1. Immunosuppressive Therapy with Oral Prednisone to Prevent Restenosis after PCI. A Multicenter Randomized Trial
- Author
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Ribichini, Flavio, Tomai, Fabrizio, De Luca, Giuseppe, Boccuzzi, Giacomo, Presbitero, Patrizia, Pesarini, Gabriele, Ferrero, Valeria, Ghini, Anna S., Abukaresh, Ramadan, Aurigemma, Cristina, De Luca, Leonardo, Zavalloni, Dennis, Soregaroli, Daniela, Marino, Paolo, Garbo, Roberto, Zanolla, Luisa, and Vassanelli, Corrado
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IMMUNOSUPPRESSIVE agents , *CORONARY restenosis prevention , *CORONARY artery bypass , *SURGICAL stents , *CORONARY disease , *C-reactive protein , *PREDNISONE , *CLINICAL trials - Abstract
Abstract: Background: Prednisone 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. Methods: Five 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. Results: One-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). Conclusion: Compared 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 &y& Elsevier]
- Published
- 2011
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