ORAl iMmunosuppressive therapy to prevent in-Stent rEstenosiS (RAMSES) cooperation: A patient-level meta-analysis of randomized trials Salvatore Cassese a, *, 1 , Giuseppe De Luca b, 1 , Flavio Ribichini c , Carmelo Cernigliaro d , Mara Sansa e , Francesco Versaci f, g , Igino Proietti h , Goran Stankovic i , Sinisa Stojkovic i , Carlos Fernandez-Pereira j , Fabrizio Tomai k , Corrado Vassanelli c , David Antoniucci l , Patrick W. Serruys m , Adnan Kastrati a , Alfredo E. Rodriguez j a Deutsches Herzzentrum, Technische Universit€ at München, Lazarettstr. 36, 80636 Munich, Germany b Department of Clinical and Experimental Medicine, Eastern Piedmont University, Novara, Italy c Department of Medicine, University of Verona, Verona, Italy d Interventional Cardiology, San Gaudenzio Clinic, Novara, Italy e Catheterization Laboratory, Division of Cardiology, Maggiore Hospital, Novara, Italy f Department of Cardiology, Cardarelli Hospital, Campobasso, Italy g Department of Cardiology, Veneziale Hospital, Isernia, Italy h Department of Cardiology, Vannini Hospital, Rome, Italy i Department of Diagnostics and Catheterization Laboratory, Division of Cardiology, Clinical Center of Serbia, Medical School of Belgrade, Serbia j Cardiovascular Research Center, Sanatorio Otamendi, Buenos Aires, Argentina k Department of Cardiovascular Sciences, European Hospital, Rome, Italy l Division of Cardiology, Careggi Hospital, Florence, Italy m Thorax Center, Erasmus University Medical Center, Rotterdam, The Netherlands article info Article history: Received 6 April 2014 Received in revised form 31 August 2014 Accepted 5 September 2014 Available online 30 September 2014 Keywords: Oral immunosuppressive therapy Coronary stents Restenosis Meta-analysis abstract Objective: The role of oral immunosuppressive therapy (OIT) to prevent restenosis after percutaneous coronary intervention (PCI) and stenting is still controversial. This study evaluates the impact of oral administration of prednisone or sirolimus to prevent restenosis. Methods: We conducted a meta- analysis of trials in which PCI-patients were randomized to bare metal stents (BMS) plus OIT (BMS þ OIT group) versus BMS or drug-eluting stents alone (BMS/DES group). Primary endpoints were target lesion revascularization and death/myocardial infarction (MI). Secondary endpoints were death, MI, stent thrombosis and in-stent late lumen loss. Hazard ratio and weighted geometric mean difference [95% confidence intervals] served as summary statistics. Results: Individual data of seven trials (1246 patients [BMS þ OIT, n ¼ 608 versus BMS/DES, n ¼ 638] with 1456 coronary lesions) were merged. At a median follow-up of 360 days, BMS þ OIT versus BMS/DES significantly reduced the risk of revascu- larization (0.49 [0.24e0.98], P ¼ 0.04). In particular, BMS þ OIT reduced the risk of revascularization (0.38 [0.21e0.67], P < 0.001) and late lumen loss (0.39 mm [0.67, 0.11], P < 0.001) as compared with BMS alone. BMS þ OIT versus BMS/DES showed a similar risk of death/MI (0.67 [0.29e1.53], P ¼ 0.34), death (0.82 [0.25e2.69], P ¼ 0.71), MI (0.58 [0.24e1.39], P ¼ 0.22) and stent thrombosis (0.43 [0.10e1.87], P ¼ 0.26). Conclusion: In patients undergoing PCI the use of BMS and oral immunosuppressive therapy reduces the risk of revascularization as compared with BMS alone but not as compared with DES alone, while these therapies display a similar risk of death/MI. The advantage of adding oral immunosup- pressive therapy to BMS is due to a lower risk of restenosis as compared with BMS alone. © 2014 Elsevier Ireland Ltd. All rights reserved. 1. Introduction Percutaneous coronary intervention (PCI) represents the most frequent revascularization option in patients suffering from * Corresponding author. E-mail addresses: cassese@dhm.mhn.de, salvatorecassese@libero.it (S. Cassese). 1 Contributed equally to the manuscript and are joint first authors. Contents lists available at ScienceDirect Atherosclerosis journal homepage: www.elsevier.com/locate/atherosclerosis http://dx.doi.org/10.1016/j.atherosclerosis.2014.09.021 0021-9150/© 2014 Elsevier Ireland Ltd. All rights reserved. Atherosclerosis 237 (2014) 410e417