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Long–term follow–up of patients treated with new generation drug–eluting stents contributes to our understanding of the risks and benefits of these devices over time. RESOLUTE US was a prospective single–arm trial designed to evaluate the effectiveness of the Resolute™ zotarolimus–eluting stent (R–ZES) in patients with de novo coronary artery disease.
Patients with lesions in vessels 2.25–4.0 mm in diameter and appropriate for one– or two–vessel treatment were enrolled. The primary endpoint at 1 year was target lesion failure (TLF); a composite of cardiac death, target vessel myocardial infarction (TVMI), and target lesion revascularization (TLR). Secondary endpoints include the components of TLF and definite/probable stent thrombosis (ST). Dual antiplatelet therapy (DAPT) was prescribed for a minimum of 6 months. Annual follow–up was obtained through 5 years.
There were 1402 patients enrolled; 68.3% males and 34.4% with diabetes, including 9.6% using insulin. Most lesions were type B2/C (75%). TLF at 2 years was 7.3% including 4.3% TLR, 1.9% TVMI and 1.5% cardiac death. Overall definite/probable ST occurred in 3 (0.2%) and1 patients (0.1%) between 1 and 2 years respectively; 67.2% of patients were on DAPT at 2 years. There were 150 patients with vessels <2.25 mm and among this cohort the 2–year rate of TLF was 8.2%. Two of the 3 ST events occurred in this cohort. Among patients with diabetes the 2–year rate of TLF was 8.9% and TLR was 5.7%. There was no ST in the diabetic subgroup through 2 years.
Two–year follow–up demonstrates low rates of TLF in all patient cohorts with very low rates of ST following treatment of coronary artery disease with the R–ZES. Outcomes in patients with diabetes further support the safety and effectiveness of the R–ZES. Full 3–year follow–up of the RESOLUTE US trial will be presented at ACC2013.
Moderated Poster Contributions
Poster Sessions, Expo North
Saturday, March 09, 2013, 10:00 a.m.–10:45 a.m.
Session Title: Coronary Stents
Abstract Category: 1. Acute Coronary Syndromes: Clinical
Presentation Number: 2101M–217
- 2013 American College of Cardiology Foundation