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)
Autor: | 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. |
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Jazyk: | angličtina |
Rok vydání: | 2013 |
Předmět: |
Male
medicine.medical_specialty Paclitaxel medicine.medical_treatment Anti-Inflammatory Agents Administration Oral Revascularization Follow-up immunosuppressive percutaneous coronary interventions Coronary artery disease law.invention Coronary Restenosis Percutaneous Coronary Intervention Randomized controlled trial Restenosis law Prednisone medicine Clinical endpoint Stent Humans Long-term follow-up Sirolimus business.industry Percutaneous coronary intervention Drug-Eluting Stents Middle Aged medicine.disease Tubulin Modulators Surgery Cortisone Treatment Outcome Drug Therapy Combination Female Randomized clinical trial Cardiology and Cardiovascular Medicine business Immunosuppressive Agents Platelet Aggregation Inhibitors Follow-Up Studies medicine.drug |
Popis: | Aims 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. Methods and 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. |
Databáze: | OpenAIRE |
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