THE ANGIOTENSIN-CONVERTING ENZYME-INHIBITION POST REVASCULARIZATION STUDY (APRES) - EFFECTS OF RAMIPRIL IN PATIENTS WITH REDUCED LEFT-VENTRICULAR FUNCTION - RATIONALE, DESIGN, METHODS, BASE-LINE CHARACTERISTICS AND FIRST-YEAR EXPERIENCE

Invasive revascularization improves prognosis, functional status and q uality of:life in patients with severe angina pectoris and impaired le ft ventricular function, and treatment with ACE-I reduces the developm ent of cardiac events and left ventricular dysfunction in patients wit hout or with mild angina pectoris. However, the effects of a combined treatment strategy with invasive revascularization and subsequent long -term ACE-I therapy in patients with limiting angina pectoris and impa ired left ventricular function have not previously been investigated. APRES is a long-term, prospective, randomized double-blind study that evaluates the effects of ramipril 10 mg o.d. on the long-term developm ent of cardiac events, left ventricular function, functional status an d quality of life following invasive revascularization in patients wit hout recent AMI or clinical heart failure and with preoperative ejecti on fraction in the range 0.30-0.50. The rationale, design and power of APRES and the choice and relevance of outcome measures are discussed. Based on experience and results from the first year of the study for screening procedure, inclusion rate, patient compliance, reproducibili ty analyses and the magnitude of outcome measures, we conclude that th e study is feasible and safe. The included patients match with the tar get population, the outcome measures seem appropriate and the power co nsiderations valid for the majority of the outcome measures.