revascularization (TLR), the composite of @entity204 or any @entity583 ( @entity583 ) and @entity715 ( @entity715 ). The incidence of MACE at 5 years was 27.3% (57 @entity1 ) in the PF-SES group and 31.7% (65 @entity1 ) in the PES group [hazard ratio (HR) = 0.87 [95% confidence interval (95% CI) = 0.61-1.24]; P = 0.40]. The combined incidence of @entity204 or @entity583 was 16.6% (34 @entity1 ) in the PF-SES group and 20.0% (39 @entity1 ) in the PES group (HR = 0.86 [95% CI = 0.54-1.36]; P = 0.52). The incidence of TLR was 16.5% (34 @entity1 ) in the PF-SES group and 16.4% (33 @entity1 ) in the PES group (HR = 1.03 [95% CI = 0.64-1.66]; P = 0.89). @entity715 occurred in 0.5% (one @entity1 ) in the PF-SES group and 1.6% (three @entity1 ) in the PES group (HR = 0.33 [95% CI = 0.03-3.14]; P = 0.32). CONCLUSION: Overall there was no significant difference in clinical outcomes between PF-SES and PES to 5 years. Extended follow-up supports the durability of efficacy and safety of PF-SES.

Five-year clinical outcomes of a polymer-free XXXX -eluting stent versus a permanent polymer @entity1311 -eluting stent: final results of the intracoronary stenting and angiographic restenosis - test equivalence between two drug-eluting stents (ISAR-TEST) trial.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity75 :: ('MESH:D001927', 'Disease') :: ['target lesion'] @entity1311 :: ('MESH:D017239', 'Chemical') :: ['paclitaxel'] @entity3446 :: ('MESH:D020123', 'Chemical') :: ['sirolimus'] @entity299 :: ('MESH:D006331', 'Disease') :: ['cardiac events'] @entity583 :: ('MESH:D009203', 'Disease') :: ['myocardial infarction', 'MI'] @entity204 :: ('MESH:D003643', 'Disease') :: ['death'] @entity715 :: ('MESH:D013927', 'Disease') :: ['ST', 'stent thrombosis']
@entity3446 :: (MESH:D020123,Chemical) :: ['sirolimus']
