Cortisone Eliminates Restenosis as Effectively As DES

INTERVENTION: Trade Name: DELTACORTENE FTE 10 CPR 25MG Pharmaceutical Form: Tablet INN or Proposed INN: Prednisone CAS Number: 53‐03‐2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: To assess the clinical efficacy and safety of the prednisone therapy after PCI as a low‐tech low‐cost systemic alternative to currently available BMS and DES. ; MedDRA version: 6.1 Level: PT Classification code 10056489 PRIMARY OUTCOME: Main Objective: is the comparison of the primary endpoint obtained in a control group of patients treated with BMS versus two alternative study groups ‐ DES ‐ BMS and oral prednisone All assuming a similar adjunctive conventional medical treatment. Primary end point(s): the primary endpoint of the study will be the occurrence of major clinical events MACE at 12 months. Secondary Objective: ‐ cost‐effectiveness analysis. This will be calculated considering all patients. This project will be subsequently presented as an amendment . ‐ comparison of the angiographic results. This will be calculated in a representative sub‐sample. INCLUSION CRITERIA: Patients with diagnosed CAD either SVD or MVD with signs or symptoms of myocardial ischemia, scheduled for percutaneous revascularization are all candidates. Either native vessels and SVG can be included with de‐novo or restenotic lesions. Lesions causing a diameter stenosis 50 in a main coronary artery LAD, RCA, LCx or their principal branches Dg, OM, PL, PDA . Chronic total occlusions successfully recanalized and completely covered with stents with optimal angiographic result and normal TIMI 3 grade flow at the end of the procedure. Stenting or balloon dilatation of small vessels 2.5 to 2.75mm is allowed. Use of rotational devices does not preclude inclusion in the study if a stent is successfully placed after either, DCA or rotablation. Use of multiple stents or balloon PCI to treat bifurcation lesions provisional, Y, T, kissing or crushing is permitted. Stenting the main branch and provisional stenting for the side branch should