Author + information
- David E. Kandzari,
- Jeffrey Chambers,
- Stilianos Efstratiadis,
- Matthew Wolff,
- Steve Lin,
- Anthony White,
- Stephen McIntyre,
- Michael Kelberman,
- William Berg,
- Alan Moak,
- Sandeep Dube,
- Thomas Christen and
- Keith Dawkins
Background: The PE Plus Post-Approval Study (PE Plus PAS) collects long-term outcomes in unselected patients treated with PROMUS Element Plus everolimus-eluting, platinum chromium stents. This is the first report of 3-year results in the largest group of unselected patients treated with PE Plus.
Methods: PE Plus PAS is a 5-year ‘all-comers’ registry enrolling 2684 patients at 52 US sites. The primary endpoint, 12-month cardiac death/myocardial infarction (CD/MI), was tested in ‘PLATINUM-like’ patients from the PE Plus PAS, PE PROVE, and PLATINUM Workhorse/Small Vessel trials who met the enrollment criteria for the PLATINUM trial. The secondary endpoint was annualized ARC definite/probable stent thrombosis (ST) after 1 year. An independent Clinical Events Committee adjudicated major adverse cardiac events.
Results: In PE Plus PAS, 30% of patients were female, mean age was 64 years, 37% had medically-treated diabetes, and >75% were treated for hyperlipidemia and hypertension. Lesion length was 17±10 mm and reference vessel diameter was 2.9±0.5 mm (N=3595 lesions). The primary endpoint, 12-month CD/MI, occurred in 1.8% of PLATINUM-like patients (upper 1-sided 95% confidence bound [UCB]=2.3%), significantly less than the prespecifed performance goal (3.2%; p<0.001). The annualized ARC definite/probable ST was 0.23% [1-sided UCB=0.42] between 1 and 2 years and was 0.18% [1-sided UCB=0.37%] between 2 and 3 years; both rates were significantly below the prespecified annual 1% performance goal. In PE Plus PAS patients overall, cardiac events at 12-months were low: CD/MI 2.3%, 5.9% target vessel revascularization (TVR), and 0.7% ARC definite/probable ST. Clinical follow-up at 3 years was available in 89.6% of patients. Low event rates were sustained : CD/MI 7.0% (4.3% cardiac death, 1.9% MI), 12.7% TVR, and 1.7% ST. The full 3-year results from PE Plus PAS including results in patients with diabetes, small vessels and long lesions will be available for the first time at ACC 2017.
Conclusions: In this large ‘all-comers’ study of patients in routine clinical practice, the PE Plus everolimus-eluting stent provided favorable results at 3 years in the largest group of unselected patients treated with PE Plus.
Poster Hall, Hall C
Friday, March 17, 2017, 3:45 p.m.-4:30 p.m.
Session Title: Coronary Intervention in Interventional Cardiology: Advanced Device Use
Abstract Category: 21. Interventional Cardiology: Coronary Intervention: Devices
Presentation Number: 1155-161
- 2017 American College of Cardiology Foundation