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).

Ribichini, Flavio Luciano; Tomai, F.; Pesarini, G.; Zivelonghi, C.; Rognoni, A.; Luca, G. D.; Boccuzzi, G.; Presbitero, P.; Ferrero, V.; Ghini, A. S.; Marino, P.; Vassanelli, Corrado; C. E. R.,

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.

Titolo:	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).
Autori:	RIBICHINI, Flavio Luciano F. Tomai G. Pesarini C. Zivelonghi A. Rognoni G. D. Luca G. Boccuzzi P. Presbitero V. Ferrero A. S. Ghini P. Marino VASSANELLI, Corrado C. E. R. mostra contributor esterni nascondi contributor esterni
Data di pubblicazione:	2013
Rivista:	EUROPEAN HEART JOURNAL
Abstract:	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.
Handle:	http://hdl.handle.net/11562/631172
Appare nelle tipologie:	01.01 Articolo in Rivista

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