Quantitative angiographic and statistical methods to assess serial changes in coronary luminal diameter and implications for atherosclerosis regression trials.

摘要: The purpose of this study was (1) to determine a threshold for categorizing individual coronary lesions as either significantly progressing or regressing, (2) whether multiple within patients progress at independent rates, and (3) calculate sample sizes atherosclerosis regression trials. Seventeen with 46 significant (2.7 lesions/patient) underwent repeat arteriography 3.0 years apart. With use the standard error mean change in diameter from initial catheterization across 5 pairs consecutive end-diastolic frames, were categorized (p less than 0.01) regressing if there 0.27 mm minimum 7.8 percent point stenosis. can also be analyzed continuous variable using patient primary unit analysis. A lesion-specific analysis accomplished model that accounts intraclass correlation (rho) degree among patients. correlations stenosis (rho = -0.24) low, indicating disease progression different is nearly independent. model, 50 per treatment group would permit detection 5.5% difference between means 2.7% percentage (not percent) stenosis.(ABSTRACT TRUNCATED AT 250 WORDS)