Conservative versus aggressive treatment strategy with angiographic guidance alone in patients with intermediate coronary lesions: The SMART-CASE randomized, non-inferiority trial

Background Although coronary angiography is still the technique most widely used to guide percutaneous coronary intervention (PCI), the appropriate angiographic indication of revascularization for intermediate coronary lesions remains controversial. The aim of this study was to compare conservative versus aggressive strategies with angiographic guidance alone in patients with intermediate coronary lesions. Methods and results A total of 899 patients with intermediate coronary lesions between 50% and 70% diameter stenosis by quantitative coronary analysis were randomly assigned to the conservative group (n = 449) or the aggressive group (n = 450). For intermediate lesions, PCI was performed using everolimus-eluting stents in the aggressive group, but was deferred in the conservative group. The primary end point was a composite of all-cause death, myocardial infarction, or any revascularization at 1 year. The number of treated lesions per patient was 0.8 ± 0.9 in the conservative group and 1.7 ± 0.9 in the aggressive group (p < 0.001). The cumulative rate of the primary endpoint was 7.3% in the conservative group and 6.8% in the aggressive group (the upper limit of the one-sided 95% confidence interval [CI], 3.4%; p = 0.006 for non-inferiority with a predefined non-inferiority margin of 5.0%). The risk of death or myocardial infarction (hazard ratio [HR] 0.50; 95% CI, 0.19–1.33; p = 0.17) and revascularization (HR 1.42; 95% CI, 0.80–2.52; p = 0.23) was not significantly different between the 2 groups. Conclusions Conservative revascularization was non-inferior to aggressive revascularization for intermediate coronary lesions. Revascularization of intermediate lesions can be safely deferred in patients undergoing PCI with angiographic guidance alone. Clinical trial registration: URL: http://ClinicalTrials.gov. Unique identifier: NCT00743899.