Is TRT Finally Safe For Heart Disease?

For over a decade, a "Black Box" warning from the FDA has loomed over Testosterone Replacement Therapy (TRT), leaving millions of men with low-T symptoms—fatigue, low libido, and muscle loss—terrified that treatment would lead to a heart attack.

The TRAVERSE Study (published in the New England Journal of Medicine) has changed the conversation forever. As a cardiologist, I believe this is the most important data we’ve seen in twenty years. Here is what every man needs to know about the heart safety of testosterone.

What was the TRAVERSE Trial?

The TRAVERSE trial was a massive, gold-standard study involving over 5,200 men aged 45 to 80. Unlike previous smaller studies, this trial specifically recruited men who already had pre-existing heart disease or were at high risk for it.

The participants were split into two groups:

1. One group received a daily testosterone gel.
2. The other group received a placebo.

The goal was simple: Does TRT increase the risk of Major Adverse Cardiovascular Events (MACE), such as heart attacks, strokes, or cardiac death?

The Big Results: Is TRT Safe?

The results were definitive: Testosterone therapy did not increase the risk of heart attacks or strokes. The incidence of cardiovascular events was nearly identical between the two groups: 7.0% in the testosterone group versus 7.3% in the placebo group. For the medical community, this proved "non-inferiority"—meaning TRT is as safe for the heart as a placebo, even in high-risk men.

Key Benefits Observed:

• Correction of Anemia: Men on TRT saw significant improvements in red blood cell health.
• Sexual Function: Improved libido and energy levels were reported.
• Diabetes Prevention: TRT was shown to reduce the progression from pre-diabetes to Type 2 Diabetes.

Pre vs Post TRAVERSE Comparison Table:

The "Cardiologist's Catch": 3 Risks to Monitor

While the headline is "TRT is safe," as your cardiologist, I must highlight three specific findings from the TRAVERSE study that require professional monitoring:

1. Atrial Fibrillation (AFib): There was a slightly higher rate of heart rhythm issues (3.5% vs 2.4%) in the testosterone group.
2. Blood Clots (VTE): A small increase in pulmonary embolisms and leg clots was noted.
3. Acute Kidney Injury: A slightly higher incidence was observed, requiring regular lab work.

Dr. Alo’s Take: The TRAVERSE study gives us the "Green Light," but you still need a driver who knows the road. This is why getting your TRT from a "pill mill" or an unmonitored clinic is dangerous. You need a physician who understands the intersection of hormones and hemodynamics.

Traverse Trial:
https://www.nejm.org/doi/full/10.1056/NEJMoa2215025 

Conclusion: Should You Start TRT?

The TRAVERSE study is a landmark victory for men's health. It tells us that low testosterone is a treatable condition, and you don't have to choose between your vitality and your heart health.

If you have symptoms of low-T, the data now supports a safe path forward—provided you are monitored by a specialist who understands cardiovascular risk.

See my other post on TESTOSTERONE for a full review on TRT and Heart Disease in men!