Feasibility, safety, and efficacy of a novel polymeric pimecrolimus-eluting stent traditional pre-clinical safety end points failed to predict 6-month clinical angiographic results. JACC. Cardiovascular interventions [JACC Cardiovasc Interv] Journal article | | Title | Feasibility, safety, and efficacy of a novel polymeric pimecrolimus-eluting stent traditional pre-clinical safety end points failed to predict 6-month clinical angiographic results. | | Author(s) | Ormiston JA, Webster MW, Schwartz RS, Gladding P, Stewart JT, Kay IP, Ruygrok PN, Hatrick R | | Institution | Mercy Angiography, Auckland, New Zealand; Auckland Heart Group, Auckland, New Zealand; Auckland City Hospital, Auckland, New Zealand. | | Source | JACC Cardiovasc Interv 2009 Oct; 2(10):1017-24. | | Abstract | OBJECTIVES: The aim of this study was to determine the safety and efficacy of a novel pimecrolimus-eluting stent in a porcine coronary model and in a phase I clinical trial.
BACKGROUND: Rapamycin- and paclitaxel-eluting stents reduce the need for repeat intervention by limiting neointimal hyperplasia but might cause delayed healing, pre-disposing patients to late stent thrombosis. Because inflammation plays a key role in restenosis, pimecrolimus, an anti-inflammatory drug, might reduce restenosis without adversely affecting re-endothelialization.
METHODS: We evaluated a novel polymeric pimecrolimus-eluting stent covered with a thin parylene C diffusion barrier in a porcine coronary model and in a phase I human clinical trial. The clinical study was a prospective, nonrandomized, first-in-human hypothesis-generating study that enrolled 15 patients who had a single de novo native coronary stenosis.
RESULTS: At 28 days and 3 months in the porcine model, histopathologic indicators predicted safety and biocompatibility when stents coated with polymer only, drug only, and 2 drug-polymer formulations were compared with bare-metal stents (BMS). In the phase I clinical trial, 15 patients had successful implantation of pimecrolimus-eluting stents. By 6 months, no patient suffered death, myocardial infarction, or stent thrombosis. However, the angiographic restenosis (61%), mean late loss (1.44 mm), and repeat target lesion revascularization (53%) were significantly higher than historical BMS controls. Whereas the primary end point was percent volume obstruction, restenosis was so severe that operators performed intravascular ultrasound examination in only 6 patients.
CONCLUSIONS: Pimecrolimus-eluting stents induced an exaggerated neointimal hyperplasia at 6 months in comparison with historical controls. | | Language | eng | | Pub Type(s) | Journal Article
| | PubMed ID | 19850264 |
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