Extended follow-up safety and effectiveness of the Endeavor zotarolimus-eluting stent in real-world clinical practice: two-year follow-up from the E-Five Registry.
OBJECTIVE
To present data from the cohort of patients in the all-comers Endeavor zotarolimus-eluting stent (ZES) registry (E-Five) who underwent 2-year follow-up.


BACKGROUND
The Endeavor ZES has been shown to be safe and efficacious for treatment of single, de novo lesions in patients with stable coronary artery disease. E-Five evaluated the ZES in over 8,000 real-world patients, at 188 sites followed to 1 year. A subset of sites continued follow-up through 2 years to evaluate late-term safety and effectiveness of the ZES in this population with diverse clinical and lesion characteristics.


METHODS
E-Five, a prospective, multicenter, nonrandomized global registry, collected 2-year outcomes for 2,116 patients from 26 centers. Sites were selected for participation based on patient accrual rates and the ability to continue follow-up activities for an additional year. Complete data was available for 2,054 patients. To observe whether or not a sustained benefit was achieved, data for all patients from the selected sites were included in the analysis.


RESULTS
The outcomes in the 2-year cohort tracked with the results of randomized controlled trials using the Endeavor ZES. One year results were MACE 7.5%, TLR 4.5%, and ARC definite/probable stent thrombosis 0.6%. Outcomes at 2 years for MACE, TLR, and ARC definite/probable stent thrombosis were 8.5, 5.1, and 0.7%, respectively.


CONCLUSIONS
Long-term efficacy and safety outcomes were maintained between 1 and 2 years for the 2-year patient cohort, with only a small number of additional MACE, TLR, and very late stent thrombosis events.
Meredith
Ian
I
MonashHeart, Monash Medical Centre and University, Melbourne, Australia. ian.meredith@med.monash.edu.au
Rothman
Martin
M
Erglis
Andrejs
A
Parikh
Keyur
K
Lotan
Chaim
C
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D001208:Asia; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007843:Latin America; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D010975:Platelet Aggregation Inhibitors; C489443:zotarolimus; D020123:Sirolimus