PMID- 30926144
OWN - NLM
STAT- MEDLINE
DCOM- 20200129
LR  - 20200129
IS  - 1879-1913 (Electronic)
IS  - 0002-9149 (Linking)
VI  - 123
IP  - 11
DP  - 2019 Jun 1
TI  - Final 5-Year Results in Unselected Patients Implanted With a Thin-Strut, 
      Platinum-Chromium, Everolimus-Eluting Stent (from the PROMUS Element Plus US 
      Post-Approval Study).
PG  - 1765-1771
LID - S0002-9149(19)30286-3 [pii]
LID - 10.1016/j.amjcard.2019.02.041 [doi]
AB  - PROMUS Element (PE) Plus post-approval study was a large prospective, 
      observational, all-comers study designed to evaluate the safety and performance 
      of a thin-strut platinum chromium everolimus-eluting PE Plus stent in everyday 
      clinical practice. A total of 2,683 "real-world" patients with limited clinical 
      or anatomic exclusion criteria were enrolled at 52 clinical sites in the United 
      States. The study met its primary end point of 12-month cardiac death or 
      myocardial infarction (CD/MI) compared with a prespecified performance goal (p 
      <0.0001). Five-year clinical outcomes were evaluated in overall PE Plus 
      post-approval study patients and high-risk subgroups. During the 5-year follow-up 
      period, CD/MI and stent thrombosis related to the PE Plus stent occurred in 9% 
      and 2.2% overall patients, respectively. The reported all-cause mortality rate 
      was 15%, with 7% classified as cardiac-related. A total of 18% patients underwent 
      target vessel revascularization, and 11% were reported as target lesion 
      revascularization. The rates of PE Plus stent-related CD/MI remained low in 
      patients with medically treated diabetes (13%), small vessels (9%), and long 
      stents (10%). PE Plus stent-related thrombosis through 5 years in patients with 
      diabetes, small vessels and long stents was 4.2%, 2.2%, and 2.6%, respectively. 
      The occurrence of target lesion revascularization was numerically higher in 
      patients with diabetes (16%) and long lesions (18%) than the small vessels 
      subgroup (11%). In conclusion, the final 5-year results establish the long-term 
      safety and efficacy of the PE Plus stent in a broad, unselected patient 
      population representative of "real-world" clinical practice.
CI  - Copyright (c) 2019 Elsevier Inc. All rights reserved.
FAU - Kandzari, David E
AU  - Kandzari DE
AD  - Piedmont Hospital, Atlanta, Georgia. Electronic address: 
      david.kandzari@piedmont.org.
FAU - Amjadi, Nima
AU  - Amjadi N
AD  - Texas Heart and Vascular, South Austin Hospital, Austin, Texas.
FAU - Caputo, Christopher
AU  - Caputo C
AD  - North Florida Regional Medical Center, Gainesville, Florida.
FAU - Rowe, Steven K
AU  - Rowe SK
AD  - Cox Medical Center, Springfield, Missouri.
FAU - Chen, Henry
AU  - Chen H
AD  - Huntsville Hospital Heart Center, Huntsville, Alabama.
FAU - Williams, Jerome
AU  - Williams J
AD  - Novant Health Heart and Vascular Institute Presbyterian Medical Center, 
      Charlotte, North Carolina.
FAU - Tamboli, Hoshedar P
AU  - Tamboli HP
AD  - Bay Area Cardiology and Vascular, Brandon, Florida.
FAU - Underwood, Paul L
AU  - Underwood PL
AD  - Boston Scientific Corporation, Marlborough, Massachusetts.
FAU - Allocco, Dominic J
AU  - Allocco DJ
AD  - Boston Scientific Corporation, Marlborough, Massachusetts.
FAU - Meredith, Ian T
AU  - Meredith IT
AD  - Boston Scientific Corporation, Marlborough, Massachusetts.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190311
PL  - United States
TA  - Am J Cardiol
JT  - The American journal of cardiology
JID - 0207277
RN  - 0R0008Q3JB (Chromium)
RN  - 49DFR088MY (Platinum)
RN  - 9HW64Q8G6G (Everolimus)
SB  - IM
MH  - Chromium
MH  - Combined Modality Therapy
MH  - Coronary Artery Disease/*therapy
MH  - *Drug-Eluting Stents
MH  - Everolimus/*administration & dosage
MH  - Female
MH  - Humans
MH  - Male
MH  - Platinum
MH  - Prospective Studies
MH  - Prosthesis Design
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
EDAT- 2019/03/31 06:00
MHDA- 2020/01/30 06:00
CRDT- 2019/03/31 06:00
PHST- 2018/12/11 00:00 [received]
PHST- 2019/02/21 00:00 [revised]
PHST- 2019/02/26 00:00 [accepted]
PHST- 2019/03/31 06:00 [pubmed]
PHST- 2020/01/30 06:00 [medline]
PHST- 2019/03/31 06:00 [entrez]
AID - S0002-9149(19)30286-3 [pii]
AID - 10.1016/j.amjcard.2019.02.041 [doi]
PST - ppublish
SO  - Am J Cardiol. 2019 Jun 1;123(11):1765-1771. doi: 10.1016/j.amjcard.2019.02.041. 
      Epub 2019 Mar 11.