TY - JOUR
T1 - 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
T2 - Cortisone plus BMS or des veRsus BMS alone to EliminAte Restenosis (CEREA-DES)
AU - Ribichini, Flavio
AU - Tomai, Fabrizio
AU - Pesarini, Gabriele
AU - Zivelonghi, Carlo
AU - Rognoni, Andrea
AU - De Luca, Giuseppe
AU - Boccuzzi, Giacomo
AU - Presbitero, Patrizia
AU - Ferrero, Valeria
AU - Ghini, Anna S.
AU - Marino, Paolo
AU - Vassanelli, Corrado
N1 - Funding Information:
This study was partially supported by a research grant of the Regione Piemonte, Torino, Italy (Progetto di Ricerca Finalizzata N° 14/ 2004-2005 for database management and monitoring of clinical reports).
PY - 2013/6/14
Y1 - 2013/6/14
N2 - 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.
AB - 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.
KW - Coronary artery disease
KW - Long-term follow-up
KW - Prednisone
KW - Randomized clinical trial
KW - Stent
UR - https://www.scopus.com/pages/publications/84879078992
U2 - 10.1093/eurheartj/eht079
DO - 10.1093/eurheartj/eht079
M3 - Article
SN - 0195-668X
VL - 34
SP - 1740
EP - 1748
JO - European Heart Journal
JF - European Heart Journal
IS - 23
ER -
