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Prednisone following bare metal stent implantation improves outcomes

Clinical Question:
Does the addition of prednisone improve morbidity and mortality in patients with coronary artery disease who receive percutaneous coronary intervention with bare metal stents?

Bottom Line:
A short-course of prednisone following percutaneous coronary intervention (PCI) with bare metal stents improves mortality and decreases cardiovascular events at 1 year in nondiabetic patients with coronary artery disease (CAD). This may be an option for patients who have contraindications to drug-eluting stents. Of note, patients in the steroid group were more likely to receive aggressive blood pressure control to counteract the effect of prednisone and this may have contributed to the overall effect. (LOE = 1b)

Reference:
Ribichini F, Tomai F, De Luca G, et al, for the CEREA-DES investigators. Immunosuppressive therapy with oral prednisone to prevent restenosis after PCI. Am J Med 2011;124(5):434-443.  [PMID:21531233]

Study Design:
Randomized controlled trial (nonblinded)

Funding:
Government

Allocation:
Concealed

Setting:
Inpatient (any location) with outpatient follow-up

Synopsis:
Using concealed allocation, these investigators randomized 375 adult CAD patients younger than 80 years and undergoing PCI to receive one of the following: bare metal stents alone, bare metal stents with prednisone, or drug-eluting stents. Patients with diabetes, uncontrolled hypertension, renal failure, or left main disease were excluded. In the steroid group, patients received 1 mg/kg oral prednisone for the first 15 days after stenting, 0.5 mg/kg on days 16 to 30, and 0.25 mg/kg on days 31 to 40. These patients were also treated with a proton pump inhibitor for gastroprotection and an oral thiazide for fluid retention and blood pressure control. In addition, all patients received dual antiplatelet therapy with aspirin and either ticlopidine or clopidogrel. Baseline characteristics were similar in the 3 groups: more than 80% of the patients were men, and the average age was 64 years. Medical therapy both before and after PCI was also similar, except for a higher use of proton pump inhibitors, diuretics, and angiotensin II receptor blockers in the steroid group following PCI. The primary end point of the study was 1-year survival without major cardiovascular events including death, myocardial infarction, or need for repeat revascularization. In the intention-to-treat analysis, patients receiving bare metal stents alone had a lower event-free survival rate than patients receiving bare metal stents plus prednisone (80.8% vs 88%; hazard ratio [HR] = 0.505; 95% CI, 0.260-0.981; P = .04) and patients receiving drug-eluting stents (80.8% vs 88.8%; HR = 0.3888; 0.197-0.764; P = .006). In the steroid group, 15% of patients experienced side effects, including fluid retention and transient hyperglycemia.

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