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Clinical research

Long-term clinical outcomes with the next-generation Resolute Stent System: a report of the two-year follow-up from the RESOLUTE clinical trial

1. MonashHEART Medical Centre, Melbourne, Australia; 2. Cardiovascular Research Centre, University of Adelaide and the Royal Adelaide Hospital, Adelaide, Australia; 3. St. Vincent’s Hospital, Melbourne, Australia; 4. Prince Charles Hospital, Brisbane, Australia; 5. Christchurch Hospital, Christchurch, New Zealand; 6. Mercy Hospital, Auckland, New Zealand; 7. The Austin Health Medical Centre, Melbourne, Australia; 8. Dunedin Hospital, Dunedin, New Zealand; 9. Fremantle Hospital, Fremantle, Australia; 10. Wellington Hospital, Wellington, New Zealand; 11. St. Vincent’s Hospital, Sydney, Australia; 12. Harvard Clinical Research Institute, Boston, MA, USA

Aims: 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.

Methods and 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.

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