The Cost of Innovation and Evidence in Cardiac Surgery
This review summarizes a systematic analysis of 216 randomized trials of cardiovascular interventions performed during 2008–2019, according to the source of trial funding. The systematic analysis showed that on average the results of each trial would change significance if only 5 patients experienced different outcomes. Industry-sponsored trials were more likely to use composite endpoints, noninferiority designs, and twice as likely as nonindustry trials to report results favoring the device arm. Over 80% of industry trials used reporting strategies or “spin” suggesting the device arm was advantageous versus fewer than half of non-industry trials. The review discusses the implications of these findings.
