Long-term clinical outcomes with the next-generation Resolute Stent System: a report of the two-year follow-up from the RESOLUTE clinical trial.
OBJECTIVE
The 12-month results of RESOLUTE were favourable for the new Resolute stent. Two-year safety and efficacy results from RESOLUTE have been evaluated and are now reported.


RESULTS
RESOLUTE was a prospective, multicentre, non-randomised, single-arm, controlled trial of the Resolute stent in 139 participants with symptomatic ischaemic heart disease due to single de novo lesions in a native coronary artery. The 2-year rates of MACE (all-cause death, myocardial infarction, emergent cardiac bypass surgery, and target lesion revascularisation [TLR]), death, late stent thrombosis, target vessel revascularisation (TVR), and target vessel failure (TVF) were assessed. Clinical events included two MACE (one TLR; one non-cardiac death) occurring between year one and two resulting in cumulative 2-year TLR, TVR, and TVF rates of 1.4%, 1.4%, and 7.9%, respectively. One possible stent thrombosis event occurred in the first year after stent implantation however no late or very late ARC-defined definite and probable stent thromboses occurred through two years.


CONCLUSIONS
The 2-year data from RESOLUTE demonstrated no safety concerns including no late stent thrombosis or loss of effectiveness with the Resolute stent. The finding that few events occurred in year two is encouraging, yet requires verification in a larger population.
MonashHEART Medical Centre, Melbourne, Australia. ian.meredith@med.mosh.edu.au
Ian T
IT
Meredith
Stephen G
SG
Worthley
Robert
R
Whitbourn
Darren
D
Walters
Dougal
D
McClean
John
J
Ormiston
Mark
M
Horrigan
Gerard T
GT
Wilkins
Randall
R
Hendriks
Philip
P
Matsis
David
D
Muller
Donald E
DE
Cutlip
D001315:Australia / Q000453:epidemiology; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000601:surgery*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D009204:Myocardial Revascularization / Q000295:instrumentation*; D009520:New Zealand / Q000453:epidemiology; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible