TRAVERSE Trial: Testosterone Therapy Does Not Increase Heart Attack Risk

For nearly a decade, the biggest question hanging over testosterone replacement therapy was whether it would give men heart attacks. Two observational studies in 2013 and 2014 raised alarms, the FDA added a cardiovascular warning to testosterone labels in 2015, and patients and providers have been uncertain ever since. The TRAVERSE trial, published in the New England Journal of Medicine in June 2023, was designed to settle the question once and for all.

The results were definitive on the primary endpoint. Among 5,246 men aged 45 to 80 with hypogonadism and either preexisting cardiovascular disease or elevated cardiovascular risk, testosterone replacement was noninferior to placebo for the incidence of major adverse cardiac events. Over a median follow-up of 33 months, testosterone therapy did not increase the rate of heart attacks, strokes, or cardiovascular death. An important secondary finding was a 22.5% reduction in new-onset type 2 diabetes among men receiving testosterone.

The trial was not without nuance. The testosterone group showed a higher incidence of nonfatal arrhythmias, including atrial fibrillation, as well as modestly increased rates of venous thromboembolic events. These are clinically relevant signals that reinforce the need for ongoing monitoring rather than a prescribe-and-forget approach to TRT.

TRAVERSE does not mean testosterone is risk-free. It means that the cardiovascular fear that kept many symptomatic men from seeking treatment was not supported by the best evidence we now have.

The Tracking Connection

TRAVERSE reinforces a core Kairos™ principle: therapy requires monitoring. The men who benefit most from TRT are those whose providers can track not just testosterone levels but also cardiovascular markers, hematocrit, PSA, mood, and metabolic indicators over time. Kairos consolidates these data streams so that both patient and clinician can spot arrhythmia risk factors, metabolic improvements, and adverse trends early, turning TRT from a gamble into a managed intervention.