PMID- 19393150
OWN - NLM
STAT- MEDLINE
DCOM- 20090514
LR  - 20191210
IS  - 1876-7605 (Electronic)
IS  - 1936-8798 (Linking)
VI  - 1
IP  - 1
DP  - 2008 Feb
TI  - Evaluation of a novel slow-release paclitaxel-eluting stent with a bioabsorbable 
      polymeric surface coating.
PG  - 81-7
LID - 10.1016/j.jcin.2007.11.009 [doi]
AB  - OBJECTIVES: We sought to evaluate a new second-generation drug-eluting stent 
      (DES), comprising a slow-release biodegradable polylactide coglycolide (PLGA) 
      polymer and low-dose paclitaxel on a thin-strut cobalt chromium stent platform, 
      in a clinically relevant animal model. BACKGROUND: Our previous work demonstrated 
      subacute vascular toxicity and necrosis triggering late excess neointima in pig 
      coronaries, with a moderate paclitaxel dose eluted from an erodible polymer. The 
      use of slower-releasing absorbable polymers with lower doses of paclitaxel is 
      expected to minimize such adverse outcomes. METHODS: Three types of stents were 
      implanted in pig coronary arteries using quantitative coronary angiography to 
      optimize stent apposition: bare-metal stents (BMS); absorbable, slow-release 
      polymer-coated-only stents (POLY); and absorbable polymer-based 
      paclitaxel-eluting stents (PACL). The dose density of paclitaxel was 0.15 
      microg/mm(2) with in vitro studies demonstrating a gradual elution over the 
      course of 12 to 16 weeks. Animals underwent angiographic restudy and were 
      terminated at 1 and 3 months for complete histopathologic and histomorphometric 
      analyses. RESULTS: At 1 month, intimal thickness varied significantly according 
      to stent type, with the lowest level for the PACL group compared with the BMS and 
      POLY groups (0.06 +/- 0.02 mm vs. 0.17 +/- 0.07 mm, 0.17 +/- 0.08 mm, 
      respectively, p < 0.001); histological percent area stenosis was 18 +/- 4% for 
      PACL compared with 27 +/- 7% for BMS and 30 +/- 12% for POLY, respectively (p = 
      0.001). At 3 months, PACL showed similar neointimal thickness as BMS and POLY 
      (0.09 +/- 0.05 mm vs. 0.13 +/- 0.10 mm and 0.11 +/- 0.03 mm respectively, p = 
      0.582). Histological percent area stenosis was 23 +/- 8% for PACL versus 23 +/- 
      11% for BMS and 23 +/- 2% for POLY, respectively (p = 1.000). CONCLUSIONS: This 
      study shows favorable vascular compatibility and efficacy for a novel DES that 
      elutes paclitaxel in porcine coronary arteries. These results support the notion 
      that slowing the release rate and lowering the dose of paclitaxel favorably 
      influences the vascular biological response to DES implant, decreasing early 
      toxicity and promoting stable healing while still suppressing neointima 
      formation.
FAU - Jabara, Refat
AU  - Jabara R
AD  - Saint Joseph's Cardiovascular Research Institute, Saint Joseph's Hospital of 
      Atlanta, 5673 Peachtree Dunwoody Road, Atlanta, GA 30342, USA. rjabara@sjha.org
FAU - Chronos, Nicolas
AU  - Chronos N
FAU - Conway, Damian
AU  - Conway D
FAU - Molema, Warner
AU  - Molema W
FAU - Robinson, Keith
AU  - Robinson K
LA  - eng
PT  - Comparative Study
PT  - Evaluation Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - JACC Cardiovasc Interv
JT  - JACC. Cardiovascular interventions
JID - 101467004
RN  - 0 (Antineoplastic Agents, Phytogenic)
RN  - 0 (Coated Materials, Biocompatible)
RN  - 0 (Drug Carriers)
RN  - 1SIA8062RS (Polylactic Acid-Polyglycolic Acid Copolymer)
RN  - 26009-03-0 (Polyglycolic Acid)
RN  - 33X04XA5AT (Lactic Acid)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
MH  - Animals
MH  - Antineoplastic Agents, Phytogenic/pharmacology
MH  - Coated Materials, Biocompatible/*chemistry
MH  - Coronary Disease/pathology/*surgery
MH  - Coronary Vessels/drug effects/*pathology/surgery
MH  - Disease Models, Animal
MH  - Dose-Response Relationship, Drug
MH  - Drug Carriers
MH  - *Drug-Eluting Stents
MH  - *Lactic Acid
MH  - Paclitaxel/*pharmacology
MH  - *Polyglycolic Acid
MH  - Polylactic Acid-Polyglycolic Acid Copolymer
MH  - Prosthesis Design
MH  - Swine
EDAT- 2008/02/01 00:00
MHDA- 2009/05/15 09:00
CRDT- 2009/04/28 09:00
PHST- 2007/08/22 00:00 [received]
PHST- 2007/11/26 00:00 [revised]
PHST- 2007/11/29 00:00 [accepted]
PHST- 2009/04/28 09:00 [entrez]
PHST- 2008/02/01 00:00 [pubmed]
PHST- 2009/05/15 09:00 [medline]
AID - S1936-8798(07)00017-9 [pii]
AID - 10.1016/j.jcin.2007.11.009 [doi]
PST - ppublish
SO  - JACC Cardiovasc Interv. 2008 Feb;1(1):81-7. doi: 10.1016/j.jcin.2007.11.009.