As part of a randomized prospective study designed to investigate the restenosis process after percutaneous transluminal coronary angioplasty (PTCA), the relation between patient-related variables and restenosis rate was examined. A total of 722 patients had successful PTCA. Angiographic follow-up was scheduled for 6 +/- 2 months after the procedure and achieved in 510 patients (71%), yielding 598 lesions for analysis. The overall restenosis rate was 40%. The rate was higher in patients undergoing early restudy for a clinical event than in those undergoing routinely scheduled follow-up restudy (71 vs 22%, p less than 0.0001). Age, sex, cigarette smoking history, diabetes mellitus and history of previous myocardial infarction were not associated with restenosis rate. Angina duration and severity before PTCA were also unrelated to restenosis rate. In summary, these variables, many of which have been previously implicated in restenosis, were not found to be predictors of restenosis. The decision to perform PTCA in individual patients should not be negatively influenced by the presence of these factors.