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Routine functional testing after percutaneous coronary intervention: results of the aggressive diagnosis of restenosis in high-risk patients (ADORE II) trial |
Eisenberg MJ, Wilson B, Lauzon C, Huynh T, Eisenhauer M, Mak KH, Blankenship JC, Doucet M, Pilote L |
Acta Cardiologica 2007;62(2):143-150 |
clinical trial |
6/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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 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 versus selective arm at 9 months (metabolic equivalents: 10.3 +/- 2.6 versus 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.
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