Routine functional testing after percutaneous coronary intervention: results of the Aggressive Diagnosis of Restenosis in High-Risk Patients (ADORE II) trial

Background - It is unclear whether routine or selective functional testing is optimal following percutaneous coronary intervention (PCI) in high-risk patients. Objectives - The aim of this trial was to compare exercise endurance, functional status, and quality of life (QOL) among high-risk patients randomized to either routine or selective functional testing following PCI. Methods - We randomized 84 patients to either routine or selective functional testing. Patients had one or more of the following: multivessel PCI, diabetes mellitus, left ventricular ejection fraction <= 35%, and/or PCI of the proximal left anterior descending artery. Patients in the routine arm (n = 41) underwent maximum endurance exercise treadmill testing (ETT) with nuclear perfusion imaging at 1.5 and 6 months. Patients in the selective arm (n = 43) only underwent functional testing for a clinical inclication. All patients underwent a maximum endurance ETT at 9 months. Exercise endurance, functional status, and QOL were assessed at 9 months. Results - Most patients were middle-aged men (58 10 years old; 87% male) who underwent PCI with stenting (94%). Among routine functional testing patients, 27.0% and 41.9% had a positive functional test at 1.5 and 6 months, respectively. Exercise endurance was improved in the routine vs. selective arm at 9 months (metabolic equivalents: 10.3 +/- 2.6 vs. 8.6 +/- 3.0, P = 0.013). There was no difference in improvement from baseline for the Duke Activity Status Index, the Seattle Angina Questionnaire, or the SF-36. Nine-month cumulative incidences of cardiac procedures and clinical events were not significantly different. Conclusions - Routine functional testing following PCI in high-risk patients may lead to improved exercise endurance but not improved QOL.