Author + information
- David Kandzari1,
- Peter Ver Lee2,
- Anil Chhabra3,
- Jerrold Grodin4,
- Maria Bartlett5,
- Richard Zelman6,
- Walt Marquardt7,
- Thomas Christen8 and
- Ian Meredith9
- 1Piedmont Heart Institute, Atlanta, Georgia, United States
- 2Eastern Maine Medical Center, Bangor, Maine, United States
- 3Cardiovascular Research, LLC, Shreveport, Louisiana, United States
- 4Dallas VA Hospital, Dallas, Texas, United States
- 5Coliseum Medical Center, Macon, Georgia, United States
- 6Cape Cod Hospital, Hyannis, Massachusetts, United States
- 7Mercy General Hospital, Sacramento, California, United States
- 8Boston Scientific Corporation, Marlborough, Massachusetts, United States
- 9Boston Scientific Corporation, Marlboro, Massachusetts, United States
PROMUS Element (PE) Plus, a thin-strut everolimus-eluting platinum chromium coronary artery stent, has shown favorable outcomes up to 3 years after implantation in a large post-approval study representative of clinical practice. Adverse event rates in diabetic patients, small vessel disease and long stent subgroups remained low at 3 years. Analyses of the 4-year clinical outcomes will provide insight into the long term safety and efficacy of the PE Plus stent in a broad, unselected patient population.
PE Plus PAS is a prospective, observational ‘all-comers’ registry that enrolled 2683 patients at 52 US sites. The primary and secondary endpoints of 12-month cardiac death or myocardial infarction (CD/MI) and annualized ARC definite/probable stent thrombosis (ST), respectively, were assessed in ‘PLATINUM-like’ patients implanted with a PE Plus stent. Patients who met the enrollment criteria for the PLATINUM trial were pooled from PE Plus PAS (N=776), PE PROVE (N=269) and PLATINUM Workhorse/Small Vessel (N=862) studies. Additional clinical end points were tested in overall PE-Plus PAS population.
The mean age of patients in this study was 64 years, 70% were male, 37% had diabetes-mellitus, and >75% were treated for hypertension or hyperlipidemia. The 12-month rate of CD/MI in PLATINUM-like patients (1.8%) was significantly less than the prespecifed performance goal (3.2%; based on PLATINUM and SPIRIT IV trials; p<0.0001). Annualized ST was 0.23% between 1 and 2 years, and 0.18% between 2 and 3 years; both rates were significantly below the prespecified annual 1% performance goal (p<0.0001). As previously reported, 1-year cardiac events in overall PE Plus PAS were low: CD/MI 2.3% (1.5% CD, 1.1% MI), 5.9% TVR, and 0.7% ST. Low event rates were sustained at 3 years: the rate of CD/MI was 7.0% (4.3% CD and 3.3% MI), 12.7% TVR and 1.7% ST. Favorable clinical outcomes were observed at 3 years in patients with long lesions (10.0% CD/MI; ST 2.9%), small vessels (7.8% CD/MI; ST 2.2%) and diabetes (9.5% CD/MI; ST 3.5%).
Over long-term follow-up, PE Plus everolimus-eluting stent demonstrates favorable efficacy in this large ‘real-world’ study of patients in routine clinical practice. The full 4-year results from PE Plus PAS overall population, including different subgroups, will be presented for the first time at TCT 2017.
CORONARY: Stents: Drug-Eluting