Immunosuppressive therapy with oral prednisone to prevent restenosis after PCI. A multicenter randomized trial.

BACKGROUND: Prednisone at immunosuppressive doses after stenting has shown remarkable efficacy in reducing ischemic recurrences in nondiabetic patients with high post-procedural levels of C-reactive protein; the study aim was to compare the clinical outcome obtained in a control group of patients treated with bare metal stents versus 2 other study groups--bare metal stent plus oral prednisone or drug eluting stents--assuming similar optimal adjunctive medical treatment. METHODS: Five tertiary Italian hospitals enrolled 375 nondiabetic patients with coronary artery disease and no contraindications to dual antiplatelet treatment or corticosteroid therapy in a randomized, controlled study performed between 2007 and 2009. Patients were allocated into 3 study groups: bare metal stents (controls), bare metal stents followed by a 40-day prednisone treatment, or drug-eluting stents. The primary endpoint was the event-free survival of cardiovascular death, myocardial infarction, and recurrence of ischemia needing repeated target vessel revascularization at 1 year as adjudicated by an independent clinical events committee. RESULTS: One-year follow-up was obtained in all patients. Patients receiving bare metal stents alone as compared to those treated with prednisone or drug-eluting stents had lower event-free survival; the primary endpoint was 80.8% in controls compared to 88.0% in the prednisone and 88.8% in the drug-eluting stent groups, respectively (P=.04 and .006). CONCLUSION: Compared with bare metal stents alone, prednisone treatment after bare metal stents or drug-eluting stent implantation result in a better event-free survival at 1 year.

A multicenter, 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) - study design and rationale.

BACKGROUND: Several randomized trials and registries have shown a reduction of restenosis after coronary angioplasty with drug-eluting stents (DESs) compared with bare metal stents (BMSs). However, cost-efficacy analysis and long-term outcome of DESs compared to BMSs deserve further assessment. Moreover, concern has been raised regarding adverse clinical events occurring late after DES implantation, in particular, late stent thrombosis related to the suspension of dual antiplatelet therapy. The use of a short-cycle oral treatment with prednisone at immunosuppressive dose after BMS implantation has shown remarkable efficacy in reducing restenosis in nondiabetic patients, with very low additional cost and without the need for long-term dual antiplatelet therapy. Such results are however limited by small sample size. STUDY DESIGN: Cortisone plus BMS or DES versus BMS alone to Eliminate Restenosis is an independent, prospective, multicenter, randomized study. It will randomize 375 nondiabetic patients with coronary artery disease in three different arms to BMS (control group), DES (DES group) or BMS followed by a 40-day prednisone treatment (prednisone group). The DES and the prednisone groups will be compared to the control group to investigate the expected clinical advantage. The primary endpoint of the study is the event-free survival of cardiovascular death, myocardial infarction and recurrence of ischemia-needing repeated target vessel revascularization at 1 year. Secondary endpoints are the event-free survival analysis at 2 and 3 years, the restenosis rate at 9 months, and cost-effectiveness at 1, 2 and 3 years. SAMPLE SIZE: The expected primary endpoint rates are 90% for DESs and for prednisone-treated patients and 77% for BMSs. The study was designed as a superiority trial, to compare DES, and BMS and prednisone, with BMS alone. A sample size of 118 patients per group provides an 80% power, assuming a complete 12-month follow-up information available for each patient. To obviate for cases of drop out, the sample size was increased to 375 patients to be enrolled in five Italian hospitals. CONCLUSION: This study will provide a magnitude of the net clinical and economic benefits of DES and of the safety and efficacy of BMS and cortisone compared to the standard use of BMS alone in nondiabetic patients with coronary artery disease.

Drug-eluting stents for the percutaneous treatment of the anastomosis of the left internal mammary graft to left anterior descending artery.

BACKGROUND: Data on the treatment of left internal mammary to left anterior descending artery (LIMA-to-LAD) anastomotic disease are scarce and not homogeneous. Both surgery and percutaneous interventions (PCI) have been attempted, but the most effective treatment has not yet been established. In particular, should PCI be performed, the role of stenting seems to be limited by less favorable results than in other subsets of lesions. OBJECTIVE: To assess the clinical impact of drug-eluting stent (DES) use in this particular subset of lesions. METHODS: We describe a cohort of patients treated with PCI on LIMA-to-LAD anastomoses, reporting acute 1-year clinical and angiographic outcomes. The clinical impact of DES use was evaluated as the requirement for target lesion revascularizations (TLR). RESULTS: Fifty-six consecutive patients were evaluated. Acute procedural success was achieved in 52 patients (92.8%). Plain balloon angioplasty allowed acute procedural success in 15 patients (28.8%), whereas stenting was required in 37 patients (71.2%) with suboptimal results or to treat complications. Bare-metal stents (BMS) were used in 17 and DES in 20 patients, without differences in acute results. One-year clinical follow-up was available in 96.1% of patients. TLR were needed in 17.3% of patients. No significant differences were detected in TLR rates after treatment with BMS and DES (26.6% vs. 25%; P=0.99). Two late stent thromboses were observed after DES deployment. CONCLUSION: PCI of the stenoses of LIMA-to-LAD anastomoses with DES did not provide any clinical improvement over BMS use in long-term outcomes; DES use was associated with some cases of late thrombosis.