title: 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).
abstract: OBJECTIVE
  To 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.
  
  
  RESULTS
  Five 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%).
  
  
  CONCLUSIONS
  The 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.
authors.affiliation: Department of Medicine, University of Verona, Verona, Italy. flavio.ribichini@univr.it
authors.forename: Flavio
authors.initials: F
authors.lastname: Ribichini
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Tomai
authors.forename: Gabriele
authors.initials: G
authors.lastname: Pesarini
authors.forename: Carlo
authors.initials: C
authors.lastname: Zivelonghi
authors.forename: Andrea
authors.initials: A
authors.lastname: Rognoni
authors.forename: Giuseppe
authors.initials: G
authors.lastname: De Luca
authors.forename: Giacomo
authors.initials: G
authors.lastname: Boccuzzi
authors.forename: Patrizia
authors.initials: P
authors.lastname: Presbitero
authors.forename: Valeria
authors.initials: V
authors.lastname: Ferrero
authors.forename: Anna S
authors.initials: AS
authors.lastname: Ghini
authors.forename: Paolo
authors.initials: P
authors.lastname: Marino
authors.forename: Corrado
authors.initials: C
authors.lastname: Vassanelli
mesh_terms: D000284:Administration, Oral; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D023903:Coronary Restenosis / Q000517:prevention & control*; D003348:Cortisone / Q000008:administration & dosage; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D011241:Prednisone / Q000008:administration & dosage*; D020123:Sirolimus / Q000008:administration & dosage; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000008:administration & dosage
chemical_list: D000893:Anti-Inflammatory Agents; D007166:Immunosuppressive Agents; D010975:Platelet Aggregation Inhibitors; D050257:Tubulin Modulators; D017239:Paclitaxel; D003348:Cortisone; D011241:Prednisone; D020123:Sirolimus
keywords: Coronary artery disease; Long-term follow-up; Prednisone; Randomized clinical trial; Stent