Author + information
- Ganesh Manoharan,
- Franz–Josef Neumann,
- Stephan Windecker,
- Martin Leon,
- Ian Meredith,
- Shigeru Saito,
- Patrick Serruys,
- Sigmund Silber,
- Alan Yeung,
- Jorge Belardi,
- Petr Widimsky and
- Laura Mauri
The RESOLUTE global clinical program comprises 5 clinical trials of 5130 patients treated with a Resolute™ zotarolimus–eluting stent (R–ZES). Long–term follow–up of this large pooled dataset provides an opportunity to assess rare, late safety events that continue to be an important concern for patients with coronary artery disease undergoing percutaneous cardiovascular intervention.
Data was pooled from the randomized RESOLUTE All Comers trial followed through 3 yrs (R–AC, N = 1140) and four single arm trials: RESOLUTE (N = 139, 5 yr follow–up); and 2–yr follow–up from RESOLUTE US (R–US, N = 1402); RESOLUTE International (R–Int, N = 2349); and RESOLUTE Japan (R–Japan, N = 100). Pooled safety endpoints (cardiac death, target vessel myocardial infarction [TVMI], and definite/probable stent thrombosis [ST]), clinically–driven target lesion revascularization (TLR) and target lesion failure (TLF) for R–ZES patients are reported. All RESOLUTE trials recommended six months dual antiplatelet therapy (DAPT).
The mean age of all patients was 64 years; 30% had diabetes and 22.5% were treated following MI. Two–thirds of lesions were class B2/C. The 2–year rate of definite/probable ST was 0.9% and very late ST (after 1 year) was 0.1%. DAPT use dropped from 88.6% at 1 year to 44.7% at 2 years. The 2–year rate of cardiac death or TVMI was 5.4% (cardiac death 2.2%, TVMI 3.4%). TLR through 2 years was 4.7% and TLF was 9.3%.
Pooled data analysis confirms the safety and effectiveness of R–ZES with low rates of cardiac death, TVMI, very late ST, and TLR through 2 years for R–ZES. Data presented at ACC will be updated with complete 3–year outcomes, including rates of DAPT use for all 5 of the
West, Room 2001
Sunday, March 10, 2013, 8:30 a.m.–8:40 a.m.
Session Title: Drug–Eluting Stents
Abstract Category: 1. Acute Coronary Syndromes: Clinical
Presentation Number: 2903–5
- 2013 American College of Cardiology Foundation