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Start Over Author "Miquel, Karine" Topic coronary vessels
2 results on '"Miquel, Karine"'

1. Actinomycin-eluting stent for coronary revascularization: a randomized feasibility and safety study: the ACTION trial.

Author

Serruys PW, Ormiston JA, Sianos G, Sousa JE, Grube E, den Heijer P, de Feyter P, Buszman P, Schömig A, Marco J, Polonski L, Thuesen L, Zeiher AM, Bett JH, Suttorp MJ, Glogar HD, Pitney M, Wilkins GT, Whitbourn R, Veldhof S, Miquel K, Johnson R, Coleman L, and Virmani R

Subjects
Aged, Coronary Angiography, Coronary Artery Disease drug therapy, Coronary Restenosis complications, Coronary Restenosis diagnostic imaging, Coronary Restenosis pathology, Dactinomycin administration & dosage, Dactinomycin pharmacology, Death, Sudden, Cardiac prevention & control, Drug Administration Schedule, Feasibility Studies, Female, Humans, Male, Middle Aged, Myocardial Infarction prevention & control, Prospective Studies, Selection Bias, Single-Blind Method, Time Factors, Treatment Outcome, Tunica Intima drug effects, Ultrasonography, Interventional, Coronary Artery Disease therapy, Coronary Restenosis prevention & control, Coronary Vessels drug effects, Dactinomycin therapeutic use, Myocardial Revascularization methods, Stents adverse effects
Abstract

Objectives: We sought to demonstrate the safety and performance of the actinomycin D-coated Multilink-Tetra stent(Guidant Corp., Santa Clara, California) in the treatment of patients with single de novo native coronary lesions., Background: Drug-eluting stents (DES) releasing sirolimus or paclitaxel dramatically reduce restenosis. The anti-proliferative drug, actinomycin D, which is highly effective in reducing neointimal proliferation in preclinical studies, was selected for clinical evaluation., Methods: The multi-center, single-blind, three-arm ACTinomycin-eluting stent Improves Outcomes by reducing Neointimal hyperplasia (ACTION) trial randomized 360 patients to receive a DES (2.5 or 10 microg/cm(2) of actinomycin D) or metallic stent (MS). The primary end points were major adverse cardiac events (MACE) at 30 days, diameter stenosis by angiography, tissue effects, and neointimal volume by intravascular ultrasound (IVUS) at six months. When early monitoring revealed an increased rate of repeat revascularization, the protocol was amended to allow for additional follow-up for DES patients. Angiographic control of MS patients was no longer mandatory., Results: The biased selection of DES patients undergoing IVUS follow-up invalidated the interpretation of the IVUS findings. The in-stent late lumen loss and that at the proximal and distal edges were higher in both DES groups than in the MS group and resulted in higher six-month and one-year MACE (34.8% and 43.1% vs. 13.5%), driven exclusively by target vessel revascularization without excess death or myocardial infarction., Conclusions: The results of the ACTION trial indicate that all anti-proliferative drugs will not uniformly show a drug class effect in the prevention of restenosis.

Published
2004
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2. Actinomycin-eluting stent for coronary revascularization: a randomized feasibility and safety study: the ACTION trial

Author

Serruys, Patrick W., Ormiston, John A., Sianos, Georgios, Sousa, J. Eduardo, Grube, Eberhard, den Heijer, Peter, de Feyter, Pim, Buszman, Pawel, Schömig, Albert, Marco, Jean, Polonski, Lech, Thuesen, Leif, Zeiher, Andreas M., Bett, J.H. Nicholas, Suttorp, Maarten J., Glogar, Helmut D., Pitney, Mark, Wilkins, Gerard T., Whitbourn, Robert, Veldhof, Susan, Miquel, Karine, Johnson, Rachel, Coleman, Leslie, Virmani, Renu, and Cardiology

Subjects
Male, Time Factors, Myocardial Infarction, Coronary Artery Disease, Middle Aged, Coronary Angiography, Coronary Vessels, Drug Administration Schedule, Coronary Restenosis, Death, Sudden, Cardiac, Treatment Outcome, Dactinomycin, Myocardial Revascularization, Feasibility Studies, Humans, Female, Single-Blind Method, Stents, cardiovascular diseases, Prospective Studies, Tunica Intima, Selection Bias, Ultrasonography, Interventional, Aged
Abstract

ObjectivesWe sought to demonstrate the safety and performance of the actinomycin D-coated Multilink-Tetra stent(Guidant Corp., Santa Clara, California) in the treatment of patients with single de novonative coronary esions.BackgroundDrug-eluting stents (DES) releasing sirolimus or paclitaxel dramatically reduce restenosis. The anti-proliferative drug, actinomycin D, which is highly effective in reducing neointimal proliferation in preclinical studies, was selected for clinical evaluation.MethodsThe multi-center, single-blind, three-arm ACTinomycin-eluting stent Improves Outcomes by reducing Neointimal hyperplasia (ACTION) trial randomized 360 patients to receive a DES (2.5 or 10 μg/cm2of actinomycin D) or metallic stent (MS). The primary end points were major adverse cardiac events (MACE) at 30 days, diameter stenosis by angiography, tissue effects, and neointimal volume by intravascular ultrasound (IVUS) at six months. When early monitoring revealed an increased rate of repeat revascularization, the protocol was amended to allow for additional follow-up for DES patients. Angiographic control of MS patients was no longer mandatory.ResultsThe biased selection of DES patients undergoing IVUS follow-up invalidated the interpretation of the IVUS findings. The in-stent late lumen loss and that at the proximal and distal edges were higher in both DES groups than in the MS group and resulted in higher six-month and one-year MACE (34.8% and 43.1% vs. 13.5%), driven exclusively by target vessel revascularization without excess death or myocardial infarction.ConclusionsThe results of the ACTION trial indicate that all anti-proliferative drugs will not uniformly show a drug class effect in the prevention of restenosis.

Published
2003

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