44417
document
A randomized comparison of the Endeavor zotarolimus-eluting stent versus the TAXUS paclitaxel-eluting stent in de novo native coronary lesions 12-month outcomes from the ENDEAVOR IV trial . OBJECTIVES The ENDEAVOR IV ( Randomized Comparison of Zotarolimus-Eluting and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease ) trial evaluated the safety and efficacy of the zotarolimus-eluting stent ( ZES ) compared with the paclitaxel-eluting stent ( PES ) . BACKGROUND First-generation drug-eluting stents have reduced angiographic and clinical restenosis , but long-term safety remains controversial . A second-generation drug-eluting stent , which delivers zotarolimus , a potent antiproliferative agent , via a biocompatible phosphorylcholine polymer on a cobalt alloy thin-strut stent has shown promising experimental and early clinical results . METHODS This is a prospective , randomized ( 1:1 ) , single-blind , controlled trial comparing outcomes of patients with single de novo coronary lesions treated with ZES or PES . The primary end point was noninferiority of 9-month target vessel failure defined as cardiac death , myocardial infarction , or target vessel revascularization . RESULTS Among a total of 1,548 patients assigned to ZES ( n = 773 ) or PES ( n = 775 ) , at 9 months , ZES was noninferior to PES with rates of target vessel failure 6.6 % versus 7.1 % , respectively ( p ( noninferiority ) < or = 0.001 ) . There were fewer periprocedural myocardial infarctions with ZES ( 0.5 % vs. 2.2 % ; p = 0.007 ) , whereas at 12 months , there were no significant differences between groups in rates of cardiac death , myocardial infarction , target vessel revascularization , or stent thrombosis . Although incidence of 8-month binary angiographic in-segment restenosis was higher in patients treated with ZES versus PES ( 15.3 % vs. 10.4 % ; p = 0.284 ) , rates of 12-month target lesion revascularization were similar ( 4.5 % vs. 3.2 % ; p = 0.228 ) , especially in patients without planned angiographic follow-up ( 3.6 % vs. 3.2 % ; p = 0.756 ) . CONCLUSIONS These findings demonstrate that ZES has similar clinical safety and efficacy compared with PES in simple and medium complexity single de novo coronary lesions . ( ENDEAVOR IV Clinical Trial ; NCT00217269 ) .
44418
Intervention_Physical
Endeavor zotarolimus-eluting stent
44419
Intervention_Physical
TAXUS paclitaxel-eluting stent
44420
Intervention_Pharmacological
Zotarolimus-Eluting
44421
Intervention_Physical
Paclitaxel-Eluting Stents
44422
Intervention_Pharmacological
zotarolimus-eluting stent ( ZES )
44423
Intervention_Physical
paclitaxel-eluting stent ( PES )
44424
Intervention_Pharmacological
zotarolimus
44425
Intervention_Pharmacological
ZES
44426
Intervention_Pharmacological
ZES
44427
Intervention_Pharmacological
ZES
44428
Intervention_Pharmacological
ZES
44429
Intervention_Pharmacological
PES
44430
Outcome_Other
safety and efficacy
44431
Outcome_Physical
9-month target vessel failure
44432
Outcome_Physical
cardiac death , myocardial infarction , or target vessel revascularization
44433
Outcome_Physical
target vessel failure
44434
Outcome_Physical
periprocedural myocardial infarctions
44435
Outcome_Physical
cardiac death , myocardial infarction , target vessel revascularization , or stent thrombosis
44436
Outcome_Physical
binary angiographic in-segment restenosis
44437
Outcome_Physical
target lesion revascularization
44438
Participant_Condition
patients with single de novo coronary lesions treated with ZES or PES
44439
Participant_Sample-size
1,548 patients
44440
Participant_Sample-size
773