ROSETTA Registry Results
Background: There is little consensus regarding the use of functional testing after percutaneous transluminal coronary angioplasty (PTCA). Some physicians employ a routine functional testing strategy, and others employ a symptom-driven strategy.
Objective: To examine the effects of routine post-PTCA functional testing on the use of follow-up cardiac procedures and clinical events.
Methods: The Routine versus Selective Exercise Treadmill Testing after Angioplasty (ROSETTA) Registry is a prospective multicenter observational study examining the use of functional testing after PTCA. A total of 788 patients (pts) were enrolled in the ROSETTA Registry at 13 clinical centers in 5 countries. The frequencies of functional testing, cardiac procedures and clinical events were examined during the first 6 months following a successful PTCA.
Results: Patients were predominantly elderly men (mean age, 61 ± 11 years; 76% male) who underwent single-vessel PTCA (85%) with stent implantation (58%). During the 6-month follow-up, a total of 237 pts were observed to undergo a routine functional testing strategy (100% having functional testing for routine follow-up), while 551 pts underwent a selective (or clinically-driven) strategy (73% having no functional testing and 27% having functional testing for a clinical indication). Patients in the routine testing group underwent a total of 344 functional tests compared with 165 tests performed in the selective testing group (mean, 1.45 tests/patient versus 0.3 tests/patient; p < 0.0001). There was little difference in the rates of follow-up cardiac procedures among the pts undergoing the routine and selective testing strategies [cardiac catheterization, 13.9% versus 17.5% (p = NS); percutaneous coronary intervention (PCI), 8.4% versus 8.7% (p = NS); coronary artery bypass graft surgery, 2.1% versus 3.3% (p = NS)]. However, clinical events were less common among pts who underwent routine functional testing, e.g., unstable angina (6.1% versus 14.4%; p = 0.001), myocardial infarction (0.4% versus 1.6%; p = NS), death (0% versus 2.2%; p = 0.02) and composite clinical events (6.3% versus 16.3%; p < 0.0001). After controlling for baseline clinical and procedural differences, routine functional testing had a persistent independent association with a reduction in the composite clinical event rate (odds ratio, 0.45; 95% confidence interval, 0.24–0.81; p = 0.008).
Conclusion: Routine functional testing after PTCA is associated with a reduction in the frequency of follow-up clinical events. This association may be attributable to the early identification and treatment of pts at risk for follow-up events, or it may be due to clinical differences between pts who are referred for routine and selective functional testing.

Restenosis continues to be the major limitation of percutaneous transluminal coronary angioplasty (PTCA). Because it is difficult to predict which patients will develop restenosis, some physicians employ routine functional testing in all their post-PTCA patients. The rationale for this approach is that routine functional testing will lead to the early identification and treatment of patients with restenosis, which may, in turn, lead to a reduction in clinical events. In contrast to a routine functional testing strategy, many physicians employ a selective or clinically-driven functional testing strategy. With this strategy, functional testing is only employed in patients who develop symptoms. Selective functional testing will not identify patients with asymptomatic restenosis, and this approach may be associated with a higher rate of follow-up clinical events.

The American College of Cardiology (ACC) and the American Heart Association (AHA) have issued guidelines for exercise testing. These guidelines suggest that routine post-PTCA functional testing be reserved for selected groups of patients such as those with decreased left ventricular ejection function (LVEF), multivessel coronary artery disease, proximal left anterior descending coronary artery disease and diabetes mellitus. If patients do not have any of these clinical characteristics, a selective functional testing strategy is recommended. Unfortunately, there are few data to support the ACC/AHA guideline recommendations regarding post-PTCA functional testing. To our knowledge, no prospective study has examined the utility of a routine post-PTCA functional testing strategy — in either selected subgroups of patients or in the general post-PTCA population. For this reason, we initiated the Routine versus Selective Exercise Treadmill Test after Angioplasty (ROSETTA) Registry. The purpose of this registry was to examine the patterns of use and outcomes of the routine and selective functional testing strategies. The primary objective was to examine the effects of routine post-PTCA functional testing on follow-up cardiac procedures and clinical events.