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)

• Published in: European heart journal 2013-06, Vol.34 (23), p.1740-1748
• Main Authors: Ribichini, Flavio, Tomai, Fabrizio, Pesarini, Gabriele, Zivelonghi, Carlo, Rognoni, Andrea, De Luca, Giuseppe, Boccuzzi, Giacomo, Presbitero, Patrizia, Ferrero, Valeria, Ghini, Anna S, Marino, Paolo, Vassanelli, Corrado
• Format: Article
• Language: English
• Subjects: Administration, Oral; Anti-Inflammatory Agents - administration & dosage; Coronary Restenosis - prevention & control; Cortisone - administration & dosage; Drug Therapy, Combination; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents - administration & dosage; Male; Middle Aged; Paclitaxel - administration & dosage; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors - administration & dosage; Prednisone - administration & dosage; Sirolimus - administration & dosage; Treatment Outcome; Tubulin Modulators - administration & dosage
• ISSN: 0195-668X; 1522-9645
• DOI: 10.1093/eurheartj/eht079

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. 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%). 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.