Lack of Neointimal Proliferation After Implantation of Sirolimus-Coated Stents in Human Coronary Arteries: A Quantitative Coronary Angiography and Three-Dimensional Intravascular Ultrasound Study
J. Eduardo Sousa,Marco A. Costa,Alexandre Abizaid,Andrea Abizaid,Fausto Feres,Ibraim Francisco Pinto,Ana C. Seixas,Rodolfo Staico,Luiz Alberto Mattos,Amanda G. M. R. Sousa,Robert Falotico,Judith Jaeger,Jeffrey J. Popma,Patrick W. Serruys +13 more
TLDR
In this article, the safety and efficacy of sirolimus-coated BX Velocity stents were evaluated in 30 patients with angina pectoris electively treated with two different formulations of SIROlimuscoated stents (slow release and fast release).Abstract:
BACKGROUND: Restenosis remains an important limitation of interventional cardiology. Therefore, we aimed to determine the safety and efficacy of sirolimus (a cell-cycle inhibitor)-coated BX Velocity stents. METHODS AND RESULTS: Thirty patients with angina pectoris were electively treated with 2 different formulations of sirolimus-coated stents (slow release [SR], n=15, and fast release [FR], n=15). All stents were successfully delivered, and patients were discharged without clinical complications. Independent core laboratories analyzed angiographic and 3D volumetric intravascular ultrasound data (immediately after procedure and at 4-month follow-up). Eight-month clinical follow-up was obtained for all patients. There was minimal neointimal hyperplasia in both groups (11.0+/-3.0% in the SR group and 10.4+/-3.0% in the FR group, P:=NS) by ultrasound and quantitative coronary angiography (in-stent late loss, 0.09+/-0.3 mm [SR] and -0.02+/-0.3 mm [FR]; in-lesion late loss, 0.16+/-0.3 mm [SR] and -0.1+/-0.3 mm [FR]). No in-stent or edge restenosis (diameter stenosis >or=50%) was observed. No major clinical events (stent thrombosis, repeat revascularization, myocardial infarction, or death) had occurred by 8 months. CONCLUSIONS: The implantation of sirolimus-coated BX Velocity stents is feasible and safe and elicits minimal neointimal proliferation. Additional placebo-controlled trials are required to confirm these promising results.read more
Citations
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Journal ArticleDOI
Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery.
Jeffrey W. Moses,Martin B. Leon,Jeffrey J. Popma,Peter J. Fitzgerald,David R. Holmes,Charles O'Shaughnessy,Ronald P. Caputo,Dean J. Kereiakes,David O. Williams,Paul S. Teirstein,Judith Jaeger,Richard E. Kuntz +11 more
TL;DR: In this randomized clinical trial involving patients with complex coronary lesions, the use of a sirolimus-eluting stent had a consistent treatment effect, reducing the rates of restenosis and associated clinical events in all subgroups analyzed.
Journal ArticleDOI
A Randomized Comparison of a Sirolimus-Eluting Stent with a Standard Stent for Coronary Revascularization
Marie-Claude Morice,Patrick W. Serruys,J. Eduardo Sousa,Jean Fajadet,Ernesto Ban Hayashi,Marco Antonio Perin,Antonio Colombo,Gerhard Schuler,Paul Barragan,Giulio Guagliumi,Ferenc Molnar,Robert Falotico +11 more
TL;DR: As compared with a standard coronary stent, a sirolimus-eluting stent shows considerable promise for the prevention of neointimal proliferation, restenosis, and associated clinical events.
Journal ArticleDOI
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention-summary article : A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention)
Sidney C. Smith,Ted Feldman,John W. Hirshfeld,Alice K. Jacobs,Morton J. Kern,Spencer B. King,Douglass A. Morrison,William W. O'Neill,Hartzell V. Schaff,Patrick L. Whitlow,David O. Williams,Elliott M. Antman,Cynthia D. Adams,Jeffrey L. Anderson,David P. Faxon,Valentin Fuster,Jonathan L. Halperin,Loren F. Hiratzka,Sharon A. Hunt,Rick A. Nishimura,Joseph P. Ornato,Richard L. Page,Barbara Riegel +22 more
TL;DR: The American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions (ACC/AHA/SCAI) 2005 Guideline Update for Percutaneous Coronary Intervention (PCI) contains changes in the recommendations, along with supporting text.
Journal ArticleDOI
Localized Hypersensitivity and Late Coronary Thrombosis Secondary to a Sirolimus-Eluting Stent: Should We Be Cautious?
Renu Virmani,Giulio Guagliumi,Andrew Farb,Giuseppe Musumeci,Niccolò Grieco,Teresio Motta,Laurian Mihalcsik,Maurizio Tespili,Orazio Valsecchi,Frank D. Kolodgie +9 more
TL;DR: The known pharmacokinetic elution profile of Cypher stents and the presence of polymer fragments surrounded by giant cells and eosinophils suggest that a reaction to the polymer may have caused late stent thrombosis.
Journal ArticleDOI
Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents.
Matthias Pfisterer,Hans-Peter Brunner-La Rocca,Peter Buser,Peter Rickenbacher,Patrick Hunziker,Christian Mueller,Raban Jeger,Franziska Bader,Stefan Osswald,Christoph Kaiser,Basket-Late Investigators +10 more
TL;DR: After the discontinuation of clopidogrel, the benefit of DES in reducing target vessel revascularization is maintained but has to be balanced against an increase in late cardiac death or nonfatal MI, possibly related to late stent thrombosis.
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