Author + information
- Gregg W. Stone,
- Paul Teirstein,
- Ian Meredith,
- Robert Stoler,
- Abram Rabinowitz,
- Vincent Pompili,
- Ameer Kabour,
- Thomas Stuckey,
- Nick Curzen,
- Shigeru Saito,
- Andrejs Erglis,
- Dominic J. Allocco and
- Keith D. Dawkins
In the PLATINUM randomized controlled trial, the PROMUS Element Everolimus Eluting Stent (PtCr–EES) was non–inferior to the cobalt chromium PROMUS/XIENCE V EES (CoCr–EES) for the primary endpoint of 12–month target lesion failure (TLF), with comparable cumulative 2–year outcomes. However, significantly lower TLF and target lesion revascularization (TLR) rates were observed for the PtCr–EES between 1 and 2 years in a landmark analysis. Three–year outcomes have not yet been reported.
Patients (N=1530) with 1 or 2 de novo native coronary artery lesions (baseline vessel diameter ≥2.50 mm to ≤4.25 mm and length ≤24 mm) were randomized 1:1 to PtCr–EES versus CoCr–EES. Exclusion criteria included acute or recent myocardial infarction (MI), left ventricular ejection fraction <30%, left main or ostial location, bifurcation disease, chronic total occlusion, and target vessel thrombus. Routine angiographic follow–up was not performed.
Baseline demographics and patient medical history were well–matched between the randomized study groups. Unplanned (bailout) stenting was more frequent in the CoCr–EES group (9.8%) compared to the PtCr–EES group (5.9%; P=0.004), due primarily to an increased incidence of inadequate lesion coverage (3.4% versus 1.4%, P=0.01). Previously reported 2–year results demonstrated no significant differences between CoCr–EES and PtCr–EES in death (2.8% vs. 2.4% respectively; P=0.71), myocardial infarction (2.2% vs. 1.6%; P=0.54), TLR (4.0% vs. 2.4%; P=0.12), or definite/probable stent thrombosis (0.7% CoCr–EES, 0.5% PtCr–EES; P=0.99). TLR between 1 and 2 years was significantly lower in the PtCr–EES group (2.2% vs. 0.7%, hazard ratio 0.33 [0.12–0.90], P=0.02), as was TLF (3.0% vs. 1.2%, hazard ratio 0.44 [0.20–0.97], P=0.04). Three–year clinical follow–up is underway.
Overall 2–year outcomes were not significantly different between PtCr–EES and CoCr–EES, although beyond 1 year a divergence in revascularization rates was noted favoring PtCr–EES. Three–year results will be presented for the first time at the ACC in March 2013 and will determine whether or not late events continue to favor PtCr–EES.
West, Room 2001
Sunday, March 10, 2013, 8:15 a.m.–8:25 a.m.
Session Title: Drug–Eluting Stents
Abstract Category: 47. TCT@ACC–i2: Coronary Intervention, Devices
Presentation Number: 2903–3
- 2013 American College of Cardiology Foundation