scholarly journals Back to the future: the crucial role of clinical registries in the era of randomized controlled trials for identifying the optimal medical therapy of heart failure

2015 ◽  
Vol 1 (1) ◽  
pp. 37-38 ◽  
Author(s):  
Francesco Pelliccia ◽  
Giuseppe M.C. Rosano
2021 ◽  
Vol 10 (2) ◽  
Author(s):  
Andrea Soares ◽  
William E. Boden ◽  
Whady Hueb ◽  
Maria M. Brooks ◽  
Helen E. A. Vlachos ◽  
...  

Background In chronic coronary syndromes, myocardial ischemia is associated with a greater risk of death and nonfatal myocardial infarction (MI). We sought to compare the effect of initial revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) plus optimal medical therapy (OMT) with OMT alone in patients with chronic coronary syndrome and myocardial ischemia on long‐term death and nonfatal MI. Methods and Results Ovid Medline, Embase, Scopus, and Cochrane Library databases were searched for randomized controlled trials of PCI or CABG plus OMT versus OMT alone for patients with chronic coronary syndromes. Studies were screened and data were extracted independently by 2 authors. Random‐effects models were used to generate pooled treatment effects. The search yielded 7 randomized controlled trials that randomized 10 797 patients. Median follow‐up was 5 years. Death occurred in 640 of the 5413 patients (11.8%) randomized to revascularization and in 647 of the 5384 patients (12%) randomized to OMT (odds ratio [OR], 0.97; 95% CI, 0.86–1.09; P =0.60). Nonfatal MI was reported in 554 of 5413 patients (10.2%) in the revascularization arms compared with 627 of 5384 patients (11.6%) in the OMT arms (OR, 0.75; 95% CI, 0.57–0.99; P =0.04). In subgroup analysis, nonfatal MI was significantly reduced by CABG (OR, 0.35; 95% CI, 0.21–0.59; P <0.001) but was not reduced by PCI (OR, 0.92; 95% CI, 0.75–1.13; P =0.43) ( P ‐interaction <0.001). Conclusions In patients with chronic coronary syndromes and myocardial ischemia, initial revascularization with PCI or CABG plus OMT did not reduce long‐term mortality compared with OMT alone. CABG plus OMT reduced nonfatal MI compared with OMT alone, whereas PCI did not.


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