Comparison between patients included in randomized controlled trials of ischemic heart disease and real-world data: A nation-wide study
American Heart Journal Jul 19, 2018
Laursen PN, et al. - Researchers performed this case-control study to compare participants of RCTs (trial participants) who had ischemic heart disease (IHD) and underwent PCI with patients who were not included (non-participants) on a trial-by-trial basis and according to indication for PCI. The RCT-participants were IHD patients who were randomized in RCTs in relation to undergoing PCI in Denmark between 2011 and 2015. The control population was identified from unselected national registry data and comprised contemporary patients with IHD undergoing PCI in the same period. They found that trial participants in recently performed RCTs, including patients undergoing PCI, were not representative of the general population of patients with IHD treated with PCI, according to clinical characteristics and mortality. Regardless of the indication for PCI, there was a mortality difference. Therefore, exercising caution was recommended when extending results from RCTs including patients undergoing PCI to the general patient population.
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