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| | | ![]() The ITACA Study
ITACA is a multicenter, prospective, randomized single-blind placebo-controlled study investigating the efficacy of verapamil SR (120mg b.i.d. p.o.) in preventing the progression of CAD in heart transplant recipients. Investigators enrolled 100 consecutive heart recipients, 88 men and 12 women. The age spread is 16-70 years, with an average age of 50.2 years. The subjects were on triple immunosuppression, and rejections of ISHLT grade 2 or higher were treated.
Coronary angiography was performed at baseline (within 60 days of surgery) and after 1 year. A centralized quantitative analysis of 9 coronary segments was done for each subject. Baseline characteristics of the treated and the placebo groups were comparable. All the subjects showed a reduction in mean and minimal coronary artery sizes (caliber) of 2% to 7% after one year.
Analysis of variance was used to assess variations attributable to treatment, to different coronary segments within subjects, and to time within subjects, accounting for interaction. No within-group differences were evident; however, there was a coronary segment interaction by period --- i.e., a different reduction with time in different segments.
Possible Influences
Dr. Gronda reported that CAD progression was slower than anticipated from previous evidence, possibly because of better immunologic treatment handling and general medical care. He and his colleagues think that verapamil’s apparent lack of efficacy on progression of CAD might be due to the limited-caliber reduction of the subjects coronary segments.
The investigators have concluded that further trials are needed. |