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Randomized Controlled Trial Multicenter Study Comparative Study
Immunosuppressive therapy with oral prednisone to prevent restenosis after PCI. A multicenter randomized trial.
- Flavio Ribichini, Fabrizio Tomai, Giuseppe De Luca, Giacomo Boccuzzi, Patrizia Presbitero, Gabriele Pesarini, Valeria Ferrero, Anna S Ghini, Ramadan Abukaresh, Cristina Aurigemma, Leonardo De Luca, Dennis Zavalloni, Daniela Soregaroli, Paolo Marino, Roberto Garbo, Luisa Zanolla, Corrado Vassanelli, and CEREA-DES investigators.
- Department of Medicine, University of Verona, Verona, Italy. flavio.ribichini@univr.it
- Am. J. Med. 2011 May 1; 124 (5): 434-43.
BackgroundPrednisone at immunosuppressive doses after stenting has shown remarkable efficacy in reducing ischemic recurrences in nondiabetic patients with high post-procedural levels of C-reactive protein; the study aim was to compare the clinical outcome obtained in a control group of patients treated with bare metal stents versus 2 other study groups--bare metal stent plus oral prednisone or drug eluting stents--assuming similar optimal adjunctive medical treatment.MethodsFive tertiary Italian hospitals enrolled 375 nondiabetic patients with coronary artery disease and no contraindications to dual antiplatelet treatment or corticosteroid therapy in a randomized, controlled study performed between 2007 and 2009. Patients were allocated into 3 study groups: bare metal stents (controls), bare metal stents followed by a 40-day prednisone treatment, or drug-eluting stents. The primary endpoint was the event-free survival of cardiovascular death, myocardial infarction, and recurrence of ischemia needing repeated target vessel revascularization at 1 year as adjudicated by an independent clinical events committee.ResultsOne-year follow-up was obtained in all patients. Patients receiving bare metal stents alone as compared to those treated with prednisone or drug-eluting stents had lower event-free survival; the primary endpoint was 80.8% in controls compared to 88.0% in the prednisone and 88.8% in the drug-eluting stent groups, respectively (P=.04 and .006).ConclusionCompared with bare metal stents alone, prednisone treatment after bare metal stents or drug-eluting stent implantation result in a better event-free survival at 1 year.Copyright © 2011 Elsevier Inc. All rights reserved.
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