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Randomized comparison of 6- versus 24-month clopidogrel therapy after balancing anti-intimal hyperplasia stent potency in all-comer patients undergoing percutaneous coronary intervention: Design and rationale for the PROlonging Dual-antiplatelet treatment after Grading stent-induced Intimal hyperplasia study (PRODIGY)

VALGIMIGLI, Marco ; CAMPO, Gianluca ; CANGIANO, Elisa ; TEBALDI, Matteo ; MINARELLI, Monica ; ARCOZZI, Chiara ; SCALONE, Antonella ; FRANGIONE, Alice ; BORGHESI, Marco ; MARCHESINI, Jlenia ; PARRINELLO, Giovanni ; FERRARI, Roberto ; PERCOCO, Gianfranco ; MONTI, Monia ; FERRARI, Fabrizio ; TUMSCITZ, Carlo ; ZUFFI, Andrea ; COLOMBO, Federico ; KUBBAJEH, Moh'd ; CAVAZZA, Caterina

The American heart journal, 2010-11, Vol.160 (5), p.804-811 [Periódico revisado por pares]

New York, NY: Mosby

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Título:
Randomized comparison of 6- versus 24-month clopidogrel therapy after balancing anti-intimal hyperplasia stent potency in all-comer patients undergoing percutaneous coronary intervention: Design and rationale for the PROlonging Dual-antiplatelet treatment after Grading stent-induced Intimal hyperplasia study (PRODIGY)
Autor: VALGIMIGLI, Marco ; CAMPO, Gianluca ; CANGIANO, Elisa ; TEBALDI, Matteo ; MINARELLI, Monica ; ARCOZZI, Chiara ; SCALONE, Antonella ; FRANGIONE, Alice ; BORGHESI, Marco ; MARCHESINI, Jlenia ; PARRINELLO, Giovanni ; FERRARI, Roberto ; PERCOCO, Gianfranco ; MONTI, Monia ; FERRARI, Fabrizio ; TUMSCITZ, Carlo ; ZUFFI, Andrea ; COLOMBO, Federico ; KUBBAJEH, Moh'd ; CAVAZZA, Caterina
Assuntos: Acute coronary syndromes ; Angioplasty, Balloon, Coronary - methods ; Aspirin ; Biological and medical sciences ; Cardiology. Vascular system ; Cardiovascular disease ; Coronary Disease - drug therapy ; Coronary Disease - pathology ; Coronary Disease - surgery ; Coronary Restenosis - etiology ; Coronary Restenosis - pathology ; Coronary Restenosis - prevention & control ; Coronary Vessels - drug effects ; Coronary Vessels - pathology ; Diseases of the cardiovascular system ; Dose-Response Relationship, Drug ; Drug therapy ; Drug-Eluting Stents - adverse effects ; Follow-Up Studies ; Heart attacks ; Humans ; Hyperplasia - etiology ; Hyperplasia - pathology ; Hyperplasia - prevention & control ; Medical sciences ; Mortality ; Patients ; Platelet Aggregation Inhibitors - administration & dosage ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) ; Stents ; Stroke ; Studies ; Thrombosis ; Ticlopidine - administration & dosage ; Ticlopidine - analogs & derivatives ; Time Factors ; Treatment Outcome ; Tunica Intima - drug effects ; Tunica Intima - pathology
É parte de: The American heart journal, 2010-11, Vol.160 (5), p.804-811
Notas: ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-News-2
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Descrição: The optimal duration of clopidogrel therapy after coronary stenting is debated because of the scarcity of randomized controlled trials and inconsistencies arising from registry data. Although prolonged clopidogrel therapy after bare metal stenting is regarded as an effective secondary prevention measure, the safety profile of drug-eluting stents itself has been questioned in patients not receiving ≥ 12 months of dual-antiplatelet therapy. Twenty-four months of clopidogrel therapy after coronary stenting reduces the composite of death, myocardial infarction, or stroke compared with 6 months of treatment. PRODIGY is an unblinded, multicenter, 4-by-2 randomized trial. All-comer patients with indication to coronary stenting are randomly treated-balancing randomization-with bare metal stent (no active late loss inhibition), Endeavor Sprint zotarolimus-eluting stent (Medtronic, Santa Rosa, CA) (mild late loss inhibition), Taxus paclitaxel-eluting stent (Boston Scientific, Natick, MA) (moderate late loss inhibition), or Xience V everolimus-eluting stent (Abbott Vascular, Santa Clara, CA) (high late loss inhibition). At 30 days, patients in each stent group are randomly allocated to receive 24 or up to 6 months of clopidogrel therapy-primary end point randomization. With 1,700 individuals, this study will have >80% power to detect a 40% difference in the primary end point after sample size augmentation of 5% and a background event rate of 8%. The PRODIGY trial aims to assess whether 24 months of clopidogrel therapy improves cardiovascular outcomes after coronary intervention in a broad all-comer patient population receiving a balanced mixture of stents with various anti-intimal hyperplasia potency.
Editor: New York, NY: Mosby
Idioma: Inglês

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