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 PCl 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 indication. 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.