Immunosuppressive Therapy with Oral Prednisone to Prevent Restenosis after PCI. A Multicenter Randomized Trial

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• 作者：Flavio Ribichini MD^a ; ^{flavio.ribichini@univr.it"" rel=""nofollow} ; Fabrizio Tomai MD^b ; Giuseppe De Luca MD^c ; Giacomo Boccuzzi MD^d ; Patrizia Presbitero MD^e ; Gabriele Pesarini MD^a ; Valeria Ferrero MD^a ; Anna S. Ghini MD^b ; Ramadan Abukaresh MD^a ; Cristina Aurigemma MD^b ; Leonardo De Luca MD ; PhD^b ; Dennis Zavalloni MD^e ; Daniela Soregaroli PhD^e ; Paolo Marino MD^c ; Roberto Garbo MD^d ; Luisa Zanolla MD^a ; Corrado Vassanelli MD^a ; CEREA-DES investigators
• 关键词：Coronary artery disease ; Prednisone ; Randomized clinical trial ; Stent
• 刊名：The American Journal of Medicine
• 出版年：2011
• 出版时间：May 2011
• 年：2011
• 卷：124
• 期：5
• 页码：434-443
• 全文大小：647 K

文摘

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.