Long-term clinical follow-up of the multicentre, randomized study to test immunosuppressive therapy with oral prednisone for the prevention of restenosis after percutaneous coronary interventions: Cortisone plus BMS or des veRsus BMS alone to EliminAte Restenosis (CEREA-DES)

Flavio Ribichini, Fabrizio Tomai, Gabriele Pesarini, Carlo Zivelonghi, Andrea Rognoni, Giuseppe De Luca, Giacomo Boccuzzi, Patrizia Presbitero, Valeria Ferrero, Anna S. Ghini, Paolo Marino, Corrado Vassanelli

Research output: Contribution to journalArticle

Abstract

AimsTo analyse the clinical outcome at 4 years in patients with coronary artery disease treated with bare metal stents (BMS) vs. BMS and oral prednisone, or drug-eluting stents (DES), all assuming similar adjunctive medical treatment.Methods and resultsFive Italian hospitals enrolled 375 non-diabetic, ischaemic patients without contraindications to dual anti-platelet treatment or corticosteroid therapy in a randomized controlled study. The primary endpoint was the event-free survival of cardiovascular death, myocardial infarction, and recurrence of ischaemia needing repeated target vessel revascularization at 1 year, and this was significantly lower in the BMS group (80.8%) compared with the prednisone (88.0%) and DES group (88.8%, P = 0.04 and 0.006, respectively). The long-term analysis of the primary endpoint was a pre-specified aim of the trial, and was performed at 1447 days (median, IQ range = 1210-1641). Patients receiving BMS alone had significantly lower event-free survival (75.3%) compared with 84.1% in the prednisone group (HR: 0.447; 95% CI: 0.25-0.80, P = 0.007) and 80.6% in DES patients (HR: 0.519; 95% CI: 0.29-0.93, P = 0.03). Prednisone-treated patients did not develop new treatment-related clinical problems. Drug-eluting stents patients suffered more very late stent thrombosis as a cause of spontaneous myocardial infarction. The need for target vessel revascularization remained lower in the prednisone and DES groups (13.6 and 15.2%, respectively), compared with BMS (23.2%).ConclusionsThe clinical benefits of prednisone compared with BMS only persisted almost unchanged at 4 years. Drug-eluting stents performed better than BMS at long-term, although the advantages observed at 1 year were in part attenuated because of the occurrence of very late stent thrombosis and late revascularizations.Clinical Trial NCT 00369356.

Original languageEnglish
Pages (from-to)1740-1748
Number of pages9
JournalEuropean Heart Journal
Volume34
Issue number23
DOIs
Publication statusPublished - Jun 14 2013

Keywords

  • Coronary artery disease
  • Long-term follow-up
  • Prednisone
  • Randomized clinical trial
  • Stent

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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